What Makes Clinical Research Ethical?

About the Author

Renee Whitmore

Renee Whitmore is an Associate Professor of English at Sandhills Community College in Pinehurst, North Carolina. Before starting at SCC in 2013, she taught English at the middle and high school levels for five years. She currently teaches a combination of traditional seated and online courses, including English Composition, Argument Research, and Creative Writing. Renee earned a Bachelor of Arts in English in 2006 and a Master of Arts in Teaching, with a specialization in English in 2011, both from the University of North Carolina at Pembroke.

Clinical research aims to advance medical knowledge by investigating human subjects.

These studies can involve a wide variety of topics, such as understanding and treating diseases, exploring behavior and how it relates to health, and evaluating how participants respond to a specific treatment.

To conduct clinical research, researchers need people to participate. However, when using human subjects, ethical standards are incredibly important to ensure each individual is safe.

This article will address why ethical research is essential and what types of ethical guidelines are in place to protect participants.

Why Is Ethics Important in Clinical Research?

Unfortunately, if we look back in history, we can easily find examples of unethical clinical studies that were performed on individuals without their consent. For example, the famous Stanford Prison Experiment in 1971 aimed to study the effect of “role-playing, labeling, and social expectations” on behavior over a two-week period. In this study, twenty-four male students were randomly assigned either to the role of guard and prisoner. Pretty soon, the “guards” began to enforce harsh measures and subject their “prisoners” to high degrees of psychological torture, leading the researcher to stop the experiment after six days.

The Stanford Prison example is only one of many clinical research trials that were unethical. Eventually, the scientific community decided that something had to be done to keep participants safe both physically and psychologically.

Dr. Christine Grady, the Chief of the Department of Bioethics, is a chief expert on this topic and has written extensively about biomedical and bioethics literature. Through Dr. Grady’s research on ethics in clinical research, we have the seven ethical guidelines that we use today.

What Are the Ethical Guidelines in Clinical Research?

The NIH Clinical Center has published the following seven ethical guidelines of research:

  1. Social and Clinical Value
  2. Scientific Validity
  3. Fair Subject Selection
  4. Favorable Risk-Benefit Ratio
  5. Independent Review
  6. Informed Consent
  7. Respect for Potential and Enrolled Subjects

Let’s look at each of these principles in detail.

Social and Clinical Value

Each clinical research study begins with a question and the point of the study is to answer that question. The social and clinical value principle requires that the information sought in the study should contribute to the scientific knowledge of health or disease. Simply put, the study should aim to be of value to the community. 

Scientific Validity

Clinical research studies should be designed in a way that ensures the information sought can be attained. NIH states that “this includes considering whether the question researchers are asking is answerable, whether the research methods are valid and feasible, and whether the study is designed with a clear scientific objective and using accepted principles, methods, and reliable practices.”

Fair Subject Selection

The clinical study should include the groups and individuals it is studying. Participants should be chosen in a way that “minimizes risks and enhances benefits to individuals and society” (NIH Clinical Center). Specific groups of people who qualify for the study should not be excluded unless there is a good scientific reason or risk.

Favorable Risk-Benefit Ratio

Every clinical research study comes with risks, including physical, psychological, emotional, or social. These risks may be insignificant, serious, short-lived, or long-lasting. The favorable risk-benefit ratio is meant to ensure that the researchers do all they can to minimize risks and maximize benefits. 

Independent Review

An independent review is established before a clinical research study begins to ensure that the study is ethical and no conflict of interest is evident. The review must check off a variety of questions before lending its approval, such as whether or not the trial is free of bias and that it is doing all it can to keep its participants safe.

Informed Consent

Informed consent requires that all participants in a given study have willingly signed up to take part and are fully aware of what the study entails. The process of informed consent ensures that each participant is informed of the purpose, methods, risks, and benefits of research.

Respect for Potential and Enrolled Subjects

Research participants should be treated with respect throughout the entire study. This includes:

  • Respecting their privacy and keeping their information confidential
  • Respecting their right to withdraw from the research study at any time
  • Informing them of new information during the research process
  • Monitoring their welfare throughout the study, which includes reactions and ensuring treatment
  • Informing them about the status of the study and the results when it is complete

Conclusion

For clinical research to be beneficial, it must be ethical. Ethics keeps researchers accountable for their actions and keeps participants safe. It is far more than just obtaining informed consent but encompasses a lengthy process that starts with a research question and ends with fairly reporting the results.