Observation

Penalties for Student Research Participants Failing to Show Up for Studies?

The Office for Human Research Protections (OHRP), a unit of the U.S. Department of Health and Human Services (HHS) that oversees participant protections in all HHS-supported research, announced this past January that federal regulations do not allow the penalization of students who sign up for a research study as part of a course requirement and then fail to show up for the appointment without cancelling in advance. The announcement and relevant documents are posted on the OHRP website (http://www.hhs.gov/ohrp/policy/correspond/OHRP20100108.html). You’ll see that OHRP’s letter to the third part management company involved describes some acceptable alternative approaches for encouraging students to come to scheduled appointments with investigators without imposing penalties on students who fail to show up.

The behavioral research community should take notice of this announcement. Some researchers and institutions don’t impose penalties, but those who do may have to change their procedures in order to, in their view, effectively conduct research with students. There is debate around the issue, ranging from the idea that consent to participate in research must be voluntary and devoid of any undue influence (and this is actually written into the federal guidelines), to the view that penalties help instill in students a sense of responsibility and respect for the scientific enterprise. Of central importance is decisions about attendance incentives and to what extent they should be decided by local IRBs.

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.

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