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prescribed to many pregnant women to prevent morning sickness and promote sleep. Subsequently, thousands of babies were born with severe birth defects due to prenatal thalidomide exposure.8 This tragedy spurred development of the Kefauver-Harris Drug Amendments to the federal Food, Drug, and Cosmetics Act. Enacted in 1962, these amendments required companies to conduct clinical trials to establish a drug's effectiveness before marketing and gave the FDA greatly expanded oversight authority. It also required that subjects of clinical trials provide informed consent.9• The Willowbrook State School study. Beginning in 1955, mentally disabled children living at the Willowbrook State School in Staten Island, N.Y., were intentionally infected with hepatitis virus as part of an ongoing experiment to test the effectiveness of various vaccines and treatments.10,11 Public knowledge of the event led to development of federal regulations for research involving children, including informed parental/guardian consent.Legally, only competent adults can provide informed consent. However, the American Academy of Pediatrics recommends obtaining assent from children as young as 7 years depending on the child's age, maturity, and psychological state. Assent is an ongoing process involving the child, parents, and members of the healthcare team in which, with parental consent, the team tells the child about the research in terms the child can understand and encourages the child to ask questions. When the team believes the child understands his or her role in the research, the child is asked to assent or dissent from participation. Unlike informed consent, assent is not required by law, although it may be required for institutional review board (IRB) approval, which will be discussed below.13• The Tuskegee study. The Tuskegee Study of Untreated Syphilis in the Negro Male, commonly called the Tuskegee study, was conducted from 1932 to 1972. In this study, researchers from the Public Health Service and the Tuskegee Institute in Alabama withheld penicillin, a known effective treatment, from study participants with syphilis in order to observe the disease's natural course. The participants were not informed about the study's purpose and did not receive treatment for their syphilis, even after penicillin became the treatment of choice in 1947. When this research came to light in 1972, the public outcry led to an inquiry by the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research. The Commission examined human rights issues of experimentation with humans and published the Belmont Report in 1979. In 1981, the Protection of Human Subjects Law was passed, providing the ethical standards followed in the US to this day.2 The Belmont Report heavily influenced the Federal Policy for the Protection of Human Subjects, known as the Common Rule, published in 1991.15-17 This regulation added basic protections for participation of pregnant women, fetuses, neonates, children, and prisoners in research. The Common Rule also established requirements for voluntary consent for participation in research and obtaining written consent from persons agreeing to participate in research on a form to be approved by the IRB during the review process. Awareness of the history that led to legal requirements for conducting research reminds us of how basic human rights were violated in the past and how we can guard against similar events in the future. The National Institutes of Health sets policies for human subjects research according to federal law.18 IRBs require evidence of current human subjects protection training by all study team members to approve a research project. Renewal of human subjects protection knowledge is required every 3 years so researchers remain current on new laws that are developed as history evolves (for example, laws and regulations involving new technology and internet use). Correct answer: c. The Belmont Report (1979) defines the ethical principles that govern all research conducted in the US based on three basic tenets: respect for persons, beneficence, and justice.16,17 All persons who serve in the role of a study investigator are required to complete human subjects training, which includes a review of content from the Belmont Report.3 Understanding interventions required to uphold these ethical principles when research is conducted is another important element of nursing advocacy. The ethical principle of respect for persons acknowledges the dignity and freedom of every person and supports the requirement that voluntary informed consent be obtained before involving a human subject in research. In relation to the conduct of research, this principle addresses a person's ability to independently and autonomously volunteer for participation in a study. It also supports the mandate that persons be fully informed regarding study procedures and risks and benefits, and that they cannot be pressured or coerced to participate in research. All study opportunities must include provisions that give research participants the freedom to withdraw from a study at any time without penalty.2 The principle of beneficence requires researchers to maximize benefits and minimize risks for research subjects. PIs must weigh the benefits and risks of a
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