A common ethical challenge when dealing with human subjects in research includes informed consent, autonomy, confidentiality, etc. Informed consent refers to the process where the participant is given all the relevant information about the trial, which is important in making an informed decision. After studying all the provided information, the participant willingly and voluntarily confirms his/her willingness to participate in the study. Informed consent is founded on the legal and moral premise of patient autonomy, that the patient has the right and the responsibility to make decisions that concern their health and medical conditions (Reiss, 2019). It is based on four principles, including the capacity to make decisions; this includes the ability to understand the options and the consequences of each provided decision, including the cost and benefits associated with each. Disclosure requires that the researcher provides all the relevant information concerning the trial/research. Documentation of the consent and competency; which indicates that an individual has the ability to make a decision and be held responsible. Failure to ensure that informed consent is observed can have serious consequences on the participants, for example, the Puerto Rico birth control trials, which resulted in the deaths of 3 participants while others experienced extreme side effects, including blood clots (Reiss, 2019).
The Institution Regulation Board (IRB) was formed to ensure informed consent and is charged with protecting human research subjects’ rights and welfare. The board comprises at least five members from different backgrounds to ensure a comprehensive review of human research. It has the authority to approve, monitor, disapprove or request modifications to the research activities as required by the federal laws and institution policy (U. S Food and Drug Administration, 2019).
References
Reiss, A. J. (2019). Conditions and consequences of consent in human subject research. In Regulation of Scientific Inquiry (pp. 161-184). Routledge. https://www.taylorfrancis.com/chapters/edit/10.4324/9780429304279-15/conditions-consequences-consent-human-subject-research-albert-reiss