Fra: NEM

Til: WMA


The national committee for medical research ethics in Norway has reviewed the various proposals for revisions of paragraph 30 of the Declaration of Helsinki, from the proposal presented for the General Assembly in Helsinki in 2003 via the work group report (dated 5 January 2004) to the draft proposal by the Finnish Medical Association (dated 4 March 2004).

From your own press release on September 14, 2003, we understand that no decision was taken due to ”sharp differences” within WMA. Proposals from various working groups have not been able to reconcile the differences. Comments and discussions in medical journals as well as in the press show that the differences of opinion are also shared outside WMA. The National Committee for Medical Research Ethics is independent of any association or authority. It coordinates the work of five Regional Committees for Medical Research Ethics in Norway which review about a thousand projects per year.

I General comment

The National Committee for Medical Research Ethics in Norway is of the opinion that it is of great importance to retain the primary intention of the Declaration of Helsinki. It is to uphold general moral principles to protect participants in medical research.

The main objective of paragraph 30 is to avoid exploitation of research subjects and vulnerable populations in countries with restricted or insufficient health care resources. The principle is laudable. In our opinion the obligations to provide resources for the local health care in general when clinical trials are performed in poor countries could even be strengthened in the declaration. Much of the controversies of the wording of paragraph 30 could have been avoided if the principles were directly addressed to the problem of exploitation. As paragraph 30 now reads, it is irrelevant for Western countries in which the populations are guaranteed the best available treatment within the national health care systems. In fact, the wording may impose unintended problems in such countries by questioning who should be responsible for providing the best treatment based on results of clinical trials. However, compared to the problems related to potential exploitation of research participants in developing countries, implementation of the best proven treatment in the rich countries is of minor importance, and should not be used as an argument to undermine the intention of paragraph 30.

Any suggestions for amendments or clarifications that undermine the intention of the paragraph should thus be resisted.

The main attributes of the Declaration is its brevity, intention of principles and guidance. This should also be upheld for paragraph 30, as well as paragraph 19.

Historically, we see the presently suggested amendments as a follow-up of the clarifications of paragraph 29. We think it was very unfortunate that WMA felt compelled to ”clarify” paragraph 29. It is unfortunate because it shows that very strong interests have influence on the WMA and that these interests are able to weaken the moral intent of the wording. Having succeeded the last time, it is no surprise that these interests now hope that they will succeed once more.

We will therefore strongly advice WMA to resist the temptation to clarify intentions in all kinds of detailed modifications and conditions. At the end it will not be helpful. The Declaration will be lost in explanatory details which again will spur new interpretations.

1.2 Specific comments

Proposed amended versions of paragraph 30 is unacceptable. Proposals are interspersed with modifiers like ”every effort” and ”any available”, as well as conditions like ”approved by the appropriate authority”. It is even suggested that as long as researchers and sponsors inform research subjects that sponsors will not be able to provide effective treatment after she or he leaves the study, it is OK. In our view such a proposal entails abuse of informed consent. The moral intention of the paragraph was to avoid exploitation of research subjects. It does not relinquish responsibility by obtaining consent from those who should not be exploited.

Since such proposals undermine the intention of the present paragraph, it should be rejected.

Proposals for a note of clarification on paragraph 30 introduce the same kind of modifiers, like ”wherever possible.” The clarification proposes conditions to be met before the requirement can be fulfilled. In our view such conditions contribute to limit the intent of the original paragraph. In addition the conditions are wraught with interpretive ambiguity. Take e.g. the condition of ”superior” instead of “best”. In comparison with “best” ”superior” can be read as a weaker obligation.

Any proposal for a note of clarification should be rejected.

1.3 Proposal for wording

The current wording of paragraph 30 reads:
”At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study.”

We suggest the following slight amendment. Delete ”identified by the study” because the meaning of the clause is unclear and can be used to qualify or limit the principle. The intention of the paragraph is clearer without the clause. Though we acknowledge that the current wording of the paragraph is not optimal, we agree with the latest work group report that there are overriding reasons for not proposing major amendments or clarifications.