Committee supervises ethics of human testing

From new cardiology studies to students that go overseas and want to interview people, the Committee for the Protection of Human Subjects answers ethical questions about human research at Dartmouth. The committee is an interdisciplinary group of experts and community members who analyze the risk posed to participants by Dartmouth-affiliated researchers' studies.

As Dartmouth's incarnation of a federally-mandated institutional review board, the committee analyzes proposals for research on human subjects from Dartmouth-Hitchcock Medical Center and the Veterans Affairs Medical Center in White River Junction, as well as the College's graduate and undergraduate departments.

While all studies involving human participants are subject to review by the committee, those that receive funding from sources other than the government must pay a review fee to the committee office.

A division of the Provost's Office, the committee is financed in part by federal funds allocated to Dartmouth for research. Accordingly, its review process follows federal policies to ensure "respect for persons, beneficence and justice," according to a Department of Health and Human Services report.

Major areas of ethical concern include the research's medical relevance, involvement of vulnerable populations, its informed consent process and use of deception, said assistant provost for research Liz Bankert, a member of the committee.

The current federal regulations were last revised in 1991 and often fail to give adequate ethical guidance on modern research questions, said Bankert, who also serves on a national research ethics advisory committee.

A forthcoming policy initiative from the Department of Health and Human Services could expand federal regulations to cover research involving the Internet, medical databases and biological specimen repositories and provide guidance for the use of new technologies like genomics. Other upcoming reforms will streamline the review process of multi-site studies. Currently, a study carried out at more than one location must receive approval from each institution's review board before research can begin.

While one solution could be to assign responsibility for all record-keeping to a single institution, new policies could also make use of commercial or national review boards to evaluate multi-site research proposals. In that case, the approval process would become more efficient but would lose the benefit of local insight.

"Right now everything is on the table," she said.

National reforms could also limit institutional review boards' regulatory power, reacting to concerns that the boards might stall research.

Committee analyst Kimberly Lyford said that though the board's primary interest is to protect human subjects, they also help protect the College from "sensitive" studies, such as those that ask undergraduates about illegal behaviors like underage drinking.

"I think that's why we try to be as careful as we are," she said. "Sometimes researchers don't understand why we are asking them to take as many precautions as we do."

Anonymous surveys and evasive questioning techniques provide some protections to students but prevent researchers from obtaining direct answers from undergraduates about their behavior.

While the National Institute of Health offers a certificate of confidentiality that protects study data from being subpoenaed, Lyford said she is unsure how effective it would be in protecting undergraduates who admitted to illegal behavior in a survey.

Proposals involving more sensitive or complicated concerns, often from researchers in the psychological and brain sciences department, require longer periods for review, while simpler, "low-risk" studies are processed more quickly, Lyford said.

Neuroscience professor Paul Whalen's brain imaging research on anxiety received serious scrutiny from the committee when he proposed a study that involved giving moderate doses of alcohol to participants.

"We found that alcohol is a pretty interesting thing to study on this campus because it's pervasive," he said. "Undergraduates are drinking alcohol, as are graduates, as is just about anybody."

In the case of Whalen's study, the committee recommended screening procedures that asked participants directly about their alcohol use in order to identify those who may have substance abuse problems. Other protections include repeated analysis of blood alcohol content levels and a waiting period after the participants finish the trial before they are released.

"I think they have a really tough job where they have to balance keeping people safe with getting science done, and I have always found them very good at balancing this," he said.

A small group of reviewers evaluate a proposed research protocol before it is discussed by the committee as a whole. Much of the deliberations revolve around the consent form's language and whether a study puts a patient or subject at undue risk.

A majority of the quorum must vote affirmatively on a proposal for it to be approved, Bankert said.

The committee reviews about 60 to 75 studies each month, including proposals for new research, renewals and revisions. Less than 10 percent of new research proposals are rejected and most are approved with minor revisions.

The committee rarely faces a split vote, Bankert said.

The committee consists of 64 members, including physicians, lawyers, professors, community members that are unaffiliated with the College and others, committee chairman Daniel O'Rourke said.

"The nice thing about the committee's makeup is that there are various members who come to the question at hand from a different point of view," he said. "It's an interactive meeting."

The office has expanded significantly since the early 1990s, when two research-related deaths incited a national overhaul of oversight requirements.

Today, three main committees run by the Committee for the Protection of Human Subjects office process most research proposals and a fourth manages time-sensitive or emergency cases.

University of Connecticut professor Rick Gibbons, who taught and conducted research at Dartmouth between 2008 and 2012, praised the committee's thoroughness in evaluating his studies, which investigated underage drinking, risky sexual behavior and adolescent drug use.

"There are federal guidelines for this, and if they're not followed, then everyone gets in trouble the College and the researcher," he said.

Gibbons said that only one research proposal, submitted by a graduate student in his lab, encountered undue difficulties in the evaluation process. The study examined the effects of media imagery on eating behavior, and its connection to eating disorders a topic that could potentially be "emotionally disturbing" delayed its approval until shortly before the student's graduation, he said.

The vast majority of the time, however, the committee review process led to distinct improvements in Gibbons' study designs.

"It's a time consuming process for people who are on the committee and they were doing a very good job," he said. "They asked appropriate questions and had clearly done their homework."

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