research 004

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How to complete Specimen ID:NES004 in Destiny 2

Destiny 2 ‘s Echoes Act Two brought more developments for the seasonal story, more activities, and more specimen quests, starting with Specimen ID:NES004 .

This Specimen quest, like others, hands you a set of objectives around Nessus. In this case, Specimen ID:NES004 is connected with the seasonal activities. This comes in handy with the addition of the new Battlegrounds and two new, coveted weapons. Here are the objectives for Specimen ID:NES004 in Destiny 2 and how to complete them.

All Specimen ID:NES004 objectives and how to complete them

• Breach Executable gave us 44 percent progress, while Battlegrounds: Delve gave us 23 percent.
• Focus Echo Engrams at the H.E.L.M.
• Extract data and defeat powerful combatants in seasonal activities
• Return to Failsafe

Open Echo Chests and focus Echo Engrams

This part is somewhat straightforward: Complete seasonal activities for Episode Echoes . When I was completely these, a regular-difficulty Breach Executable counted for 44 percent of the objective, while a Battlegrounds: Delve just after pushed that number to 66 percent and another Breach Executable did the trick. Once you’re past the threshold, you’ll need to focus Echo Engrams into your gear of choice.

If you don’t want to consume your weekly Deepsight, you can focus on the random Echo Engrams that grant you weapons and armor . They counted this objective for us and even got us another roll of Aberrant Action while still letting us save the Deepsight for later.

How to extract data and defeat powerful combatants for Specimen ID:NES004

The wording on this objective is slightly confusing. It tells you to secure extracted data in the Breach Executable activity and defeat powerful combatants in Battlegrounds. However, we cleared both objectives in a single run of Battlegrounds: Conduit , sparing us from having to dive into another Breach Executable. Progress for defeating powerful combatants is easy to track mid-activity, but the “extract data” objective completed at the end of the run. We didn’t try to run Breach Executable before Battlegrounds .

After you’ve completed the necessary steps, Failsafe will ask you to return to the H.E.L.M. Speaking to her will complete the quest and grant you the Mirror-Encrypted Hydra Tail specimen, which doubles your reputation bonuses from seasonal armor and bolsters the reputation gained by using a seasonal class item.

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Technical Assistance Webinar for RFA-NR-24-004: Transformative Research to Address Health Disparities and Advance Health Equity

February 13, 2024 | 2:00 pm - 3:30 pm (ET) | Virtual

On February 13, 2024 at 2:00 p.m. (ET), NINR hosted a technical assistance webinar for funding opportunity RFA-NR-24-004 : Transformative Research to Address Health Disparities and Advance Health Equity (U01 Clinical Trial Optional) . 

NIH staff provided an overview of the funding opportunity and answered questions from potential applicants. Questions were submitted prior to the webinar through the registration form. 

Funding Opportunity Purpose

The Transformative Research to Address Health Disparities and Advance Health Equity Initiative is soliciting applications to support unusually innovative intervention research addressing social determinants of health (SDOH) which, if successful, would have a major impact on preventing, reducing, or eliminating health disparities and advancing health equity. Projects should clearly demonstrate, based on the strength of the logic, a compelling potential to produce a major impact on advancing NIH’s commitment to addressing SDOH to accelerate progress in improving health for all. Preliminary data are not required for this initiative.

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RES-004: Research Misconduct

Academic Division and the Medical Center.

Policy Statement

• General Policies and Principles
• Rights and Responsibilities
• Conducting the Inquiry
• The Inquiry Report
• Conducting the Investigation
• The Investigation Report
• Requirements for Reporting to ORI When PHS Funding is Involved
• Institutional Administrative Actions
• Other Considerations
• Record Retention
• Compliance with Policy

The discovery of new knowledge through research is a fundamental part of the life of a faculty member at the University of Virginia. The formulation of testable hypotheses, the organization of research design, the mobilization of financial support, equipment, technological assistance, and space and time to perform the required experiments all require a strong effort and helpful cooperation from many people. The collection of vital research observations, their analysis and interpretation, and successful research publication are important steps in the dissemination of new knowledge.

The pursuit of new knowledge is a very worthy goal and should be directed in ways that express the highest traditions of science, of the University, and of the intellectual integrity of the individual and the institution. It is the intention and the hope of the University of Virginia that the research climate will permit the pursuit of new knowledge with vigor. This research climate must encourage and support the intellectual integrity of researchers and must discourage any and all activities that might interfere with the integrity of these pursuits.

Research misconduct in any form is a serious threat to this endeavor, and threatens the integrity of the science, the research investigator, and the institution. Research misconduct, therefore, cannot be tolerated at the University of Virginia.

When allegations of research misconduct are made, the University is committed to a thorough investigation into such allegations while protecting the rights of all involved.

All employees or individuals associated with the University of Virginia should report observed, suspected, or apparent misconduct in research. When allegations of research misconduct are made, the University is committed to a thorough investigation into such allegations while protecting the rights of all involved.

• Allegation: A disclosure of possible research misconduct through any means of communication. The disclosure may be by written or oral statement or other communication to an institutional or HHS official.
• Conflict of Interest: Real or apparent interference of one person's interests with the interests of another person, where potential bias may occur due to prior or existing personal or professional relationships.
• Deciding Official: The UVA official who makes final determinations on allegations of research misconduct and any responsive institutional actions. Currently, this individual is the Vice President for Research.
• Good Faith Allegation: Allegation made with the honest belief that research misconduct may have occurred. An allegation is not in good faith if it is made with knowing or reckless disregard for information that would negate the allegation.
• Inquiry: Gathering information and initial fact-finding to determine whether an allegation or apparent instance of research misconduct warrants an investigation.
• Investigation: The formal development of a factual record and the examination and evaluation of that record to determine if misconduct has occurred, and, if so, to determine the responsible person and the seriousness of the misconduct.
• Office of Research Integrity (ORI): The office within the U.S. Department of Health and Human Services (HHS) that is responsible for the research misconduct and research integrity activities of the U.S. Public Health Service.
• PHS Regulation: The Public Health Service regulation establishing standards for institutional inquiries and investigations into allegations of research misconduct, which is set forth at 42 C.F.R. Part 93, Subpart A, entitled "Public Health Service Policies on Research Misconduct."
• PHS Support: PHS funding, or applications or proposals therefore, for biomedical or behavioral research , biomedical or behavioral research training, or activities related to that research or training, that may be provided through: Funding for PHS intramural research ; PHS grants, cooperative agreements, or contracts or subgrants or sub contracts under those PHS funding instruments; or salary or other payments under PHS grants, cooperative agreements or contracts .
• Research Integrity Officer (RIO): UVA official responsible for assessing allegations of research misconduct and determining when such allegations warrant inquiries and for overseeing inquiries and investigations. The RIO is appointed by the Vice President for Research.
• Research Misconduct or Misconduct in Research: Fabrication, falsification, plagiarism, in proposing, performing, or reviewing research or in reporting research results. It does not include honest error or honest differences in interpretations or judgments of data.
• Research Record: One type of University record that includes, but is not limited to: grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files.  In addition, research records include any data, document, computer file, computer diskette, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research that constitutes the subject of an allegation of research misconduct.
• Respondent: The person against whom an allegation of research misconduct is directed or the person whose actions are the subject of the inquiry or investigation. There can be more than one respondent in any inquiry or investigation.
• Retaliation 1 : Any action that adversely affects the employment or other institutional status of an individual that is taken by an institution or an employee because the individual has in good faith, made an allegation of research misconduct or of inadequate institutional response thereto or has cooperated in good faith with an investigation of such allegation.
• U.S. Public Health Service (PHS): An operating component of the Department of Health and Human Services (HHS).
• Whistleblower: Person who makes an allegation of research misconduct.

