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Local research review boards have been around since the mid-1960s when the federal government issued its first policy designed to protect human subjects. The policy mandated that local communities create committees to review grant applications for projects requesting federal funds. These committees were to be made up of members who were capable of assessing the project and determining the risks to and assure the safety of the human subjects participating.
Two years later when the National Institutes of Health took a look at these local review boards, they noted that 73% had members who were exclusively from the scientific community.1 In May 1969, federal guidelines were revised to require that institutions gain input from not only the scientific community, but also from the community at large.
Local review boards became IRBs in 1974, and at that time, federal regulations stated IRBs should have a minimum of five members. These members are to come from a variety of fields — science, law, and any other area related to the study or the study population.
Additionally, IRBs are to have at least one nonaffiliated member, someone who is not from the scientific community and who comes from the community at large. They can include ministers, teachers, attorneys, businesspersons, or homemakers, as long as the community member is able to represent the views and mores of the population from which the study participants will be drawn.
There are various ways to recruit community board members. "Usually, people who are already on the IRB help us with the recruitment," says Charlotte L. Shupert, PhD, manager of research compliance and assurance at Oregon Health and Science University (OHSU) in Portland. "Other people they know become interested in their activities on the board and are often interested in serving." OHSU has three IRBs. Each has at least one nonaffiliated member — among them are a history professor, a minister, and a family counselor.
The city of Philadelphia Department of Public Health (PDPH) uses similar recruiting methods, says Judith Samans-Dunn, MSIA, executive secretary of the PDPH IRB. "We use various methods depending on current needs, including asking for interest among users of our services, asking members and associates for recommendations, and occasionally responding to unsolicited referrals from various sources."
The PDPH IRB is made up of 13 members, among them three medical doctors, three nurses, two psychology professionals, four public health professionals, and one layperson. All have voting rights, as do the members of OHSU’s IRBs. "All members’ input is considered with the same weight," reports Samans-Dunn.
"The nonresearchers review protocols in exactly the same manner as all other members of the IRB, and their opinions are respected and acted upon in exactly the same way," echoes Shupert.
Samans-Dunn says that community members have helped the IRB with issues involving expanding explanations on the consent form, accommodating non-English-speaking patients, adjusting the language level used to communicate with subjects, and recruiting.
"Each of the community members bring the perspective of the subject and the nonmedical community into the room," says Shupert. "They are very good at pointing out when protocols are burdensome or inconvenient for subjects. Researchers can easily become excited about the possibility of learning something and lose sight of exactly what a researcher may be asking a subject to do. Our community members rarely lose sight of what the subjects duties and burdens are, and help us see studies from that perspective."
1. Stewart WH. Clinical Research and Investigation Involving Human Beings. Experimentation with Human Beings. New York City: Russell Sage Foundation; 1972.