Ethical Issues in Nursing Research

• Development of ethical codes and guidelines

1947 Nuremberg Code criteria for research

1. Inform the subjects about the study
2. Qualified to conduct research

3. Based on animal experiments , if possible

4. Avoid injury to research subjects
5. Good of society
6. Stop the study if problems occur
The Belmont Report three Basic Principles to Research Subjects:
1. respect for person- the research subjects should have autonomy and self-determination
2. beneficence- research subjects should be protected from harm
3. justice- research subjects should receive fair treatment

• Elements of Informed Consent- concerns subject’s participation in research in which they have
full understanding of the study before the study begins. It is the principal means for
ensuring that the rights of research subjects are protected.
1. researchers identified and credentials presented
2. subject selection process is described
- one of the primary goal of all researchers is to choose an unbiased sample
3. purpose of the study is described
The purpose of the study should be clearly presented. The material should be in
the preferred language of the potential subjects and at the subjects reading level
for all printed material.
The researcher should be honest in presenting the purpose of the study.
4. study procedures are discussed
All aspect of the study should be fully explained.
Debriefing- is a meeting with research participants that ensures their
understanding of the reasons and justification for the procedure used in the
study.
5. potential risk are described
Subject must be told of the discomfort either physical or psychological as a
result of participations.
6. potential benefits are described
All research that should be conducted must benefit the society, a research that is
conducted to satisfy the researcher curiosity is unethical.
7. compensation if any is discussed
Monetary compensation should be avoided and all compensations if possible
should come from the listed possible benefits of the study.
8. alternative procedure if any are disclosed
9. anonymity or confidentiality is assured
Anonymity- occurs when no one, including the researcher, can link the subjects
with the data they provided.
Confidentiality- involves protection of the subject’s identity by the researcher.
10. right to refuse or to participate or to withdraw from the study without penalty is assured
All participation in nursing research must be voluntary.
No form of coercion should be involved and there must be no penalty involve
for non participation.
11. offer to answer all questions is made
12. means of obtaining study result is presented

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• Documentation of informed consent
- Consent can be obtain in a written form
- Oral permission may be obtain in a presence of a third subject
- A legally authorized representatives can give consent for subjects who are incapable of proper
decision making.
• The nurse researcher as patient advocate- responsibility to protect the privacy and the dignity
of the people involve in the research and to protect them from harm.
Clinical trials are studies conducted to evaluate new treatments, new drugs, and new or
improve medical equipment.
Assent- means that the underage child or adolescent freely chooses to participate in the
study.

• Guidelines for Critiquing the ethical aspect of the study

1. The study must be approved by the international review board.
2. Obtain Informed consent from the subjects.
3. There is available information about provisions for anonymity or confidentiality.
4. Selection process of subjects used must not be biased.
5. Subjects must not have been coerced into acting as subjects.
6. Benefit of participation in the study must outweigh the risk involved.
7. Provide the subject the opportunity to ask questions about the study and told how to
contact the researcher if other questions arose.
8. Subjects must be told how they could get the results of the study.