All individuals at the University of Virginia engaged in research must comply with this policy and its associated procedures. This includes any person paid by, under the control of, or affiliated with the University of Virginia, such as scientists, trainees, technicians and other staff members, students, fellows, guest researchers, or collaborators at the University of Virginia. The U.S. Public Health Service (PHS) regulation at 42 C.F.R. Part 93, Subpart A applies to allegations of research misconduct and research misconduct involving: (i) applications or proposals for PHS support for biomedical or behavioral extramural or intramural research, research-training or activities related to that research or research-training; (ii) PHS supported biomedical or behavioral extramural or intramural research or research-training programs; (iii) PHS supported extramural or intramural activities that are related to biomedical or behavioral research or research-training; and (iv) plagiarism of research records produced in the course of PHS supported research, research-training or activities related to that research or research-training.

The policy and associated procedures will normally be followed when an allegation of possible misconduct in science is received by an institutional official. Particular circumstances in an individual case may dictate variation from the normal procedure deemed in the best interests of the University of Virginia and PHS. Any change from normal procedures also must ensure fair treatment to the subject of the inquiry or investigation. Any significant variation should be approved in advance by the Vice President for Research of the University of Virginia.

Responsibility to Report Misconduct: All employees or individuals associated with the University of Virginia should report observed, suspected, or apparent misconduct in research to the Research Integrity Officer or to the Vice President for Research. If an individual is unsure whether a suspected incident falls within the definition of research misconduct, he or she may call the Research Integrity Officer at (434) 924-3606 to discuss the suspected misconduct informally. If the circumstances described by the individual do not meet the definition of research misconduct, the Research Integrity Officer will refer the individual or allegation to other offices or officials with responsibility for resolving the problem.

At any time, an employee may have confidential discussions and consultations about concerns of possible misconduct with the Research Integrity Officer or the Vice President for Research and will be counseled about appropriate procedures for reporting allegations.

Protecting the Whistleblower: The Research Integrity Officer will monitor the treatment of individuals who bring allegations of misconduct or of inadequate institutional response thereto, and those who cooperate in inquiries or investigations. The Research Integrity Officer will ensure that these persons will not be retaliated against in the terms and conditions of their employment or other status at the University of Virginia and will review instances of alleged retaliation for appropriate action.

Employees should immediately report any alleged or apparent retaliation to the Research Integrity Officer.

Also, to the extent allowed by law, the University of Virginia shall maintain the identity of respondents and complainants securely and confidentially and shall not disclose any identifying information, except to: (1) those who need to know in order to carry out a thorough, competent, objective and fair research misconduct proceeding; and (2) ORI as it conducts its review of the research misconduct proceeding and any subsequent proceedings. For example, if the whistleblower requests anonymity, UVA will make an effort to honor the request during the allegation assessment or inquiry within applicable policies and regulations and state and local laws, if any. The whistleblower will be advised that if the matter is referred to an investigation committee and the whistleblower's testimony is required, anonymity may no longer be guaranteed. Institutions are required to undertake diligent efforts to protect the positions and reputations of those persons who, in good faith, make allegations.

Protecting the Respondent: Inquiries and investigations will be conducted in a manner that will ensure fair treatment to the respondent(s) in the inquiry or investigation and confidentiality to the extent possible without compromising public health and safety or thoroughly carrying out the inquiry or investigation.

University employees accused of research misconduct may consult with legal counsel or a non-lawyer personal adviser (who is not a principal or witness in the case) to seek advice and may bring the counsel or personal adviser to interviews or meetings on the case.

Cooperation with Inquiries and Investigations: University employees will cooperate with the Research Integrity Officer and other institutional officials in the review of allegations and the conduct of inquiries and investigations. Employees have an obligation to provide relevant evidence to the Research Integrity Officer or other institutional officials on misconduct allegations.

Preliminary Assessment of Allegations: Upon receiving an allegation of research misconduct, the Research Integrity Officer will immediately assess the allegation to determine whether there is sufficient evidence to warrant an inquiry, whether PHS support or PHS applications for funding are involved, and whether the allegation falls under the PHS definition of scientific misconduct.

The Research Integrity Officer will appoint the inquiry and investigation committees and ensure that necessary and appropriate expertise is secured to carry out a thorough and authoritative evaluation of the relevant evidence in an inquiry or investigation. The Research Integrity Officer will attempt to ensure that confidentiality is maintained.

The Research Integrity Officer will assist inquiry and investigation committees and all institutional personnel in complying with these procedures and with applicable standards imposed by government or external funding sources. The Research Integrity Officer is also responsible for maintaining files of all documents and evidence and for the confidentiality and the security of the files.

Whistleblower: The whistleblower will have an opportunity to testify before the inquiry and investigation committees, to review portions of the inquiry and investigation reports pertinent to his/her allegations or testimony, to be informed of the results of the inquiry and investigation, and to be protected from retaliation. Also, if the Research Integrity Officer has determined that the whistleblower may be able to provide pertinent information on any portions of the draft report, these portions will be given to the whistleblower for comment.

The whistleblower is responsible for making allegations in good faith, maintaining confidentiality, and cooperating with an inquiry or investigation.

Respondent: The respondent will be informed of the allegations when an inquiry is opened and notified in writing of the final determinations and resulting actions. The respondent will also have the opportunity to be interviewed by and present evidence to the inquiry and investigation committees, to review the draft inquiry and investigation reports, and to have the advice of counsel.

The respondent is responsible for maintaining confidentiality and cooperating with the conduct of an inquiry or investigation. If the respondent is not found guilty of research misconduct, he or she has the right to receive institutional assistance in restoring his or her reputation.

Deciding Official - Vice President for Research: The Deciding Official will receive the inquiry and/or investigation report and any written comments made by the respondent or the whistleblower on the draft report. The Deciding Official will consult with the Research Integrity Officer or other appropriate officials and will determine whether to conduct an investigation, whether misconduct occurred, whether to impose sanctions, or whether to take other appropriate administrative actions [see Institutional Administrative Actions].

The Deciding Official will report to ORI as required by regulation and keep ORI apprised of any developments during the course of the inquiry or investigation that may affect current or potential HHS funding for the individual(s) under investigation or that PHS needs to know to ensure appropriate use of Federal funds and otherwise protect the public interest.

Initiation and Purpose of the Inquiry: Following the preliminary assessment, if the Research Integrity Officer determines that the allegation provides sufficient information to allow specific follow-up, and falls under the PHS definition of scientific misconduct, he or she will immediately initiate the inquiry process. In initiating the inquiry, the Research Integrity Officer should identify clearly the original allegation and any related issues that should be evaluated. The purpose of the inquiry is to make a preliminary evaluation of the available evidence and testimony of the respondent, whistleblower, and key witnesses to determine whether there is sufficient evidence of possible research misconduct to warrant an investigation. The purpose of the inquiry is not to reach a final conclusion about whether misconduct definitely occurred or who was responsible. The findings of the inquiry must be set forth in an inquiry report.

Sequestration of the Research Records: After determining that an allegation falls within the definition of misconduct in science, the Research Integrity Officer must ensure that all original research records and materials relevant to the allegation are immediately secured. The Research Integrity Officer may consult with ORI for advice and assistance in this regard.

