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ORI Introduction to RCR: Chapter 3. The Protection of Human Subjects

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Despite the many rules governing research with humans, tough choices continually arise that have no easy answers.
Informed consent. It is widely agreed that research subjects should be fully informed about experiments in which they may participate and give their consent before they enroll. However, some subjects, such as children, some adults with impaired decisionmaking capacity, and some critically ill patients, cannot give informed consent, either because they are not old enough to understand the information being conveyed or because they have lost their ability to understand.
These and other problems could be eliminated by forbidding researchers to do studies that raise difficult questions about respect for persons, beneficence, and justice, but this would make it difficult or even impossible to get some crucial information needed to make informed decisions about medicine and public health. Since children do not respond to medicines in the same way as adults, it is important to include children in some clinical trials. However, it is not easy to decide when they should be included and how consent can/should be obtained.
Right to withdraw. It is widely agreed that research subjects should have the right to withdraw from experiments at any time, but in some cases they cannot. In the final stages of development, mechanical hearts are tested on patients whose own heart is about to fail. But if it has not failed,and once the mechanical heart replaces the weakenedheart, there is no turning back. The patient can technically withdraw from the experiment and undergo no further testing, but he or she cannot withdraw from the conditions imposed by the experiment, no matter how distressing living with the mechanical heart might be. Knowing this, under what conditions should these experiments be allowed?
Risk without benefit. In one recent experiment, researchers wanted to test whether a common surgical procedure used to relieve arthritis pain had any benefits. To gather information about benefits they designed a clinical trial in which subjects in the control group received sham surgery. An operation was performed, but the common surgical procedure was not performed.
The researchers in this case complied with all regulations, which included thorough IRB review. None of the patients experienced any adverse effects, and the studyconcluded that the common surgical procedure did not provide significant benefits. However, since surgery always involves some risk, the subjects in the control group were placed at risk without any expectation that they would benefit. Should this be allowed, and if so, under what circumstances?
These and other questions must ultimately be answered by IRBs during the review process. Researchers who serve on IRBs need additional training to help them deal with the growing complexities of biomedical, social, and behavioral research. Researchers who use human subjects in research should seriously consider having some formal training in bioethics so that they can participate in the critical reasoning process needed to respond to the complex moral issues raised by the use of human subjects in research.