Conducting Ethical Nursing Research Projects

Conducting a research project can be time-consuming and stressful, tempting some busy nurse researchers to cut corners. They might obtain consent signatures, but not take the time to ensure that patients fully comprehend the project. Or perhaps they neglect to weigh a patient prior to administering a medication that calculates dosing by weight and instead rely on information in the patient’s chart. The ramifications could be minor or catastrophic. Either way, it’s a violation of research ethics.

“When you conduct a research study, the work doesn’t end with approval from the Institutional Review Board (IRB),” says Linda Lewicki, PhD, RN, Senior Nurse Researcher at Cleveland Clinic and Vice-Chair of the IRB. “You have to comply with federal regulations and keep in mind the ethical principles of the Belmont Report. They should carry through all research activity, up to and including reporting your research results.”

Adhering to governmental guidelines

As a member of the IRB, Dr. Lewicki says her stance on research ethics has one primary goal – to protect enrolled subjects. “It’s imperative to design a study that minimizes risks to participants, meets the parameters approved by the IRB and honors the three principles of the Belmont Report,” she says.

Released in 1979 by the U.S. Department of Health and Human Services, the Belmont Report presents three basic ethical principles that should underlie biomedical and behavioral research involving human subjects:

1. Respect for persons – Individuals should be treated as autonomous, and those with diminished autonomy (due to illness, dementia, etc.) are entitled to protection.
2. Beneficence – People should be treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being.
3. Justice – This relates to receiving the benefits of research or bearing its burdens. An injustice occurs when a person is denied without good reason some benefit to which they are entitled or when some burden is unduly imposed.

In addition, researchers must adhere to the Federal Policy for Protection of Human Subjects, also known as the Common Rule. Published in 1991, it sets forth the baseline standard of ethics for government-funded research in the U.S.

Minimizing potential research risks

When applying the Common Rule and principles from the Belmont Report, Dr. Lewicki says breaches in research ethics typically occur in one of three main areas: protocol development, study implementation, and data analysis and reporting.

A sound study design is at the heart of protocol development, says Dr. Lewicki. “You need a clearly defined aim, purpose and hypothesis,” she says. To ensure risks are minimized during protocol development, she offers the following advice:

• Ensure that the data you plan to collect will very specifically address your research question.
• Use valid tools and instruments to collect data.
• Make sure your sample size and statistical analysis are justified and reasonable.
• Choose a study team with appropriate expertise and experience or seek a mentor.
• Eliminate or manage any conflicts of interest.
• Carefully consider the inclusion and exclusion criteria for enrolling subjects.
• Conduct a risk-benefit analysis, examining physical, psychological, social, legal and economic risks.
• Confirm that there is either a direct benefit to participants or a societal benefit of the research.

One of the biggest factors related to study implementation is the consent of subjects. The written form must contain all the required elements, including information on the research, risks and discomforts, benefits, alternative procedures of treatment, confidentiality, research-related injuries, costs and the subject’s signature. The person conducting the consent interview must be knowledgeable about the protocol and have received human subject protection education. In addition, the interview must be done in a manner and setting that allows potential participants to process the information, ask questions and seek more information, if necessary.

Dr. Lewicki cites other considerations related to study implementation:

• Collect study data in a private setting and manner.
• Secure all data in accordance with HIPAA.
• Restrict study records and data to authorized personnel.
• Follow the protocols approved by the IRB: Do not deviate or change them without IRB approval.

When things go awry in the final area of research – data analysis and reporting – it’s often because of time pressures, says Dr. Lewicki. Perhaps the research is required for a nursing student and graduation is looming. Or maybe the nurse researcher wants to complete the project prior to a work review period in order to move up the career ladder. The most common problems with data analysis and reporting are fabrication, falsification and plagiarism.

“This can lead to termination, loss of funding or retraction of your manuscript,” says Dr. Lewicki. “Ultimately, it can ruin your reputation.” And worse yet, it may have dire consequences for patients, ranging from a breach in privacy to physical harm.

Acting as a nurse researcher and care provider

Unfortunately, breaches in ethics still occur: participants are pressured to enroll, research procedures begin without securing consent, researchers deviate from approved protocols and so on. The U.S. Department of Health and Human Services oversees compliance issues and publishes allegations of noncompliance on its website.

Perhaps the best way to avoid problems with research ethics is to keep in mind that nurse researchers are both researchers and care providers. “We are there to support patients, either by treating and curing their illnesses or supporting them to a comfortable end,” says Dr. Lewicki. “The same caring and art we display in our everyday practice should be applied to any research we conduct.”