Appointment of the Inquiry Committee: The Research Integrity Officer, in consultation with other institutional officials as appropriate, will appoint an inquiry committee and committee chair within 10 days of the initiation of the inquiry. The inquiry committee should consist of individuals who do not have real or apparent conflicts of interest in the case, are unbiased, and have the necessary expertise to evaluate the evidence and issues related to the allegation, interview the principals and key witnesses, and conduct the inquiry. These individuals may be scientists, subject matter experts, administrators, lawyers, or other qualified persons, and they may be from inside or outside the University of Virginia.

The Research Integrity Officer will notify the respondent of the proposed committee membership in 10 days. If the respondent submits a written objection to any appointed member of the inquiry committee or expert based on bias or conflict of interest within 5 days, the Research Integrity Officer will determine whether to replace the challenged member or expert with a qualified substitute.

Charge to the Committee and the First Meeting: The Research Integrity Officer will prepare a charge for the inquiry committee that describes the allegations and any related issues identified during the allegation assessment and states that the purpose of the inquiry is to make a preliminary evaluation of the evidence and testimony of the respondent, whistleblower, and key witnesses to determine whether there is sufficient evidence of possible research misconduct to warrant an investigation as required by the PHS regulation. The purpose is not to determine whether research misconduct definitely occurred or who was responsible.

At the committee's first meeting, the Research Integrity Officer will review the charge with the committee, discuss the allegations, any related issues, and the appropriate procedures for conducting the inquiry, assist the committee with organizing plans for the inquiry, and answer any questions raised by the committee. The Research Integrity Officer and institutional counsel will be present or available throughout the inquiry to advise the committee as needed.

Inquiry Process: The inquiry committee will normally interview the whistleblower, the respondent and key witnesses as well as examining relevant research records and materials. Then the inquiry committee will evaluate the evidence and testimony obtained during the inquiry. After consultation with the Research Integrity Officer and institutional counsel, the committee members will decide whether there is sufficient evidence of possible research misconduct to recommend further investigation. The scope of the inquiry does not include deciding whether misconduct occurred or conducting exhaustive interviews and analyses.

• Elements of the Inquiry Report: A written inquiry report must be prepared that states the name and title of the committee members and experts, if any; the allegations; the PHS support (if any); a summary of the inquiry process used; a list of the research records reviewed; summaries of any interviews; a description of the evidence in sufficient detail to demonstrate whether an investigation is warranted or not; and the committee's determination as to whether an investigation is recommended and whether any other actions should be taken if an investigation is not recommended. Institutional counsel will review the report for legal sufficiency.

Comments on the Draft Report by the Respondent and the Whistleblower: The Research Integrity Officer will provide the respondent with a copy of the draft inquiry report for comment and rebuttal and will provide the whistleblower, if he or she is identifiable, with portions of the draft inquiry report that address the whistleblower's role and opinions in the investigation.

Confidentiality: The Research Integrity Officer may establish reasonable conditions for review to protect the confidentiality of the draft report.

Receipt of Comments: Within 14 calendar days of their receipt of the draft report, the whistleblower and respondent will provide their comments, if any, to the inquiry committee. Any comments that the whistleblower or respondent submits on the draft report will become part of the final inquiry report and record. Based on the comments, the inquiry committee may revise the report as appropriate.

Decision by Deciding Official: The Research Integrity Officer will transmit the final report and any comments to the Deciding Official, who will make the determination of whether findings from the inquiry provide sufficient evidence of possible research misconduct to justify conducting an investigation. The inquiry is completed when the Deciding Official makes this determination, which will be made within 60 days of the first meeting of the inquiry committee. Any extension of this period will be based on good cause and recorded in the inquiry file.

Notification: The Research Integrity Officer will notify both the respondent and the whistleblower in writing of the Deciding Official's decision of whether to proceed to an investigation and will remind them of their obligation to cooperate in the event an investigation is opened. The Research Integrity Officer will also notify all appropriate institutional officials of the Deciding Official's decision.

Within 30 days of a finding by the Deciding Official that an investigation is warranted, the Research Integrity Officer will provide ORI with the Inquiry Report as required and in addition provide notification as required by research sponsors.

Time Limit for Completing the Inquiry Report: The inquiry committee will normally complete the inquiry and submit its report in writing to the Research Integrity Officer no more than 60 calendar days following its first meeting, unless the Research Integrity Officer approves an extension for good cause. If the Research Integrity Officer approves an extension, the reason for the extension will be entered into the records of the case and the report. The respondent also will be notified of the extension.

Purpose of the Investigation: The purpose of the investigation is to explore in detail the allegations, to examine the evidence in depth, and to determine specifically whether misconduct has been committed, by whom, and to what extent. The investigation will also determine whether there are additional instances of possible misconduct that would justify broadening the scope beyond the initial allegations. This is particularly important where the alleged misconduct involves clinical trials or potential harm to human subjects or the general public or if it affects research that forms the basis for public policy, clinical practice, or public health practice. The findings of the investigation will be set forth in an investigation report.

Sequestration of the Research Records: The Research Integrity Officer will immediately sequester any additional pertinent research records that were not previously sequestered during the inquiry. This sequestration should occur before or at the time the respondent is notified that an investigation has begun. The need for additional sequestration of records may occur for any number of reasons, including the institution's decision to investigate additional allegations not considered during the inquiry stage or the identification of records during the inquiry process that had not been previously secured. The procedures to be followed for sequestration during the investigation are the same procedures that apply during the inquiry.

Appointment of the Investigation Committee: The Research Integrity Officer, in consultation with other institutional officials as appropriate, will appoint an investigation committee and the committee chair within 10 days of the notification to the respondent that an investigation is planned or as soon thereafter as practicable. The investigation committee should consist of at least three individuals who do not have real or apparent conflicts of interest in the case, are unbiased, and have the necessary expertise to evaluate the evidence and issues related to the allegations, interview the principals and key witnesses, and conduct the investigation. These individuals may be scientists, administrators, subject matter experts, lawyers, or other qualified persons, and they may be from inside or outside the University of Virginia. Individuals appointed to the investigation committee may also have served on the inquiry committee. The Research Integrity Officer will notify the respondent of the proposed committee membership within 5 days. If the respondent submits a written objection to any appointed member of the investigation committee or expert, the Research Integrity Officer will determine whether to replace the challenged member or expert with a qualified substitute.

Charge to the Committee: The Research Integrity Officer will define the subject matter of the investigation in a written charge to the committee that describes the allegations and related issues identified during the inquiry, defines research misconduct, and identifies the name of the respondent. The charge will state that the committee is to evaluate the evidence and testimony of the respondent, whistleblower, and key witnesses to determine whether, based on a preponderance of the evidence, research misconduct occurred and, if so, to what extent, who was responsible, and its seriousness.

During the investigation, if additional information becomes available that substantially changes the subject matter of the investigation or would suggest additional respondents, the committee will notify the Research Integrity Officer, who will determine whether it is necessary to notify the respondent of the new subject matter or to provide notice to additional respondents.

The First Meeting: The Research Integrity Officer, with the assistance of institutional counsel, will convene the first meeting of the investigation committee to review the charge, the inquiry report, and the prescribed procedures and standards for the conduct of the investigation, including the necessity for confidentiality and for developing a specific investigation plan. The investigation committee will be provided with a copy of these instructions and, where PHS funding is involved, the PHS regulation.

Investigation Process: The investigation committee will be appointed and the process initiated within 30 days of the completion of the inquiry, if findings from that inquiry provide a sufficient basis for conducting an investigation.

