April/May Newsletter

Disseminating Human Research Protections Trainings to New Audiences

OHRP, in partnership with the Centers for Disease Control and Prevention’s (CDC’s) Human Research Protections Office and Public Health Infrastructure Center, has added three free human research protections (HRP) courses on TRAIN, one of the largest public health learning networks with more than six million users.

These courses are longstanding OHRP trainings already available on the OHRP website; Human Research Protection Foundational Training (Lessons 1–5), Considerations for Reviewing Human Subjects Research, and Participant-Centered Informed Consent Training.

Offering them through TRAIN makes the content easier to find and access for state, tribal, territorial, and local health departments; public health institutes; federally qualified health centers; students; and other public health professionals. Learners can print a training certificate after completing each course.

In the coming months, OHRP and CDC will work with partners to promote the courses on TRAIN and evaluate their use and value. As a TRAIN affiliate, CDC can also add additional HRP trainings as needed.

TRAIN is managed by the Public Health Foundation. Create a free account and explore the course catalog at: https://train.org/main/home.

You’re a What? “Institutional Review Board Specialist”

The human research protections (HRP) workforce has a new resource they can point to when trying to explain to others what they do for a living.

In March, the Bureau of Labor Statistics (BLS), the statistical arm of the Department of Labor, published an interview outlining the career trajectory, insights, and helpful advice from Ben Mooso, a 13-year HRP veteran currently employed as an institutional review board (IRB) specialist at the University of California, Berkeley.

This interview marks the first time BLS has highlighted the HRP profession in any of its data or communications products. The interview in Career Outlook is a newsletter-style companion to the Occupational Outlook Handbook (OOH), the federal government’s premier source for career guidance and information. First published in 1949, the OOH is the most accessed BLS resource with wide readership ranging from middle and high school students to job seekers, human resources officials, researchers, and journalists.

IRB specialists and other HRP professionals are classified as Compliance Officers in the 2018 Standard Occupational Classification (SOC) System. All U.S. workers (>150 million) are currently classified into one of 867 detailed occupational categories. SOC categories are revisited every 8-10 years with the next SOC update to be implemented in 2028.

OHRP Incident Report Submissions: Key Things to Know

When an institution or IRB submits an incident report to OHRP, providing accurate and complete information helps ensure timely and effective oversight. Below are key points submitters should keep in mind when preparing a report.

Which Institutions Should Be Identified on the Report?

The incident report form requires identification of the conducting, reviewing, and reporting institution(s). In some cases, these are the same institution, such as with a single-site study reviewed by an internally operated IRB. In other cases, all three could be different, such as a multi-site study with an independent IRB review where a coordinating center provides a report about an incident occurring at one of the sites. Entering accurate information helps OHRP identify both the IRB-operating organization and the engaged institution(s). A need to distinguish the conducting, reviewing, and reporting institutions is one of the most common reasons OHRP asks submitters for additional information.

The report should include:

• The FWA(s) of all institutions conducting the research that are impacted by the event.
• The seven-digit IORG number of the institution or organization that operates the reviewing IRB. Note that this is different than the IRB number: an institution’s IORG might include multiple registered IRBs.

Do You Anticipate Submitting a Follow-Up Report?

Selecting the correct report status helps OHRP understand the stage and completeness of the submission. The option to identify a submission as an “initial report” or “follow-up report” helps institutions comply with the Common Rule requirement for prompt reporting even when additional corrective actions are pending. Institutions should select the option for “initial report” when they foresee that a follow-up report will be necessary, such as when corrective actions are pending. OHRP may also request a follow-up report.

What About the Research Sponsor?

Institutions can select more than one research sponsor if applicable. Please note that institutions should only select “FDA (Food and Drug Administration)” from the drop-down menu when FDA is funding or otherwise supporting the research. This field is not intended to obtain information about whether the research is an FDA-regulated clinical investigation. For NIH-funded research, we recommend identifying the specific NIH Institute or Center when known.

What are Common Questions OHRP Asks about the Description of the Incident and the Corrective Action Plan? 
Often, submitted descriptions do not include sufficient details on the event or the IRB’s assessment for OHRP to evaluate the report. For example, OHRP often asks for clarification on whether a reported study suspension or pause was required by the IRB or by another party (e.g., sponsor, institutional official, etc.) and whether the institution or IRB determined a proposed corrective action plan to be sufficient. As explained in our 2022 guidance on reporting incidents, OHRP assesses the adequacy of the corrective actions taken or planned to address the incident.

