Page 483 - Encyclopedia of Nursing Research

450 n RIGHTS OF HUMAN SUBJECTS

the opportunity for questions about or with-
Rights of human subjects drawal from the project after treatment has
R begun, should all be provided to the research
subject.
Rights are just claims that are due to some- For adequate comprehension of infor-
one. legal rights are valid claims recognized mation, the research subject must have time
by a legal system. Moral rights are valid to consider the information and to ask ques-
claims derived from customs, traditions, or tions. This means that when the ability to
ideals which may be upheld or protected by comprehend information is limited (such as
the law. Human rights are valid claims that when a subject’s mental competence is lim-
are due to members of the human species ited), the researcher must allow the research
and may be legal, moral, or both. subject additional opportunity to consider
The rights of human subjects in research whether or not to participate in the study.
include the right to informed consent, the Voluntary consent to participate in
right to privacy, the right to refuse to partic- research means that the research subject has
ipate in research, and the right to withdraw exercised choice, free of coercion and other
from a research study, without penalty, at any forms of controlling influence by other per-
time. These four rights are all derived from sons. A research subject’s consent is valid
a general right to liberty and are both moral only if it is voluntarily given. Voluntariness
and legal. They are supported by moral prin- protects the patient’s right to choose goals
ciples of the social community, professional and to choose among several goals when
codes of research ethics, and by legal pro- offered options. However, consent cannot be
tections. They become relevant in nursing given unless the research subject is “compe-
research because all nurses have a responsi- tent,” or can make decisions based on rational
bility to protect, and sometimes defend, the reasons. Both competence and voluntariness
basic rights of patients within the health care are required for a subject’s consent to be truly
system. When the nurse is also a researcher, informed.
the nurse has the added responsibility to Nursing research on the informed con-
make sure that these particular rights are not sent of human subjects has focused on the
violated by the research process. comprehension of information by research
Informed consent is a process that pro- subjects, subjects’ competency for informed
tects research subjects’ autonomy, protects consent (i.e., adolescents and mentally
research subjects from harm, and assists retarded minors), and the factors that influ-
the researcher to avoid fraud and coercion ence the informed consent of adolescents and
in the role of researcher. It is also a process adults. The study designs have been explor-
that encourages researcher responsibility atory and quasi-experimental and have
for how information is communicated in included relatively small sample sizes.
research, promotes rational decision making The right to privacy includes the right
by human subjects, and involves the public to keep personal information about one-
in promoting self-determination as a social self private, undisclosed, and away from
value. Informed consent has information ele- public scrutiny. It also includes the right to
ments and consent elements. bodily integrity, or freedom from unwanted
For adequate disclosure of information, intrusions on body parts. One way that the
the research subject must be informed of research subject’s right to privacy is pro-
the procedures to be used throughout the tected is by following rules of confidentiality.
study. Information about available alterna- For example, information about the research
tive treatment procedures, a discussion of subject may not be disclosed without the sub-
risks and benefits of these procedures, and ject’s permission and then only under certain