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December 9, 2008

Purdue policies safeguard subjects in human research studies

Christine Weber-Fox, associate professor of speech sciences, and 5-year-old Happy Alves demonstrate how a child participates in
a stuttering study.

In trying to identify the role the brain plays in stuttering, researcher Christine Weber-Fox must tailor elements of her study for people across the lifespan.

Participants of age 4 may have video games to pass the time during lab preparations. An 80-year-old may use large-print consent forms because informed agreement is an essential step.

"We think it's really important to make sure that participants understand the full scope of the study," says Weber-Fox, associate professor of speech sciences.

Ensuring that participants fully understand a study is part of Purdue's commitment to safeguarding the rights and welfare of those involved in human subject research.

In various ways, the research process assesses risks and benefits beforehand and assures participants' understanding of what they will be doing.

"We pay attention to things like how we construct a consent form and who needs to sign the form, and adapt the process for different ages," Weber-Fox says. "We have separate forms for young children, teens, parents, and adults. Each one essentially does the same thing in that it explains what the purpose of the experiment is, what we will be doing, what the risks are and what the benefits are, but the wording is appropriate for different ages."

Human subject research is defined as a systematic collection of information about people with the intent to create generalizable knowledge, says Peter Dunn, associate vice president for research. At Purdue, this includes socio-behavioral studies; clinical studies; testing of products, materials, human-machine interfaces, and alterations to the environment; and evaluation of educational, financial, and agricultural practices.

Protocol review

Purdue's Human Research Protection Program and Institutional Review Boards (IRB) guide researchers through the University's requirements. An IRB consists of faculty members from various disciplines and at least one member not affiliated with the institution.

Investigators who want to engage in human subject research must first submit a protocol, which provides a written description of and the scientific or scholarly rationale for a proposed research activity. One of the University's two IRBs — one dedicated to social science research, the other to biomedical — reviews the protocols.

The IRBs evaluate potential risks to the subjects, anticipated benefits of the research, informed consent processes and recruitment procedures.

"It's the job of the IRB to protect the rights, welfare, safety and privacy of participants," says Richard Mattes, who serves as chair of both IRBs. "We must ensure that individuals who choose to participate in human subject research understand the risks and benefits associated with their decision. The IRB has to make sure their decision is freely made and that they fully understand what will take place during the study.

"It's not our position to dictate the science of researchers. They're the ones with the expertise in their field. The IRB has to evaluate the merit of the science to the extent that we require that benefits outweigh risks."

After reviewing the protocol, the committee may approve, modify, table, or deny the proposed research activity. The IRB can approve a protocol up to a maximum of one year, at which time the researcher must submit materials for a continuing review.

Not all protocols need review by the full IRB. Protocols fall into one of three levels of review based on perceived risk to participants: exempt (low risk), expedited (minimal risk) and full (greater than minimal risk).

A member of the IRB may review protocols determined to be exempt or expedited. Protocols that require a full review go before the entire IRB during one of its monthly meetings.

"The vast majority of protocols we see at Purdue are exempt, and the next most prevalent is expedited," Dunn says. "We see a relatively small percentage that require full IRB review. At a medical school, you would see a different distribution."

For fiscal year 2007, the IRBs reviewed 1,097 new protocols and conducted 986 continuing and amendment reviews.

"It's very rare that we don't approve a protocol," says Mattes, professor of foods and nutrition. "If the investigator is willing to work with us, we can almost always find a way to achieve their goals while meeting our obligation to protect human study participants. It may take longer or cost more money, and it may not be the path the investigator initially had in mind. But if there is a way to get it done, the committee is very happy to work with an investigator to find that way to do it."

In addition to earning protocol approval, researchers and some project personnel must complete online training that details the underlying ethical principles, federal and state laws and regulations, and Purdue policies and procedures concerning human subject research. Certification lasts for five years.

Meeting challenges

Kristine Hershberger, IRB administrator, says one of the biggest challenges is turnaround time on each protocol.

"We want to be very responsive to the researchers, but at the same time we have to maintain quality reviews," she says. "From the perspective of the investigator, their research is very important to them. But when we have 2,000 protocols going through the process, we're trying to be responsive to everyone. We've been really lucky that our board members are very interested and committed to their work."

Other challenges to the IRBs relate to the diversity of the research itself.

"We have a large international student population, and to a large degree because of that we have a good number of protocols that involve research outside of the United States," she says. "It's a challenge to make sure we understand the local context as part of the review process."

The Human Research Protection Program is also taking on another challenging task: achieving accreditation by the Association for the Accreditation of Human Research Protection Programs, an independent, nonprofit organization.

To earn accreditation, institutions must provide evidence of their commitment to scientifically and ethically sound research and to continuous improvement.

"It is a voluntary process to apply for AAHRPP accreditation," Dunn says. "The accreditation is kind of a gold seal of approval."

Purdue is doing a self-study for accreditation now, and the goal is to submit an application during the spring semester.

"Many Big Ten institutions have been accredited by AAHRPP or are in the process of applying now," Dunn says. "Applying for AAHRPP accreditation is part of our institution's commitment to preeminence."

Web resources

-- Human Research Protection Program: www.purdue.edu/research/vpr/rschadmin/ rschoversight/humans/index.shtml

-- Executive Memorandum No. B-45 — Duties and Responsibilities of the University Committee on the Use of Human Research Subjects: www.purdue.edu/policies/pages/teach_res_outreach/b_45.html

-- VPR Policy I.1.2 — Education Policy for Conducting Human Subject Research: www.purdue.edu/research/vpr/rschadmin/rschoversight/ humans/docs/education_policy.doc