August Newsletter

IRB Member Trainings

Although it may seem surprising to many, human subjects protections training for your institutional review board (IRB) is not actually a requirement of 45 CFR part 46. However, the regulations at 45 CFR 46.107(a) do call for IRB members to have “professional competence” and “knowledge of institutional commitments (including policies and resources) and regulations, applicable law, and standards of professional conduct and practice.”

In joint guidance, OHRP and FDA include training and education for IRB members, support staff, and investigators as an additional topic that institutions may want to address in their written procedures.

OHRP offers a variety of free training resources available for institutions and IRBs to use at: https://www.hhs.gov/ohrp/education-and-outreach/human-research-protection-training/index.html

OHRP also offers a “Training Checklist for Someone Working with IRBs.” This checklist provides a basic list of resources for the following individuals:

1. New IRB members (including community members)
2. Investigators wanting to know what to expect when submitting a protocol for review
3. IRB administrators
4. Existing IRB members who want to brush up on the basics 

Register for the “Sickle Cell Disease and Gene Therapies” Webinar Series

In observance of National Sickle Cell Awareness Month, OHRP is partnering with the HHS Office of Minority Health (OMH) to host a two-part webinar series in September on sickle cell disease (SCD) and gene therapies.

OHRP is leading the first webinar on September 18, “Trust, Clinical Trials, and Transformative Therapies: Ethical Pathways in Gene Therapy and Sickle Cell Disease”. This event will bring together individuals living with SCD (i.e., warriors), clinical researchers, bioethics experts, and a community-based organization to explore how diverse partners can collectively build confidence and trust around life-changing, novel therapies in historically underserved populations.

The second webinar, “Innovations and Advances in Sickle Cell Disease Gene Therapies” is led by OMH and will be held on September 25. This webinar will focus on the Centers for Medicare & Medicaid Services (CMS) Cell and Gene Therapy Access Model, which leverages outcomes-based agreements to reduce costs and increase access for eligible warriors enrolled in participating state Medicaid programs.

Learn more about emerging gene therapies and register for both webinars below!

Click here to register for Part 1(September 18, 2025, from 1:00 – 2:30 PM ET)

Click here to register for Part 2 (September 25, 2025, from 2:00 – 3:30 PM ET) 

Compensation in Consent Forms (45 CFR 46.116(h))

A provision in the 2018 Requirements requires that informed consent forms for clinical trials, including social, behavioral or educational research studies that meet the definition of a clinical trial, must be posted on a public website to ensure transparency and participant understanding (45 CFR 46.116(h)). The goal of this requirement is to support public trust by increasing transparency for HHS-conducted or supported clinical trials. Simultaneously, the requirement creates a repository of sample consent forms that may be used to help develop more informative consent forms and processes.

A recent issue brief published by HHS’s Office of the Assistant Secretary for Planning and Evaluation (ASPE), Use of Participant Compensation in U.S. Clinical Research Studies, illustrates the utility of posted consent forms as a resource. By using a text mining approach to examine consent forms posted on ClinicalTrials.gov, the brief demonstrates that over half of represented trials included compensation, and whether or not a trial offered compensation varied by intervention type, trial phase, and the health conditions being studied. The brief highlights the need for additional research to better understand compensation in clinical research and its potential role in offsetting costs like travel and lost wages and influencing study recruitment and retention.

By clearly outlining compensation details in consent forms, researchers can support transparency and trustworthiness. By fulfilling applicable requirements for HHS-supported and conducted clinical trials to be posted, research institutions can help enable groups like ASPE to advance our knowledge of informed consent and human research protections more broadly. For more information about the informed consent posting requirement, readers can view OHRP’s guidance and detailed instructions on how to use Regulations.gov as one option to fulfill the posting requirement.