About | HeinOnline Law Journal Library | HeinOnline Law Journal Library | HeinOnline
LOG IN
LOG IN

69 Medico-Legal J. 1 (2001)

handle is hein.journals/medlgjr69 and id is 1 raw text is: Medico-Legal Journal (2001) Vol. 69 Part 1,1 3 D Medico-Legal Society 2001 1 Research Governance - Global or Local? Martin A Mansell MD FRCP, Consultant Nephrologist, Middlesex Hospital All the criminals in their coats and their ties are free to drink Martinis and watch the sun rise... Hurricane, Bob Dylan. The conduct of medical research is now under scrutiny to an unprecedented extent. There is tension between the objectives of the industrialised Western countries who initiate research programs and the needs of the rest of the world where the research may be carried out and who have a different set of health problems. Closer to home the ethical questions are being debated with increasing ferocity and possible adverse effects on research participants have impli- cations for the unlikely combination of NHS Trusts and negligence lawyers alike. Add to this the current occupation of the moral high ground by the propo- nents of evidence-based medicine and there is a sure recipe for ill informed comment, as exemplified by this editorial. A recent conference has estimated that about £40 billion is spent annually on health research world- wide although only a tiny proportion, perhaps 10%, is directed against the most common diseases. In the Western countries the health priorities are degenera- tive disease and cancer, while in the Third World infectious diseases such as tuberculosis and Aids dominate the agenda. This contrast is distressing but not surprising and may be taken as another example of the unequal distribution of global resources. High- technology research conducted in poor countries not only has little relevance to their own health problems but may also hinder the development of their own research ethos and infrastructure.' There is a clear perception that the international health agencies and pharmaceutical companies which provide the funding pay relatively little atten- tion to the health needs of the particular countries in which development research takes place. It has been suggested that the two sides should see each other as equal partners in a joint endeavour and that this will be facilitated by the development of local and national ethics committees in the countries involved.2 This immediately raises the problem of how well ethical standards based on particular religious, moral and legal principles translate across national borders. There is a very readable discussion of this particular problem in a paper by two eminent and well respected medical authorities concerning the use of kidneys for transplantation that have been retrieved from either paid living donors or executed criminals.' Those of you who believe in absolute truth will find it disquieting. The most recent revision of the Declaration of Helsinki has reaffirmed the principle that interna- tional research programs should not exploit poorer countries at the expense of the industrialised coun- tries who initiate, fund and administer the studies in which they are interested.' One example would be the assessment of new anti-retroviral therapies in the African countries that have a heavy burden of HIV infection and Aids. Is it ethical to assess the benefits of a new drug by comparing it with a control group of Aids patients who receive no therapy? What happens to the study patients at the end of the trial period when a new and effective drug is withdrawn and cannot be continued because of lack of funding? The new Declaration has given robust answers to these and other points of issue, including the require- ment that patient participation in medical research is only acceptable if it is likely directly to benefit the patient, rather than society as a whole. I have always been baffled by this view which seems to be in conflict with much of current clinical research and I hope that one of our readers will explain it to me in the correspondence section that the Journal has just launched. Of course, medical research in general and drug development in particular has a major financial angle and it is estimated that the NHS receives about £150 million annually from this source. The UK share of the global research market is declining due to a wide variety of factors. These include poor recruitment to clinical trials by busy clinicians, unreasonable delays in approval caused by a multiplicity of research

What Is HeinOnline?

HeinOnline is a subscription-based resource containing thousands of academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.



Short-term subscription options include 24 hours, 48 hours, or 1 week to HeinOnline.

Purchase Access

Contact us for annual subscription options:

Contact Us

Already a HeinOnline Subscriber?

Log In

profiles profiles most