Ethics in research

How can we make sure that the research we want to do doesn’t take advantage of vulnerable populations? First of all, it might be useful to define what we mean by a vulnerable population.

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The vulnerable populations refers to but not limited to children, minors, pregnant women, fetuses, human in vitro fertilization, prisoners, employees, military persons and students in hierarchical organizations, terminally ill, comatose, physically and intellectually challenged individuals, institutionalized, elderly individuals, visual or hearing impaired, ethnic minorities, refugees, international research, economically and educationally disabled and healthy volunteers. Due to their circumstances, the communities may be inclined to participate in a clinical study or be unjustifiably influenced by the expectations of predicted benefits associated with participation.

Shivayogi (2013)

Ethical research that involves human beings is premised on the concept of respect for persons, which can also be stated as a recognition of the inherent autonomy of an individual.

An autonomous person is defined as an individual who is capable of self-legislation and is able to make judgments and actions based on his/her particular set of values, preferences, and beliefs. Respecting a person’s autonomy thus involves considering his/her choices and decisions without deliberate obstruction. It also requires that subjects be treated in a non-degrading manner out of respect for their dignity. In practice, respect for persons is operationalized by obtaining Informed Consent from all individuals who are going to be research subjects.

Ethical treatment of research participants

Here is an example of one way in which vulnerable research participants are exposed to ethical concerns as part of participation in a clinical trial. As you’ll see in the video these challenges are especially problematic in developing countries.

Here’s a link to the transcript, and you can also download the video for offline viewing.

In order to avoid exploiting populations who are most at risk, we need to ensure the following:

  1. Informed consent is a vital part of recruiting participants, and should be the number one priority when identifying people to take part in the study.
  2. The standard of care provided to participants in control groups (mainly relevant for clinical trials) should be equivalent to the best available care in the country.
  3. All research involving human subjects must be subject to review by an ethics review board.
  4. Ensuring that all participants will benefit from their participation, either through continued access to medication, or a local equivalent.

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Informed consent is such an important part of conducting research, whether among vulnerable populations or not, that it’s important to spend a bit more time reviewing it. In order for the process of informed consent to be correct and legal, the patient must have (Wilder, 2013):

  1. Knowledge of the nature or extent of the harm or risk
  2. Appreciated and understood the risk
  3. Consented to the risk
  4. The consent must have been comprehensive

You are encouraged to explore the issue of consent in more detail. Here is a useful introduction with links to further information. You can also download some informed consent templates from the WHO.

Questions to reflect on

Imagine you are planning a research project in your own country. Think about the questions you want to answer and who the most suitable people to answer those questions are.

  • Can you come up with a few ways in which they may be directly or indirectly disadvantaged by participating in your project?
  • What issues of consent can you think of that might be appropriate to consider? What information do your potential participants need? What will you do if they cannot give consent (i.e. they are minors or they are incompetent)?
  • Can you think of all the stakeholders you need to contact in order to get permission to conduct your study? Are your participants children, or minors?
  • Who are you responsible to with respect to sharing the results of your research? Who will benefit the most? How will you ensure that your participants also benefit from your findings?

Readings

  • Mandal, J., Acharya, S., & Parija, S. C. (2011). Ethics in human research. Tropical Parasitology, 1(1), 2–3. http://doi.org/10.4103/2229-5070.72105
  • Slowther, A., Boynton, P., & Shaw, S. (2006). Research governance: ethical issues. Journal of the Royal Society of Medicine, 99(2), 65–72.

References and resources

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