Practical issues in implementation of WMA’s draft Declaration of Helsinki

The working group of the World Medical Association (WMA) has published a revised draft of the Declaration of Helsinki for public consultation till June 15, 2013 (1). There are many positive changes in the document with respect to compensation, education of investigators, informed consent in the case of stored samples, etc. The changes represent a step forward for ethics. However, there may be certain points of concern regarding the implementation of the Declaration.

Point 20 of the document (1) states that medical research involving a disadvantaged or vulnerable population or community is justified only if it is responsive to the health needs and priorities of this population or community and the research cannot be carried out among a non-vulnerable population. Will this additional clause be harmful to vulnerable populations? Researchers may use it to conduct research among vulnerable people. This was prohibited earlier, the provision being that to begin with, many new markers had to be tried among the general population before conducting the study, depending on its merit, among a vulnerable population. With the addition of this clause, the same new markers can be tried simultaneously on the general and vulnerable populations. The same can be applied to drug trials. Point 20 also states that consideration should be given to ensuring that the community receives a fair level of additional benefits. How is it possible to measure this? Also, what is the meaning of “fair level”?

A component of point 22 states that the protocol must describe the arrangements for post-study access by the study subjects to interventions identified as beneficial in the study. Though this is very important ethically, there is a need to consider how far it is practicable. After a clinical trial has concluded, it takes from a few days to a few months to assess and reach conclusions about the beneficial effects, and it may take some time to obtain the Drugs Controller General’s approval for marketing the drug. Is it possible for a company/ institutional ethics committee (IEC)/investigator/study participant to give consent for a drug, for which the analysis of the efficacy is being worked out? The participants thus have to revert to the drugs or measures they were taking earlier till the Drug Controller General grants approval. The word “arrangement” may refer to subsidised drugs or free drugs. Would this assurance of free drugs act as an inducement to participate in trials, especially those involving cancer and end-stage disease? A component of point 32, on the subject of informed consent, states that an IEC should decide on the impracticability of obtaining informed consent in the case of stored samples. As all IECs are independent, there will be various opinions on the matter.

Further, how can impracticability be decided upon? Is the difficulty in obtaining informed consent due to a large number of samples, the fact that they have come from different parts of the country, or the fact that they are taken anonymously? Are we going to permit telephonic or verbal consent if these participants are unable to come to the centre personally? Point 33 of the draft, which deals with placebo, permits their use “for compelling and scientifically sound methodological reasons…”. This needs to be deleted altogether. Again, it is difficult for an IEC to determine what “compelling and scientifically sound methodological reasons” are. The same may be true of point 37, which pertains to unproven interventions. The proposed provision opens a Pandora’s box in the area of stem cell studies and other studies on genetically engineered techniques. Though the draft is a reform measure aimed at promoting ethical research, it would be useful if an appendix were added to describe the practical aspects of its implementation.