February/March Newsletter

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February/March 2026

In This Newsletter:

Important Announcement about Office for Human Research Protections Electronic Submission System and Federalwide Assurance Updates

Changes to the Federalwide Assurance (FWA) are coming soon and will temporarily impact access to OHRP’s electronic submission system for both FWAs and institutional review board (IRB) registration. OHRP is updating the FWA to implement burden-reducing provisions in the revised Common Rule (the “2018 Requirements”) at 45 CFR 46.103 and to adopt other non-regulatory changes to decrease unnecessary burden and clarify the applicability of 45 CFR part 46 to HHS-supported or conducted nonexempt human subjects research. Details about the revisions to the FWA form, OMB No. 0990-0278, can be found online. Click here to Access the Electronic Submission System (ESS).

Implementing these changes requires system updates to the software applications that OHRP uses to manage FWA and IRB registration applications. The Electronic Submission System (ESS) for OHRP’s IRB registration and FWA registries will undergo system upgrades that require scheduled downtime on March 12, 2026, beginning at 7:30 PM EST. Please note that FWA and IRB registration applications cannot be submitted or processed during the scheduled downtime. We expect to resume normal service on March 23, 2026. If you are planning an initial or renewal application for either an FWA or an IRB registration prior to March 23rd, we strongly encourage you to complete and submit as soon as possible, and no later than March 6, 2026. Thank you for your patience as we complete the ESS system upgrades. Please contact IRBorFWA@hhs.gov if you have questions or need assistance.

OHRP to Host Booth on February 27 at NIH Rare Disease Day Event

Rare Disease Day takes place worldwide, typically on or near the last day of February each year, to raise awareness among policymakers and the public about rare diseases and their impact on patients’ lives. Since 2011, the National Center for Advancing Translational Sciences (NCATS) has sponsored Rare Disease Day at the National Institutes of Health (NIH) as part of this global observance.

OHRP was invited by NCATS to host an exhibitor booth at the Rare Disease Day hybrid event at the NIH main campus on February 27. The booth will provide an opportunity for OHRP staff to engage with researchers, advocacy organizations, individuals/families living with rare diseases, and others and educate them about OHRP, its mission, and core programs.

One OHRP initiative that will be highlighted at the booth is “About Research Participation”, a portfolio of consumer-facing videos and resources to help the public learn about research studies and make informed decisions about participating in research.

NIH Rare Disease Day is free and open to the public. To register and view the agenda, click here.

Slides and Recordings Now Available for Sickle Cell Disease Gene Therapy Webinars

Last September, OHRP and the HHS Office of Minority Health (OMH) co-hosted a two-part webinar series on sickle cell disease (SCD) and gene therapies. The series was a highlight of National Sickle Cell Awareness Month and averaged 478 live attendees per session.

OHRP led the first webinar, which discussed efforts to build confidence and trustworthiness in clinical trials and emerging therapies. The second webinar, led by OMH, focused on increasing access to gene therapies and reducing costs.

Slides and recordings for both webinars are available on the OHRP website and below:

Part 1—Trust, Clinical Trials, and Transformative Therapies: Ethical Pathways in Gene Therapy and SCD

Part 2—Innovations and Advances in SCD Gene Therapies

  • Click here for recording

Both webinars featured individuals/families living with SCD who had recently been approved for gene therapy (Part 1; time stamp 06:30) or had received gene therapy via clinical trial (Part 2; time stamp 35:42). Additional perspectives were shared by researchers, clinicians, and state and federal government officials.

A written summary of both webinars is being developed and will be posted to the OHRP website when available.

OHRP Mailbox Spotlight: When is IRB Approval Required?

OHRP responds to questions about interpretation and application of the HHS regulations for the protection of human subjects at 45 CFR part 46, institutional review board (IRB) review, and other related matters through the general inquiries mailbox, OHRP@hhs.gov. OHRP reviewed emails we received between 2020 and 2024 to identify trends. A common question was, “When is IRB approval required?”

OHRP offers a variety of free educational resources for institutions, IRBs, and investigators to use when considering whether an activity requires IRB approval. These resources also help inform the public about HHS’s human research protections regulations. Some materials include the following:

Looking Ahead to Patient Safety Awareness Week (March 8–14, 2026)

Each March, the healthcare and research communities observe Patient Safety Awareness Week (PSAW), a national initiative dedicated to advancing safe, high-quality care and preventing harm. In 2026, PSAW will take place March 8–14, offering an important opportunity for clinicians, investigators, and human research protection professionals to reflect on and strengthen safety practices across clinical and research settings.

A culture of safety and open communication supports both patients and research participants. Patient safety and human research protections have interconnections and overlapping goals. Many research activities occur in clinical environments, and many clinical innovations are evaluated through research.

PSAW provides an opportunity to highlight the shared responsibility of institutions, investigators, clinicians, and oversight bodies to protect individuals who participate in research and receive care.

Several principles that support patient safety also contribute to human research protections:

  • Risk identification and mitigation
  • Quality improvement and monitoring
  • Informed engagement and communication

Educating staff and research participants can also promote safety in clinical research. OHRP’s “About Research Participation” resources can be used to help clinical staff engage with patients who are considering research participation. The resources answer some common questions and suggest other questions that an individual may want to ask when considering research participation. These materials are intended for public use and distribution, and we invite you to use and share them freely.

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