Human Research Protection Program (HRPP) Resources

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OHRP supports institutions in their efforts to evaluate and improve the quality of their human research protections programs (HRPP). OHRP is actively developing and updating outdated resources to assist institutions to achieve this objective. In addition, OHRP is available for consultation to answer specific questions at OHRP@hhs.gov.

Self-Serve Training by Role

Learning about the HHS regulations and policies for the protection of human subjects in research can be challenging. To help you get started, OHRP has compiled educational resources tailored for different roles in human subjects research. Consider attending an OHRP educational event and joining OHRP's mailing list for our monthly newsletter.

• Training Checklist for Someone Working with IRBs
  OHRP created this training checklist to provide basic training on human research protections for someone working in the field. Individuals who may benefit from the checklist include: New IRB members (including community members), IRB administrators, investigators wanting to know what to expect when submitting a protocol for review, and existing IRB members who want to brush up on the basics.
• Educational Resources for Investigators
  OHRP created this list of resources to help investigators learn about and succeed in their role in protecting research subjects. The resources include an introduction to human research protections (including free training), discussion of the Common Rule, and videos to aid in the understanding of informed consent and the IRB review process.
• Checklist of Resources for Learning about Research and Research Participation
  This checklist helps explain what research and research participation is to community leaders and members. It includes informational resources written in easy-to-understand language and offers a progressive, step-by-step way for lay community members to learn about the complexities of research participation and oversight.

For comprehensive training modules on the basics of human research protections with printable completion certificates, check out OHRP's Human Research Protection Training.

Self-Assessment Tool

Institutions can use the OHRP Self-Assessment Tool to conduct a basic self-evaluation of their HRPPs and identify their strengths and areas for improvement. It can be found at: Self-Assessment Tool: The checklist is provided for reference only. OHRP does not provide model responses, review, or comment on institution’s self-evaluation responses.

OHRP offers a comprehensive basic-level training for the research community on human research protections based on the requirements of the revised Common Rule (or the 2018 Requirements), including printable completion certificates. Access these training lessons on OHRP’s Human Research Protection Training webpage.

If you have questions about HRPP quality assessment requirements related to NCATS’s SMART IRB Authorization Agreement, please contact the NCATS SMART IRB office directly.

OHRP Consultation

OHRP is happy to answer questions and provide guidance for institutions with questions about their HRPPs. To contact OHRP with questions, email OHRP@hhs.gov or call OHRP at (240) 453-6900.

Additional Educational Resources

OHRP offers additional educational modules at our Online Education page. These educational modules provide information and answer common questions about the HHS regulations to protect human subjects in research and IRB review of human subjects research.

If you have questions about OHRP's educational resources, contact OHRP at OHRP-EDU@hhs.gov or call OHRP at (240) 453-6900.