The investigation will normally involve examination of all documentation including, but not necessarily limited to, relevant research records, computer files, proposals, manuscripts, publications, correspondence, memoranda, and notes of telephone calls. Whenever possible, the committee should interview the whistleblower(s), the respondents(s), and other individuals who might have information regarding aspects of the allegations. Interviews should be recorded or transcribed and the recordings or transcripts of the interviews should be prepared, provided to the interviewed party for comment or revision, and included as part of the investigatory file.

The final report must describe the policies and procedures under which the investigation was conducted, describe how and from whom information relevant to the investigation was obtained, state the findings, and explain the basis for the findings. The report will include the actual text or an accurate summary of the views of any individual(s) found to have engaged in misconduct as well as a description of any sanctions imposed and administrative actions taken by the University. When PHS funding is involved, the final report, as described, must be submitted to ORI. Sponsors will be notified as required of the investigation findings.

Respondent: The Research Integrity Officer will provide the respondent with a copy of the draft investigation report for comment and rebuttal. The respondent will be allowed 5 days to review and comment on the draft report. The respondent's comments will be attached to the final report. The findings of the final report should take into account the respondent's comments in addition to all the other evidence.

Whistleblower: The Research Integrity Officer will provide the whistleblower, if he or she is identifiable, with those portions of the draft investigation report that address the whistleblower's role and opinions in the investigation. The report should be modified, as appropriate, based on the whistleblower's comments.

Institutional Counsel: The draft investigation report will be transmitted to the institutional counsel for a review of its legal sufficiency. Comments should be incorporated into the report as appropriate.

Confidentiality: In distributing the draft report, or portions thereof, to the respondent and whistleblower, the Research Integrity Officer will inform the recipient of the confidentiality under which the draft report is made available and may establish reasonable conditions to ensure such confidentiality. For example, the Research Integrity Officer may request the recipient to sign a confidentiality statement or to come to his or her office to review the report.

Institutional Review and Decision: Based on a preponderance of the evidence, the Deciding Official, the University of Virginia Vice President for Research, will make the final determination whether to accept the investigation report, its findings, and the recommended institutional actions. If PHS funding is involved, if this determination varies from that of the investigation committee, the Deciding Official will explain in detail the basis for rendering a decision different from that of the investigation committee in the institution's letter transmitting the report to ORI. The Deciding Official's explanation should be consistent with the PHS definition of research misconduct, the institution's policies and procedures, and the evidence reviewed and analyzed by the investigation committee. The Deciding Official may also return the report to the investigation committee with a request for further fact-finding or analysis. The Deciding Official's determination, together with the investigation committee's report, constitutes the final investigation report for purposes of ORI review.

When a final decision on the case has been reached, the Research Integrity Officer will notify both the respondent and the whistleblower in writing. In addition, the Deciding Official will determine whether law enforcement agencies, professional societies, professional licensing boards, editors of journals in which falsified reports may have been published, collaborators of the respondent in the work, or other relevant parties should be notified of the outcome of the case. The Research Integrity Officer is responsible for ensuring compliance with all notification requirements of funding or sponsoring agencies.

Transmittal of the Final Investigation Report to ORI When PHS Funding is Involved: After comments have been received and the necessary changes have been made to the draft report, the investigation committee should transmit the final report with attachments, including the respondent's and whistleblower's comments, to the Deciding Official, through the Research Integrity Officer.

Time Limit for Completing the Investigation Report: An investigation should ordinarily be completed within 120 days of its initiation, with the initiation being defined as the first meeting of the investigation committee. This includes conducting the investigation, preparing the report of findings, making the draft report available to the subject of the investigation for comment, submitting the report to the Deciding Official for approval, and submitting the report to the ORI (when required).

The decision to initiate an investigation must be reported in writing to the Director, ORI, on or before the date the investigation begins. At a minimum, the notification should include the name of the person(s) against whom the allegations have been made, the general nature of the allegation as it relates to the PHS definition of research misconduct, and the PHS applications or grant number(s) involved. ORI must also be notified of the final outcome of the investigation and must be provided with a copy of the investigation report. Any significant variations from the provisions of the institutional policies and procedures should be explained in any reports submitted to ORI.

If the inquiry or investigation is terminated for any reason without completing all relevant requirements of the PHS regulation, the Research Integrity Officer will submit a report of the planned termination to ORI, including a description of the reasons for the proposed termination.

If the University determines that it will not be able to complete the investigation in 120 days, the Research Integrity Officer will submit to ORI a written request for an extension that explains the delay, reports on the progress to date, estimates the date of completion of the report, and describes other necessary steps to be taken. If the request is granted, the Research Integrity Officer will file periodic progress reports as requested by the ORI.

When PHS funding or applications for funding are involved and an admission of research misconduct is made, the Research Integrity Officer will contact ORI for consultation and advice. Normally, the individual making the admission will be asked to sign a statement attesting to the occurrence and extent of misconduct. When the case involves PHS funds, the University cannot accept an admission of research misconduct as a basis for closing a case or not undertaking an investigation without prior approval from ORI.

The health or safety of the public is at risk, including an immediate need to protect human or animal subjects;

HHS resources or interests are threatened;

Research activities should be suspended;

There is reasonable indication of possible violations of civil or criminal law;

Federal action is required to protect the interests of those involved in the research misconduct proceedings;

Research misconduct proceedings should be made public prematurely so that HHS can take appropriate steps to safeguard evidence and protect the rights of those involved; or

The research community or public should be informed.

Institutional Administrative Actions: The University of Virginia will take appropriate administrative actions against individuals when an allegation of misconduct has been substantiated. If the Deciding Official determines that the alleged misconduct is substantiated by the findings, he or she will decide on the appropriate actions to be taken, after consultation with the Research Integrity Officer. The actions may include:

• Withdrawal or correction of all pending or published abstracts and papers emanating from the research where research misconduct was found.
• Removal of the responsible person from the particular project, letter of reprimand, special monitoring of future work, probation, suspension, salary reduction, or initiation of steps leading to possible rank reduction or termination of employment.
• Restitution of funds as appropriate.  

If the respondent, without admitting to the misconduct, elects to resign his or her position prior to the initiation of an inquiry, but after an allegation has been reported, or during an inquiry or investigation, the inquiry or investigation will proceed. If the respondent refuses to participate in the process after resignation, the committee will use its best efforts to reach a conclusion concerning the allegations, noting in its report the respondent's failure to cooperate and its effect on the committee's review of all the evidence.

Restoration of the Respondent's Reputation: If the University finds no misconduct and ORI concurs (when PHS funding is involved), after consulting with the respondent, the Research Integrity Officer will undertake reasonable efforts to restore the respondent's reputation. Depending on the particular circumstances, the Research Integrity Officer should consider notifying those individuals aware of or involved in the investigation of the final outcome, publicizing the final outcome in forums in which the allegation of research misconduct was previously publicized, or expunging all reference to the research misconduct allegation from the respondent's personnel file. Any University actions to restore the respondent's reputation must first be approved by the Deciding Official.

Protection of the Whistleblower and Others: Regardless of whether the University or ORI determines that research misconduct occurred, the Research Integrity Officer will undertake reasonable efforts to protect whistleblowers who made allegations of research misconduct in good faith and others who cooperate in good faith with inquiries and investigations of such allegations. Upon completion of an investigation, the Deciding Official will determine, after consulting with the whistleblower, what steps, if any, are needed to restore the position or reputation of the whistleblower. The Research Integrity Officer is responsible for implementing any steps the Deciding Official approves. The Research Integrity Officer will also take appropriate steps during the inquiry and investigation to prevent any retaliation against the whistleblower.

