Nursing Care and Concept of Informed Consent
Informed Consent In Research
consent is the process by which a potential subject or a legal representative
is given explanations about the to withdraw from the study
without repercussions.
When And Why Consent Is Taken
This must occur prior to obtaining written or verbal
consent for enrollment. The use of informed consent for research and the
process for obtaining it have evolved over the past 50 years. 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 towards 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
Tuskegee, Alabama, to determine the course of the untreated disease; and not
reporting 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).
Nuremberg Code and Its Role
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 research 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 Nursing 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).
Nature and Components of Consent
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 understanding of the consent form, research in emergency or critical
care situations, genetic research, and use of blood cell line development.
Language and Description of Consent
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.
Competence 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.
(e) the community is aware of the research prior to
the initiation of the study.
Informed Consent In Nursing Research
Nursing
research on informed consent has primarily 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, lesions, 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.