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    NOVEMBER 18, 2004
 
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Subjects in experiments have new protector


Richard C. Throm, director of the Office of Human Subjects Protection, coordinates Temple’s Institutional Review Boards, which oversee research involving human subjects.

On any given day, hundreds of volunteers participate as human subjects in scientific research projects at Temple, from clinical trials that could lead to new drugs, to behavioral studies that could provide a better understanding of the human psyche.

A new office at Temple looks after the welfare of every one of those volunteers: the Office of Human Subjects Protection.

The OHSP and its first director, Richard C. Throm, made their debut this August. The office — which falls under the portfolio of Kenneth J. Soprano, vice president for research and graduate studies — coordinates Temple’s Institutional Review Boards, the bodies watching over all research at Temple involving human subjects. There are three IRBs: two at the Health Sciences Center overseeing clinical studies, and one on Main Campus overseeing research in the social and behavioral sciences.

Throm and the IRBs have the authority to modify or reject any research protocols involving human subjects submitted by Temple faculty, staff or students. Their responsibility is enormous. If Temple’s IRBs were to fail to properly monitor research on human subjects, the University could lose federal funding and suffer permanent damage to its reputation.

But Throm’s top priority is always the welfare of the people who volunteer to participate as scientific subjects. His self-described mission: “to protect our volunteers, to make sure they’re treated ethically and fairly and to make sure all of the potential risks are minimized to the fullest extent possible — the risks must never outweigh the benefits.”

Acknowledgement of the need to respect and preserve the rights and well-being of human subjects emerged from some of the darkest — and frighteningly recent — chapters in the history of science: Nazi sterilization programs in the 1930s and ’40s and experimentation on prisoners during World War II, the experimental injection of retarded children with hepatitis in New York state in the 1960s, and the infamous Tuskegee Syphilis Experiment of 1932–1972, in which black men with syphilis were denied treatment to study the natural course of the disease.

The disclosure of these horrors inspired a series of international and federal codes. In this country, the Belmont Report (1979) and the Code of Federal Regulations (a.k.a. “The Common Rule,” 1991) are the rule books for scientific research on human subjects. The Belmont Code spells out the ethical principles that all researchers must follow: “respect for persons” (including those with diminished autonomy), “beneficence” (maximizing benefits and minimizing harm) and “justice” (fairness in the selection of human subjects). The Code of Federal Regulations, which is updated constantly, outlines in detail the proper conduct of research on human subjects — including the rules of informed consent — and mandates the creation of review boards at institutions conducting research on humans.

“There have been instances when humans haven’t had a say in their participation in research,” Throm said. “We’ve had to learn from our history; now we do our best to make sure everybody’s protected.”

Local scientists don’t need to look far for examples of what can go horribly wrong when federal rules are stretched or broken. In September 1999, Jesse Gelsinger, an 18-year-old with a rare genetic disease, died after receiving an experimental gene therapy treatment at the University of Pennsylvania’s Institute for Human Gene Therapy.

Questions were raised about the disclosure of the treatment’s risks to the boy’s family, and the Food and Drug Administration criticized the conduct of the researchers. Overrun by a blizzard of negative headlines, Penn eventually disbanded the institute (although human gene therapy is now conducted elsewhere at the school).

Keeping tabs on Temple’s volunteers gets more complicated every day — not because of any fundamental change in the way research on human subjects is conducted, but because the volume of research just keeps growing. In July 2003, the latest month for which figures are available, there were nearly 1,000 active research projects (about half clinical trials and half social or behavior studies) involving human subjects at Temple.

“And the numbers increase annually,” Throm said.

The OHSP and the IRBs offer a wide range of services to help Temple’s researchers stay on top of rules and regulations, including training sessions and workshops on subjects ranging from managing the informed consent process to advertising for volunteers. (To learn more about their services, go to www.research.temple.edu/irb).

Throm is in the process of rolling out the OHSP’s latest advance, the Adverse Events Reporting System, a sophisticated, Web-based monitoring system that was custom-developed for Temple researchers. Whenever something unexpected happens to a human subject in a Temple study — for example, a volunteer suffering an unanticipated reaction to an experimental treatment and requiring hospitalization — the investigator logs on to the system, accesses his or her research protocol (every active protocol at Temple is in the system) and reports the event using pull-down menus. Once entered, the “adverse event” then becomes part of an ever-growing, searchable database.

“Over time, we’ll be able to see trends,” Throm said. “Then we’ll be able to protect future patients by doing the appropriate risk reduction.”

Throm admitted that some researchers think of the OHSP and the IRBs as a bureaucratic obstacle.

“We are viewed as a roadblock by some investigators — they think we put volunteers’ interests ahead of theirs,” he said. “And it’s true, our No. 1 mission is protecting our human subjects. But we also want to protect the faculty, staff and students of the University by making sure the quality of their work is high and that it complies with the law. Believe me, no one wants to wake with bad headlines.”

- By Hillel J. Hoffmann

Want to volunteer?
You’ve probably seen the ads asking for volunteers to participate in medical, social or behavioral research projects at Temple. They’re everywhere, from campus bulletin boards to SEPTA trains. And every one of those posters or fliers — if they’re legitimate — has been reviewed by Richard Throm of Temple’s Office of Human Subjects Protection and the Institutional Review Boards. If you’re interested in volunteering, and you want to make sure the ad you’re reading has met the rigorous standards of the IRBs, look for an IRB stamp or other notation indicating IRB approval. If you have questions, go to the IRB Web site, www.research.temple.edu/irb.


 

 


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