Lakhasly

Pregnant women may participate in clinical research where the "purpose of the activity is to meet the health needs of the mother" regardless of the degree of risk to the fetus and offspring. If the purpose of the research is not to meet her health needs, she may participate only if "the risk to the fetus is minimal."The main problem concerns the broad phrase "health needs of the mother." Consider an established treatment for a disease or condition that is safe and effective for women whenever it is given, but also has a very high risk of affecting future offspring if given during pregnancy. Ethical judgment of whether the woman should be able to have the treatment during pregnancy will depend not merely on whether the treatment will affect her "health," but also on the burdens and benefits to her of having treatment during pregnancy or after.The type of benefit to her alone is not determinative, but the magnitude is. The more minor the benefits the less discretion the woman should have to accept treatment, if there is any risk beyond minimal to offspring.Such a standard requires weighing the importance to the woman of the health need in question versus the risk to offspring.

Pregnant women may participate in clinical research where the "purpose of the activity is to meet the health needs of the mother" regardless of the degree of risk to the fetus and offspring. If the purpose of the research is not to meet her health needs, she may participate only if "the risk to the fetus is minimal."

While this rule is generally sound, it conceals some problems. The main problem concerns the broad phrase "health needs of the mother." Consider an established treatment for a disease or condition that is safe and effective for women whenever it is given, but also has a very high risk of affecting future offspring if given during pregnancy. Ethical judgment of whether the woman should be able to have the treatment during pregnancy will depend not merely on whether the treatment will affect her "health," but also on the burdens and benefits to her of having treatment during pregnancy or after. The type of benefit to her alone is not determinative, but the magnitude is. The more minor the benefits the less discretion the woman should have to accept treatment, if there is any risk beyond minimal to offspring.

Such a standard requires weighing the importance to the woman of the health need in question versus the risk to offspring. Treating morning sickness or a cold during pregnancy is certainly a health need. But if the drug used to treat those conditions is teratogenic, it would be unethical to take it even though it is directed at treating her "health." If this is true about established therapies, then it is even more true about experimental therapies. If use of an experimental drug poses more than minimal risks to the fetus and offspring, a woman should have even less of a moral right to take such a drug to treat a cold, morning sickness, or any condition that is not life-threatening or very serious, where the primary purpose of the research is to meet her health needs. Thus a researcher, an IRB, or other review body should make a judgment about the degree of the benefits or burdens of taking or forgoing the experimental treatment relative to the harm to the fetus and offspring if it is given. A purpose of treating the "health needs" alone of the pregnant woman is not ethical when the benefits to her are greatly outweighed by the risks to fetus and offspring. The current federal regulations are overbroad to the extent that they would permit such research to occur.