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Informed Consent

Informed consent is a legal document whereby a participant agrees to voluntarily take part in a research study. An informed consent is part of a code of ethics instituted by organizations, such as universities, hospitals, and independent research firms that use human subjects for purposes of research. Informed consent is a product of the Belmont Report, a code of ethics prompted by the National Research Act of 1974. According to the Office for Human Research Protections (OHRP), informed consent must report voluntariness, comprehension, and disclosure of information and serves as a record of participant agreement. Informed consent must be granted prior to the use of human subjects for research purposes. This entry discusses the history of informed consent, informed consent for the study of human subjects, and the use of informed consent during the research process.

History of Informed Consent

Informed consent developed, in part, from the National Research Act of 1974. Due to the unethical treatment of subjects during the Tuskegee Syphilis Study, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was summoned to create a code of ethics. The Tuskegee Syphilis Study is most notably the worst case of human suffering caused by a lack of ethics during a long-term study conducted in the United States. The study investigated the history of untreated syphilis among approximately 600 Black males, 399 with the disease and 201 without the disease, from 1930 until the study was shut down in 1972. Syphilis is known to cause fatigue, anemia, and possibly death. The participants were recruited without informed consent and were deceived during the research process. The participants were told that they would receive free treatments, such as exams, meals, and burial insurance, as incentives to join the research study. Penicillin, an antibiotic treatment for syphilis, was discovered in 1947. The participants were not informed nor were they treated with the medication. The commission created in response to the unethical treatment of human subjects during the Tuskegee Syphilis Study crafted the Belmont Report. The Belmont Report is a set of ethical principles and code of conduct for the treatment of human subjects participating in research.

The Belmont Report emphasizes three basic ethical principles for conducting research with human subjects: respect, beneficence, and justice. Informed consent emphasizes, above all, respect for persons involved in the process of research. First, researchers should respect participants and treat persons as autonomous agents. As part of the informed consent process, researchers must disclose any risks or benefits of participating in research and avoid deception, coercion, and misleading incentives. The second principle is beneficence. The researcher is maintaining that no harm will come to participants who willingly take part in the study. The third principle is justice. The principle of justice states that all participants will be treated equally and there will be no unfair treatment based on participant characteristics, such as vulnerable or at-risk populations. A standard informed consent attends to all three of these ethical principles.

Informed Consent for the Study of Human Subjects

According to the OHRP, informed consents include the following criteria: voluntariness, comprehension, and disclosure of information. First, participants should voluntarily agree to participate in research without pressure and/or manipulation from the researcher. In addition, participants must have the option to voluntarily opt out of participating in research at any given moment during the research process. Second, participants must understand what is asked of them in order for them to make an autonomous, informed decision regarding participating in the study. Informed consent involving vulnerable, at-risk, and dependent populations must undergo additional special procedures. Vulnerable, at-risk, and/or dependents are identified as participants with diminished autonomy based upon the individuals’ capacity to understand what is asked of them to participate. When possible, researchers should attempt to obtain consent from the participants even if they need a representative. Pregnant women, children, and prisoners are members of a population with special provisions for obtaining informed consent. Third, informed consents must disclose the purpose of the study, risks, benefits, alternatives, confidentiality protocols, compensation, contact information, and conditions for the participant to withdraw from the study at any time.

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