Consent for research on stored body samples

Sometimes intellectual debates can become very emotional very quickly. Twice I've been involved in something close to a shouting match over whether it is acceptable to test stored body specimens without consent. The word “Nazi” was soon used, and the beliefs of protagonists diverged rather than converged. As testing specimens that have been kept is common practice, we thought we ought to commission a debate.

As a prelude to the debate we have some data. Birgitta Stegmayr and Kjell Asplund went back to people who had participated in research 10 years earlier and asked for consent for genetic research on their stored blood sample (p 634). Over 90% said yes, and only 2.2% specifically said no. Almost the same proportions said yes to industrial research. A second short report illustrates how research on stored samples can be useful. David Hilton and colleagues have looked at over 8000 appendix and tonsil samples removed between 1995 and 1999 and tested for prion protein (p 633). They found a single occurrence, giving a prevalence of prion protein accumulation of 120 per million among people aged 10-50 between 1995 and 1999. This is the first estimate of the number of people who may be a potential source of variant Creutzfeldt-Jakob disease by iatrogenic spread.

In the debate, Paul van Diest, a professor of oncological pathology, argues the case for testing without consent provided that the material is anonymised; enough material is left for the patient's own needs; and the reuse is for useful non-commercial research and is reviewed by a scientific review board (p 648). People should also be informed, he says, when samples are collected that material may be reused in the future, something that isn't always done. Van Diest argues that the principle of solidarity, helping others, is more important than the right of self determination over discarded material.

Julian Savulescu, a professor of applied ethics, agues that consent must be obtained (p 649). Patients may be harmed by information that is discovered about them. Consent is important to respect autonomy: “When we involve people in our projects without their consent we use them as means to our own ends.” Seeking consent builds public confidence in medicine and research.

Both protagonists make strong cases, illustrating perhaps why debates over this issue can become so heated. We look forward to hearing what readers have to say, and we urge you to vote on the issue on http://www.bmj.com/.

Had he not died last week, we might have asked Douglas Black (p 661) to comment on this debate. His deep wisdom on ethical matters was much valued by doctors, but he will also be remembered for his humanity and bone dry wit. Born in the Shetlands, a son of the manse, he had, he said “the twin advantages of poverty and culture.” He had time and means to think. All his life he battled with bureaucrats, meaning that “my respect for politicians had ample room in which to grow.”