J Altern Complement Med. 2001 Dec; 7(6): 697-702.

Ethical issues regarding fee-for-service-funded research within a complementary medicine context.

Evans S, Block JB.

Genetic Services Management, Inc, Omaha, NE 68131, USA. sevans@gsm-usa.com

Ethical issues are presented concerning the appropriate use of a fee-for-service strategy to fund clinical research assessing preventive complementary medicine approaches, particularly the effectiveness of dietary supplements for disease prevention. Reasons for the need for such an alternative funding approach are identified and historical precedents are noted. Presuming a priori key desiderata of doing no harm, not taking advantage of the ill, and pursuing recognized useful purposes, six key ethical questions from the relevant literature are identified and discussed. Arguments are advanced that there is a sound rational, ethical basis (1) to ask patients to pay for clinical experimentation in the focused area of supplement-directed disease prevention; (2) to accept the reality that those who cannot pay may not participate; (3) to permit moderate profit from the ongoing research; (4) to allow researchers to receive fees for their support of such clinical research; (5) to pursue this alternative funding strategy in addition to conventional sources; and (6) to expect that patients can give informed consent in such settings. It is demonstrated that patient-funded research has been an integral component of clinical research for decades and that there is no inherent reason why explicit patient payment of fees need be less ethical than any other commonly accepted funding models. Accordingly, an ethical case is made for the appropriateness and value of significantly expanded fee-for-service-funded research within a complementary medicine context, particularly the assessment of dietary supplements for disease prevention.