Legal and Moral Rights in Research

Nursing Research and Legal & Moral Rights

 Rights of Human Subjects,Rights of Research Participants,Consent and Autonomy of Subject,Information Item,Consent Items,Nursing Research and Informed Consent,Right of Privacy,Signed Permission,Refuse Right,Right to Withdraw,Importance of Moral Integrity in Research.

Rights of Human Subjects

    Rights are just claims that are due to someone. Legal rights are valid claims recognized by a legal system. Moral rights are valid claims derived from customs, traditions, or ideals which may be upheld or protected by the law. Human rights are valid claims that are due to members of the human species and may be legal, moral, or both.

Rights of Research Participants 

    The rights of human subjects in research include the right to informed consent, the right to privacy, the right to refuse to participate in research, and the right to withdraw from a research study, without penalty, at any time. 

    These four rights are all derived from a general right to liberty and are both moral and legal. They are supported by moral principles of the social community, professional codes of research ethics, and by legal protections. 

    They become relevant in nursing research because all nurses have a responsibility to protect, and sometimes defend, the basic rights of patients within the health care system. When the nurse is also a researcher, the nurse has the added responsibility to make sure that these particular rights are not violated by the research process.

Consent and Autonomy of Subject

    Informed consent is a process that protects research subjects' autonomy, protects research subjects from harm, and assists the researcher to avoid fraud and coercion in the role of researcher. 

    It is also a process that encourages researcher responsibility for how information is communicated in research, promotes rational decision making by human subjects, and involves the public in promoting self-determination as a social value. Informed consent has information elements and consent elements.

Information Item

    For adequate disclosure of information, the research subject must be informed on the procedures to be used throughout the study. Information about available alternative treatment procedures, a discussion of risks and benefits of these procedures, and the opportunity for questions about or withdrawal from the project after treatment has begun, should all be provided to the research subject.

    For adequate comprehension of information, the research subject must have time to consider the information and to ask questions. This means that when the ability to comprehend information is limited (such as when a subject's mental competence is limited), the researcher must allow the research subject additional opportunity to consider whether or not to participate in the study.

Consent Items

    Voluntary consent to participate in research means that the research subject has exercised choice, free of coercion and other forms of controlling influence by other persons. A research subject's consent is valid only if it is voluntarily given. 

    Voluntariness protects the patient's right to choose goals and to choose among several goals when options offered. But consent cannot be given unless the research subject is “competent,” or can make decisions based on rational reasons. Both competence and voluntariness are required for a subject's consent to be truly informed.

Nursing Research and Informed Consent

    Nursing research on the informed consent of human subjects has focused on the comprehension of information by research subjects, subjects' competency for informed consent ( ie , adolescents, mentally retarded minors), and the factors that influence the informed consent of adolescents and adults. The study designs have been exploratory and quasi experimental and have included relatively small sample sizes.

Right of Privacy

    The right to privacy includes the right to keep personal information about oneself private, undisclosed, and away from public scrutiny. It also includes the right to bodily integrity, or freedom from unwanted intrusions on body parts. 

    One way that the research subject's right to privacy is protected is by the following rules of confidentiality. For example, information about the research subject may not be disclosed without the subject's permission and then only under certain conditions. In a like manner, research data is not publicly connected to the research subject, thereby assuring subject privacy.

Signed Permission 

    Another way that the research subject's right to privacy is protected is by obtaining an informed consent and signed permission for invasive procedures used during the research process. For example, informed consent must be obtained before passing a Levine tube to obtain gastric contents for analysis. 

    Nursing research on the privacy of human subjects is not yet documented. Potential areas for nursing research are identifying how research studies protect or do not protect the privacy of human subjects, describing research subjects' perceptions of how their privacy was protected or not protected during a study, identifying researchers' attitudes towards rules of confidentiality under different research conditions, and identifying institutional review board (IRB) members' knowledge of and attitudes toward protection of human subject privacy in research studies.

Refuse Right 

    Right to Refuse to Participate in Research. The right to refuse to participate in research. protects the subject from being coerced to: participate in research and assures that research subjects are truly voluntary. Nursing research on the right to refuse to participate in research is not yet documented. 

    Potential areas for nursing research are identifying the conditions under which research subjects' refuse to participate in a study and describing why subjects have refused to participate in particular types of research studies.

Right to Withdraw

    Right to Withdraw from a Research Study. Human subjects have the right to withdraw from a research study without any untoward treatment of them. Even though they had previously consented to participate in a research study, subjects have the right to change their minds and withdraw from the study at any time.

    Nursing research on the right to withdraw from a research study is not yet documented. Potential areas for nursing research are identifying the conditions under which research subjects withdraw from a study and describing the course of treatment of subjects who do and do not withdraw from studies involving particular diseases.

Importance of Moral Integrity in Research

    The protection of human rights in research studies is important to the moral integrity of nursing research. International and professional codes of research ethics strongly support the morality of research, and the American Nurses Association's Ethical Guidelines in the Conduct, Dissemination, and Implementation of Nursing Research (Silva, 1995) supports the morality of nursing research. However, nursing research on the protection of human rights in research is at an early stage of development. 

    As the 21st century approaches, nursing research should include studies of how human rights are protected in research and the factors that inhibit or promote their protection in various kinds of research designs.