Introduction
What is research ethics?
Research ethics deals with acceptable norms in the design and application of a research study. It governs the standards of conduct of investigators in scientific research in order to uphold important principles including autonomy, justice and beneficence (WHO).
What is Risk-Benefit Assessment?
Since the Belmont Report, most biomedical research guidelines require a sort of risk-benefits assessment in order to carry the research scientifically and ethically. The principles underlying this sort of assessment are beneficence and non-maleficence.
Justification for risk-benefit assessment are twofold “to verify the scientific/social validity of the research since an unscientific research is also an unethical research; and to ensure that the risks that the participants are exposed to are necessary, justified, and minimized.” (Bernabade et al 2012)
Therefore, participation in research trials is best when participants derive something health, or something other, valuable from it, or when it significantly improves generalizable knowledge without inducing unreasonable and unjust harm.
Assigned Reading
Rid, A., & Wendler, D. (2011). A framework for risk-benefit evaluations in biomedical research. Kennedy Institute of Ethics journal, 21(2), 141–179. https://doi.org/10.1353/ken.2011.0007
Thesis: In their paper Rid and Wendler (2011) note the importance of risk-benefit assessment and highlight the paucity of comprehensive and concrete guidance to perform these assessment. This has resulted in rather unsystematic methods often largely based on intuitions and a disparity of assessment across several research studies. In order to address this gap the authors, designed the first step-by-step comprehensive guiding framework for risks benefits assessments in research ethics. Their framework is based on extant guidelines and regulations, other relevant literature and normative analysis.
Discussion Questions
The following questions were considered by seminar participants prior to the discussion:
- What were some of the strengths of the framework?
- What were some of the weaknesses or more vague elements of the framework?
Reflection Points
1. Evaluation of the requirements that studies meet a minimum threshold of “social value” – social value is a normatively laden concept (what ones person thinks as contributing to social value, another might think of as subtracting). It is also vague and may be too easy to apply (can hand waive that every study has social value of some sort).
2. “Enhancement” as an idea in their framework (requirement to “enhance” the social value the study and “enhance” potential benefits to participants). What is the normative justification for this? Why do researchers have an obligation to do this? Or IRB members? Also, consider potential unintended consequences of this – may negatively affect some of the science in the study, may impose costs on researchers or society, etc.
3. Evaluation of “clinical” benefit to participants. Is this biasing against non-clinical studies? Is this too narrow (benefits of psychological or other nature – such as fulfilled desire to be altruistic)? On the other hand, too broad or hand-waving (“benefit” from talking to researchers about feelings)? Violates equipoise/therapeutic misconception?
4. Steps 5, 6, 7/ the “weighing steps” – steps where the identified risks (and their likelihood), clinical benefits, net risks, and social value are weighed to establish whether the assessment is favorable toward allowing the study. How exactly is this weighing done? Ideas of “informed and impartial social arbitrator” and “informed clinician” are introduced to help, but these constructs are vague and can allow for introduction of bias.
5. Lack of context – avoids questions such as whether the study is therapeutic or non-therapeutic? Whether the study involves people who are dying, etc.6. May be too biased towards approval since it primes people to consider “social value” in first and last step–social value is easy to come by.
References and Additional Resources
Bernabe, R.D.L.C., van Thiel, G.J.M.W., Raaijmakers, J.A.M. et al. (2012). The risk-benefit task of research ethics committees: An evaluation of current approaches and the need to incorporate decision studies methods. BMC Med Ethics 13, 6 https://doi.org/10.1186/1472-6939-13-6
Abdalla M.E. (2017) Ethical Issues Involved with the Analysis of Risks and Benefits. In: Silverman H. (eds) Research Ethics in the Arab Region. Research Ethics Forum, vol 5. Springer, Cham. https://doi.org/10.1007/978-3-319-65266-5_8
Rid, Annette & Wendler, David. (2010). Risk-benefit assessment in medical research–critical review and open questions. Law, Probability and Risk. 9. 151-177. 10.1093/lpr/mgq006.