![]() ![]() Some incentives may pressure potential participants into joining a study, thereby stripping participants of complete self-determination. While researchers often use various rewards and incentives in studies, they must review carefully this possibility of coercion. Additionally, giving potential participants extreme rewards for agreeing to participate can also be a form of coercion, because the rewards may provide an enticing-enough incentive that the participant feels they need participate, while if such a reward were not offered they would otherwise have declined. Coercion refers to threats of penalty, whether implied or explicit, if participants decline to participate or otherwise opt-out of a study. Researchers must also ensure that they do not coerce potential participants into agreeing to participate in studies. Whether because of the individual’s developmental level or because of various illnesses or disabilities, some individuals require special research protections that may involve exclusion from research activities that can cause potential harm, or appointing a third-party guardian to oversee the participation of such vulnerable persons. As noted in the Belmont Report definition above, not all individuals have the capacity to be autonomous concerning research participation. Researchers must also inform participants that they may stop participating in the study at any time without fear of penalty. Also, self-determined participants must have the ability to ask the researcher questions and the ability to comprehend questions asked by the researcher. To ensure participants have the autonomous right to self-determination, researchers must ensure that potential participants understand that they have the right to decide whether or not to participate in research studies voluntarily and that declining to participate in any research will not affect in any way their access to current or subsequent care. According to the Belmont Report, “an autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of such deliberation." This dictates researchers must work to protect research participants’ autonomy while also ensuring full disclosure of factors surrounding the study, including potential harms and benefits. The first protective principle stemming from the 1978 Belmont Report is the principle of Respect for Persons, also known as human dignity. Additionally, the Belmont Report details research-based protective applications for informed consent, risk/benefit assessment, and participant selection. The Belmont Report contains three basic ethical principles: (1) respect for persons, (2) beneficence, and (3) justice. ![]() A direct descendant of this code was drafted in 1978 in the United States, known as the Belmont Report, and this legislation forms the backbone of regulation of clinical research in the USA since its adoption. This set of international research standards sought to prevent gross research misconduct and abuse of vulnerable and unwitting research subjects by establishing specific human subject protective factors. The first such ethical code for research was the Nuremberg Code, arising in the aftermath of Nazi research atrocities brought to light in the post-World War II Nuremberg Trials. As the aftermath of these practices, wherein uninformed and unaware patients were exposed to disease or subject to other unproven treatments, became known, the need for rules governing the design and implementation of human-subject research protocols became very evident. Examples include the Tuskegee Syphilis Study from 1932 to 1972, Nazi medical experimentation in the 1930s and 1940s, and research conducted at the Willowbrook State School in the 1950s and 1960s. Multiple examples of past unethical research studies conducted in the past throughout the world have cast a significant historical shadow on research involving human subjects. ![]()
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