These are some possible questions to ask if you are asked to take part in a medical study: Is taking part the best possible course for me? If you weren't doing this research, what would you say is best for me? Why are you doing this study? Do you hope to learn something important? Has your institution's review group {usually called an Institutional Review Board, or IRB} approved? If the answer is no or "We have no IRB," I would say no to participating. What are my obligations in time, travel or expense? The main tangible one is likely to be time, for you may have to return for periodic treatments or checkups. Some centers may be able to reimburse you for any travel expense. What are my alternatives if I don't take part? A patient should always be told about alternatives, Dr. Fernando Cassorla of the National Institutes of Health emphasizes. A typical NIH consent form, for example -- one for study of an experimental rheumatoid arthritis drug -- frankly tells prospective subjects: "you need to know about the alternatives" before consenting to participate, and lists several other drugs. What are the chances that I will be helped if I get this experimental treatment? The frank answer may be, "We don't know." But there may be some indications. Ask: Have there been any previous studies? How many of the patients seemed to benefit? If the study cannot help me personally, can my participation help others? How? Will I actually be getting the drug (or treatment) under study? Or is this a "blinded" study, in which patients are randomly assigned to receive either the treatment or a placebo or "dummy pill"? In such studies, which are important research tools, neither patients nor doctors should know which patients are in which group. Would you be willing to be randomized, or let a member of your family be randomized, given the same illness? Dr. Thomas Chalmers of Mount Sinai Medical Center in New York has told fellow researchers: "I think the major ethical principle is that you shouldn't be involved in a trial unless you would be willing to be randomized yourself if you had this disease."

In some studies, participants are told, "If you get the placebo and the experimental drug proves effective, you'll be offered it too when the study is ended." What are the possible complications or risks? A 1976 NIH study of 133,000 human subjects all over the nation showed there had been "trivial" injuries in 4,957 cases, temporarily disabling ones in 974 (a bit less than one subject in 100) and death or permanent disability in 57 (just under one in 2,000). Still, the authors said, "The risks of participating in non-therapeutic research may be no greater than those of everyday life, and in therapeutic research, no greater than those" in everyday medical treatment. Will there be pain? "Often people are surprised because they haven't been told there will be some pain," NIH's John Fletcher says. What if I do have a complication or suffer some harm? Who will pay for the care? Will you pay for me as long as I am affected, or only as long as I am here?

The answer may not be satisfactory. NIH consent forms, for example, say: "The Clinical Center will provide short-term medical care for any physical injury resulting from your participation in research here. Neither the Clinical Center nor the Federal Government will provide long-term medical care or financial compensation for such injuries, except as may be provided through whatever remedies are normally available under law."

This means that if you need long-term care, you may have to try to sue the government. I personally would not consent to be a research subject of anyone who told me I would not be cared for, if injured, as long as I am affected, even for life.

"I don't think it's right," says NIH ethicist Fletcher of this stingy government policy. In 1977 a federal task force strongly recommended compensation for any seriously injured subjects. The recommendation was never accepted. Who do I call if I have any questions, or am having a problem? You should be told who you can call 24 hours a day, seven days a week. What if I say no to participating? Will you treat me anyway? Am I free to withdraw from a study at any time without penalty? Will you continue treating me then, or must I seek treatment elsewhere?

NIH generally accepts only patients with problems it currently studies. But once a patient is accepted, Cassorla says, "We will care for you even if you don't participate in a study. To say 'You have to go home if you don't participate in our study' would be coercion" -- and unethical. You should also be able to withdraw from a study at any time without being penalized or cut off from treatment. --