Guardians of Safety

Institutional Review Boards protect subjects and researchers — and the institution itself

It’s twelve o’clock on Thursday afternoon as the regular crowd shuffles into a conference room near the U-M hospital cafeteria. It’s mostly doctors and scientists — but also a pharmacist, a writer, a minister, an attorney and some community volunteers from the Ann Arbor area — all gathered for a weekly meeting of one of the medical school’s four Institutional Review Boards, called IRBMED for short.

John Weg, Patricia Ward and Raymond Hutchinson

There’s an alphabet soup of federal agencies overseeing research involving human subjects — OHRP, NIH, FDA, OCR, OBA — and they all require that IRB approval be obtained before any research study involving people can begin.

The IRB’s job is to protect the safety, welfare, privacy and dignity of people who volunteer to participate in clinical research. Board members must weigh the risks of participating in the study with its potential benefits — either directly to study participants or to knowledge that can be used to help others. If the potential benefits don’t outweigh the risks, the IRB has the authority to reject a research study. If the IRB votes “no,” no one can overrule that decision.

Every research protocol, every adverse event, every consent document, every progress report for every clinical research study in the U-M Medical School is reviewed in detail by an IRB board member, who makes a presentation about the study to the board. Then the board votes to either approve, request revisions or reject the study. In late 2004, IRBMED had processed 4,486 submissions for 939 principal investigators and 2,934 clinical research studies.

“Our first obligation is to protect patients and other individuals who participate in clinical research,” says John G. Weg, M.D., co-chair of IRBMED and a professor emeritus of internal medicine in pulmonary and critical care. “In this way, we facilitate the ability of the investigator to do research.”

When it comes to protecting the safety and rights of people in clinical research studies, the federal government is extremely serious. Since 1999, the Office of Human Research Protection has sanctioned six major U.S. medical centers for violating federal rules and regulations governing research with human subjects by shutting down all federally funded research at those institutions. The U-M has never had its research privileges suspended, and the people responsible for U-M’s nearly $750-million research enterprise want to keep it that way.

“Serving on the IRB is a serious role with a lot of responsibility,” says Raymond J. Hutchinson, M.D., a professor of pediatrics and communicable diseases and co-chair of IRBMED. “I don’t think people realize the amount of time and dedication IRB members commit to the review of these protocols.”

“The amount of clinical research in the medical school and the complexity of federal regulations have increased exponentially in the last 20 years,” Weg says. “In 1980, the medical school had one IRB with 12 members run by one person and his secretary. Now we have four IRBs with 72 members run by a full-time director with an administrative staff of 17.”

“It’s a moving target, because all the agencies that supervise us are continually re-evaluating and re-interpreting their regulations,” says Patricia Ward, director of IRBMED. “We try to use our expertise to efficiently and effectively help investigators conduct their research in a responsible way.”

“No one is in love with regulations and they have become more restrictive than they used to be,” Hutchinson says. “But once you understand the IRB’s mission, you feel better about the rules.”

Sally Pobojewski, Medicine at Michigan’s science editor, is a new member of the U-M Medical School's Institutional Review Board.