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The National Institute on Aging (NIA) Division of Behavioral and Social Research (BSR) fosters innovative and scientifically rigorous clinical trials to advance behavioral, social, psychological, and economic research on aging and AD/ADRD, which is aligned with the NIA mission through:
- Research conduct
- Adequate protection of human subjects
- Scientific data quality
- Assuring regulatory compliance
- Timely and efficient clinical trial implementation
BSR supports a wide range of clinical trials, including large clinical trials infrastructure projects.
- Pre-award: clinical trials risk assessment and oversight determination, human subjects’ safety monitoring, and data and safety monitoring plans.
- Post-award: appointment of NIA Safety Officers (SOs) and NIA Data and Safety Monitoring Boards (DSMBs), and monitoring of clinical trial recruitment and retention, human subjects' safety, scientific rigor, data quality, and clinical trial progress.
Clinical Trial Risk Categories
BSR conducts an independent risk assessment for each clinical trial. In addition to human subjects' safety risk, the final risk determination assesses multiple factors impacting clinical trial risk (e.g., study design, interventions, study population, PI experience, financial risk, reviewer concerns). Considering all factors, NIA may require NIA-appointed oversight bodies (i.e., Safety Officer or Data and Safety Monitoring Board) for clinical trials that are determined to have medium to high risks.
See the following for more information:
Clinical Trial Oversight Levels
| Oversight Required for All Clinical Trials | A DSMP review and approval by NIA BSR is required.Study teams should use the |
| Locally Appointed Oversight Entity | Locally appointed oversight entities such as Data and Safety Monitoring Committees and Safety Monitors advise the PI and do not require appointment by the NIA.The DSMP should include membership, expertise, roles, and responsibilities for the locally appointed oversight body. |
| NIA Appointed Safety Officer (SO) | The SO is an independent, licensed health care professional that advises the PIs and NIA.The NIA will inform the PI if an NIA-appointed SO is required.PIs propose a licensed healthcare professional to the NIA and provide a brief description of their relevant expertise, CV, and the |
| NIA Appointed Data and Safety Monitoring Board (DSMB) | The DSMB is an independent group of experts that advises the PIs and NIA.The NIA will inform the PI if an NIA-appointed DSMB is required.PIs propose at least 3 DSMB members (e.g., subject matter expert, clinical trialist, etc.) to the NIA, along with their relevant expertise, CVs, and |
Additional tips:
- Investigators should not name nominees to oversight bodies unless required by the Notice of Funding Opportunity (NOFO) or application instructions. If NIA requests a NIA-appointed DSMB or SO for your clinical trial, the NIA will request investigators to submit nominations in the event of funding.
- NIA offers guidelines related to
Guideline%20for%20Budgeting%20for%20Data%20and%20Safety%20Monitoring%20Activities.docx (21.11 KB) (Word, 21K) for data and safety monitoring activities.
Helpful Clinical Trial Templates
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DSMP-template-guidelines-nia-bsr_08-2025_.docx (90.9 KB) (Word, 91K): Every clinical trial application requires a data and safety monitoring plan (DSMP). We strongly encourage researchers to use the BSR DSMP template to create the study’s DSMP. Please reference this document to ensure you include all needed information. - BSR DSM Report Template (
DSMP-Report-Template-Open-Session-NIABSR-May2025.docx (161.37 KB) (Word, 161K),DSMP-Report-Template-Closed-Session-NIABSR-May2025.docx (118.77 KB) (Word, 118K)): The DSM (Data and Safety Monitoring) report templates are used to make periodic data and safety monitoring reports to the body providing study oversight (e.g., DSMB, SO). Investigators should consider using this template for clinical studies sponsored by NIA BSR. -
so-dsmb-coi-form.pdf (222.53 KB) (PDF, 222K): This form should be completed and signed by the nominated SO or DSMB members for trials requiring an NIA appointed SO or DSMB.
Frequently Asked Questions
Q: How do we determine the appropriate oversight level for our clinical trial?
A: The oversight level proposed must be appropriate for the clinical trial’s risk level. Rationale for oversight level should be provided. All clinical trials are monitored by the PI and Institutional Review Board (IRB). For some minimal risk studies, IRB and PI oversight may be sufficient. For a greater than minimal risk study, further monitoring by an independent NIA-Appointed Safety Officer and/or Data and Safety Monitoring Board may be required. Prior to clinical trial grant funding, NIA will assess the study’s risk (e.g., data and human subject safety) to determine the appropriate oversight and monitoring level.
Q: If my institution appoints a DSMB for review of the trial, will NIA accept it as an NIA-appointed DSMB?
A: For a DSMB to be accepted as an NIA-appointed DSMB, NIA needs to determine that a DSMB is the appropriate oversight level for the proposed clinical trial. Additionally, each nominated DSMB member will need to be reviewed for conflicts of interest (COIs) whether potential, perceived, or real, by the NIA and the DSMB roster needs to be approved by the NIA Director.
Q: Do I need NIA approval for an existing NIA-appointed DSMB to oversee my new study?
A: Yes, if a PI wants to leverage an existing DSMB for a new study, the PI will need to submit updated CVs and signed COIs to the NIA for approval. Once approved, the DSMB and NIA will also need to review the new study’s DSMP and ALL study materials prior to the initial meeting (even if the new DSMP mirrors a parent study).
Q: What is a benign behavioral trial?
A: A trial that involves no appreciable risk of harm, pain, or emotional distress for the subjects. For example, a clinical trial using a music, health education, or electronic messaging interventions might be considered a benign behavioral clinical trial.
- Recommendations on Benign Behavioral Intervention from the U.S. Department of Health and Human Services’ Secretary’s Advisory Committee on Human Research Protections (SACHRP)
- NIH Exempt Human Subject Research: Exemption 3 benign behavioral interventions in adults (PDF, 449K)
- Minimal risk Exemption 3 clinical trials do not need to be monitored by a formal DSMB. These trials may use a risk appropriate data and safety monitoring plan approved by the IRB of record and NIA.
Q: What is a clinical trial dissemination plan?
A: The NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information requires all NIH-funded awardees and investigators conducting clinical trials to register and report trial results on Clinicaltrials.gov. The clinical trial dissemination plan must contain sufficient information to assure the following:
- The applicant will ensure that clinical trial(s) under the award are registered, and results information is submitted to ClinicalTrials.gov as outlined in the policy and according to the specific timelines stated in the policy.
- Informed consent documents for the clinical trial(s) will include a specific statement relating to posting of clinical trial information at ClinicalTrials.gov.
- The recipient institution has an internal policy in place to ensure that clinical trials registration and results reporting occur in compliance with policy requirements.
Clinical trials must be registered in ClinicalTrials.gov no later than 21 calendar days after the first study participant is enrolled. Results information must be submitted to ClinicalTrials.gov no later than one year after the trial's primary completion date.
Q: Where can I find help with my application?
A: See the General Application Guide for NIH and other PHS Agencies.
For more information:
- See the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
- See the NIH Guide Notice on the Delayed Enforcement and Short-Term Flexibilities for Some Requirements Affecting Prospective Basic Science Studies Involving Human Participants
- See the NIH Grants Policy Statement, Section 4.1.3.1 NIH Policy on Dissemination of NIH-Funded Clinical Trial Information
- Always remember to read your Notice of Funding Opportunity (NOFO)
Contact
If you have additional questions, e-mail niabsrct@nih.gov .
Looking for program officials? Use the Matchmaker tool in the NIH RePORTER to easily find staff associated with specific projects or types of research. Enter abstracts, research bios, or other scientific text, and explore a list of similar projects and program officials from the RePORTER.
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