The solicitations blare from fliers and classified ads across campus: RESEARCH SUBJECTS NEEDED! Whether you're a right-handed male or a pot smoking female, science wants you.
But how do you know it's safe? Are you sure mad scientists aren't going to commit atrocities on your drugged-up body? Enter the Internal Review Board (IRB).
Federal regulations require an oversight committee at every research institution that performs studies on human subjects and receives federal funds. At Tufts, this committee is the IRB.
All researchers who conduct studies using humans must submit their plans to the board. If all aspects are in order and protocol has been followed correctly, the IRB approves the study and the researcher may begin experimentation.
Tufts currently has three IRBs: one for the Medford campus and two for the Boston campus, which deal mostly with the New England Medical Center. There is also a similar committee for the veterinary school.
Father Dave O'Leary is the chairman of the Medford IRB and one of the Boston boards. "Good researchers don't want to hurt their subjects and make headlines," he said, adding that the board exists to ensure that researchers carefully consider subjects' safety.
Since the group meets only once per month, researchers must submit their plans well in advance. These plans include detailed steps of the proposed study, the involvement of human subjects, descriptions of possible risks and measures taken to counteract them, and sample consent forms and volunteer recruitment plans.
The IRB reviews the material and addresses any concerns to the researcher. If all is in order, the study receives approval.
According to O'Leary, the board heavily scrutinizes the issue of consent. Consent forms must be written in clear language, and subjects cannot be coerced in any way.
The second important consideration is confidentiality. Subject identification needs to be protected, and the number of people who can trace results back to the subjects should be limited, he said.
The steps necessary for approval are listed on a five-page document on the web page for the Office of the Associate Provost for Research. According to O'Leary most problems arise when researchers do not read the web page carefully enough.
Understanding the rules can be more difficult than it sounds. "Regulations have changed a lot in recent past," Associate Provost for Research Peggy Newell said. A renewal of interest by the federal government has caused what she described as a "moving target sometimes for the faculty."
Experimental research has come under increased scrutiny in the recent past. Last June, a woman died during an asthma study at Johns Hopkins University. A government investigation faulted the University and temporarily suspended all federally funded research projects there, a huge blow for a famed research institution.
Such incidents cause the government to strengthen regulations, and affect the IRB's process and requirements - hence the ever-evolving web site. "We try to learn by watching closely what has happened at other institutions," Newell said.
The Child Development department has many students who must go through the IRB to complete coursework.
"If a student is doing research on a vulnerable subject...[they] need to go through the IRB," Janet Zeller, Director of the Tufts Day Care center, said. Zeller is also a professor in the Child Development department and a member of the IRB.
The school has been working on assisting students through this transitional period of changing regulations. According to Zeller, many professors will collect proposals and submit them to the IRB for their students.
Although students may find the system unwieldy, it is important for them to learn to protect the safety and confidentiality of their subjects, Zeller said.
Despite the potential inconveniences, most have only praise for the IRB. According to Newell, Tufts has obtained a healthy record in past research by erring on the side of caution.
Associate Professor of Psychology Sal Soraci has had positive experiences with the IRB.
"This is clearly an important evaluative process, as human participants are involved," Soraci said. "Imagine the alternative...having only the individual researcher as a 'check' on his/her research. This would obviously be unsatisfactory."
In the end, according to its members, the IRB provides a powerful safety service for the Tufts research community, and stands as an important learning tool for students. "It's wonderful to see that even when students do research they are respectful [of their subjects' safety]," Zeller said.
