Updated NIH Protocol Templates, New SaMD Addendum, and Emergency Planning Resource

The five protocol templates for non-exempt human subjects research have been revised to make them clearer, more consistent, and easier to use. The revisions largely clarify and reorganize existing requirements rather than introduce new requirements.

Across the templates, key changes include:

• Clearer, more streamlined instructional language, with less duplication and greater use of cross-references between protocol sections.
• More focused descriptions of study procedures and assessments, with detailed operational instructions directed to a Manual of Procedures (MOP), SOP, or other study document when appropriate.
• New or reorganized sections addressing the use of existing data and specimens, including when data or specimens collected under other NIH protocols will be incorporated into the research.
• Clearer instructions for collaborations and sharing data or specimens with external investigators, including distinguishing activities involving identifiable information from those involving de-identified data or specimens.
• Improved guidance for multi-site research, including what belongs in the study-wide protocol versus a participating-site Protocol Addendum.
• Reorganized and streamlined instructions for informed consent, study interventions, participant withdrawal/discontinuation, safety reporting, statistical considerations, and data management, as applicable to each template.

Investigators are not required to convert currently approved protocols to the revised templates. The revised templates should be used for new protocols being drafted.

When using the revised templates, investigators should read the instructional text carefully. Information that appeared in one location in an earlier template may now be requested in a different section.

OHSRP has developed a new Protocol Addendum for Studies Involving Software as a Medical Device (SaMD).

Investigators submitting a new protocol or modification involving SaMD or a novel software function must use the SaMD Addendum to determine what information is required for their study. The new Addendum is available in PROTECT > IRB > Library > Templates.

The addendum is designed to help the IRB determine whether software is being studied or used as a research tool, whether it may be regulated as a medical device, and whether the protocol adequately addresses the software and its associated risks. It includes screening questions to help investigators determine which portions of the addendum apply to their research.

Investigators conducting research involving SaMD are also strongly encouraged to complete the NIH CITI training “Essentials of Software as a Medical Device & Clinical Decision Support Systems.”

OHSRP has also added a new Planning for Emergencies webpage to assist research teams in considering and planning for emergencies that may occur during the conduct of human subjects research.

Investigators should use the revised protocol templates for new protocols and the SaMD Addendum, when applicable, for new protocols and modifications.