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Human Subjects Division (HSD)

Regulatory Updates

OHRP: Student Pools and Use of Penalties

Jan 11, 2010 at 6:28am

OHRP has posted on its website a 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 (see http://www.hhs.gov/ohrp/policy/protocol/ohrp20100108.html). 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.