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Protecting Human Research Participants

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Ethical guidelines and considerations in research experiments involving human subjects are a fairly new construct. Prior to the twentieth century, elaborate set of rules and regulations regarding the use of human subjects in experiments merely did not exist. However, one of the most critical elements of research are ethical considerations, and the goal of a research experiment is to discover new information to broaden the knowledge of the human society. Therefore, distorting, falsifying, or misinforming research participants for the purpose of manipulating different reactions is highly unethical, and the values that research ethics rely on including integrity, accuracy, and objectivity are always violated. The Milgram Experiment on Obedience and the Stanford Prison Experiment are examples of two of the most intriguing and widely discussed social psychology experiments that have violated the basic principles of research ethics involving human subjects.

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Research with human subjects can occasionally result in a dilemma for investigators. When the goals of the research are designed to make major contributions to a field, such as improving the understanding of a disease process or determining the efficacy of an intervention, investigators may perceive the outcomes of their studies to be more important than providing protections for individual participants in the research. Although it is understandable to focus on goals, our society values the rights and welfare of individuals. It is not considered ethical behavior to use individuals solely as means to an end. The importance of demonstrating respect for research participants is reflected in the principles used to define ethical research and the regulations, policies, and guidance that describe the implementation of those principles. The first accounts of this study appeared in the national press in 1972

The resulting public outrage led to the appointment of an ad hoc advisory panel by the Department of Health, Education and Welfare (which later was split into the Department of Education and the Department of Health and Human Services [HHS]) to review the study and develop recommendations to ensure that such experiments would never again be conducted. The principle of justice may arise in decisions about inclusion and exclusion criteria for participation in research and requires investigators to question whether groups are considered for inclusion simply because of their availability, their compromised position, or their vulnerability — rather than for reasons directly related to the problem being studied.

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The creation of Institutional Review Boards to assure the protection of research subjects came out of terrible research abuses that resulted in the Belmont Report and federal regulations establishing rules for federally funded research and its independent review. The Common Rule became widely accepted as the way to oversee human research that is funded by federal agencies, or used in FDA submissions. The Office of Human Research Protections, now under the Secretary of DHHS, created Federalwide Assurances with groups that receive federal funding and others, the vast majority of which have agreed to apply the same ethical rules to all research regardless of funding source. There are controversies over the best methods to protect human research subjects, confusion about how to handle some of the gray areas, increased regulatory burdens, and debates about the adequacy of the IRB system. New exciting directions have evolved and overall, research subjects appear better protected than ever. Patients enroll in research trials for many different reasons

Commonly they hope for improvement in their disease, though researchers always tell them this cannot be guaranteed. After all, if we knew the outcome for sure, there would be no need for research. Often they hope to contribute to knowledge that will help others in the future, perhaps because they have seen a friend, relative, or even a stranger suffer or die due to lack of a cure that might come from medical research. While the reasons for enrolling in a research study may be many, patients expect that their safety will be looked after carefully, and do not expect to be hurt by their participation. But sometimes harm does come to research participants, and researchers must be sure the patient has given a truly informed consent, realizing the potential risks as well as the potential benefits of the research. Everyone in research is responsible for human subject protection. Institutional Review Boards (IRB) are unique in that this is their sole reason for existence.

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Altogether, the examples from history and the scarcity of contemporary examples demonstrate that the regulations for the protection of humans participating in research have evolved in a way that minimizes the probability that subjects will be harmed when they choose to participate in research. The examples also reinforce the importance of individual responsibility. Failure of IRBs to provide appropriate review and oversight can lead to severe consequences, as can abrogation by the investigator to place the well-being of the subjects as the primary responsibility in any research protocol

Understanding how we arrived at the current approach and some of the failures that directed this course can support efforts to continually reevaluate and improve the safety of subjects who are willing to participate in research activities.

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Heller J. New York Times. July 26, 1972.

Mahoney M. R., Sargent D. J., O'Connell M. J., Goldberg R. M., Schaefer P., and Buckner J. C. (2005). Dealing With a Deluge of Data: An Assessment of Adverse Event Data on North Central Cancer Treatment Group Trials. J Clin Oncol. 2005

CFR 46.102d.

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