OHRP: No penalties for research no-shows

University students can't be docked class credits

Many universities are rewriting their student subject pool policies in the wake of a decision by the Office of Human Research Protections (OHRP) regarding penalizing students who fail to show up for research appointments.

The OHRP correspondence, released in January, states that taking away research credits from students as punishment for breaking their appointments violates federal requirements that research participation be completely voluntary.

The ruling came in the form of a letter to an Estonian company that provides human subject pool management software, but the ruling also is causing repercussions at universities that do not use the software.

"Under the provisions of 45 CFR 46.116(a)(8), students must be free to choose not to participate in research that they have signed up for at any time prior to the start of their involvement in the research," OHRP Associate Director for Regulatory Affairs Michael Carome, MD, wrote in a letter to the company. "Furthermore, students must be free to communicate their decisions not to participate in research in whatever way they choose, including by simply not showing up for the research."

The correspondence notes that the ruling applies to non-exempt human subjects research conducted or supported by the U.S. Department of Health and Human Services (HHS) or to non-federally supported research to which an OHRP-approved Federalwide Assurance applies.

James R. Larson, PhD, a psychology professor the University of Illinois at Chicago, has coordinated UIC's student subject pool for 25 years. His institution does not use the software in question, but he's still revamping UIC's policies, which did assess penalties against students who missed research appointments.

"I think assessing these penalties is very common," he says.

Options for credit

Under the terms of the UIC student subject pool, students in Psychology 100 classes gain credits for participating in IRB-approved studies conducted by psychology researchers on campus. Students also can earn credits by serving as simulated clients in training sessions for advanced psychology students, which is not technically research, but has a participatory element to it, Larson says. A third credit option is for a student to complete a written assignment based on published research.

He says the university has its own software to track students' participation. Students can sign up for studies online and researchers record their attendance. Prior to the OHRP letter, students who failed to show up for a scheduled research appointment without cancelling up to the day before were penalized one hour's credit (a total of eight credits are required for the course).

"Certainly if there was an emergency or a legitimate excuse, those penalties were waived," Larson says. "But if they don't show up, if they just forgot, they're being irresponsible."

According to the UIC's subject pool policy, students can withdraw from a study without penalty if they stay for the informed consent process and determine that they don't want to participate. Larson says he believes most students who skipped appointments weren't doing so because they were concerned about the requirements of the study.

"There's really no evidence that's the case," he says. "I think what goes on in a psychology subject pool is probably a little different than what goes on in medical research or where people from the community are participating.

"It's not that college students aren't adults, but they haven't quite got it together yet. They just tend to blow things off a lot."

Researchers, students hampered

Larson says that even with the previous penalties in place, the pool usually had a 6% to 8% no-show rate. He says no-shows can greatly hamper researchers, particularly those who study one-on-one interactions or small groups.

"Some people do research where they'll get 10 or 15 people in a room to fill out a questionnaire. One person missing from that or even 6% missing from that is not a huge setback to the research," he says.

"But lots of researchers do research one person at a time. And it takes an hour to collect the data points. So if somebody doesn't show up they've lost that hour, they've collected no data."

Larson says if a researcher is looking at the dynamics of a group of three or four people and one participant is missing, the study may not be able to go forward. "In this scenario, you have four times the opportunity for someone not to show up. That's very problematic for those kinds of researchers."

He says no-shows also inconvenience other students who are working to get their required credits.

"If the person had withdrawn from the study (with notice), another student could have made use of that opportunity," Larson says. "I've got 1,000 students who are trying to earn these extra credit points. And the competition gets a little fierce sometimes, so it's a problem when someone else is not showing up and preventing others from doing what they want to do."

Alternatives offered

In its letter, OHRP recommends some possible options for dealing with no-shows that do not violate federal requirements:

  • Awarding a credit point, or some fraction of a point, to students for showing up for appointments.
  • enalizing students who don't show up by limiting the amount of credits they can earn through research participation, as long as there are non-research alternatives available to them.

Larson says he plans to use a form of the latter suggestion. If a student fails to show up without giving a day's notice, that student cannot earn that particular credit through research participation or by serving as a simulated subject in training exercises – leaving only the option of a written assignment for that credit. The student can continue to earn other credits through participating in research.

Larson still must get the changes approved by his IRB, which reviews the subject pool policies annually.

The American Psychological Association released a statement to members outlining the OHRP correspondence and asking for input from researchers. According to Sangeeta Panicker, PhD, director of research ethics for the Washington, DC-based APA, both her office and the organization's newly formed Committee on Human Research will examine the OHRP decision to assess its impact.

Health and Human Services spokesperson Lt. Kate Migliaccio says about 20 people, most of them psychology researchers, have submitted emails in response to OHRP's invitation for comments on the correspondence.

"Most of the comments disagreed with this determination and many asked for OHRP to reconsider its position," Migliaccio says. "However, none of these individuals addressed why the additional options that were outlined in the letter might not lessen or even eliminate their concerns."

Larson says he's unsure how his institution's new approach will affect no-show rates. But he sees no point in trying to fight OHRP over the matter.

"I tend to see the federal government as an unmovable object," he says. "They've laid out an alternative that may work. It seems like we ought to at least try it. We don't know if it will work, it's an empirical question, we'll see."

For more information on the correspondence, visit the agency's Web site at www.hhs.gov/ohrp/policy/correspond/.