Failure of the Belmont Report

Grady, C. (2010). Do IRBs protect human research participants? JAMA, 304(10), 1122-1123. Retrieved from http://jama.jamanetwork.com/article.aspx?articleid=186530

Ethical guidelines are the frameworks and standards that govern psychologists in conducting a morally justified research to respect the rights of the participants. Since the researchers are responsible for the welfare of the participants, it is vital for them to act in accordance with a specific strict code of ethics and moral principles. One of the common ethical framework used in many psychological studies is IVCARD where ‘I’ stands for Informed Consent, ‘V’ equals Voluntary Participation, ‘C’ is Confidentiality, ‘A’ being Accurate Reporting, ‘R’ is Right To Withdraw and ‘D’ as Do No Harm. Although there are few disadvantages of these strict ethical guidelines, the advantages outweigh them. This is evident from two of the

P2 Understand ethical issues relating to research in health and social care Ethical principles Protection from harm- In any health care setting it is always important to make sure that all the individuals in all the aspects of the area are being protected from harm. In any organization the most important policy is the protection policy this enables the staff to make sure that all the individuals feel safe. Protection from harm does not only mean being protected from abuse It could be protecting people's health and wellbeing and enabling them to live free from harm, neglect and abuse.

Ethics, in our society, are the moral principles that govern our behavior, dictating what is right from wrong. The specifics of ethics changes as values in our society change and evolve. This occurs in Rebecca Skloots book, The Immortal Life of Henrietta Lacks. One major reoccurring theme in the book is the lack of informed consent and autonomy. Fortunately, now there are safeguards which protect human rights in regard to health care and research. The Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, now part of the Department of Health and Human Services, created The Belmont Report, which is one such safeguard establishing principles for all human research (USDHHS, 1979). This paper will discuss the ethical issue of informed consent within The Immortal Life of Henrietta Lacks, the disregard to parts of the Belmont Report, as well as compare the role of the nurse in charge of Henrietta’s care versus the standards of care set for modern nurses.

The publishing of the book, Immortal Life of Henrietta Lacks, not only brought light to an incredible story but also to the incredible need for change in legislation and governing bodies within the research system. Since its release in 2010, there have been various policy introductions coming from the United States Department of Health and Human Services. Among one of the greatest is titled, “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.”

After termination of the study, the government implemented and has regulated several changes that impact nursing and public policy today. After ethical concerns had been publically raised and the study was terminated, the National Research Act was signed into law in 1974. This policy was used in the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which proved helpful in identifying policy issues such as the lack of identified basic principles of research conduct and lack of informed consent. Regulations were passed according to this panel’s recommendations that required voluntary consent from all persons involved in studies which are funded or conducted by the Department of Health, Education and Welfare (DHEW) (CDC, 2013). For nurses, this involves a responsibility to ensure that research participants are advocated for and the consent being obtained is used as an educational, informative

Respect for human dignity includes two rights; the right to self-determination and the right to full disclosure. When conducting a research study these two rights must be maintained to ensure that the participants are not coerced into participation and that they are making the choice of their own free will. Patients must be provided with all the information necessary to make an informed decision and voluntarily participate. No deception or concealed data collection can be done because it will violate the patients’ rights.

The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. Retrieved December 13, 2011, from hhs.gov/ohrp/humansubjects/guidance/belmont.html

Just by reading the table of contents from the Belmont Report, one can point out different topics that are directly related to the Tuskegee Syphilis study. For example, regarding the ethical principles and guidelines for research involving human subjects, the Belmont Report discusses about the boundaries between research and practice. The Tuskegee Syphilis study promised free care to enroll people in the study, when in reality the research study was observing the natural progression of untreated syphilis in rural African-American men. The Belmont report describes that practice refers “to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success”1, it

Institutional Review Boards (IRBs) are groups that are formally designated by an institution to protect the rights and the welfare of human subjects. This is done by reviewing, approving and monitoring the medical research (Layman & Watzlaf, 2009). However, in order to do this efficiently, there are 3 ethical theories that the IRB must rely on. The first theory is beneficence which means “do no harm/promote good”. The second theory is autonomy, and the third theory is justice. Furthermore, IRBs review all the research that is conducted via data sources regarding human participation (i.e. medical records, tumor registry, and Medicare data). That said, IRBs are important because they help protect the rights and welfare of those participating

Following the public outrage over the Syphilis Study at Tuskegee, Congress established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1974. The National Commission was charged with:

In an article by “Vulnerable individuals represent a broad and vaguely defined group of people. Participants can be said to be vulnerable to the extent that their ability to give informed consent may be affected by physical, mental or emotional responses to their situation” (Nordentoft & Kappel, p. 369). When planning a research project, a researcher or IRB should consider the vulnerable participant as there is often diminished capacity to participate in their care thereby bringing into question the validity of understanding informed consent and the ability to withdraw from participation at any time. The Institutional Review Board (IRB) serves to protect vulnerable populations such as children, prisoners, pregnant women, and the physically

“Respect for human beings involves giving due scope to peoples capacity to make their own decisions. In the research context, this normally requires that participation be the result of a choice made by the participants” (NHMR, 2007, p.3).  Freegard 2012 (p.60), states that “respecting the rights of others,” includes a responsibility for Health professionals “to let others know about their rights” and that this forms the basis of an informed consent.

However, the framework has also provoked controversy and questions about its adequacy to resolve critical issues in bioethics and in clinical practice. In response, Beauchamp and Childress here offer an extended defense of their theory and critical examination of points of debate.

The principle of vulnerability is focused on treating and helping those who have disadvantages, or considered vulnerable. Unfortunately, this is not a universal thought, nor are the qualifications of being vulnerable the same for all. This principle is used in order to protect and not take advantage of the disadvantaged individuals. This principle is one of the reasons why one may observe societies take extra care of children or the elderly. The principle is borne from a respect of all peoples and a combination of the four core principles of bioethics, except for the principle of justice.