Classmate (Chayah’s) response-There are multiple potential ethical challenges that may be faced as a researcher working with human subjects. Some general examples could include dignity, bodily integrity, autonomy, and privacy factors. Our country has checks and balances in place to provide safety, informed consent, and confidentiality (Kapp, 2006). The lack of informed consent is a huge potential pitfall of ethical standards with any study with humans. Historically there have been many instances of harm coming to persons because they did not know at all or fully understand what they were signing up to do. Examples such as the Tuskegee study or Puerto Rico birth control trials unfortunately shows the harm that can come to people when they are not informed in order to actually give consent. There is much room for harm to do be done potentially and safety protocols need to be in place. Current regulations are that participants consents must be documented, they must be informed of risks and benefits or participation, alternatives to participate, that they have the right to stop being involved in the study at any time, knowledge of the purpose, and what is the expected nature of inventions (Kapp, 2006). Ethics can become more complicated in this area when dealing with persons that have potential to be taken advantage of such as prison inmates, children, or the developmentally delayed. Other people such as pregnant women may inherently be at more at risk in any study. The researchers and oversight need to carefully evaluate that such persons are indeed giving informed consent without coercion or misinformation. Any study that the Common Rule (rule of ethics) or FDA regulation apply to must be reviewed by an IRB or institutional review board that is recognized as one by the federal office of Human Research Protections (Kapp, 2006). A study then can have continued IRB oversight or minimally an annual report (Kapp, 2006). The primary purpose of an IRB is to examine, prior to and as needed, that participants in a human study are protected and their rights are being respected (U.S. Food and Drug Administration, 2019). The research body has a duty to take steps to meet these premises and the board ensures that this is happening. There is a group process to examine the protocols in place for a study that works to ensure that it follows current regulations. An IRB has authority to grant approval, provide feedback concerning needed modifications, or to reject a research plan (U.S. Food and Drug Administration, 2019).
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