Balancing risk and research

Joan Sieber, PhD, is retired from teaching at California State University, East Bay, but she still remembers the frustration faced by one graduate student dealing with an institutional review board (IRB) years ago.

The student wanted to survey scientists about how they handled setbacks in their research. But the IRB wanted the student to first mail a consent form to each subject, and only send out the questionnaire once a consent form was signed and sent back--a step that would have significantly reduced the response rate, Sieber says.

The argument over the consent form went back and forth between the student and the IRB for about six months, delaying the student's graduation.

"There was much argument, and I think the student just gave up and undertook a different project," Sieber says. "I think it left [him] with a very bitter taste in his mouth."

For graduate students pursuing psychological research, working with IRBs will be one of their most significant challenges--both while earning their doctorates, and during their careers if they enter the academic world.

All federally funded research institutions must have an IRB, whose members are drawn from the university community and also include at least one nonacademic member drawn from the community. The IRB's mandate is to ensure that the rights and welfare of a study's participants are protected, and the board members often ask questions about research methodology, a study's potential benefits, and the ways the researchers will secure participant consent and preserve confidentiality.

"IRBs are, essentially, a way of institutionalizing reflection about how it is people carry out the practice of psychological research," says Ivor Pritchard, PhD, senior fellow at the federal Office for Human Research Protections, within the U.S. Department of Health and Human Services.

Often, they live up to their mission. For instance, Celia Fisher, PhD, a professor of psychology at Fordham University, says an IRB has helped protect the privacy of one group of people she studies, drug users who are HIV positive.

For one study, Fisher and her fellow researchers wanted to recruit drug-using subjects from a network of drop-in social service centers. At the IRB's suggestion, Fisher hired someone unconnected with the research to conduct interviews and obtain informed consent from potential participants--keeping researchers separated from the initial contact.

"This way, they were able to not reveal to us their drug-use habits, unless they truly wanted to be in the study," she says.

But working with IRBs is something that can frustrate even veteran researchers. Some persistent problems researchers face in dealing with IRBs include defining what constitutes minimal risk to human participants, coping with delays and facing varying requirements from different IRBs when a study involves multiple locations.

But perhaps the most ominous problem, say researchers, is IRB "mission creep"--a tendency to add requirements driven not by regulations or ethics, but concerns over the possibility of lawsuits and bad publicity.

But there are steps students and veteran psychology researchers can take to make their interactions with IRBs more efficient and productive. For instance, students who know they'll need to complete a study for a specific class should consider starting to work with an IRB before the course begins, Pritchard says. And institutions and professional organizations are meeting them halfway. In fact, an APA presidential task force is studying ways to improve the operation of IRBs, and may pay special attention to easing the burden for students conducting minimal-risk research.

STICKING POINTS

Among psychological researchers, two perennial concerns with IRBs are defining "minimal risk" to human participants and ensuring confidentiality, says Fisher, who co-chaired a 2005 conference on minimal risk sponsored by APA's Science Directorate at Fordham. Researchers complain that some IRBs have started to evaluate risk as any conceivable harm--however improbable--that a study could cause. For instance, it's extremely unlikely that students taking a survey on drug use will start abusing drugs more as a result, but an IRB might ask a researcher to consider that possibility. Protecting participants' confidentiality is also an important mission of IRBs, but researchers contend that some boards place too much emphasis on the damage that might be done if participants' information was released. For example, in a drug-use study, an IRB may become hung up on the damage to a teen's desire for privacy if someone else got access to her survey response. IRBs more profitably would use their time to ensure that confidentiality procedures keep such breaches from happening, says Fisher, who serves as the director of the university's Center for Ethics Education.

For some students, that question of risk can discourage them from pursuing promising lines of research, particularly in working with adolescents, Fisher says."Students are under a timeline," she says. "They don't want to spend two years trying to get permission from the IRB."

A 2003 National Academy of Sciences report, "Protecting Participants and Facilitating Social and Behavioral Sciences Research," outlines other concerns with IRBs. For one, researchers believe IRBs spend too much time documenting consent, rather than developing forms that would ensure participants fully understand what they were consenting to.

Another group of experts with the Center for Advanced Study published a paper on IRBs in 2005, which concluded that IRBs now tend to require more documentation for studies involving low risk-or even no risk--to participants. That type of overzealousness can undermine the overall research process, says paper co-author C.K. Gunsalus, a law professor at the University of Illinois.

