Nursing Research: Informed Consent

Informed consent is the process by which a potential subject or a legal representative is given explanations about the purpose of the research and the risks, inconveniences, costs, potential benefits, and right to withdraw from the study without repercussions. This must occur prior to obtaining written or verbal consent for enrollment. The use of in-formed consent for research and the process for obtaining it have evolved over the past 50 years. 

informed consent

The major impetus for increased attention to the issues of informed consent was a series of studies involving unethical actions on the part of researchers toward their subjects. These studies involved human rights violations in which subjects were neither informed nor had the ability to refuse participation. Highly publicized examples included experiments conducted on Nazi prisoners in concentration camps; withholding treatment for a group of poor Black men with syphilis in Tuskeegee, Alabama, to determine the course of the untreated disease; and not informing elderly patients at the Jewish Chronic Disease Hospital in New York that they were injected with live cancer cells (National Commission for the Protection of Human Subjects, 1979).The Nuremberg Code, which outlined ethical standards for research, was adopted in response to the human rights violations in Nazi prison camps. This was followed by the Declaration of Helsinki, adopted by the World Medical Assembly in 1964. In the United States the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979) developed a code of ethics for the protection of human subjects, specifying guidelines for re-search sponsored by the federal government.
The basic principles of beneficence, justice, and respect for persons were the guiding ethical principles. This was followed by federal regulations, specifying in greater detail the conditions under which humans could be used in research sponsored by the federal government. Professional organizations then issued their own guidelines. In 1975, the American Nurses Association published Human Rights Guidelines for Nurses in Clinical and Other Research.
Today research involving human subjects requires that, prior to giving consent, the subject or legal representative be informed of the purpose, duration, and procedures of the study; risks or discomforts; potential benefits; alternatives to participation; confidentiality; compensation; person to contact for questions; and a statement that participation is voluntary. There are special provisions when subjects are fetuses (in and ex utero), children, pregnant women, or prisoners
(USDHHS, 1983).
Not all research involving humans requires informed consent. The local institutional review board (IRB) is the authority for determining the need for informed consent. Issues about informed consent debated in the literature include understandability of the consent form, research in emergency or critical care situations, genetic research, and use of blood cell line development.
Understandability of the consent form has two components: the subject’s ability to understand the information in the consent form and the reading level. The subject must be legally competent to give informed consent.
Competency to give consent can be affected by the age of the potential subjects (child vs. adult); mental ability (Alzheimer’s patients or mentally retarded adults); medical condition (unconsciousness, sedated, incubated); or ability to read, speak, and understand English. The researcher has to ensure that the consent form is written at a level that can be understood by the subject.
Until the fall of 1996 the ability of researchers to conduct studies in emergency and critical care situations, when the potential subject was not able to give informed consent and the legal representative was not available, was severely limited. A change in federal regulations (USDHHS, 1996) allows the exemption from informed consent requirements for emergency research under very specific conditions: (a) the subject’s condition is life-threatening, (b) available treatments are unproved or unsatisfactory, (c) consent cannot reasonably be obtained prior to the initiation of the intervention, (d) there is the potential for direct benefit to the subject, and (e) the community is aware of the research prior to the initiation of the study.
Nursing research on informed consent primarily has addressed the issue of patient advocacy, with emphasis on the patient’s ability to understand the informed consent document. Susman, Dorn, and Fletcher (1992) investigated how much information 44 subjects, aged 7 to 20 years, retained about the research protocol in which they were enrolled. They found that over 50% of the subjects understood that they could ask questions about the research study, knew how long they would be in the study and what the benefit of the study would be, and were aware that they could withdraw at any time. However, less than 3% knew the purpose of the study, 9% knew the risks associated with the study, and 14% knew what procedures were
associated with the study.
A second study focused on what subjects understood of the words used in research consent forms. Lawson and Adamson (1995) interviewed 86 adults on research protocols and found that over 80% understood the following commonly used terms: efficacy, lesion, orally, benefits, adverse reactions, placebo, compensation, ineligible, and withdrawal of consent. Conversely, less than 50% of the subjects understood words such as protocol, open label, and nonsteroidal anti-inflammatory drugs.

Techniques for improving subject under-standing of the research include giving a copy of the informed consent form to the subject, viewing a videotape of the research procedure, and calling subjects after they have signed the consent to answer questions or concerns. Additional research is needed in the area of informed consent.