How do current research protocols prevent human rights violations, such as what happened with the Willowbrook Study?
The Hepatitis study which was conducted at the Willowbrook State School for Children with Mental Retardation is probably one of the worst ethical research issues that diverted the research communities’ attention towards the ethicality of the studies being conducted during that time. Children with mental retardation and other types of mental disorders were deliberately exposed to the infectious Hepatitis virus and were then used as subjects for a study. With the current standards in research, studies that are somewhat unethical will be limited and denied. In schools and other academic institutions located in specific states in the U.S. and some European countries, an ethics committee is required which will be responsible for identifying the possible ethical implications and human rights violations in a given study. Today, it is also a research norm to have any individual who will participate in any research study, whether a subject or not, read and sign and informed consent to make sure that everyone who participated has done so willingly and is not forced (Ritchie & Shopes, 2003). With the combined efforts of the members of the research ethics committee, and the presence of informed consents, there is a good chance that what happened at the Willowbrook institution will not happen again.
Why were institutional review boards established? What, if there are any, special considerations must be made for children, pregnant women, and prisoners who are asked to participate in a research study? Would military personnel be considered vulnerable?
An institutional review is an independent institutional committee designed to monitor, review, and regulate, all institutionally planned researches that involve humans or human rights. Such organization is established to ensure that the welfare, safety, and most importantly, the human rights of the research subjects are protected. IRBs have the power to approve and disapprove a research proposal. Meaning, it can deny the implementation of any particular research after conducting some form of assessment. If the IRB for a particular institution discovered ethical flaws in a particular research, the members of the committee will usually ask the researchers to revise their current research proposal to make it more ethical or free from any form of possible violation of human rights. Usually, children and special populations are given special considerations because in some countries, they are treated differently (Thaddeus, 2009). For example, adolescents in the U.S. are treated differently with the adolescents from other countries. Usually, military personnel would be as vulnerable as a member of a normal adult population because they are covered by almost the same type of social services and privileges. However, some would argue that military personnel could be more vulnerable to violations of human rights because of their culture which emphasizes seniority, etc.
What historical events influenced the development of laws to protect individuals when participating in research studies?
The passing of new laws and research protocols which aim to protect individuals when participating in research studies actually occurred as a result of all the unethical research implementation practices that happened in the past decades. One historical ethical issue that contributed to the passing of such laws is the Nazi Experiment that happened that happened sometime during the World War II. Approximately 16 German physicians recruited by the Nazis allegedly practiced unethical experiments on gypsies, Jews, and even political prisoners which resulted to the passing of the Nuremberg Code, which was soon followed by other international ethical codes which finally removed the physicians’ conviction immunity as a result of conducting or participating in the implementation of an unethical research. Next is the Stanley Milgram’s experiment which also occurred during the World War II (Marsden & Melander, n.d.). A specific level of electrical shock, strong enough to elicit pain responses, was allegedly administered to the research subjects who were referred to in the study as “learners” whenever they commit a mistake. Lastly, the Tuskegee Syphilis Study which was a 4-decade project originally administered by a U.S. government health agency. The main ethical concern in that study was the fact that only African American men were recruited as research subjects because the researchers believe they have “bad blood”, a very common disease during that time. All of these, plus the latest ethical issues in research surely have contributed to the continuous passing of new laws and research protocols aimed to provide protection to the rights and welfare of all present and future research subjects.
Works Cited
Marsden, S., & Melander, M. (n.d.). Historical Cases of Unethical Research University of North Dakota Press. Print.
Ritchie, D., & Shopes, L. (2003). Oral History Excluded from IRB Review: Application of the Department of Health and Human Services Regulations for the Protection of Human Subjects at 45 CFR Part 46 Subpart A to Oral History Interviewing. Oral History Association.
Thaddeus, M. (2009). Multi-Institutional Healthcare Ethics Committees: The Proceduraally Fair Internal Dispute Resolution Mechanism. 31 Campbell Law Review.