"The more you do silly things in the name of ethical regulation," says Gunsalus, "the more you erode the buy-in that's essential from the community."

In her view, IRB focus on documentation creates unnecessary paperwork and consumes valuable time. For students, it also shifts the emphasis away from understanding how to behave as an ethical professional to overzealous documentation, she says.

LOOKING FOR CHANGES

To improve the working relationships between IRBs and psychological scientists, APA President Sharon Stephens Brehm, PhD, formed the Presidential Task Force on Institutional Review Boards and Psychological Science, a six-member group chaired by Thomas Eissenberg, PhD, an associate professor at Virginia Commonwealth University. One question the task force is exploring is how many research protocols fall into each of the three categories for IRB review: full-board review, expedited and exempt. Under full-board review, a majority of the IRB members present at a meeting must approve the research for it to go forward. A study can fall under expedited review if it involves no more than minimal risk to human participants and fits into one of nine categories of research that may be reviewed by an IRB through an expedited review procedure, or if it involves minor changes in recently approved research.

Under expedited review, the IRB chair can carry out the review, or designate an experienced IRB member to conduct it.

Research can also be exempt from IRB review if, for example, it involves the collection or study of existing data that are publicly available. Research may also be exempt from review if the information is recorded in a way that participants cannot be identified.

To back up its findings with evidence, the task force directed members to ask their universities' research offices to report on how many protocols submitted to their local IRB in 2006 qualified as exempt. They are finding that what should be exempt protocols at some schools go through a lengthy IRB review process, Eissenberg says.

The task force is investigating if there might be methods for quickly deciding whether a protocol is exempt, which would allow IRBs to skip much of the administrative back-and-forth that swallows up researchers' and IRB members' time. Such achange would make life easier for many psychology graduate students, he says.

"I think a lot of students are falling into this category,"Eissenberg says. "All of my graduate research would have been considered exempt."

For students, the benefits would include shorter wait times for approval, greater emphasis on data collection, less emphasis on describing details of protocols for exempt IRBs, and less regulatory burden once the study gets approved and data collection is ongoing, Eissenberg says.

The task force may also encourage institutions to educate students on IRBs' functions, and why they are necessary, he says.

At press time, the task force planned to present its preliminary findings on Aug. 19 during APA's Annual Convention in San Francisco, and will meet again in October to start developing a formal report on their findings.

NEGOTIATING THE SYSTEM

How can you wind your way through the IRB maze? Howard University sixth-year clinical psychology student Ericka Jenifer advises students to seek out the people who know.

In her experience, that meant developing a rapport with Donalia Clay, the administrative assistant for Howard's IRB, who offered her advice on writing her protocols and kept her informed of their status.

"She was just extremely helpful in making sure things went smoothly," says Jenifer who has studied relationships between post-traumatic stress disorder (PTSD), emotional eating and eating pathology in female survivors of sexual assault. She is currently researching the interactions between PTSD, racism and anger among African Americans.

In addition to developing contacts with IRB officials, students and professors familiar with the IRB process advise students to:

• Write clearly. IRB members often come from different disciplines, so avoid jargon when you explain your study. Succinctly describe the research's purpose and methodology. Given that IRB members are usually donating their time review protocols, making it both readable and comprehensive will speed up the approval process, Jenifer says.

• Cover the main points in the protocol. Describe all of the potential benefits of your research, how you will recruit participants and obtain consent, who your study population is and how you will protect confidentiality. If your research is minimal risk, explain why. "Don't leave anything for them to have to assume," Pritchard says.

• Get feedback. Ask classmates and professors to look for gaps in your proposal. Experienced researchers can spot the "red flags" that might slow down your application. For instance, any study that might deceive subjects as part of the research would need a complete description of why the deception is necessary, and how subjects will be debriefed afterward, says J. Michael Oakes, PhD, an epidemiologist at the University of Minnesota who studies IRBs.

• Learn how IRBs work. Read the IRB regulations at the federal Office for Human Research Protections' Web site, at www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Also, read "The Belmont Report," the document providing the foundation for the IRB system, available at www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm. Students can also get an insider's view of IRBs by sitting in on an IRB meeting, with their permission, of course.

• Understand IRB timelines. Given that most IRBs meet monthly, build extra time into your application process so that any changes don't eat into the time you need to recruit your subjects and gather your data.