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OHRP Correspondence

  • Student Subject Pools and Use of Penalties for Students Who Fail to Show up for Scheduled Research Appointments (January 8, 2010)

    OHRP has posted its January 8, 2010 letter to a commercial company, which provides a web-based system for managing student subject pools, in the belief that others may find the content to be useful. This letter clarifies that imposing penalty credits on students who fail to show up for scheduled appointments with investigators without cancelling by a specified deadline violates the requirement of Department of Health and Human Services (HHS) regulations at 45 CFR part 46.116(a)(8). Such penalties may not be implemented for non-exempt human subjects research conducted or supported by HHS or for non-federally supported research to which an OHRP-approved Federalwide Assurance (FWA) applies. OHRP's determination in this matter applies to any system used for managing student subject pools, not just the commercial web-based system referenced in OHRP's letter.

    While the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) has language identical to the provision under HHS regulations at 45 CFR 46.116(a)(8) prohibiting imposition of any penalty if an individual refuses to participate in research and most other federal departments and agencies accept the FWA for the research that they conduct or support, OHRP does not interpret or enforce the human subjects protection regulations for any other federal department or agency. Therefore, OHRP's determination regarding the use of penalties as a component of student subject pool management systems does not necessarily extend to research conducted or supported by other federal departments and agencies. OHRP recommends that, for research conducted by a federal department or agency other than HHS, institutions using the student subject pool management system referenced in our letter (or similar systems) consult with that department or agency regarding the acceptability of imposing penalties on students.

    Finally, OHRP's letter describes some acceptable alternative approaches for encouraging students to show up for scheduled appointments with investigators without imposing penalties on students who fail to show up.

    The links below provide the full text of OHRP's January 8, 2010 letter. OHRP welcomes comments on the content of this memorandum. Comments on this or other topics may be submitted to OHRP by email at ohrp@hhs.gov. Please include the phrase "January 8, 2010 letter regarding student subject pools" in the subject field. Alternatively, comments may be submitted to:

    Office for Human Research Protections
    1101 Wootton Parkway, Suite 200
    Rockville, MD 20852

    Comments received, including any personal information provided, will be made available to the public upon request.

    Letter [PDF - 116KB]

 

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Last Updated: January 11, 2010