Allegations Not Made in Good Faith: If relevant, the Deciding Official will determine whether the whistleblower's allegations of research misconduct were made in good faith. If an allegation was not made in good faith, the Deciding Official will determine whether any administrative action should be taken against the whistleblower.

Interim Administrative Actions: University officials will take interim administrative actions, as appropriate, to protect Federal funds and ensure that the purposes of the Federal financial assistance are carried out.

Record Retention: After completion of a case and all ensuing related actions, the Research Integrity Officer will prepare a complete file, including the records of any inquiry or investigation and copies of all documents and other materials furnished to the Research Integrity Officer or committees. The Research Integrity Officer will keep the file for seven years after completion of the case, or any ORI or HHS proceedings under Subparts D and E of 42 CRF Part 93, whichever is later, unless custody of the records has been transferred to HHS, or ORI has advised that the records no longer need to be maintained. ORI or other authorized HHS personnel will be given access to the records upon request when PHS funding is involved.

Compliance with Policy: Failure to comply with the requirements of this policy may result in disciplinary action up to and including termination or expulsion in accordance with relevant University policies.

Questions about this policy should be directed to Office of the Vice President for Research .

Updated to align with HHS regulations 10/30/19.

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NIH Director's Transformative Research Award

Funding Opportunities

Current funding opportunities.

------->

Announcement	Title	Letter of Intent Due Date	Application Due Date	Contact
	NIH Director’s Transformative Research Awards (R01 Clinical Trial Optional)	N/A	9/3/2024	Patricia Labosky, Ph.D.
	Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)	N/A		Patricia Labosky, Ph.D.
	Notice of Special Interest (NOSI): Research Supplements to Promote Re-Entry, Re-integration into, and Re-training in Health-Related Research Careers (Admin Supp - Clinical Trial Not Allowed)	N/A		Patricia Labosky, Ph.D.
2024 NIH Directors Transformative Research Awards (R01 Clinical Trial Optional)	N/A	09/01/2023	Patricia Labosky [email protected]

Past Funding Opportunities

• 2024 NIH Directors Transformative Research Awards (R01 Clinical Trial Optional) -  RFA-RM-23-006
• 2023 NIH Directors Transformative Research Awards (R01 Clinical Trial Optional) -  RFA-RM-22-020
• 2022 NIH Directors Transformative Research Awards (R01 Clinical Trial Optional) -  RFA-RM-21-017
• 2021 NIH Directors Emergency Transformative Research Awards (R01 Clinical Trial Optional) -  RFA-RM-20-020
• 2021 NIH Directors Transformative Research Awards (R01 Clinical Trial Optional) -  RFA-RM-20-013
• 2021 Notice of Special Interest (NOSI): Common Fund ALS-related Transformative Research Award (R01 Clinical Trial Optional) -  NOT-RM-20-019
• 2020 NIH Director's Transformative Research Awards (R01 Clinical Trial Optional) -  RFA-RM-19-007
• 2019 NIH Director's Transformative Research Awards (R01 Clinical Trial Optional) -  RFA-RM-18-009
• Notice of Change of the Components of Participating Organizations for RFA-RM-17-007 “NIH Director's Transformative Research Awards (R01)” -  NOT-RM-17-028
• Notice of Change of the Review and Selection Process of RFA-RM-17-007 NIH Director's Transformative Research Awards (R01) -  NOT-RM-17-035
• Notice of Correction of Letter of Intent for RFA-RM-16-007 NIH Director's Transformative Research Awards (R01) -  NOT-RM-16-012
• 2016 NIH Director's Transformative Research Award (R01) -  RFA-RM-15-005
• 2015 NIH Director's Transformative Research Award (R01) -  RFA-RM-14-003
• 2014 NIH Director's Transformative Research Award (R01) -  RFA-RM-13-008
• 2013 NIH Director's Transformative Research Award (R01) -  RFA-RM-12-017
• 2012 NIH Director’s Transformative Research Award (R01) -  RFA-RM-11-006
• 2011 NIH Director's Transformative Research Award (R01) -  RFA-RM-10-010
• 2010 NIH Director's Transformative Research Award (R01) -  RFA-RM-09-022
• 2009 NIH Director's Transformative Research Award (R01) -  RFA-RM 08-029

This page last reviewed on March 19, 2024

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• About Firearm Injury and Death
• Facts and Stats
• Funded Research
• Data Trends
• Funded Research Findings
• Funded Data Projects

RFA-CE-22-004

What to know.

CDC funded four research awards under RFA-CE-22-004: Research Grants to Prevent Firearm-Related Violence and Injuries.

RFA-CE-22-004: Research grants to prevent firearm-related violence and injuries

The intent of this initiative is to support research to improve understanding of firearm injury, inform the development of innovative and promising prevention strategies, and rigorously evaluate the effectiveness of strategies to keep individuals, families, schools, and communities safe from firearm-related injuries, deaths, and crime.

RFA-CE-22-004 is intended to directly support activities under one or both of the following research objectives:

• Objective one: Research to improve understanding of firearm injury and inform the development of innovative and promising prevention strategies.
• Objective two: Research to rigorously evaluate the effectiveness of innovative and promising strategies to keep individuals, families, schools, and communities safe from firearm-related injuries, deaths, and crime.

Developing and evaluating an extreme risk protection order implementation protocol with impacted communities

• Three-year project: September 30, 2022-September 29, 2025
• Principal investigator: Shannon Frattaroli, Johns Hopkins University
• First-year award: $643,055

This study will develop and pilot test implementation guidance for law enforcement agencies using Extreme Risk Protection Order (ERPO) laws.

Learn more‎

Understanding personal, social network, and neighborhood environmental contributors to firearm access and violence among young adults experiencing homelessness.

• Three-year project: September 30, 2022 – September 29, 2025
• Principal investigator: Hsun-ta Hsu, University of Missouri – Columbia
• First-year award: $597,148

This study will investigate how individual, social network, and neighborhood environmental characteristics are associated with firearm risks for youth experiencing homelessness and examine the role their social network may play in moderating these risks.

Optimizing firearm suicide prevention in healthcare

• Principal investigator: Julie Richards, Kaiser Foundation Hospitals (KFH)
• First-year award: $649,586

This study will examine patient-centered strategies in healthcare settings to identify and engage patients at high risk of firearm suicide and pilot test intervention strategies.

Firearm violence perpetration: a nationally representative multi-wave survey of youth and young adults across the United States

• Principal investigator: Bruce Taylor, National Opinion Research Center First-year award: $649,979

This study will survey youth and young adults to identify risk and protective factors associated with firearm violence.

Firearm Injury and Death Prevention

Firearm injury and death is a serious public health problem that impacts the health and safety of Americans. CDC works to understand the problem of firearm injury and death and prevent it.

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• Cloud deployment and architecture

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Prepare for the CompTIA Cloud+ CV0-004 certification exam

Don't be caught unprepared for the exam. take advantage of these study tips from the author of 'the official comptia cloud+ certification self-paced study guide.'.

• Damon Garn, Cogspinner Coaction

Preparing for a challenging certification exam like CompTIA's Cloud+ can be daunting. There are many different resources available, and cloud services is a broad subject area to cover.

This important certification benefits on-premises and cloud administrators by taking a vendor-agnostic approach to cloud services. It prepares administrators for specializing with a given vendor or for understanding multi-cloud options and environments. While this article specifically applies to the new CompTIA Cloud+ exam, candidates can use this approach for any certification exam.

