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Institutional Review Board

Background Information on Human Research Protections


Review the set of infographics Protecting Research Volunteers to get an overview of the General system of protections.

Review the Belmont Report, which provides the ethical foundation for protecting human research subjects in the US.

Free Training on Human Research Protections


Complete the OHRP's free online Human Research Protection Training, an up-to-date comprehensive training based on the requirements of the revised Common Rule. This five-lesson training satisfies the NIH educational requirements for training on human research protections for investigators and key personnel. 

Information on When the Common Rule Applies to an Activity


Watch the video When Does the Common Rule Apply? Review the Basics Under the Revised Rule (~18 minutes) to understand the requirements and flexibilities afforded by the regulations for human research protections. 

Review Human Subject Regulations Decision Charts. According to OHRP, these "graphic charts are intended to aid those who need to decide if an activity is research involving human subjects that must be reviewed by an institutional review board (IRB) and whether informed consent or the documentation of informed consent can be waived under the 2018 Requirements found for the U.S. Department of Health and Human Services (HHS) at 45 CFR part 46, Subpart A."

Videos and Information on Informed Consent


Informed Consent: What to Expect? (Video for prospective participant of research, ~8 minutes)
General Informed Consent Requirements (Video for investigators, ~19 minutes)
What's New in Informed Consent: Revisions to the Common Rule (~27 minutes)
Information on Clinical Trial Informed Consent Posting Requirement
Informed Consent FAQs
Revised Common Rule Q&A on Informed Consent

Videos on Institutional Review Boards (IRBs)


Institutional Review Boards (~7 minutes)
What you Should Know About IRB Review of Research (recorded webinar, ~55 minutes)

Information on Reporting Incidents to the IRB and ORHP


Guidance on Reporting Incidents

Videos for Investigators Who Do Research Primarily with Data & Biospecimens


Regulatory options for Secondary Research with Private Information and Biospecimens Part 1 (~25 minutes)
Regulatory options for Secondary Research with Private Information and Biospecimens Part 2 (~16 minutes)

Materials for Investigators Doing Clinical Research


Videos of the discussion in OHRP's 1-day 2018 Exploratory Workshop entitled Meeting New Challenges in Informed Consent in Clinical Research.

Understanding the HHS Regulations for the Protection of Human Subjects in Research


Watch videos to learn more about the regulatory requirements for human subjects in the Revised Common Rule.
Access a collection of Revised Common Rule Resources. 
IRB Resources

 
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