Ethical issues in research involving human participants

Yet, this assessment can be a difficult one to make, as there are no clear criteria for irbs to use in judging whether the risks of research are reasonable in terms of what might be gained by the individual or should be able to identify whether a clear and direct benefit to society or the research participants might result from participating in the study. For all subject populations in which autonomy is diminished, research investigators are responsible for meeting ethical and regulatory obligations to protect the right for self-determination of any prospective or current research en also require special consideration.

Ethical issues in psychological research with human participants

Informed consent involves the knowledge of the potential risks inherent in participating in research and what personal or general benefits, if any, may be gained by participating. However, not all research participants receive these entitlements and not all are protected by the existing oversight system.

By contrast, the term "research' designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). This report views the oversight system as a whole, provides a rationale for change, and offers an interrelated set of recommendations to improve the protection of human participants and enable the oversight system to operate more ting research r testing a new medical treatment, interviewing people about their personal habits, studying how people think and feel, or observing how they live within groups, research seeks to learn something new about the human condition.

In 1947, the nazi war crimes tribunal issued the first internationally recognized code of research ethics, the nuremberg code (1947; jama, 276, 30, nov. When research poses significant risks or when its risks are imposed on participants without their knowledge, it clearly requires oversight.

There are, for example, risks of psychological harm, physical harm, legal harm, social harm and economic harm and the corresponding benefits. Social science, humanities, business, public health, and health services) contribute to the development of the definition and the list of research activities subject to the oversight gh the definition of research involving human participants should be applied to all disciplines, the risks differ both qualitatively and quantitatively across the spectrum of research.

The assessment of risks and benefits requires a careful arrayal of relevant data, including, in some cases, alternative ways of obtaining the benefits sought in the research. As the complexion of research continues to change and as technology advances, new and challenging ethical dilemmas will emerge.

This, too, seems insufficient since the research subject, being in essence a volunteer, may wish to know considerably more about risks gratuitously undertaken than do patients who deliver themselves into the hand of a clinician for needed care. One standard frequently invoked in medical practice, namely the information commonly provided by practitioners in the field or in the locale, is inadequate since research takes place precisely when a common understanding does not exist.

Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. Public health reports 68(4): pool hy (1996): the ethics of research involving human subjects: facing the 21st century.

Given their dependent status and their frequently compromised capacity for free consent, they should be protected against the danger of being involved in research solely for administrative convenience, or because they are easy to manipulate as a result of their illness or socioeconomic condition. Although some reforms by particular federal agencies and professional under way,1 it will take the efforts of both the executive and legislative branches of government to put in place a streamlined, effective, responsive, and comprehensive system that achieves the protection of all human participants and encourages ethically responsible y, scientific investigation has extended and enhanced the quality of life and increased our understanding of ourselves, our relationships with others, and the natural world.

December 1, 2000http:///html/programs/ e, schumann sh, simpson l, olansky s (1953): twenty years of followup experience in a long-range medical study. In cloning human beings (1997), we recommended federal support of public education in biomedical sciences that increasingly affect our cultural values.

The requirement that research be justified on the basis of a favorable risk/benefit assessment bears a close relation to the principle of beneficence, just as the moral requirement that informed consent be obtained is derived primarily from the principle of respect for persons. Thus, to facilitate the extension of the same protections to all humans participating in research, a unified, comprehensive federal policy promulgated and interpreted by a single office is endation 2.

The surviving participants were only given treatment in 1972, after the nature of the study became publicly known, 23 years after publication of the nuremberg code. No matter what potential benefit is offered to individual participants or society at large, the possibility of benefit from one element of a study should not be used to justify otherwise unacceptable our view, irbs should appreciate that for some components of a study, participants might incur risks with no personal potential benefit, for example, when a nondiagnostic survey is included among the components of a psychotherapy protocol or when placebos are given to some participants in a drug trial.

If it refers to the individuals to be involved in the research, then the same intervention could be classified as minimal risk or greater than minimal risk, depending on the health status of those participants and their particular experiences. However, meaningless or overly rigid oversight engenders disdain on the part of researchers, creates an impossible and pointless workload for irbs, and deters ethically sound research from going ng that the level of review corresponds to the level of within areas of research that need oversight, many individual studies will involve little or no risk to participants.

Overall, the emphasis should be on knowing how to protect participants rather than on knowing how to navigate research regulations. In fact, waiving the informed consent process is justifiable in research studies that include no interaction between investigators and participants, such as in studies using existing identifiable data (e.

In june of 2000, the department of health and human services announced a requirement calling for education of all key personnel working on phs-funded studies with human subjects (nih, 2000). At this time, injured research participants alone bear both the cost of lost health and the expense of medical care, unless they have adequate health insurance or successfully pursue legal action to gain compensation from the specific individuals or organizations that were involved in conducting the research.