Human Subjects Protection and Ethics

Because much of the research supported by the NIH is conducted on human subjects, the NIH has several offices and programs in place to protect participants and address bioethical research issues. For example, to protect the rights and welfare of human subjects, the NIH has established at least fourteen separate Institutional Review Boards (IRBs). IRB committee members must review, and approve, all human-subject research activities prior to, and throughout, a study. Each principal investigator (the scientist in charge of directing a research project) must prove to the IRB that all of their human subjects provided informed consent before participating in study procedures. In addition, researchers must ensure the privacy of their participants is protected and their data are kept confidential.

In addition to offices that protect research participants, the NIH contains a number of offices that address ethical concerns and appraise the potential social consequences of scientific pursuits. For example, the Office of Science Policy (OSP) advises the NIH director on policy issues that affect the informed consent: agreement to a procedure after understanding the risks

In 1998 the U.S. Congress committed to increase the budget of the National Institutes of Health to more than $27 billion. A press conference calling for the increase featured entertainers Christopher Reeve and Mary Tyler Moore. [AP/Wide World Photos. Reproduced by permission.]

research community. In addition, OSP coordinates the Trans-NIH Bioethics Committee (T-NBC), composed of scientists, ethicists, and IRB members. This group is explicitly responsible for developing policies and considering the ethical, legal, and social implications of NIH-funded research.

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