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Human Research Protection Program Fundamentals

OHRP supports institutions in their efforts to evaluate and improve the quality of their human research protections programs (HRPP), and offers resources to help institutions evaluate and strengthen the quality of their HRPPs. Available resources include a basic tutorial about the HHS regulations to protect human subjects in research, and an HRPP self-assessment.

The following resources comprise OHRP’s Quality Assessment Program. Completion of the online tutorials and self-assessment tool provides individuals with the basic expertise required for HRPPs. In addition, OHRP is available for consultation to answer specific questions as needed.


Introduction to Human Research Protections

Online tutorials explain the basics about the HHS regulations to protect human subjects in research, how HRPPs work to protect human subjects in research, and institutions’ responsibilities in human research protections.

New online tutorials are being prepared and will be posted here once completed. In the meantime, you can view the previous versions at: https://ohrp-ed.od.nih.gov/CBTs/Assurance/login.asp. (Once you are on the page, click "browse" to navigate to the available modules.)

Please note:

  • The previous versions of the training modules are out of date, and developments over recent years have made portions of the information obsolete. OHRP cautions viewers to verify the validity of the information in these modules before relying on it in a human research protections program.
  •  Links to OHRP guidance documents in these training modules no longer work. Below are updated links to those guidance documents.

·  Informed Consent Checklist

o   https://www.hhs.gov/ohrp/regulations-and-policy/guidance/checklists/index.html

·  Informed Consent, Legally Effective and Prospectively Obtained

o   https://www.hhs.gov/ohrp/regulations-and-policy/guidance/legally-effective-and-prospectively-obtained/index.html

·  Informed Consent of Subjects Who Do Not Speak English

o   https://www.hhs.gov/ohrp/regulations-and-policy/guidance/obtaining-and-documenting-infomed-consent-non-english-speakers/index.html

·  Certificates of Confidentiality

o   https://www.hhs.gov/ohrp/regulations-and-policy/guidance/certificates-of-confidentiality/index.html

·  Continuing Review Guidance

o   https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-continuing-review-2010/index.html


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.  OHRP is developing an updated self-assessment tool and will make it available when it is complete.

The list of QA questions in the tool is for institutional self-assessment only. Please do not submit your responses to OHRP for review. OHRP does not collect or assess responses to this online self-assessment tool, and currently does not support any other quality assessment program. Information on programs and materials that have been archived are outdated and no longer applicable.

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, send an email to OHRP-EDU@hhs.gov or call OHRP at (240) 453-6900.

Additional Educational Resources

OHRP offers additional educational modules on the Online Education page. These short, interactive 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 your HRPP or OHRP’s quality assurance program resources, contact OHRP at OHRP-EDU@hhs.gov or call OHRP at (240) 453-6900.

Content created by Office for Human Research Protections (OHRP)
Content last reviewed on March 4, 2016