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The federal regulations are quite clear. If a research study uses humans as subjects, the project must be approved by an institutional review board to ensure that ethics guidelines are followed and that the privacy of the participants is respected. But if an undergraduate is conducting the study, can this person, possibly still a teenager, assume such huge responsibility?
At Brown, the answer until this summer has been yes. But no longer: In July, Brown announced that the primary investigator for any research project submitted to the institutional review board for approval must be a faculty member. In the past, the informal policy allowed undergrads to assume chief accountability, with faculty signing on as a research co-sponsor. Undergraduates were the primary investigators on 35 of the 135 study projects that Brown’s IRB approved in the 2006 fiscal year.
“We didn’t feel that undergrads should be totally responsible when they are still learning,” said Dorinda Williams, Brown’s director of the human research protections office, which staffs the review board. Doing so, she said, places undergrads in an “untenable position.”
Williams added that university officials explored the problem for a number of months and found that they were the only Ivy League institution to allow undergraduates to serve as the primary investigator. An article in The Brown Daily Herald said that the university was changing its policy because undergraduate students were submitting poorly written applications to the review board.
However, Williams said the quality of the submissions is not what spurred Brown to act. “It was a symptom, not an issue,” she said. But she went on to say that many of the proposals from undergraduates lacked clarity and detail about the ethical nuances of study. “It is important that people understand the complications of working with people,” she said.
The
story also quoted anonymous faculty members complaining that the change in university policy would decrease the number of students doing research. “From the start, there were faculty that were not pleased,” Williams confirmed.
Brown’s associate vice president for research, Regina White, said that she had also heard grumblings. “I had one faculty member tell that they would not advise students if they were using human subjects,” she said. “I hope that is not the case.”
White added that she felt it was inappropriate to place students who are still relatively early in their educations in a position where they have to make potentially profound ethical judgments. Students will still conduct research, but they now sign on as co-investigators.
Brown may have been alone in the Ivy League in allowing undergraduates to act as primary investigators in research experiments, but at least some other colleges let undergrads assume full ethical accountability for their scientific studies. The policy posted at Wheeling Jesuit University, for example, is quite explicit: “[N]o applications to the IRB from either an undergraduate or a graduate student will be reviewed unless sponsored by a faculty or staff member familiar with the student and the proposed activity.”
“If the student is going to conduct the research, then they are the P.I,” said Bev Carter, chair of the institutional review board at Wheeling Jesuit. “They are responsible for all the ethical issues.” Still, faculty must advise the students on the study. But not all of them seem to take it completely seriously, she suggested. "Sometimes we had faculty tell us that they didn’t read the proposal and just signed off.”
Carter said that she has often had to reject proposals from undergraduates because they didn’t contain enough substance. Training, she said, can help both faculty and students improve their understanding of requirements.
She agreed with officials at Brown that faculty need to actively mentor students, but said that the students conducting the research should remain responsible for addressing ethics. “I think that students need to learn this,” she said.
When asked if undergrads should assume chief responsibility for a study, Carol Blum, director of research compliance at the Council on Government Relations, said, “It’s not something that you would want a 19-year-old to do. But you do want them to learn research.” She said that she was not certain if other large research universities allowed undergrads to take the lead on proposals to IRBs.
“I don’t think it’s a great idea on the face of it,” said Gregory Cooper, who directs the ethics program at Washington and Lee University. He pointed out that the National Institutes of Health requires that graduate students receive a short course in ethics. Undergrads would lack even this short amount of training, he said. “It seems like an awful burden to put on an undergrad.”
However, his colleague, Jeanine Stewart, a professor of psychology, read Washington and Lee’s IRB guidelines and was surprised to find that undergraduates may shoulder primary responsibility. “It would appear that our policy does not preclude that,” she said.
