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Presented by the FDP Human Subjects Protections Subcommittee

Current federal regulations allow considerable latitude for institutions to develop their own internal policies and procedures for human subjects research.

With this Practical Guide, we seek to provide a set of tools that will allow institutions to reduce administrative burdens and maintain superior standards of human subject protection while adhering to federal regulations. These tools are based on the suggestions of our forward-thinking colleagues, particularly the Secretary’s Advisory Committee on Human Research Protections (SACHRP), and on our own experiences with successful demonstration projects. We welcome further input from others as we continue to develop and improve this resource.

Some ideas and examples presented in this guide may require customization and considerable consultation with various interested institutional parties prior to implementation. Other resources, like “Ways to Make Your Study Exempt” are meant to empower individual investigators.

Please click here to access the full Practical Guide for Reducing Regulatory Burden.


The Federal Demonstration Partnership (FDP) Human Subjects Protections Subcommittee is a part of the FDP Research Compliance Standing Committee.

Please contact Lois Brako (, if you have general questions, comments, or ideas about this guide. Feedback about specific topics should be directed to the contact listed at the end of each section.