The HRP‑503 is a standardized protocol template used specifically for biomedical and cancer research—primarily interventional, clinical, or investigational studies that involve living participants and/or biomedical agents. 

Criteria

The HRP‑503a is a formal protocol template designed for social, behavioral, and educational (SBS) research that does not involve biomedical or clinical interventions. It ensures investigators include all critical information for human-subject studies in these domains.

Choose HRP‑503a when your project involves:

• Social, behavioral, educational, or psychological research (e.g., interviews, focus groups, ethnography, observational studies, classroom interventions) University at Buffalo+15FSU Research+15Rutgers Research+15
• No biomedical or clinical interventions (e.g., no drug administration or medical procedures) FSU Research
• Primary data collection directly from individuals—whether identifiable or anonymous—and where participants provide informed consent
• Educational or behavioral interventions without associated health risks

The HRP-508 serves as a local site supplement to a sponsor‑provided protocol when your institution is participating in a multi-center, industry-sponsored study. It captures site-specific details—such as local recruitment, consent procedures, staffing, facilities, and community considerations—that aren’t covered in the central sponsor protocol.

Use this template when:

• You’re conducting a multi-site biomedical or clinical trial using a sponsor-developed protocol
• Your site is not the lead, but wants to document local implementation specifics
• You need to outline site-level adaptations, like local IRB submissions, staffing, space, recruitment strategies, translation services, etc.
• You’re part of a sIRB/I rely arrangement and must provide institutional context to the IRB of record, including local communications and oversight plans

The HRP‑503b – Template Protocol: Not Human Subjects Research (NHSR) is a standardized framework designed to help researchers request formal determination that their project does not involve human subjects—thus falling outside IRB oversight.

Scenarios