Protecting Human Research Participants
The circumstances that influenced the need for a policy to protect human research subjects is the terrible research abuses that resulted in federal regulations establishing rules for federally funded research as well as the Belmont Report. Additionally, the exploitation of people participating in research putting into consideration researchers has more knowledge and control than the subjects (Miracle, 2016). Consequently, it resulted in the creation of Institutional Review Boards to guarantee the protection of research subjects’.Therefore, as a way to oversee the FDA submissions or human research funded by federal agencies the Common Rule became widely accepted. Researchers can variously harm human research subject, for instance, the Milgram Obedience studies in the 1960s whereby the participants were told to give electric shocks which were not real to an unseen individual in another room and they did not stop despite the protest thus causing discomfort to the participants thus violating the principle of informed consent. Furthermore, Havasupai Tribe research in the 1990s whereby researchers collected blood samples from tribe members to study type II diabetes and later used the samples while sharing with other researchers to study schizophrenia which is unethical since it violates the privacy of the subjects.
The vulnerable population are the disadvantaged portion of people in the community that require augmented protections in research, specific ancillary considerations as well as utmost care to prevent them being taken advantage for by researchers without their informed consent (Bracken et al., 2017). The vulnerable populations include: prisoners, drug users, physically and intellectually challenged individuals children, pregnant women, terminally ill, fetuses, minors, human in vitro fertilization, elderly individuals, and educationally disabled. Their circumstances might be taken as an opportunity by researchers to participate in the clinical study without their consent due to their lack of understanding of their rights as a subject in any study, therefore, be influenced by the expectations of the predicted benefit associated to the participants.
To start with is the principle of respect for persons which incorporate two ethical principles which are persons with lessened self-sufficiency are entitled to protection as well as individuals should be treated as autonomous agent (Brännmark, 2017). Additionally, is the principle of beneficence whereby it advocated for no harm should be caused to the patient. Additionally, the caregivers should maximize possible benefits to the patients and minimize any possible harm. Finally, is the principle of justice which demands that all the subjects should be treated equally without favours without considering whether the ones they can afford the service as well as avoid the groups unlikely to participate in the research study. There is there undying importance of the three principles which include that to conduct research is a privilege, not a right extended to the researchers by research subjects, institutions and the society. Additionally, the likely benefits should not be outweighed by the cost or risks of the research. Finally, studies with human subjects are necessary for welfare and health thus all ethical codes should be applied effectively.
The subjects must understand their rights to avoid any exploitation by the researchers without them having proper informed consent which is considered an unethical practice and it is not acceptable. Additionally, the vulnerable population is given protection to ensure that they are not involved in a clinical study without their family being consent in case one is not capable of making the best decision (White, 2020). Finally, it is important to for any researcher to know the rights to avoid violating the patient privacy which can lead to either termination of the license since the action is against the code of ethical practices.
References
Bracken-Roche, D., Bell, E., Macdonald, M. E., & Racine, E. (2017). The concept of ‘vulnerability ‘in research ethics: an in-depth analysis of policies and guidelines. Health Research Policy and Systems, 15(1), 8.
Miracle, V. A. (2016). The Belmont Report: The triple crown of research ethics. Dimensions of Critical Care Nursing, 35(4), 223-228.
White, M. G. (2020). Why human subjects research protection is important. Ochsner Journal, 20(1), 16-33.
Brännmark, J. (2017). Respect for persons in bioethics: towards a human rights-based account. Human Rights Review, 18(2), 171-187.