Ethical Challenges

5. Current and Unresolved Issues


Risk/benefit assessment:

An assessment of risk/benefit is done by the investigator and by the ethics review committee. That assessment most often is a judgment. Although it may be informed by expert opinion, the literature and current best practices, there is rarely an objective metric to make the assessment. Different investigators, community groups and/or ethics committees may come up with different assessments.  This can present problems and cause delays, particularly for multi-site research.

Rid and Wendler’s Guidance for Risk/Benefit Assessment

Balancing risk of harm against potential direct or future benefit

There may be risk of harm to find out whether the research has potential for benefit.  Despite efforts made to design research to minimize risk of harm and maximize benefit, if any, there may be known or unanticipated harms.  There also are differences among subjects in perception of risk and benefit and in actual risk and benefit as a function of the subject’s condition or situation. 

Example 5

A. Military action is occurring in hot climates. It is important to military leadership to study the impact of temperature on performance. Healthy volunteer college students are recruited to exercise on a treadmill wearing a 50 pound backpack at an ambient temperature of 110 degrees. They are to walk at 4.5 miles/hr for one hour or until they reach a pre-determined maximum heart rate. How would you assess the risk/benefit? Are there special precautions that you would take?

B. A terminally ill person consents to undergo a risky experimental therapy that has potential benefit to others in the future. How does one assess the risk/benefit ratio? It may be very different for the individual and for society. If the therapy is effective and the subject is still alive, do the researchers have an obligation to offer it to the subject when the research is completed?

Rid and Wendler’s Guidance for Risk/Benefit Assessment

  • The research is scientifically sound so that valuable knowledge may result
  • The proposed intervention(s) are necessary to achieving the research goals.
  • Evaluate the risk of harm to subjects on the basis of existing data and subject characteristics.
  • Evaluate the probability and magnitude of possible benefits to subjects on the basis of existing data and subject characteristics.
  • Evaluate whether research benefits outweigh risks or vice versa on the basis of data and best judgment.
  • Assess whether risks are justified by potential benefits using available data and expert experience.
  • Evaluate whether risks are justified by the potential value of the research (Rid & Wendler, 2011).