The Honor of Protecting Participants While Conducting Research or Clinical Projects
Article Outline
- The History of Research Subject Protection
- Boundaries Between Practice and Research
- So What Is One to Do?
- References
- Copyright
Dr. Barbara Resnick
The History of Research Subject Protection
The modern story of human subjects’ protections begins with the Nuremberg Code, developed for the Nuremberg Military Tribunal as standards by which to judge the human experimentation conducted by the Nazis. The Code captures many of what are now taken to be the basic principles governing the ethical conduct of research involving human subjects. The first provision of the Code states that ‘the voluntary consent of the human subject is absolutely essential.’ Giving individual consent and expressing a willingness to participate knowingly in research is critical to ethical experimentation involving human subjects. The Code goes on to provide the details involved with the consent process: capacity to consent, freedom from coercion, and comprehension of the risks and benefits involved. Other provisions require the minimization of risk and harm, a favorable risk-to-benefit ratio, evidence that the research will result in useful findings, and evidence that the participant can easily withdraw from participation at any time. Similar recommendations were made by the World Medical Association in its Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects, first adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964, and subsequently revised by the 29th World Medical Assembly, Tokyo, Japan, 1975, and by the 41st World Medical Assembly, Hong Kong, 1989. The Declaration of Helsinki further distinguishes therapeutic from nontherapeutic research.
In the United States, regulations protecting human subjects first became effective on May 30, 1974. Promulgated by the Department of Health, Education and Welfare (DHEW), these regulations raised to regulatory status the National Institutes of Health Policies for the Protection of Human Subjects, which were first issued in 1966. The regulations established the Institutional Review Board (IRB) as one mechanism through which human subjects would be protected. IRBs are also commonly referred to as ethical review boards. These boards have been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the subjects. In the United States, the Food and Drug Administration (FDA) and Human Health Services regulations have empowered IRBs to approve, require modifications in (to secure approval), or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects that are scientific, ethical, and regulatory.
In July 1974, the passage of the National Research Act established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission stressed the basic ethical principles that must underlie the conduct of biomedical and behavioral research involving human subjects, as established in the Belmont Report, created in 1978 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The report, which was named after the Belmont Conference Center at the Smithsonian Institution, established the following ethical principles with regard to research: Respect for persons, beneficence, and justice. Respect for persons involves recognition of the personal dignity and autonomy of individuals, and special protection of those persons with diminished autonomy. Beneficence entails an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm. Justice requires that the benefits and burdens of research be distributed fairly. The report also describes how these principles apply to the conduct of research. Specifically, the principle of respect for persons underlies the need to obtain informed consent; the principle of beneficence underlies the need to engage in a risk-to-benefit analysis and to minimize risks; and the principle of justice requires that subjects be fairly selected.
Boundaries Between Practice and Research
Unfortunately, it is easy to blur research with interventions that occur within clinical practice, particularly when implementing new programs or procedures on a unit or within a facility. Practice is described as ‘interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success. This might be the implementation of a clinical practice guideline related to falls or urinary incontinence. Conversely, research involves activities 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 might be testing a new way to implement a clinical practice guideline such as use of a stage-based intervention approach to optimize behavior change among residents and caregivers.
Research and practice may occur simultaneously. The safety and effectiveness of any type of “experimental” procedure or practice should be carefully evaluated and reviewed by an IRB or some type of oversight committee. This is essential if the information is reported to others and used in future discussions about the intervention. In research endeavors, participants are asked to consent to allow the researcher to report the findings to other providers. In clinical practice, without consent, the patients have not agreed to this process. Moreover, the Health Insurance Portability and Accountability Act (HIPAA) further cautions against such reporting. The Privacy Rule with HIPAA, which was mandated in April 2003, established regulations for the use and disclosure of Protected Health Information (PHI). PHI is any information about health status, provision of health care, or payment for health care that can be linked to an individual. This is interpreted rather broadly and includes any part of a patient’s medical record or payment history.
When engaging in research with older individuals, it is critical that we give the principle of respect for persons special consideration. In addition to the large number of older adults with documented cognitive impairment, older individuals without known cognitive problems are at risk for delirium during periods of acute illness or transitions. We must therefore ensure that these individuals have been given a fair opportunity to agree or refuse to participate in a research based intervention or have personal information used to report on clinical projects. I strongly recommend the use of the Evaluation to Sign Consent test,1 rather than a simple cognitive screening tool such as the Mini-Mental State Exam.2 The Evaluation to Sign Consent test asks the participant to answer 5 questions related to the study being proposed. Their ability to answer these items reflects an understanding as to what they have consented to. Although it is not cognitive status alone that explains one’s ability to pass the Evaluation to Sign Consent test, the use of this tool allows those with mild to moderate impairment to have a voice in whether they participate in any given research endeavor. If the older individual does not pass the Evaluation to Sign Consent test, the designated proxy should be asked to consent for the individual. Although not widespread, individuals have begun to put willingness to engage in research into their end of life care preferences.
So What Is One to Do?
Clinical projects are terrific and can be implemented within facilities as the set standard or protocol of care at any given time. One could, for example, require routine nose swabs of all new residents to establish evidence of methicillin-resistant Staphylococcus aureus. To report on your findings, however, IRB approval, or some type of ethics committee review, would be required. This type of activity might be considered exempt from a full review in some cases. What is critical, however, is that there is documented evidence that this project has been reviewed and either considered exempt and no consent needed from participants or approval given and consent obtained. Although much of this may seem overly cautious in our day-to-day nursing interventions, remember from whence this all came. Moreover, it could be your mother or grandmother whose urinary function, cognitive status, or agitation is being described and reported on or who is exposed to an invasive, unpleasant procedure that will provide her with no potential benefit. Geriatric Nursing upholds the mandates of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and requires evidence of IRB approval or exemption as appropriate to the given research/clinical project. Feel free to contact us if you have questions about whether an IRB or ethics committee review is needed.
References
PII: S0197-4572(07)00228-5
doi:10.1016/j.gerinurse.2007.08.004
© 2007 Mosby, Inc. All rights reserved.
