Researching on humans? You’ve got paperwork

By Jeff Frankel

Rider is now obligated by federal law to have all survey research questions pass a litmus test before being passed out.

The requirement, which will affect all students, faculty and administrators, comes from the Department of Health and Human Services (HHS), and specifies that all potential surveys must protect the identity of the participants and explain any possible dangers that may result.

“Any human being who’s part of a study ought to be fully informed that she or he is involved in a study, [be made aware of] what are the risks, what are the benefits, and so forth,” said Dr. Jim Castagnera, associate provost and in-house legal adviser.

Universities come under the federal law if the institution receives federal funding for research, which Rider does, he said. Some funding comes from the National Science Foundation and the National Institutes of Health.

Rider has long had a human subjects research policy, but it was voluntary. However, over the summer, faculty in the Marketing Department
wanted to access “high-powered” federal databases for research. To accomplish that, Rider needed to file Institutional Research Board (IRB) papers with HHS, said Castagnera.

“When we did that, we became officially subjected to those regulations,” he said.

It now means that anyone who wants to conduct a survey or hold a focus group must first file papers with Dean of Students Tony Campbell. If the research methods protect the identity of and do not harm the human subject, the test is exempt, said Campbell, meaning nothing more is required of the researcher beyond filing the papers.

However, if there is any risk to the subject, if information obtained is recorded in such a manner that human subjects can be identified, or if disclosure of the responses outside the research could be damaging to the subjects’ financial standing, employability or reputation, then further evaluation and paperwork is required.

The human subject research guidelines for Rider and the form are available at www.rider.edu/2564_3633.htm.

The board that reviews surveys, the IRB, is made up of seven members: four representing each college, one student, Castagnera who is the chairperson, and one outside member not affiliated with the University, as required by law.

While faculty wishing to conduct a survey must go through the IRB, students can submit forms to either Campbell or Dean Larry Johnson of the Princeton campus.

“They can come to us [the IRB] if there is some project they feel needs to have safeguards in place,” said Castagnera. “But 99.9 percent of the time…the dean is simply going to say, ‘That’s exempt research, there’s no harm in it, sign off on it, and be on your way.’”

Even if some surveys contain material and are changed to protect the study participants, there is nothing wrong with that, said Carol Brown, associate dean of Education.

“It’s OK that the panel rejects students’ surveys” and students must rework them, she said, because students will learn the requirements of research in the professional world.

As of now, there is no way to punish those who do not follow the guidelines or file the papers, said Campbell. Enforcement is in an “educational period.” The policy will be included in the handbook at a later date, and a memo was sent to the campus community Wednesday, Feb. 28. The policy had already been circulated in December by the University Academic Policy Committee.

“At this point, it’s brand new, so there is nothing in The Source,” the school’s policies and regulations, he said.

The rules even apply to students who want to study others for class projects that require participants from outside the classroom. “Faculty members are responsible for pursuing the approvals,” said Campbell. In-class surveys do not have to be filed.

Policies similar to what Rider is now required to follow are nothing new in the world of academia. The rules have been followed by many academic researchers, and all surveys should follow “informed consent,” if any risks are involved, said one psychologist at Rider.

“Ethical psychologists would not violate that,” said Dr. Mike Epstein of the Psychology Department.

The changes have taken some students by surprise, however.

“I had no idea,” said senior journalism major Casey Noon, who currently is conducting interviews for her BHP thesis. “I have done maybe 10 surveys throughout the four years that I’ve been here, and I never sent in a form.”

The laws began in the 1970s after the Tuskegee Experiment, where researchers tested the effects of syphilis on poor, illiterate black sharecroppers over a period of 40 years, long after the discovery of penicillin, which is the standard treatment for the illness. Participants did not give informed consent and were not told of their diagnosis.

“Out of the policies and court cases that began with those very nefarious studies, came a series of federal policies on human subject research,” said Castagnera.

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