Take a look at these five tips for successful exam preparation, including strategies such as how to create an effective study plan and a variety of ways to gain hands-on experience.

Create a study plan

The optimal study plan establishes a roadmap, ensuring coverage of all aspects of the certification exam. Study environment, learning style and basic exam information are all essential parts of a study plan.

Create a study plan using the following steps:

• Set the stage. Dedicate a study location to prevent distraction. Create a schedule that places study times during the most productive hours of the day. These factors can look different for everyone, so candidates should learn what is most beneficial for them.
• Develop a learning style. Candidates should also investigate what learning style works best for them, whether that's reading, hearing or actively doing exercises. Emphasize whichever method helps retain the most information.
• Review the exam objectives. The CompTIA Cloud+ exam objectives are a critical resource. They provide a clear list of what material is on the test. Develop an understanding of all the concepts, including proper implementation of any specified cloud configurations.

Gather CompTIA Cloud+ resources

Gather study materials, but don't go overboard:

• Study guides. Dedicated CompTIA Cloud+ study guides can be very useful. They typically organize the information logically, with concepts building on each other. This includes courseware from any training attended. Spend some time examining reviews of the books. Read samples, if possible, to determine the efficacy of the author's writing style. Avoid books written for the outdated CV0-003 Cloud+ exam.
• Vendor documentation. Cloud service providers offer lots of online documentation. Be sure to spend time finding and bookmarking these resources. Be aware of the rapidly changing nature of cloud computing technologies -- sometimes the Cloud+ objectives cover older material.
• White papers. Supplement with articles and white papers, which are particularly useful resources because they relate specific cloud technologies to real-world problems.

Research CompTIA Cloud+ practice tests

Part of an effective study plan should include taking practice exams. Practice exams can provide a helpful benchmark to gauge a candidate's knowledge. They can also help to budget exam time and become familiar with the test format.

Quality practice exams with large question pools and evaluation options come at a cost. Be careful of free resources and carefully read practice exam reviews. A few practice exam options include the following:

• CertMaster Practice for Cloud+. Prepare for the CompTIA Cloud+ exam by using CompTIA's own assessment and training resource. This option provides analytics on knowledge gained and eLearning tools to practice necessary skills.
• MeasureUp Practice Test. This training tool offers two different modes for users: certification and practice. Certification mode lets users test and assess their knowledge. In practice mode, users can focus on their own specific problem areas.
• Pearson Exam Cram and Practice Test. Includes a study guide with hundreds of practice questions, real-time feedback and two practice exams for users to become acquainted with the CompTIA Cloud+ format.

Be cautious with practice exams. They aren't always an effective measure of your level of preparation. Be sure to take the new Cloud+ CV0-004 practice exam rather than the older CV0-003 exam.

Gain hands-on experience

Hands-on experience is a key component of exam preparation. Many training providers, including CompTIA's official training , offer lab environments to practice implementing specific technologies. This includes labs on VM deployments, virtual network peering and cloud monitoring.

AWS, Microsoft and Google offer a variety of free services to help cloud users get started with their technologies. Create an account and work with these cloud resources. Remember that CompTIA certification exams are vendor-agnostic, so focus on concepts rather than specific processes. Comparing deployments and services between two cloud providers helps solidify what is vendor specific and what is a general concept.

Candidates should also check in with their organization's IT team if the organization uses cloud technologies. See whether the cloud resources are available for learning. The team may have a dedicated lab environment to practice on or work with.

Expect some performance-based questions on the exam. These questions ask you to configure systems, organize resources and interact with the test software beyond mere multiple-choice questions. Consider additional certifications to develop relevant competencies before the exam, including CompTIA's Network+, Server+, Security+ and Linux+. CompTIA also suggests two to three years of hands-on experience as a systems administrator or cloud engineer .

Schedule the CompTIA Cloud+ certification exam

The final task is to schedule the exam. It may seem odd to schedule the test while preparing to study but paying for the exam and establishing a test date lends a sense of urgency. This can help candidates develop a more disciplined mindset toward their exam preparation.

Schedule an exam time by creating an account on CompTIA's website. There are two options for taking the exam: online and in person. Those taking an online exam should run CompTIA's system test to ensure they have a stable internet connection. Others interested in taking the exam in person must search for an authorized testing center during the exam sign-up process. CompTIA also offers various accommodations for anyone who requires a particular exam environment.

The current price for the CompTIA Cloud+ certification exam is $369. CompTIA offers training and certification bundles that provide economical options. Many third-party training providers also offer certification prep courses online and in person.

Damon Garn owns Cogspinner Coaction and provides freelance IT writing and editing services. He has written multiple CompTIA study guides, including the Linux+, Cloud Essentials+ and Server+ guides, and contributes extensively to TechTarget Editorial and CompTIA Blogs.

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Submit your entry for the Best of VMware Explore 2023 Awards for a chance to win.

Part 1. Overview Information

National Institutes of Health ( NIH )

RM1 Research Project with Complex Structure

• August 13, 2024 - This RFA has been reissued as RFA-DE-25-004
• September 11, 2023 -Notice of pre-Application Technical Assistance Webinar for RFA-DE-24-003 Collaborative Science to Achieve Disruptive Innovations in Dental, Oral and Craniofacial (DOC) Research (RM1 Clinical Trial Not Allowed). See Notice NOT-DE-23-016 .
• August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 .
• August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 .

See Section III. 3. Additional Information on Eligibility .

This Notice of Funding Opportunity (NOFO) is designed to support highly integrated research teams to address challenging questions with the potential to significantly advance dental, oral and craniofacial (DOC) fields of research. Each project should have a unified and well-defined scientific goal within the NIDCR mission that requires a team with diverse perspectives and expertise in a variety of intellectual or technical areas and is beyond the experience and capabilities of one or two investigators. Teams are encouraged to consider transformative, and disruptive innovative objectives with defined 5-year outcomes.

October 23, 2023

Application Due Dates			Review and Award Cycles
New	Renewal / Resubmission / Revision (as allowed)	AIDS - New/Renewal/Resubmission/Revision, as allowed	Scientific Merit Review	Advisory Council Review	Earliest Start Date
November 22, 2023	Not Applicable	November 22, 2023	March 2024	May 2024	July 2024

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Not Applicable

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section i. notice of funding opportunity description.

As modern scientific research addresses more complex, multifactorial issues, the need for team science is growing. Team science is a collaborative effort that leverages strengths and expertise across a variety of fields to tackle difficult scientific questions. Collaborative science can rapidly advance scientific and technological innovation by increasing research impact, novelty, productivity, and reach. Although traditional single investigator-driven research is well suited for answering many scientific questions, collaborative teams of investigators with diverse skills and knowledge may be particularly helpful for tackling complex scientific problems leading to transformative, disruptive innovations. The response to the COVID-19 pandemic provides an excellent example of the success of collaborative science, particularly across previously disconnected fields. Furthermore, team science can provide an opportunity to broaden the scope of inquiry based on the background, experience, and expertise of the research team members and unique perspective they bring to bear on the research questions.

Program Objectives and Scope

A team science approach expands our ability to pursue challenging problems in a comprehensive, transdisciplinary, rigorous, and mechanistic manner. Program Directors/Principal Investigators (PDs/PIs) should each bring a distinct scientific viewpoint or expertise necessary to pursue the transdisciplinary approach. Success of team science hinges on well-managed team interactions, clear timelines and benchmarks for success and evidence of commitment to diversity, equity, and inclusion.

