Feature

University officials charged with protecting human research participants face a tall order: design a system that meets federal regulations, safeguards participants and shields the institution from legal liability without stymieing investigators who are conducting valuable studies. But a growing organization, the Association for the Accreditation of Human Research Protection Programs (AAHRPP), believes it can help.

Founded in 2001 by a group of primarily biomedical nonprofits, but including the Consortium of Social Science Associations--of which APA is a member--AAHRPP certifies human protection programs including institutional review boards (IRBs). These federally mandated ethics committees oversee any research requiring human participants.

Through AAHRPP accreditation, an IRB reviews and documents all of its practices, gains suggestions for improvement from IRB specialists--often officials from other research institutions--and demonstrates a commitment to protecting human subjects and soliciting from them truly informed consent to participate in the research, says psychologist and AAHRPP Executive Director Marjorie Speers, PhD. Going through the accreditation process can even garner extra resources for the university IRBs that review behavioral research, which are often separate from well-funded biomedical oversight committees, she says.

"Accreditation is especially helpful to behavioral and social science programs because often those programs are understaffed and under-resourced," says Speers.

But with added leverage may come new roles, notes Joan Sieber, PhD, a psychology professor at California State University at Hayward and a member of AAHRPP's Council on Accreditation. In particular, accredited behavioral science IRBs require psychological researchers to use their expertise to ensure participants know their rights as participants, instead of just asking them to sign a form--all too often the standard for university research, she says.

"Consent forms unfortunately tend to be written by university lawyers; they are dense legalese," says Sieber. "As a psychologist, you want to interview someone about how they really feel about something--make sure they understand what they are signing up for."

While Sieber believes accreditation is worth the time and the cost to a university's research administration--from $8,100 to $26,600 depending on the complexity of the research program--some psychologists say that voluntary accreditation adds an unnecessary layer of oversight to an already bloated process.

Accreditation's benefits

In an effort to assuage such concerns, AAHRPP "bends over backwards" to suggest areas of improvement rather than prescribing specific solutions, says Sieber.

"AAHRPP encourages each institution to be thoughtful and creative in figuring out the best ways to do research ethically," she says.

In fact, the heart of the accreditation process--institutional self-evaluation--provides a structure by which a university can find potential areas of improvement, she notes. For example, clinical researchers at the University of Iowa discovered through the AAHRPP-guided self-assessment that they recruited many research participants from their medical center, but these potential participants were often surprised by waiting-room requests to join a study. To better prepare potential recruits to make informed decisions, the University of Iowa's IRB created informational brochures detailing the kinds of questions patients may want to ask before signing up for a study--such as the time commitment and potential risks of participation.

Additionally, the University of Iowa benefited from simply documenting its existing IRB procedures through the AAHRPP application process, says its associate vice president for research, David Wynes, PhD. Recorded and publicly available procedures can even provide some protection against litigation, notes Sieber.

Moreover, AAHRPP documentation and verification can decrease the likelihood of an audit from federal agencies, such as the Office for Human Research Protections (OHRP) at the Department of Health and Human Services, claims Speers.

But who is looking out for the interests of investigators? According to Sieber, an AAHRPP accreditation requires that a university not burden researchers with unnecessary oversight.

"IRBs at organizations seeking accreditation are surprised that AAHRPP faults them for failing to use expedited review and exemption as permitted by the [federal] regulations," she says. For example, the law says that studies of adults that do not require that participants provide their names can bypass much of the IRB approval process, notes Sieber. AAHRPP discourages oversight committees from wasting their resources by reviewing such research, she says.

The accreditation organization also encourages IRBs to exempt some psychological research--specifically, studies where there is almost no risk to adult participants--from informed-consent requirements, says Sieber.

"AAHRPP is...working to guide IRBs to use the flexibility permitted within the federal regulations to foster, rather than inhibit, good science and creative research on sensitive problems," she notes.

Researcher responsibility

Despite these benefits, AAHRPP accreditation may be beyond the budgets of some universities. Mississippi State University, for example, has decided not to pursue accreditation at this time, though the school's administrators do see the value in such oversight, says Tracy Arwood, the school's director of regulatory compliance.

"The cost is just prohibitive," she says. "This is probably not uncommon for schools, especially state schools, given all of our state budgets are in a budget crunch."

And many of the benefits of AAHRPP oversight, such as the procedural documentation that results from self-evaluation, can be obtained free-of-cost through the OHRP's Quality Improvement Program, note some researchers.

But for many universities, accreditation is worth the cost, notes Speers. Fourteen research organizations--including three universities--have already received accreditation, she notes, and nearly 200 more are currently in the application process. Once accredited, researchers at these institutions will be required to:

  • Know state and federal regulations. When reviewing a human protection program, AAHRPP looks for an educational component in which researchers can continually bone-up on their ethical and legal obligations.

  • Provide a system for detecting harm to participants. For example, an investigator might conduct a follow-up assessment of participants' mental health well after testing a clinical intervention.

  • Respond to participant complaints. If during an experiment, or afterward, a participant reports a negative experience, investigators at accredited institutions relate that information back to the IRB and use the feedback to improve future experiments.

  • Report unanticipated problems. Researchers communicate events such as unanticipated participant distress to the IRB and work with the oversight committee to avoid future problems.

  • Solicit truly informed consent. In most cases, investigators assist research participants in understanding and accepting the potential risks of a study, whether by consent form or some other tool.

"AAHRPP is seeking to make IRBs operate in a way that is truly more ethical," says Sieber. "In many cases, a simplistic reading of the regulations produces interpretations that lead to unethical research."

Further Reading

Visit the AAHRPP Web site. For more information about federal human protection requirements, check www.apa.org/science for upcoming workshops and events.