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Published on 11/17/1999 All articles from this issue

El Camino Hospital IRB is watchdog for medical research

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By Leslie K. Martin / Town Crier Staff Writer

If you have a medical condition such as asthma, cancer or a heart problem, chances are that ongoing community clinical studies have helped provide the medication or medical devices you use. The job of the institutional review board (IRB) at El Camino Hospital is to approve, deny or adjust protocol, with a view to human rights, for the studies brought to them by drug companies or community physicians.

"The IRB is essentially a government approved category for hospitals that want to sponsor research projects in their hospital or community," said Owen Aurelio, chief operations officer at El Camino Hospital. The studies also advance medical research, and many studies are coordinated as part of larger academic and medical studies throughout the state.

The IRB reviews, analyzes and passes judgment on 20 to 25 new protocols (or clinical studies) each year and currently has 60 open cases, which will be examined yearly until completion.

IRB Chairman Michael Greenfield explained that protocol must detail potential benefits or risks, identify side effects, and explain how the study is to be implemented. The board plays a strong role in protocol ethics.

Greenfield said the board looks for "patient confidentiality, and to make sure patients are not having things done to them that shouldn't be done to them."

Community clinical tests are a vital ingredient in the Food and Drug Administration's drug and medical device approval process. Drugs and devices cannot be used to treat people until they have first been tested on people. When a physician wants an angioplasty research study reviewed, or if a drug company creates a new vaccine and needs to do a human drug trial, IRBs can evaluate the scientific merit of those studies.

Study volunteers come from the community. Some patients may themselves seek out the latest medical breakthroughs; some may hear of studies through their doctor; some people may respond to a community ad.

The results, Greenfield said, are "potential benefits for the members of the community. Some things that have now become standard care like cardiac stents - many of those stents were done at El Camino (hospital) in these groups."

Greenfield said that community research is usually less expensive than that at universities like Stanford.

Current studies involve a number of drug therapies or devices for immunology, cancer, kidney infections or failures, diabetes, Parkinson's disease, mammograms, stem cell studies and intervention cardiology.

The board is comprises hospital physicians and residents.

Greenfield said the board appreciates community participation as past members have been dedicated and have provided great input.

For more information on becoming an IRB board member, call Angy Eperjessy at El Camino Hospital, 940-7042.