How to Comply with the New NIH Transparency Rules for r/sNA Research
On June 1, 2025, an implementation update from the NIH Office of Science Policy (OSP) took effect. These requirements apply to institutions conducting NIH-funded research involving recombinant or synthetic nucleic acid (r/sNA) molecules that fall under Section III of the NIH Guidelines.
Under the new rules, Institutional Biosafety Committees (IBCs) must take two key steps:
- Publicly post approved IBC meeting minutes from meetings held on or after June 1, 2025, and
- Disclose names and contact information for key IBC personnel.
These changes reflect NIH’s belief that increased transparency into IBC membership and decision-making processes will help build public trust in the systems that protect all Americans.
Compliance Best Practices for NIH-Funded Institutions
If your institution is just reacting to the new transparency rules, there is good news: It is not too late to comply. However, now is the time to act. The sooner you align your processes, the smoother your path to compliance will be.
These four steps can help you effectively meet the updated expectations.
1. Update Policies & Workflows
Although an institution holds ultimate responsibility for compliance, the day-to-day work of aligning with the new NIH transparency requirements should fall to those who manage biosafety oversight, such as the
- Biological safety officer
- IBC administrator
- Research compliance team
These individuals or teams should take the lead in evaluating whether current institutional policies, SOPs, and workflows require revisions in light of the new rules. Where gaps are identified, make updates proactively to prevent compliance issues from arising.
Taking early ownership of this review ensures that the institution can adapt smoothly and demonstrate a good-faith effort to meet NIH expectations.
2. Draft Clear & Appropriate Meeting Minutes
The NIH Office of Science Policy has long specified the requirements for the information institutions must include in IBC meeting minutes, and the expected content has not changed with the new transparency rules. What has changed is the requirement to post those approved minutes publicly for meetings held on or after June 1, 2025.
To ensure compliance, use the NIH’s established meeting minutes template as your guide. This template includes all required elements and excludes unnecessary or confidential details from the beginning. The clearer and more compliant your minutes are at the drafting stage, the easier it will be to prepare them for public release.
Identifying what qualifies as confidential information can be nuanced. If there is any uncertainty about what should or should not be redacted before posting, consult your institution’s legal counsel to ensure you are striking the right balance between transparency and protection of proprietary or personally identifiable information.
Once meeting minutes are reviewed and approved, they should be posted on your institution’s public-facing website as soon as possible. If your institution does not already have a public-facing page for meeting minutes, there is no need to start from scratch. You can simply create a new section or page within your existing website to meet this requirement.
3. Maintain Up-to-Date Contact Information
As part of the IBC registration process, institutions must submit their contact information to the NIH through its electronic registration system. Historically, the NIH publicly posted only the name of your biosafety committee, signaling to the public that your institution was engaged in research requiring biosafety oversight. However, under the new transparency rules, the NIH now also publicly discloses the names and contact information of certain personnel affiliated with IBC.
The publicly available information now includes:
- Name of the committee
- Committee Chair’s name and contact information
- Institutional Contact’s name and contact information
- Biological Safety Officer’s name and contact information
- Names of all IBC members
To comply with these requirements, institutions must review and update their IBC rosters in two instances:
- Annually
- Immediately upon any change (e.g., a staff departure, updated email address, or new chairperson appointment).
NIH’s registration system sends automated reminders to help institutions meet the annual update requirement, but institutions should not rely solely on these alerts.
Instead, develop an internal process that ensures updates happen promptly and consistently. For example, suppose a designated contact person leaves the institution or changes roles. In that case, the update should be made in the registration system right away to avoid missed NIH communications or compliance issues.
Ultimately, institutions should clearly designate who is responsible for maintaining IBC registration and communications and establish SOPs for making timely updates.
4. Work with an Experienced IBC Partner
For institutions navigating these new NIH transparency requirements, partnering with an experienced IBC administrator can significantly ease the burden of compliance.
There are two primary scenarios where this support can be helpful:
- Institutions with existing IBCs may require guidance on how to modify their current policies and procedures to comply with the new rules.
- Institutions just getting started may benefit from collaborating with a qualified external partner who can help establish and administer a compliant committee from the outset.
Experienced IBC partners are already familiar with the NIH Guidelines and stay current on implementation updates. They often have SOPs, templates, and workflows already in place that align with current compliance expectations, including the new transparency rules.
Rather than starting from scratch, institutions can leverage this expertise to meet requirements more efficiently and with greater confidence.
Conclusion
The new NIH transparency rules are part of a broader push to build public trust in the biosafety systems that support modern science. For institutions conducting r/sNA research, this is an opportunity to demonstrate a commitment to responsible research practices.
Whether your IBC is well-established or still taking shape, act now. By updating your policies, refining your documentation, keeping your contact information current, and seeking expert support where needed, you can meet these expectations with confidence.
Compliance does not have to be complicated, but it does require a deliberate approach. A thoughtful and well-organized response today will help ensure your institution remains transparent and trusted well into the future.
About the Authors:
Raffaella Hart, MS, CIP, serves as Senior Vice President at BRANY, where she leads the organization’s IRB, IBC, and Quality Assurance services. A Certified IRB Professional (CIP) with over 25 years of experience in IBC and IRB administration, she was instrumental in achieving and maintaining BRANY IRB’s full AAHRPP accreditation. Hart holds a Master of Science in Healthcare Science with a focus in Clinical Research Administration from The George Washington University and a B.S. in Psychobiology from Binghamton University. Her work has been featured in IRB Advisor, Clinical Trials, The CenterWatch Monthly, The Monitor, and Seminars in Nuclear Medicine.
Vanessa Rodriguez is BRANY’s IRB/IBC Supervisor. Ms. Rodriguez joined the BRANY team in 2009. Her ability to learn, navigate, and apply the regulations relevant to both IRB and IBC has led to several promotions at BRANY, including her most recent promotion to IRB/IBC Supervisor. Ms. Rodriguez is extremely knowledgeable in her role as BRANY’s IBC administrator. Vanessa continuously educates herself on the NIH Guidelines related to research involving human gene transfer or use of recombinant or synthetic nucleic acid molecules by attending conferences, speaking with liaisons at the Office of Science Policy, and meeting with IBC committee members and biosafety officers, in addition to her own research on these topics. Ms. Rodriguez has over 15 years of experience in research administration, including IBC administration, and is a Certified IRB Professional (CIP).
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