26  Ethical principles for trial design

Experimental research is full of examples of ethical failures. One of the most notorious is the Tuskegee Syphilis Study, in which almost 400 hundred African American men were denied safe and effective treatment for almost 40 years.

Today there are many frameworks for ethical conduct of trials. One landmark framework comes from the Belmont Report (1979), a US Congress initiated national commission into ethical guidelines for research involving human subjects. It proposed three central principles for the conduct of trials: respect for persons, beneficence, and justice.

The Menlo Report (2012) was later developed in the light of increased digitisation of research practices and the difficulty in applying the ideas in the Belmont report in the digital age. It affirmed the three principles from the Menlo report and proposed a fourth: respect for law and public interest.

These principles form the basis of many Institutional Review Board ethical approvals in university and government. Each principle is described below:

26.1 Respect for Persons

The Menlo report described respect for persons as having the following components:

  • Participation as a research subject is voluntary, and follows from informed consent
  • Treat individuals as autonomous agents and respect their right to determine their own best interests
  • Respect individuals who are not targets of research yet are impacted - Individuals with diminished autonomy, who are incapable of deciding for themselves, are entitled to protection.

Practically, respect for persons has tended to revolve around the principle of informed consent. People should be given information about the experiment in a comprehensible format and then voluntarily agree to participate.

It is easy to come up with scenarios where informed consent does not appear appropriate or would undermine the very purpose of the experiment. For example, Marianne Bertrand and Sendhil Mullainathan (2004) sent fictitious CVs in response to ads with randomly assigned African American or White sounding names. White names received 50% more callbacks for interviews. Obtaining informed consent from employers would be impractical and make the experiment pointless.

There have been hundreds of discrimination studies of this nature. The lack of consent has been justified for reasons including the limited harm to employers and the social benefit of an accurate measure of discrimination. These justifications have enabled experiments of this nature to pass Institution Review Board processes.

26.2 Beneficence

The Menlo report described beneficence as having the following components:

  • Do not harm
  • Maximize probable benefits and minimize probable harms
  • Systematically assess both risk of harm and benefit.

One major potential source of harm is “informational risk”, the risk that information gathered in a trial may be disclosed. This is often dealt with through anonymisation, although there are ample examples of failures or re-identification of data after anonymisation processes. This leads to requirements to develop data protection plans and sharing protocols.

26.3 Justice

The Menlo report described justice as having the following components:

  • Each person deserves equal consideration in how to be treated, and the benefits of research should be fairly distributed according to individual need, effort, societal contribution, and merit
  • Selection of subjects should be fair, and burdens should be allocated equitably across impacted subjects.

Early conceptions of this concept focused on protection. More focus today, however, is on access, with groups such as women and minority groups needing to be explicitly included in trials so that they can benefit from the knowledge gained.

26.4 Respect for Law and Public Interest

The Menlo report described respect for law and public interest as having the following components:

  • Engage in legal due diligence
  • Be transparent in methods and results
  • Be accountable for actions.

The Belmont report took respect for law and public interest to be part of beneficence, but the Menlo report argues it deserves explicit consideration. It extends beyond the participants to society and law more generally.

26.4.1 An example

For one week in January 2012, approximately 700,000 Facebook users were placed in an experiment to study “emotional contagion,” the extent to which a person’s emotions are impacted by the emotions of the people with whom they interact. … Participants in the Emotional Contagion experiment were put into four groups: a “negativity-reduced” group, for whom posts with negative words (e.g., sad) were randomly blocked from appearing in the News Feed; a “positivity-reduced” group, for whom posts with positive words (e.g., happy) were randomly blocked; and two control groups, one for the positivity-reduced group and one for the negativity-reduced group. The researchers found that people in the positivity-reduced group used slightly fewer positive words and slightly more negative words relative to the control group. Likewise, they found that people in the negativity-reduced group used slightly more positive words and slightly fewer negative words. Thus, the researchers found evidence of emotional contagion …

Salganik (2018) Bit by Bit: Social Research in the Digital Age

Using the principles above, what ethical questions arise in that experiment?