Risks in an Occupational Health Study October 3, 2001, Fall 2001 

Mercy Mencovitz, as chief of the Occupational Therapy Department at the state’s most prestigious research hospital, has served on its institutional review board for the past three years. The IRB is responsible for reviewing all research involving human subjects to assure that the subjects’ rights and welfare are protected.

Having reviewed the 13 protocols for this month’s meeting, she was not expecting much controversy over the one entitled “Assessment of Carcinogenic and Mutagenic Potential of Employment in the Organic Solvent Chemical Industry.” As an occupational therapist, she has worked with patients who had suffered from chemical exposures and burns while working in the county’s large chemical plants. She realizes the study is important.

She believes that the risks to the subjects are quite modest. Using the legal authority of the state’s laws permitting occupational health assessments, the investigators are proposing to do a thorough record review of the plant’s medical facility. They would also access from the payroll department records of time missed from work over the past 20 years. This would be combined with intensive interviews with present and former employees. A subsample would also be recruited for in-hospital exercise tolerance tests and a battery of other tests related to lung function. These would include administration of very modest doses of some of the chemicals these workers were exposed to in the plant. They would be administered through ventilators. Blood and urine samples would be studied for metabolites. Exposures were calculated to be equal to the typical ambient air levels in the plant.

The protocol claimed that none of these would be particularly stressful or dangerous and that workers would be compensated at their usual pay rates for time missed from work.

When the meeting begins, the lead reviewer presents a summary of the protocol. He seems to agree with Ms. Mencovitz that the risks are minimal. He recommends routine approval.

Then the other members of the committee are given an opportunity to question the protocol. Dr. Lenore Huntington, a nurse and chief of Oncology research center at the hospital, waits until others have asked minor, routine questions. She begins probing the assessment of benefits and risks. She says she is concerned about the lung function and exercise tolerance test on these workers. Many of them are in their fifties and sixties. Was there any evidence about the risks, say, of myocardial infarction, from workers who were not used to exercise?

Assured by the cardiologist on the committee that these risks were really quite modest, she then pursues the question of purposeful exposure of workers to potentially carcinogenic chemicals.

Several defenders of the protocol point out that since the workers are being taken off the job for the tests and the exposure levels are calculated to equal the exposure in the plant, there is no change in risk to the workers. In fact, since they would be exposed only briefly during the battery of tests, their day’s exposure would actually be less than if they had been in the plant that day.

Dr. Huntington is not satisfied. She is not convinced that purposeful exposure of the subjects by the investigators to a potential carcinogen, even at low does, is morally the same as exposures obtained by the workers through their daily work. She argues that even if the exposure levels are the same or lower, the experimental administration is unacceptable.

Then she introduces her real concern. She had often been the recipient of the IRB’s aggressive questioning of the risks to which subjects were exposed in her oncology protocols. That questioning was often led by Dr. Ralph Goldstein, from the Department of Social Medicine, who is a co-investigator in this project. (Dr. Goldstein has excused himself from the meeting because of his conflict of interest in the chemical exposure protocol.)

Dr. Huntington says she thinks this is one of the most dangerous protocols she has seen come from the IRB. Mr. Melvin Green, a radiation therapist and chemo therapist has also expressed concern about this protocol. She says she is particularly concerned about the social and psychological risks of these workers. What would happen to them, she asks, if the blood levels are found to be unacceptably high or if former workers are found to have unusually high rates of cancer? Wouldn’t the plant managers be forced to lay the high-risk workers off? Perhaps the plant would even be forced to close, costing these workers their jobs. These are workers who had been in these plants for many years and at their ages would be unlikely to find new work. She says she can envision whole industries being shut down, even the county employment base eroded. She claims that the risks are very significant. She urges a vote against the protocol as posing risks to the subjects and others that were beyond what is tolerable.

Ms. Mencovitz is stunned. What she had perceived to be a routine, low-risk protocol was being denounced by Dr. Huntington as one of the most dangerous protocols the IRB had ever seen. How should she assess the risks and benefits? How would she vote?