The final report of the President’s Advisory Committee on Human Radiation Experiments identified the following as areas in need of attention:
1. Unrealistic expectations of patients with serious illnesses about the potential benefits of research participation, which leads to a conflation of treatment and research.
2. Overly optimistic assessments and portrayal of potential benefits by researchers.
3. Clinician-researcher conflict of interest.
4. The inadequacy of current informed consent methods. This includes the language used, explanation and portrayal of the requirements of participation, its experimental nature, and the associated risks and benefits. Voluntariness and participant understanding are also not adequately assessed. Also, some information, such as effect on quality of life and the financial consequences of participation are rarely even mentioned.
5. Research with children. What do we mean by minimal risk? What is the value and role of assent. When should children become involved in the consent process and when should they become the primary decision-maker? Also, how do we protect the rights and well-being of institutionalized children? How do family dynamics and the stresses of caring for seriously ill/handicapped children affect the parents’ ability to act as advocates for their children?
6. Classified Research.
7. Research involving environmental releases (and generally, research on whole populations or geographical areas.
8. Handling of past and present mistakes, injustices, and wrongdoings.
The Tuskeegee, Willowbrook School, and Gulf War studies mirror many of the issues raised above. But they add concerns regarding the impact of social and cultural factors on the practice of research. For example, the role of racism in the selection and treatment of research participants. These experiments force us to address the impact of past wrongs on current research and health care practices. They illustrate the tremendous importance of truth-telling, nonmaleficence, and autonomy in our dealings with research participants. Finally, they force us to examine the degree to which participation in research is voluntary, and how we might improve this.
Source:
Human Radiation Experiments Report, http://raleigh.dis.anl.gov/roadmap/achre/summary.html#recommendation, 6/2/98.