Considerations for Reviewing Human Subjects Research

Covers various considerations for reviewing human subjects research, including subject selection, risk minimization, balancing risks and benefits, and privacy and confidentiality.

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About this Course

These short interactive scenarios are designed to enhance your understanding and knowledge of the considerations for conducting ethical research and protecting human research participants. Topics covered include the equitable selection of subjects, minimizing risks in research, balancing risks and benefits, and protecting research participants’ privacy and data confidentiality.

This course is meant to supplement basic human subjects research training covered in CITI Program’s Human Subjects Research (HSR) series.

Note: This course is only available for subscribing organizations who utilize the HSR series. The course is available at no additional charge.

Disclaimer: The material is a faithful, unchanged (other than reformatting to fit CITI Program’s platform) duplication of the Department of Health and Human Services (HHS) Office for Human Research Protections’ (OHRP) CONSIDERATIONS FOR REVIEWING HUMAN SUBJECTS RESEARCH programs. It is available here at no additional charge. While the CITI Program and the OHRP Trainings are identical in substantive content, OHRP is not responsible for the accuracy of the content reproduction, operation, or record keeping related to the CONSIDERATIONS FOR REVIEWING HUMAN SUBJECTS RESEARCH programs on the CITI Program website and does not endorse CITI Program or any of its products or services.

Language Availability: English

Suggested Audiences: Human Subject Protection Staff, IRB Administrators, IRB Members, Research Personnel, Researchers, Students

Organizational Subscription Price: Included with Human Subjects Research series, available as part of an organizational subscription package or for $1,000 per year/per site for government and non-profit organizations; $1,200 per year/per site for for-profit organizations
Independent Learner Price: N/A


Course Content

Equitable Selection of Subjects

This scenario examines how IRB reviewers and investigators could apply the concept of equitable selection of subjects in research. It takes approximately 30 minutes to complete.

Recommended Use: Required
ID (Language): 21811 (English)
Author(s): Office for Human Research Protections (OHRP)

Minimizing Risks in Research

This scenario examines the concept of research risks and how these risks to participants could be identified and minimized. It takes approximately 30 minutes to complete.

Recommended Use: Required
ID (Language): 21812 (English)
Author(s): Office for Human Research Protections (OHRP)

Balancing Risks and Benefits

This scenario discusses what IRBs may consider as anticipated benefits of research and whether they may be reasonable against the research risks individual participants may bear.

Recommended Use: Required
ID (Language): 21813 (English)
Author(s): Office for Human Research Protections (OHRP)

Protecting Privacy and Data Confidentiality

This scenario examines how researchers can protect research participants’ privacy and what they researchers could do to protect the confidentiality of the research data.

Recommended Use: Required
ID (Language): 21814 (English)
Author(s): Office for Human Research Protections (OHRP)


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