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Division of Behavioral and Social Research's Clinical Trials Office (CTO)

About BSR's Clinical Trials Office

The BSR Clinical Trials Office (CTO) oversees pre-award policy compliance, risk management, training, outreach, and administrative support for BSR-supported clinical trials. Prior to a clinical trial grant award being issued, the office conducts risk assessments to evaluate risk to human subjects, data, and NIH/NIA with the goal of ensuring appropriate oversight and monitoring. The office also collaborates with division Program Officers (POs) to review study materials to ensure compliance with NIH and NIA policy. Post-award, the office coordinates with study teams, NIA-approved Safety Officers and Data and Safety Monitoring Boards, as applicable, regarding human subject protection, adverse events, and recruitment and retention. The office also supports large clinical trials infrastructure projects, including the NIA IMPACT Collaboratory and the Edward R. Roybal Centers for Translational Research in the Behavioral and Social Sciences of Aging.

Oversight Levels

When preparing your application, the data and safety monitoring plan should provide the rationale for the oversight proposed (without naming nominees unless required by the NOFO or application instructions) which will be considered during the NIA BSR risk assessment process. For NIA-appointed DSMBs or Safety Officer, NIA will request for investigators to provide nominations for approval in the event of funding. Listed below are the different oversight levels to consider for NIA BSR clinical trials.

Clinical Trials Oversight Levels and Requirements

Oversight level

Requirement

Data and Safety Monitoring Plan (DSMP)

  • All clinical trials require a data and safety monitoring plan.

  • DSMP requires review and approval by the NIA.

Locally Appointed Oversight Entity

  • DSMP requires review and approval by the NIA and should include details regarding membership, expertise, roles, and responsibilities for the locally appointed oversight body.

  • Any locally appointed oversight entity such as Data and Safety Monitoring Committee and Safety Monitor are advisory to the principal investigators and do not require appointment by the NIA.

NIA Appointed Safety Officer (SO)

  • DSMP requires review and approval by the SO and NIA.

  • The SO is an independent licensed health care professional that is advisory to NIA and the principal investigators.

  • PI proposes 1 licensed healthcare professional to the NIA with a brief description of their relevant expertise, CV, and the signed conflict of interest form. The SO is reviewed and approved by the NIA.

NIA appointed Data and Safety Monitoring Board (DSMB)

  • DSMP requires review and approval by the DSMB and NIA.

  • The DSMB is an independent group of experts that is advisory to the NIA Director and the principal investigators.

  • PI proposes at least 3 members (i.e., subject matter expert, clinical trialist, etc.) including a biostatistician to the NIA with brief descriptions of their relevant expertise, CVs, and the signed conflict of interest form. The DSMB is reviewed and approved by the NIA.

Helpful Clinical Trial Templates

  • DSMP Template: 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.

  • SO/DSMB COI Form: 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 propose the oversight level that our clinical trial needs?

A: The oversight level proposed must be appropriate for the level of risk identified and justification should be provided. A low-risk study will require ongoing monitoring by the Principal Investigator (PI) and Institutional Review Board (IRB). A study with greater than minimal risk may require monitoring by an independent NIA-Appointed Safety Officer and/or an independent NIA-Appointed Data and Safety Monitoring Board along with ongoing monitoring by the Principal Investigator and IRB. Prior to a clinical trial grant award being issued, our office conducts risk assessments to evaluate risk (such as to human subjects, data, and NIH/NIA) with the goal of ensuring the appropriate oversight and monitoring.

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, each DSMB member will need to be reviewed by the NIA and 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 or pain or emotional distress for the subjects. May include certain research such as those involving music, health education, electronic messaging interventions, etc.

Q: What is a clinical trials dissemination plan?

A: The NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information sets the expectation that all NIH-funded awardees and investigators conducting clinical trials will register and report results of their trial in Clinicaltrials.gov. The clinical trials 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; and

  • the recipient institution has an internal policy in place to ensure that clinical trials registration and results reporting occur in compliance with policy requirements.

As friendly reminder, clinical trials are required to be registered in ClinicalTrials.gov not later than 21 calendar days after the enrollment of the first participant and results information from those trials must be submitted not later than one year after the trial's primary completion date.

Q: Where can I go to for application help?

A: See the General Application Guide for NIH and other PHS Agencies.

For more information:

Program Contacts:

Director: Petra Jacobs, MD, MHS

Clinical Trials Coordinators: Dennis Ongubo, MD, MPHTM, Jonathan Gooch, and Jennifer Merickel, PhD

Clinical Trials Specialists: Ama Donkor, MPH, Nicholle Igbinyemi, MPH, and Morayo Adenuga, MsC

nia.nih.gov

An official website of the National Institutes of Health