Themes

Balancing harms and benefits

What is this about?

Every research project that involves humans should balance harms and benefits.

Why is this important?

When considering any research project, the potential net benefit should outweigh the potential net harm. This is in line with the universally recognized ethical principles of beneficence (doing good) and non-maleficence (not doing harm). These two principles stem from the belief that human beings have inherent dignity, which was formalized in the UN Declaration of Human Rights (1). In biomedical research, harms will almost inevitably be experienced alongside benefits. That’s why it’s important to carefully assess how important the benefits are and under what cost. These dilemmas should always be communicated to research participants, to ensure fully informed consent.

A number of mid-20th century studies, such as the Tuskegee syphilis experiment, were conducted to examine the natural history of a disease by either deliberately exposing human subjects to damaging stimuli, or by not giving them effective treatment (2). These are some of the most prominent examples of disproportionate harm to benefit.

For whom is this important?

All stakeholders in researchResearch subjectsEthics committee membersPrincipal investigatorsPhD Students

What are the best practices?

The Belmont report (3), the Declaration of Helsinki (4) and similar ethical and legal documents were enacted by governing bodies and professional associations.

In Detail

1. UN General Assembly. Universal Declaration of Human Rights. Accessed 28 May 2019. Available at: https://www.un.org/en/universal-declaration-human-rights/

2. Alsan M, Wanamaker M. Tuskegee and the health of black men. Q J Econ. 2018;133(1):407–455.

3. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Accessed 28 May 2019. Available at: https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html

4. World Medical Association. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. JAMA. 2013;310(20):2191–2194.

The Embassy Editorial team, The Embassy editorial team, Iris Lechner, Stefan Veen, Andrijana Perković Paloš, Ružica Tokalić contributed to this theme. Latest contribution was Mar 25, 2021

Other information

Good Practices & Misconduct

Informed consent