SciDev.Net

This Compilation lists the human subjects research legislation, regulations or guidelines for 79 countries, the European Union and the Commonwealth of Independent States, and several international organisations. It was developed for IRBs/Ethics Committees, researchers, funding agencies and others involved in international research with the aim of helping these groups familiarise themselves with the laws, regulations and guidelines of countries in which research will be conducted. A description of the methods used to collect and update the information is included.

This paper maps African countries' knowledge base through patent applications and publications. It shows South Africa as academically, and technically, the strongest country of the continent. The number of publications is growing in other African countries, but patenting remains limited all-round.

The paper ends on a positive note, arguing that African countries already possess the basis for knowledge-driven development.

This editorial is one of three articles that started the current debate about appropriate standards of care in clinical trials (the other two were an article by Peter Lurie and Sydney Wolfe in the same edition of the New England Journal of Medicine (see below), and an editorial in The Lancet). Marcia Angell criticises the placebo-controlled trials that were conducted to test an intervention to reduce mother-to-child transmission of HIV.

The article refers to the importance of researchers being in equipoise (i.e. not knowingly giving some groups of participants inferior treatment) and of not subsuming the interests of individual participants for the greater good. The author lists justifications that were given by research sponsors for this work: that participants were not being denied treatment that they would otherwise receive and that a placebo-controlled trial was the fastest and most efficient way to obtain information of relevance to the areas where the research was being conducted.

Angell concludes that these justifications were reminiscent of those of the infamous Tuskegee study where participants in the United States were not informed that they were enrolled in research, and were denied effective treatment for syphilis when this became available. Concern is expressed that the HIV study appears to mark a retreat from ethical principles about research conducted in developing countries as set out in international guidance - for example, participants received a local standard of care rather than the ‘best’ current treatment as required in the Declaration of Helsinki - and the reasons for this are critically examined.

This "education and debate section" focuses on the 2000 revision of the Declaration of Helsinki, and comprises four articles commissioned from researchers working in the developing world, the developed world, the pharmaceutical industry, and a patient representative.

South African researcher Stephen Tollman argues that "despite the increasingly inclusive aspirations of the revised declaration, some of the absolute and exclusionary language could unintentionally endanger research in developing countries". Consumer advocate Hilda Bastian lists nine gains for consumer rights arising from the revision, but goes on to discuss a number of perceived problems in more detail. UK researcher Richard Doll distinguishes five different types of medical research and claims that "strict application of the declaration’s principles would make a wide range of clinical, biological and epidemiological research impracticable or invalid".

To some extent this conclusion is mirrored in the article from two members of the pharmaceutical industry. Laurence Hirsch and Harry Guess of Merck Laboratories say that several provisions in the revision do not provide better protection of research participants in clinical trials, and inadvertently hamper the development of safe and effective vaccines and drugs.

Evelyne Shuster opens this article with the Nuremberg Code - the precursor to the Declaration of Helsinki and other international and national guidance on the ethics of medical research. 

Shuster discusses the role of physicians in the formulation of the Code during the famous Nuremberg trials of Nazi physicians. The lawyers' arguments about unethical research conducted in Germany, France, the Netherlands, Britain and the United States demonstrate how views about what constitutes acceptable and unacceptable research have changed over the last century. 

The article goes on to summarise how medical researchers have used the Code, and its effect on guidance and regulation over the five decades following its publication. 

In this article Asad Jamil Raja discusses some of the revised provisions in the 2000 revision of the Declaration of Helsinki and considers their implications for developing countries. Two points singled out for particular consideration are paragraph 19 (which requires a "reasonable likelihood" that research populations will benefit from the results of research) and the controversial paragraph 30 (which concerns what should happen after research).

The article goes on to consider the role of the pharmaceutical industry in medical research and proposes three measures to improve the ethics of healthcare: an examination of the ethics of the pharmaceutical and biotechnology industry, for the World Health Organisation to play a more proactive role in resource allocation for global healthcare and health research, and measures to strengthen the capacity for ethical review in developing countries.

Particularly useful for those in developing countries about to embark on an HIV vaccine trial, this article describes the social, behavioural and ethical issues that arose in 1996 when Uganda was preparing for Africa's first HIV vaccine trial (which ran from 1999-2000).

Most notable were misconceptions about vaccine safety and its effects, such as whether the vaccine itself could cause disease, or was a treatment for infection. The authors describe the strategies employed to overcome these barriers, for example, through public outreach education and media communication.

This study examined the effectiveness of two different methods of informing prospective participants about HIV research in Haiti. The first group of participants received information in a single interview with a physician. In a subsequent assessment of their understanding, only 20 per cent passed a questionnaire test.

The consent procedure was then modified to include three meetings with a Haitian social worker over 7-10 days before a final meeting with a physician-researcher. Of those participants agreeing to take part in the research, 80 per cent passed the comprehension test.

Noting the lack of practical guidelines on how best to inform and test the understanding of research participants in developing countries, Fitzgerald and colleagues conclude that a formal assessment of comprehension should be a routine part of the consent process.

Click here for a related commentary article.

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This article from the Gambia Government / Medical Research Council Joint Ethical Committee is an early response to the criticisms in the New England Journal of Medicine and The Lancet that placebo-controlled trials to prevent mother-to-child transmission of HIV were unethical.

The authors express concern that important research in developing countries would be threatened if research practice were changed in response to such criticisms. In particular, research that only compared new interventions with the best available therapy in developed countries would fail to provide information about interventions that are relevant and affordable for the local situation.

The authors note that there is sometimes a need to re-examine interventions that have proved effective in developed countries before it is possible to make an informed public health decision about introducing them in the developing world. They conclude that "stopping trials in Africa that are trying to help improve the health of poor people so that those in affluent countries can have peace of mind seems a tortured form of ethical logic".

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In this article Lindegger and Richter focus on two contentious aspects of informed consent. The first is the problem of 'social desirability' whereby participants may consent to take part in research because they wish to impress researchers or to please others in the community. The second is ways to determine whether participants' comprehension of the research is adequate to enable them to make an informed choice.

Other topics that are covered are conflicts that can occur between ethical principles and cultural practices when consent to research is sought, and how decisions about whether or not to take part in research should be made by communities and individuals. While consideration of these issues takes place within the context of South African HIV vaccine trials, the issues raised and the useful discussion that follows have a much wider relevance.