Themes

Research with humans

What is this about?

In research with humans, human beings are not only researchers, but also the main subjects of research. Such research can be observational or interventional, and can be medical (including biology, physiology, and clinical trials) or non-medical (social science, political science). Because of ethical issues arising from human research, this area is heavily regulated, to protect the rights and dignity of research participants (1).

Why is this important?

New drugs and procedures require detailed testing before being put into use. While a lot can be answered using in vitro experiments and animal testing, testing on humans is necessary in order to verify the safety and efficacy of novel treatments.

For whom is this important?

What are the best practices?

Throughout history, multiple violations of ethical principles in human research have happened. Most known and most widely publicized are experiments done by Nazis and Japanese during the WW2. In the aftermath of the WW2, the Nuremberg code was published to provide basic guidelines in human research (2). To further improve ethics of human research, the World Medical Association developed the Declaration of Helsinki in 1964 (3). While providing some guidance, they did not eradicate research misconduct. In the United States, a huge study was conducted to assess the impact of syphilis, and hundreds of participants were barred from seeking treatment in what was known as Tuskegee experiment. Following the public outcry, the Belmont report was published in 1978 (4).

These documents set important standards in human research and provide the foundations of medical ethics. Some of the important points are respect for the person, personal autonomy (and informed consent), justice, and beneficence (5). Nowadays, different countries have different laws regarding clinical research, and these are closely related with ethical committees.



References

1. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. World Medical Association Declaration of Helsinki Special Communication. JAMA. 2013;310(20):2191-4.

2. Moreno JD, Schmidt U, Joffe S. The Nuremberg Code 70 Years Later. Jama. 2017;318(9):795-6. Epub 2017/08/18.

3. Tyebkhan G. Declaration of Helsinki: the ethical cornerstone of human clinical research. Indian J Dermatol Venereol Leprol. 2003;69(3):245-7.

4. Sims JM. A brief review of the Belmont report. Dimens Crit Care Nurs. 2010;29(4):173-4.

5. Weise MV. Medical Ethics Made Easy. Prof Case Manag. 2016;21(2):88-94.

Ružica Tokalić contributed to this theme.

Latest contribution was May 29, 2019