Codes of Practice and Informed Consent

In nursing practice, the care and well-being of the patient is a priority. In nursing research, however, the value, accuracy, and reliability of the research is another consideration.

Clinical research is fundamental to medical advancement. However, history shows that researchers have not always treated participants with the respect they deserve. This has been especially true for participants from historically marginalized groups such as prisoners, people with disabilities, or people of color.

Nurses and others responsible for caring for these patients often experience “moral injury:” the suffering caused by having to witness or participate in unethical treatment.

In 1985, the American Nurses Association (ANA) updated its earlier statement on Human Rights Guidelines for Nurses in Clinical and Other Research to provide a framework for nurses to understand their obligations to protect participants and their own rights.

These guidelines are consistent with but narrower than the ANA's Code of Ethics for Nurses, gives nurses the tools to make ethical decisions, protect participants, and protect themselves and others from undergoing moral injury.

This page summarizes the ethical codes of practice and informed consent in nursing and helps you to understand how to apply them.

Nursing Activities and Ethical Issues

Nurses leading or supporting research face ethical considerations when new processes are used without understanding the outcome. In other words, they must decide the right thing to do when there is no certainty that a technique or procedure will help patients and there is a risk of harm.

Nurses are not alone in this responsibility. Organizations that perform research typically assign groups to protect the rights of research participants and those engaged in research.

Informed Consent for Nurses

The concept of “informed consent” puts the choice in the hands of the person most likely to be affected by the choice. For nurses working in an organization where research takes place, they must:

• Be informed if they will be expected to provide treatment or care as part of a research double-blind investigation. (Double-blind means neither the researcher nor the patient knows if the patient is receiving the treatment under investigation or the control).
• Be informed if they will be asked to collect data for research.
• Be allowed to opt out of research if they are not informed in advance of that expectation.
• Be informed of any potential risk to patients from research, how to recognize that risk, and how to respond.

Informed Consent for Participants

Participants must also be informed of any potential risks from participating in a study. As advocates for patients, nurses participating in research must understand the nature of patient informed consent and report to the appropriate authorities if a participant did not give full and informed consent to any part of a study.

While this applies to any participant in any research study, the ANA notes that nurses have special responsibility to those who are vulnerable to potential exploitation or not capable of informed consent.

Human rights

Researchers have the obligation to protect participants from risk of injury. While all research carries some level of risk, the risk must be both minimized and proportionate to the potential benefit to the participants and the potential knowledge to be gained.

Participants must also understand that they can withdraw from research at any time for any reason, without experiencing any retaliation or change in the quality of care.

Nurses must also advocate for and protect each participant’s right to privacy and dignity, ensuring that no physical, psychological, or social disadvantage affects subjects either during the study or when the findings are published. Patients must understand what information they are expected to share as part of the study and where and how that information might be published.

Participants

While patients are the most obvious category of participants whose rights must be protected, this also includes donors of organs, tissues, and services and people who respond to requests for information, such as survey respondents and volunteers.

Nurses must be especially watchful of the rights of certain participants, including prisoners, students, residents or clients of facilities that treat mental health conditions, and people in the military. They also need to be especially careful of the rights of minors. Minors should participate in research only with a parent or guardian’s informed consent.

In general, children and those with limited civil freedom should not participate in research unless they or others in similar conditions or categories are likely to benefit.

The Benefits of Research

The guidelines note that supporting research creates societal benefits that nurses should support. It states that nurses are obligated to support scientific knowledge that helps improve nursing practice and better patient care.

For those seeking more information about the responsibilities of nurses in supporting research, Provision 7 of the Code of Ethics for Nurses further details the moral imperative to advance nursing knowledge.

Other Resources

• The Department of Health and Human Services’ Office for Human Research Protections has a variety of resources, including free online education.
• The University of Pittsburgh has resources on protecting research participants, including participants with low literacy levels,