Human research participants are individuals who participate in study especially medical experiments. Medical research may involve experiments such as finding out why people in a certain areas do not contract a certain diseases. A study may involve drug testing to find out if a certain drug may cure a suspected disease. Human research participants vary in age, class, income, and economic activities. The society values human rights and ensures their protection during experiments (Fiske & Hauser, 2014). The vulnerable subjects are in most cases given special protection by the government regulations. Participant in medical research only consent when they are fully aware of the consequences of the experiment. Experiments are never designed to expose the participants in any form of harm.
The National Institutes of Health (NIH) are in charge of ensuring that the human participants are under protection. The issue of protecting human subjects came about after harmful effects of destruction of participated in the past researches, among these were the Nazi medical war crimes of 1939 to 1945 (Fiske & Hauser, 2014). The experiment violated both the medical ethics and the rights of the participants.
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The Office for Human Research Participant replaced the NIH office of protecting participant from research risks. The outlines handling of the subjects during research, and with it comes the policies for Institutional Review Boards. Belmont report advanced some restrictions and principles for protecting human subjects. Among the areas identified by literature material include:
Personal Autonomy: Individuals participating in the research should be allowed to make their own personal decision to participate in research with no any form of coercion. The vulnerable members of the society are also protected through the consent procedures.
Beneficence – the research studies must have maximal benefits and minimal risks to the human participants.
Justice - the possible benefits and risks of the research should be distributed fairly among societies, individuals and even groups.
HHS has various subsections developed to protect participants during research. Among the areas of interest are:
Subpart A: Protection of human subjects. The subsection identifies mainly individual who participates in medical research.
Subpart B: Protection of neonates, human fetuses, and pregnant mothers who are involved in a researches. This provision prohibits experiment that may compromise the health of the pregnant woman and the viability of the neonates.
Sub part C: The sub segment protects minority groups including prisoners involved in biomedical, or any other form of research. Prisoners have become subject to misuse owing to their delicate situation, The section protect them against health, personal activities involved, and the environment damage owing to researches.
Subpart D: Children participants are identified as important subject of researches. HHS demands parental assent before children can be used to in experiments
Subpart E: The section outlines the mandate of the Institutional Review Boards (IRB) registration. The IRB has the mandate to approve or disapprove any research activity thus assuring the individuals’ welfare in the study.
Advantages Subject Protection
Use of coercion was rampant in the traditional experiments. The new provisions ensure the human participants participate voluntarily with no any form of coercion. Respect for persons will ensure that those who lack mental and physical capacity have equal chance of participation in the researches, just like the other subjects (Aliyeva et al. 2013). The principles beneficence will protect the human subjects from exposure to risks and harmful effects during the medical study. It also ensures that the participants are subjected to maximum profit and benefits of the medical study. Subpart B of HHS regulations ensure the viability of neonates and the safety of vulnerable groups; it offers equal protection to participants.
Disadvantages of Subject Protection
The regulations limit the participation levels. Researchers may fail chance the intended results since due to lack of study participants. The restrictions may be costly and the investigators may incur high cost of undertaking researches to maximize the possible benefits to the participants.
References
Fiske, S. T., & Hauser, R. M. (2014). Protecting human research participants in the age of big data. Proceedings of the National Academy of Sciences , 111 (38), 13675-13676.
Aliyeva, M., Clough, B. A., Campbell, M., Mateo, N. J., Zarean, M., & O'Donovan, A. (2013). Protocols for Protection of Human Participants: A Comparison of Five Countries. Journal of Empirical Research on Human Research Ethics , 8 (3), 2-11.
