Protecting Human Subjects in Student Inquiry Projects

Federal regulations and resources

Free OHRP workshop in Minneapolis on Monday, May 7, 2012 (Acrobat (PDF) 231kB Feb23 12)
A link to the workshop announcement and registration information; limited to the first 100 to register

45 CFR 46 – The Common Rule
The federal regulations governing human subjects protection and IRB policies and procedures

The Belmont Report
The ethical bedrock of human subjects protection, prepared in 1979 and setting forth the ethical principles that underlie the Common Rule and the expectations for other research activities involving human subjects that are not subject to the Common Rule

Office for Human Research Protections (OHRP)
Home page for OHRP, a division of the federal Department of Health and Human Services, responsible for providing regulatory oversight, education, and guidance related to the protection of human research subjects and the enforcement of federal regulations

OHRP policy and guidance
Index page to a wide variety of educational and advisory materials for investigators, institutions, and IRB members

OHRP decision charts
A series of decision charts that can help determine whether a proposed investigation or inquiry activity constitutes research with human subjects that must be reviewed by an IRB

OHRP human subjects research FAQs
Recommendations and policy advice representing OHRP's current thinking on a wide variety of topics, including research with children, informed consent, and the distinction between research and "quality improvement activities."

OHRP guidance on research conducted outside the US
A brief section of the 1993 OHRP guidebook that treats the special circumstances of international research; this material is in the OHRP archives and has not been updated, but was recommended by OHRP staff

OHRP guidance on research with special classes of subjects
A chapter of the 1993 OHRP guidebook devoted to research with children, the elderly, members of minority groups, students, and other categories of research participants; this material is in the OHRP archives and has not been updated, but was recommended by OHRP staff

OHRP guidance on determining when an institution is "engaged" in human subjects research
Recommended factors to consider in determining institutional responsibility for research investigations, which can have a bearing on the jurisdiction of an institution's IRB in relation to specific projects

Information about institutional Federalwide Assurances
Definitions, procedures, and FAQs concerning the process and implications of filing, updating, and maintaining a Federalwide Assurance of institutional compliance with the requirements of the Common Rule