What Happens to a Report After Submission?

The submitter will receive an initial confirmation of submission by email, including a report record number. In 1 – 2 business days, the submitter will receive a full a copy of the submitted report by email as a pdf. We recommend retaining this pdf for the institution’s records. An OHRP staff member may contact the submitter with questions after reviewing the submission.

Where Can I Find More Information?

OHRP’s Incident Reporting website includes video tutorials, reporting instructions, guidance, and a link to the online report submission form.

The New Streamlined FWA is Here

We are pleased to announce that updates to the Federalwide Assurance (FWA) application form are now live in the Electronic Submission System.

You can now access current forms, including the FWA application and instructions, on OHRP's website.

If you have questions or need assistance with the Electronic Submission System, please contact IRBorFWA@hhs.gov.

National Women’s Health Week (May 10 - 16) and Women’s Participation in Research

According to the National Institutes of Health’s (NIH’s) Office of Research on Women’s Health (ORWH), about half of participants in NIH-supported clinical research are now women. Ensuring that women are also represented in basic research is important to increase awareness about how biological sex differences affect medical care, close knowledge gaps, and drive therapeutic advancements and breakthroughs.

In observance of National Women’s Health Week (May 10 - 16), the week starting with Mother’s Day, OHRP is highlighting several HHS efforts to increase women’s participation in research. This year’s National Women’s Health Week theme is “Prevention, Innovation, and Impact: A New Era in Women’s Health,” which reflects an ongoing commitment to proactive, science-based, and coordinated care and highlights the importance of moving beyond fragmented care to focus on prevention, early detection, and better health outcomes.

• In March, the HHS Office on Women’s Health (OWH) hosted the inaugural HHS National Conference on Women’s Health, which included a session titled “Accelerating Transformative Women’s Health Research” co-presented by the NIH Director, Jay Bhattacharya. OWH also offers free Continuing Medical Education (CME/CE) courses on select women’s health topics.
• ORWH supports DiscoverWHR, a centralized portal for accessing information about women’s health research, including clinical trials, funding opportunities, and patient-facing educational materials. ORWH also chairs the internal Coordinating Committee on Research on Women's Health to help ensure that women’s health is integrated across NIH.
• The Food and Drug Administration (FDA) Office of Women’s Health recently published draft guidance, Study of Sex Differences in the Clinical Evaluation of Medical Products, which provides recommendations for increasing enrollment of female participants in clinical trials, analyzing and interpreting sex-specific data, and including sex-specific information in regulatory submissions of medical products. FDA also maintains a listing of pregnancy exposure registries where pregnant women can volunteer to participate in observational research that collects data on the effects of medical product exposures during pregnancy.

NIH Clinical Research Policy Updates and Engagement Opportunities

OHRP’s colleagues at the National Institutes of Health (NIH) have announced several new policy efforts aimed at strengthening the clinical research enterprise. These efforts are relevant to the human research protections community and present multiple opportunities for stakeholder engagement. For questions about these initiatives, please contact SciencePolicy@od.nih.gov.

Draft Resources for Implantable Device Trials

NIH has released two draft resources to support participants in implantable device clinical trials. These resources provide guidance on post-trial considerations, including planning for participants’ ongoing care needs, points to consider, and sample informed consent language. NIH is accepting public comments on these resources through this website until May 25, 2026.

Policy Development: Sharing Summary-Level Study Results with Participants

NIH is undertaking a comprehensive policy development process to establish requirements for researchers and institutions to responsibly share summary level study results to research participants in plain language for all NIH-supported clinical research. As part of this effort, NIH is partnering with the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard to co-host a public webinar on April 27 (1:00 – 2:30 PM ET). Additionally, on-demand comments are open now and can be provided to the NIH Office of Science Policy through this website until the draft policy is released.

Modernizing Data and Safety Monitoring Policy

NIH is pursuing updates to its Data and Safety Monitoring Policy to support clinical research that studies that are scientifically sound and rigorously designed to produce high-quality, reliable data that advances the health of all Americans. A public webinar on this topic will be held on May 13 (11:30 AM – 1:00 PM ET). As with the above effort, on demand comments are open now and can be provided to the NIH Office of Science Policy through this website until the draft policy is released.