OHSRP Website and Human Research Protections Policy Updates

As part of our ongoing effort to make guidance easier to find and use, we have converted many of the PDF guidance documents that were previously attached to policies into webpages. This makes the information easier to locate using the website search function and allows us to keep the guidance current and accessible in one place.

Below are some of the more significant new and revised resources. Where a recent policy change affects study teams, we have highlighted that change along with the relevant webpage.

• Single Patient Expanded Access – revised. This page has also been updated to reflect the August 10 revision to Policy 3014-502, Expanded Access. The revised policy clarifies that when relying on another Sponsor's IND, the NIH PI must obtain a Letter of Authorization (LoA) from the manufacturer, or Sponsor if also the manufacturer, permitting cross-reference to the IND. The LoA must be included in the expanded access submission to the FDA.
• IND Safety Reports – revised
• Investigator Brochures and Package Inserts – new. This replaces the previous Word document linked from the New Study Submission and Modification pages.

• Study Self-Audit Tool – new
• Preparing for PI Departure – new. This replaces the previous guidance document associated with Policy 300.
• Selecting Investigators for Your NIH Study – revised
• Single Patient Modification – new
• Continuing Review – revised. This page now incorporates the June 20 revision to Policy 3014-205, Requirements for IRB Submissions.

Important Continuing Review change: Data and safety monitoring reports containing findings that have not previously been reported to the IRB must now be submitted with the Continuing Review. Examples include a previously unsubmitted FDA Form 483 inspection finding or response, a DSMC/DSMB report received since the last Continuing Review, or major findings from routine IC monitoring that were not previously reported through an RNI. Information that has already been reported to the IRB does not need to be submitted again.

• NIH CITI Training – revised. This page now incorporates relevant guidance previously associated with Policies 105 and 109 and includes a link to the new CITI Hub.

• Clinical Research Conflict of Interest Review – new
• Deputy Ethics Counselor Review – revised and renamed
• Protocol Royalty Analysis Committee (PRAC) Review – new

These webpages replace the PDF guidance documents previously associated with Policy 102.

Our resources in this area have been updated to reflect the July 20 revision to Policy 3014-404, Research Involving NIH Staff or Immediate Family Members of the Study Team as Subjects.

Important consent monitoring change: The revised policy provides greater flexibility in how required consent monitoring may be accomplished when an NIH staff member is subordinate to an investigator or works in the unit where the research is being conducted. The policy now provides several options for an independent third party to monitor the consent process and, when such a monitor is not available, permits monitoring by another qualified investigator consistent with the requirements of the policy.

Related resources include:

• NIH Frequently Asked Questions for NIH Staff Who are Considering Participation in NIH Research – revised. The FAQs have been updated to reflect the Policy 404 changes and now focus specifically on information relevant to NIH staff participants. This resource will remain a PDF because investigators are required to provide it to prospective NIH staff participants.
• Joining an NIH Study Conducted by a Family Member – new. Information for immediate family members of study team members is now available separately on this webpage. Please share this resource with family members who are considering participation in an NIH study conducted by their relative.

• Assent – revised. This page now includes guidance regarding both assent of minors and assent of decisionally impaired adults.
• Recruitment – revised. Relevant content from the guidance previously associated with Policy 302 has been incorporated into this page.
• Peer Recruitment – new. This page also incorporates relevant guidance previously associated with Policy 302.
• Pregnancy Considerations for Research Protocols – new. This replaces the previous PDF guidance associated with Policy 400.
• Collecting Information about Participants' Family Members – new
• GDPR and UK Privacy Notices – new

• International Research – revised
• Preparing Your Protocol for International Research – new
• Preparing Informed Consent for International Research – new

These webpages now incorporate the relevant guidance documents previously associated with Policy 700.

The NIH Federalwide Assurance webpage has also been revised and now incorporates relevant content that was previously contained in guidance associated with Policy 109.

In addition, the previous guidance document regarding gadolinium administration has been retired. The applicable language regarding disclosure of gadolinium risks is already available in the OHSRP Consent Library and should be used when preparing informed consent documents.

We encourage investigators and study teams to use the OHSRP website as the primary source for current guidance. We will continue to update and expand these resources to make NIH human research protections requirements easier to find, understand, and apply.