Human beings can be ethically frail under the pressure of situational forces, therefore the constraining force of the law is required. The ethics community need to have the confidence and courage to seek for the best ethical guidelines to become such constraining laws. However laws are themselves only ethical when they informed by a consensus that includes and represents the needs of the parties they are intended to protect, therefore the voice of the volunteer must be heard. Specific examples are adduced to show how the current Clinical Trials Regulations are either insufficient in their scope, or not being fully met. To conclude eight suggestions are given as to how volunteers might be better protected. These include the establishment of an independent funded body to inform and support volunteers, a volunteers charter, greater consultation with volunteers, and a change in ethos involving a more egalitarian partnership between all those involved in the development of new medicines
An untraced quote which has been in my mind for years. For more on this explanation of wrong-doing and evil see Zimbardo Philip G. Transforming People into Perpetrators of Evil: The Robert L. Harris Memorial Lecture. http://www.sonoma.edu/users/g/goodman/zimbardo.htm (accessed March 2007).
3.
Although I confess that I cannot see the logic in limiting custodial sentences to two years, as the Regulations do, when the exact crime and its consequences has not been established in the context of a particular case.
4.
ErichH Loewy. Ethics and the Law. http://www-hsc.usc.edu/∼mbernste/tae.ethics&law.loewy.html (accessed March 2007). Dr Loewy is Professor and Endowed Alumni Association Chair of Bioethics Associate Faculty, Department of Philosophy University of California.
5.
ProfessoLoewy also states that how a society treats its vulnerable is another measure of how civilised, or not, it is. I consider that volunteers can fairly be called a vulnerable group, and for a variety of reasons and considerations. These include the social and economic, the nature of the activity they are engaged in, and, most undeniably, due to the fact that the reality of their vulnerability is evidenced whenever things go wrong.
6.
VinclerLA. Law and Medical Ethics. http://depts.washington.edu/bioethx/topics/law.html (accessed March 2007). Vincler is the Assistant Attorney General and Faculty Associate, Department of Medical History and Ethics University of Washington School of Medicine.
The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18 1979. http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm (accessed December 2006).
10.
SteinerTJ. Guinea pig duties: 5. Coercion and inducement into clinical research. Res Ethics Rev2006; 1: 3–9.
I have always been struck by the way this ‘right’ is presented to volunteers as if it were some wonderful boon or magnificent concession, whereas in reality it is just one of our basic human rights. There are, after all, very few situations (prison being one of them) in which we are not ‘free to withdraw at any time’.
See http://www.ccra.org.uk/CCRA/ (accessed March 2007). An outline of the CERES proposal for a contact point can be found here.
18.
The data for SUSARS and deaths in each year from 2001 to 2005 can be found at http://www.mhra.gov.uk (accessed March 2007).
19.
NicholsonR. Op cit.
20.
SteinerTJ. Guinea pig duties: 7. Contingent rights of patients in clinical research. Res Ethics Rev2006; 3: 85–91.
21.
DowdyDW. Partnership as an ethical model for medical research in developing countries: the example of the ‘implementation trial’. J Med Ethics2006; 32:357–360. Available at http://jme.bmj.com/cgi/content/abstract/32/6/357 (accessed March 2007).
22.
I am indebted to Mr Christopher Roy-Toole, of Newcastle REC 1 for bringing this paper to my attention during the conference at Birmingham, 16 March, 2007.