The goal of this funding opportunity is to support transdisciplinary research that solves important problems related to DOC fields. The funding opportunity is designed to support highly integrated research teams of three to six PDs/PIs to address ambitious and challenging research questions of high priority to NIDCR . This funding opportunity aims to support a team of experts, with well-defined roles, that seek to cross technical and conceptual boundaries through transdisciplinary collaboration to achieve a common goal. The research goal should be clear, cohesive, and sufficiently focused so that meaningful and measurable outcomes or deliverables can be achieved.

Novel team-science collaborations should focus on challenging and complex research goals that would not be achievable by a single investigator and that are of high priority to NIDCR, for example:

• Patient-controlled technologies that draw on best practices from other fields of medicine and that reduce health disparities and/or improve oral health throughout the life span.
• Preventative dental caries vaccine development leading to significant reduction in early childhood caries incidence.
• Non-opioid pharmacotherapies treatments for DOC-related pain that minimize undesirable side effects.
• Dental Restorative Systems with clinical service life that exceed current commercial materials.
• Approaches to advance prophylactic and therapeutic strategies to manage HIV and its oral manifestations and comorbidities.

Program Organization

Applications responding to this funding opportunity are expected to propose a single, well-integrated research plan of sufficient scope, complexity, and impact to justify the investment of significant resources. Applicants are expected to describe a cohesive program with a single set of specific aims sufficient to accomplish program objectives having concrete outcomes that can be achieved within a maximum of 5 years. Program objectives that are unlikely to be achieved within 5 years are not appropriate for this funding opportunity. This program requires a Multiple PI (MPI) structure with a minimum of three and up to six PDs/PIs who each bring a distinct scientific viewpoint or expertise necessary to pursue the transdisciplinary approach being proposed in the application. It is highly encouraged to include early career stage investigators as part of the team. The application must include a clear timeline and metrics for identifying successful completion of program aims and goals, and criteria for acceptable outcomes. The following elements must also be included in the application:

Team Management Plan

In addition to the required multiple PI leadership plan, applications must develop a comprehensive team management plan submitted as Other Project Information as an attachment (see Section IV). The Team Management Plan should focus on management of the whole team/key personnel and address the following points:

• Organizational structure and team composition
• Shared leadership, contributions, and distributed responsibility for decision-making
• Resource sharing and allocation, including intra-team data sharing, archiving, and preservation
• Credit assignment
• Communication and management of shared responsibilities plans
• Conflict resolution

A scientific project manager or program coordinator may be included as part of the team. Depending on the specific data needs of the project, data/resource sharing and management systems and/or hiring of professional data science staff should also be considered. Many resources exist to aid in developing effective team-based programs including the NCI Collaboration and Team Science Field Guide .

Plan for Enhancing Diverse Perspectives (PEDP)

The NIH recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.

To support the best science, NIDCR encourages inclusivity in research. Examples of structures that promote diverse perspectives include but are not limited to:

• Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based)
• Individual applications and partnerships that enhance geographic and regional heterogeneity
• Investigators and teams composed of researchers at different career stages
• Participation of individuals from diverse backgrounds, including groups traditionally underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031 ), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women
• Utilization of project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application (see further below). Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material .

Applications must include a Plan for Enhancing Diverse Perspectives (PEDP) submitted as Other Project Information as an attachment (see Section IV). The PEDP will be assessed as part of the scientific and technical peer review evaluation.

Consultation with NIDCR staff

It is strongly recommended that potential applicants consult the NIDCR program staff a minimum of 8 weeks prior to submission. While staff will not evaluate the technical and scientific merit of the proposed project, they can advise potential applicants on whether the proposed research strategy meets the goals and mission of the Institute, whether it addresses one or more high priority research areas, and whether it is appropriate for a collaborative science team program.

Non-responsive applications will be withdrawn, and will not be reviewed. Non-responsive applications include:

• Research outside the NIDCR mission
• Applications that lack a minimum of three PDs/PIs or that exceed the maximum of six PDs/PIs
• Applications that lack a Team Management Plan
• Applications that lack the two required tables described in section IV

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial?

NIDCR intends to commit $4 million in FY 2024 to fund 3-4 awards.

Applications are limited to $750,000 direct costs per year. A detailed budget is required. The nature and scope of the proposed research will vary among applications. The requested budget should be consistent with the number of PDs/PIs and the complexity and needs of the proposed program.

Applications may request up to five years of support.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession
• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement , are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019 .

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

Any eligible scientists with the interest and ability to develop a team science program to address an important research question are welcome to work with their institutions to submit an application. The application is required to be submitted as a multiple PI application, with a minimum of 3 and a maximum of 6 PDs/PIs. It is highly encouraged to include early career stage investigators as part of the team.

To be successful, programs of this level of complexity are expected to require significant effort from all PDs/PIs involved. Generally, each PI should devote at least 2.4 person months (i.e., the equivalent of 20% effort on a full-year appointment, 26.7% on a 9-month appointment, or 40% on a 6-month appointment) throughout the duration of the award.

Multiple PI projects will be subject to the NIH’s Policy on Special Council Review of Research Applications if one or more of the PD/PIs has NIH research support that exceeds the SCR threshold.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application . This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications ).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Yasaman Shirazi, PhD Chief, Scientific Review Branch Telephone: 301-594-5593 Fax: 301-480-8303 Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

For this specific NOFO, the Research Strategy section is limited to 15 pages .

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

All instructions in the SF424 (R&R) Application Guide must be followed.

1. Team Management Plan (Required 3 pages maximum):

The application is required to be submitted as a multiple PI application, with a minimum of 3 and a maximum of 6 PDs/PIs. It is highly encouraged to include early career stage investigators as part of the team. In addition to the required multiple PD/PI leadership Plan, a Team Management plan must be submitted as an "Other Attachment" titled Team-Management-Plan.pdf , applicants must address how the entire group will function to accomplish program objectives and vision. In addition to the required multiple PI leadership plan, applications must develop a comprehensive team management plan submitted as Other Project Information as an attachment (see Section IV). The Team Management Plan should focus on management of the whole team/key personnel and address the following points:

• Organizational structure and team composition : The program management structure should avoid giving any single individual undue authority that prevents contributions from the wider team for setting program priorities, resource distribution, and reward. NIDCR recognizes that strong leadership is required for complex team efforts to be successful, while at the same time effective team leadership requires decision-making based on an amalgam of interests, expertise, and roles, guided by agreed upon project objectives. Applicants should develop a management structure based on project objectives that effectively promotes the proposed research. The structure should account for team composition, institutional resources, and policies. NIDCR does not specify any particular organizational structure, as this may vary across research questions and groups. Inclusion of a scientific project manager or coordinator as a Senior/Key Person with adequate authority is recommended. If a project manager or coordinator is included, describe how the qualifications of this individual are appropriate for such a role and for the subject and scale of the proposed project.
• Shared leadership, contributions, and distributed responsibility for decision-making : The Team Management Plan should include a description of how the PDs/PIs will establish and sustain a diverse and interdisciplinary team of researchers with an optimal range of backgrounds, expertise, and skills to successfully accomplish the goals of the program. One key consideration is that teams employing complementary approaches and having diverse areas of intellectual and technical expertise are more productive if the process for making decisions incorporates different points of view.
• Resource sharing and allocation, including intra-team data sharing, archiving, and preservation : Applications should describe management and decision-making processes that promote collective input for allocation of program resources with flexibility when resources may need to be dynamically reallocated to achieve programmatic goals. A plan for how intra-team, institutional, and regional resources that are integral to the team goals will be shared and made accessible to team members should also be included. Additionally, a framework for sharing and/or integrating data across team members must be customized to fit the science and the specific data needs of the project. Plans for data archiving and long-term preservation for team use should also be described. Depending on the needs and challenges of managing team data, applicants may also include and justify data/resource sharing and management systems and/or hiring of professional data science staff. Note that this is independent of the Data Management and Sharing (DMS); this section should address the sharing among the team.
• Credit assignment: A plan for how credit will be shared, especially with early career stage investigators, should be included. Methods for attributing contributions to publications should be described to enable individual professional assessment in joint projects.
• Communication and management of shared responsibilities plans: Practical aspects should be described, including frequency and logistics of real time communication across all key personnel, consultants, trainees, and other significant contributors regardless of effort level. If a scientific project manager or coordinator is included, describe the role of this individual in coordinating team activities and communication. An important and meaningful impact of team science may come from shaping future scientists. Because of the transdisciplinary expertise of the research groups, trainees are exposed to and can learn diverse scientific terminology, approaches and methodologies, resulting in multi-faceted, early-stage investigators. Plans for how trainees will be immersed in, and benefit from diverse approaches taken by the collective team program should be described. Activities could include shared mentorship, inter-lab meetings, all-hands tutorials, shared meeting and document space, inter-lab visits, and trainee presentations.
• Conflict resolution : The Team Management Plan must describe how major decisions will be made and how conflicts will be resolved.

