A study of the presumptive approach to consent for organ donation: a new solution to an old problem.
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Biomedical subjects
Publications and source records attributed to Stacey Wertlieb.
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The United Network for Organ Sharing (UNOS) waiting list was designed as a just and equitable system through which the limited number of organs is allocated to the millions of Americans in need of a transplant. People have trusted the system because of the belief that everyone on the list has an equal opportunity to receive an organ and also that allocation is blind to matters of financial standing, celebrity or political power. Recent events have revealed that certain practices and policies have the potential to be exploited. The policies addressed in this paper enable those on the list with the proper resources to gain an advantage over other less fortunate members, creating a system that benefits not the individual most in medical need, but the one with the best resources. These policies are not only unethical but threaten the balance and success of the entire UNOS system. This paper proposes one possible solution, which seeks to balance the concepts of justice and utility.
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It is essential that anyone involved in research involving human subjects be familiar with the purpose and role of institutional review boards. Institutional review boards are designed, first and foremost, to protect human research subjects by overseeing the implementation of federal regulations regarding protection of human subjects. The federal government requires institutional review board approval for any human subject research that receives federal funding, and many scholarly journals require proof of institutional review board approval of the research before publication. In this article, the answers to 10 frequently asked questions about the role of institutional review boards highlight the important contributions made by institutional review boards to the conduct of ethically sound research. The aim is to generate a working knowledge of the institutional review board's function that can be used by every researcher contemplating working with human research subjects. This is the first in a series of 3 articles examining common issues in research ethics.
In the last half century, informed consent has become a central tenet of all research involving human subjects. However, even after the worldwide adoption of regulations aimed at ensuring the protection of subjects, some abuses continue. The installation of oversight bodies, such as institutional review boards, has prevented the bulk of deliberate mistreatment; however, unintentional coercion is still a problem. Informed consent is not limited to obtaining a signature on a consent form, but a process of decision making designed to protect the rights of patients and subjects. It is a constant, ongoing exchange of information between researcher and subject. Although research is invaluable to the advancement of medicine and transplantation, researchers have the responsibility to protect their subjects' rights and autonomy. This paper provides an overview of informed consent, principles behind the process, and implications of current regulations to assist readers in their endeavor for sound and ethical research.
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