Guiding Ethical Principles and Explanation
The ethical foundation for ongoing monitoring of protocols can be traced to the principle of beneficence, which requires that subjects be treated in an ethical manner by protecting them from harm and making efforts to secure their well-being. A beneficent action in the design of research protocols involving human subjects maximizes benefits to society, and in many cases to individual subjects, while minimizing possible harms. Prior to approving a protocol, the IRB performs a risk assessment that weighs the anticipated benefits of the research against the probability and magnitudes of possible harms, ensures that the risk of conducting the research is acceptable, and works with the investigator to fulfill his/her obligation to minimize the risks and maximize the benefits (regardless of the relationship between the risks and benefits). It is generally not possible to meet the standard primum non nocere, or “above all, do no harm” when designing and conducting research with human subjects. But no research protocol is approved (e.g., can be ethically justified) unless the risks (the statistical probability of harm) are in a reasonable or favorable relationship to the anticipated benefits. However, not all potential harms or benefits can be precisely determined or even anticipated. Ongoing monitoring of approved protocols provides information upon which actions may be taken by investigators to keep the risks in a reasonable relationship to the benefits as the research progresses and unanticipated risks or benefits, if any, reveal themselves.
Additional information on the ethical principles guiding research with human subjects is located in module #1.