2. Plan for Enhancing Diverse Perspectives (PEDP) (Required- 1 page maximum)

In an "Other Attachment" titled "PEDP.pdf", all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups traditionally underrepresented in the biomedical, behavioral, and clinical research workforce.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse backgrounds, including those from underrepresented groups in research.

Data sharing costs: Applicants may include costs associated with preparing and submitting data to a data archive per NOT-OD-21-015

PEDP implementation costs: Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7 ( https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm )

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

The proposed research must be presented as an integrated scientific program with a single set of specific aims organized to address the overall objectives rather than individual PI contributions. The application should fully describe the biomedical problem being addressed, its significance within the relevant scientific field(s), and how successful accomplishment of the goals and outcomes would provide substantial scientific advances by the end of the 5-year period. This should include how the proposed work will enable the applicants to challenge existing paradigms, overcome long-standing bottlenecks to substantial progress, and/or develop new synergies between different scientific fields.

The Research Program section should thoroughly describe the underlying premise and scientific foundation of the project, experimental rationale, approaches, and steps taken to assure scientific rigor, with attention to the reasons a team science approach is required. Applications should describe critical research metrics and any innovative aspects of the approach, including those arising from collaborative interactions. Two tables are required and must be included within the page limit for the Research Plan:

• A table, organized by specific aims, that identifies the contributions expected from each PI toward accomplishing that aim . For a truly integrated collaborative project, it is expected that most or all of the scientific aims will require substantial contributions from more than one PI. This table will aid reviewers in assessing the degree of integration and collaboration, and the availability of appropriate intellectual and technical expertise, for each aim.
• A table that identifies metrics and performance criteria and a timeline for completion . The metrics should define successful completion of program aims and goals, and criteria for acceptable outcomes. It is useful to identify interdependent steps with critical risks. Risk management and alternative approaches can be addressed elsewhere in the Research Strategy and can reference the table. This table will aid reviewers in assessing the feasibility and likelihood that the work plan is adequate for achieving project objectives within the funding period.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications .

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Pre-award costs are allowable only as described in the NIH Grants Policy Statement .

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide . If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII .

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form . Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIDCR, NIH. Applications that are incomplete or non-compliant will not be reviewed.

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this NOFO: Evaluate the program’s scope and complexity and how it warrants a team approach. How well do the specific aims form a single cohesive program, and if accomplished will these aims advance the stated goals of the program? To what extent will the scientific questions provide definitive outcomes, and can they be accomplished during the funding period? If successful, to what extent will the proposed program's integrated team research effort be transformative and uniquely advance a scientific field/community? To what extent do the overall goal challenge existing paradigms, overcome long-standing roadblocks to progress, and/or develop new synergies between different scientific fields? To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

Specific to this NOFO: Evaluate how the planned effort by the PD/PIs is appropriate and sufficient for the work proposed? How sufficient is the critical mass and diversity of investigator backgrounds and expertise for addressing the proposed scientific problem? To what extent, is there evidence for synergistic interactions among PDs/PIs beyond the additive benefits of additional investigators? If the application includes collaborating investigators who will not receive direct support, is it clear how these investigators will participate and what role they will play in the program? If foreign investigators are involved, are they uniquely qualified to participate in the team? To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this NOFO: How likely is it that the innovative ideas or approaches proposed can only be pursued through this team science and not through independently funded individual of MPI research project grants? To what extent does the program involve innovative combinations of scientific fields and/or intellectual viewpoints to address its goals? To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this NOFO: To what extent does the program present as a coherent and fully integrated set of specific aims? How appropriate are the timeline and metrics proposed for accomplishing the specific aims? How well does the work plan make adequate use of existing institutional and/or regional resources? How well does the combination of scientific expertise present a compelling case that collaborative, interdisciplinary research will enable scientific advance? To what extent do the tables provide sufficient detail on the timing and duration of key project metrics? How realistic are the timelines proposed for achieving project goals? To what extent do the contributions from the PD/PIs suggest a high degree of commitment, integration, and collaboration? Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific to this NOFO: How adequate are the resources and infrastructure for accomplishing the specific aims and supporting team science? To what extent is there synergy to be gained from the involvement of multiple departments and institutions? How well does the range of departments and/or institutions involved enhance the diversification of the teams in terms of the backgrounds, and expertise and skills of the researchers? To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Team Management Plan (Attachment)

To what extent does the team management plan provide fair and adequate governance processes that will be used for decision-making, allow for flexibility in pursuing the aims and allocation of resources and assure that all investigators are encouraged to have a voice in decision-making? To what extent does the team management plan provide for effective team leadership and management with distributed responsibility and decision-making processes? Is the team plan sufficiently detailed to create a sustainable environment for maintaining trust and shared vision? How well does the management plan include adequate plans for shared professional credit? To what extent is there evidence of institutional buy-in for shared professional credit for team activities that is sufficient for professional advancement? If shared research resources will be utilized, how likely is it that the plans ensure all team members have the access they require? If a scientific program manager or coordinator is proposed, are the qualifications and role of this individual appropriate? Are adequate plans presented to establish and sustain a team of researchers with an optimal range of backgrounds, expertise and skills, and plans to arrive at major decisions, accounting for different points of view?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects .

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research .

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section .

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms ) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDCR , in accordance with NIH peer review policy and procedures , using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the NIDCR national Advisory Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons . Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications .

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement .

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities , including of note, but not limited to:

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form ( HHS Assurance of Compliance form (HHS 690 ) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html .

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov .
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html .
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html . For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm .
• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html .

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement . Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement .

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement . NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact) Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources) Email: [email protected] (preferred method of contact) Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace) Contact Center Telephone: 800-518-4726 Email: [email protected]

Amanda Melillo, PhD National Institute of Dental and Craniofacial Research (NIDCR) Telephone: (301) 529-7217 Email: [email protected]

Yasaman Shirazi, PhD National Institute of Dental and Craniofacial Research ( NIDCR ) Telephone: 301-594-5593 Email: [email protected]

Gabriel Hidalgo, MBA National Institute of Dental and Craniofacial Research (NIDCR) Telephone: 301-827-4630 Email: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts . All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.