Despite rapid developments in the methods, scope and character of medical science, regular revision has kept the Declaration of Helsinki at the forefront of providing relevant ethical guidance. In addition, many of the core principles of the Declaration have since been adopted into national law and other international and national guidelines on the ethical conduct of clinical studies. “The wide-ranging participation in the latest revision process demonstrated the continuing international significance of the Declaration for those conducting medical research, says Parsa-Parsi. The variety of perspectives given also demonstrated the value of international dialogue in ensuring that the ethical principles it contains remain relevant to researchers the world over, and also in raising awareness of the importance of maintaining such principles”. The question is how can a single document on research ethics be shared and applicable all around the World? “Organizations such as World Health Organization -says Paul Ndebele, Director, Medical Research Council Zimbabwe – have a large part to play in order to ensure that research ethics standards are uplifted in all member countries. While WMA reaches out to so many countries through the national medical associations, the influence of the DOH may be limited by the fact that the WMA is specifically for Physicians. WHO can work with Government Ministries or Departments of Health to ensure that human research ethics standards are improved in all countries”. Someone has announced that the nearly continuous process or revision undermines the authority of the Declaration. Based on Parsa-Parsi opinion “It is WMA policy to carry out regular reviews of all guidelines in order to ensure that they remain up to date and relevant. The past half century has seen rapid developments in medical science which have altered the character and scope of medical research. It has therefore been necessary to address these developments in the Declaration of Helsinki through regular revisions. In this way the guidelines remain at the forefront in providing relevant and up to date ethical guidance for all actors involved in clinical studies on human subjects. This ensures the enduring protection of research subjects”.
According to Emanuel et al. in “The 50th Anniversary of the Declaration of Helsinki”, …this new revision of the declaration is more effective at protecting research participants, because for the first time, the declaration requires compensation and treatment for research-related injuries…. “By having the compensation requirement – says Ndebele- included in DOH, WMA has ensured that this requirement applies to research participants from both rich and poor countries. It is common to find in informed consent forms for studies supported by certain sponsors, statements that clearly state that the sponsor does not provide compensation for trial related injuries. Such statements are a clear breach of the principle of justice”. Other two important news of DoH are risks monitor and protection of vulnerable populations (Box “WMA declaration of Helsinki – Ethical principles for medical research involving human subjects”). Parsa-Parsi explains that “This is indeed a significant addition to the Declaration. The workgroup considered it very important to introduce a new paragraph reflecting the obligation to ensure that subjects who are harmed as a result of participation in research will receive compensation and treatment. The Declaration of Helsinki is a global document and it is extremely important that this aspect of patient safety extends to all participants, also in areas where this is not yet common practice. With current trends seeing ever more studies carried out in less developed regions of the world, this is will provide a basis for universal access to compensation”. The revised declaration’s emphasis on the dissemination of research results, including studies with negative results, should increase the value of medical research (paragraphs 23, 35, and 36). Nevertheless, the proposed declaration contains persistent flaws. Ezekiel J Emanuel, Vice Provost for Global Initiatives and chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania, proposes by the column of The Lancet that there are nine distinct problems with the current version of the Declaration of Helsinki: “it has an incoherent structure; it confuses medical care and research; it addresses the wrong audience; it makes extraneous ethical provisions; it includes contradictions; it contains unnecessary repetitions; it uses multiple and poor phrasings; it includes excessive details; and it makes unjustified, unethical recommendations”.
Research in poor communities
An extract from the article “The 50th Anniversary of the Declaration of Helsinki”, points out some problems with the Research in poor community and the concept of vulnerability: …the declaration is confused and mistaken about vulnerability and appropriate protections. First, the group the declaration has in mind that is in need of special protections is vulnerable because they are poor and have limited access to medical services, not because they are at higher risk of harms. Failure to make this clear undermines the protections. What is necessary to protect poor populations is very different from what is necessary to protect participants who are at higher risk of harm, cannot consent, or, because of their position, eg, being a student, are at increased risk of coercion. Second and more importantly, the declaration is confused about what constitutes appropriate protections and the appropriate means to achieve those protections. To be clear and comprehensive, the declaration should state that populations who are vulnerable to exploitation should always receive a fair level of benefits… Based on Parsa-Parsi opinion “There are many, varied and wide-ranging reasons why certain individuals or groups could be considered to be vulnerable, not just because they are poor or have limited access to medical services. Paragraphs 19 and 20 are indeed addressed at groups who have “an increased likelihood of being wronged or of incurring additional harm”, and paragraph 19 states that such groups should receive “specifically considered protection”, this indicates that the specific situation which makes the group vulnerable, whatever this may be, should be taken into account in providing appropriate protection. The wording of paragraph 20 protects vulnerable groups from being included in research which will not benefit them and when it can be carried out in other groups which are less vulnerable. During the revision process, many stakeholders, particularly from resource poor areas of the world, expressed concerns that the inclusion of benefits in this provision could induce people to participate in studies for the wrong reasons”. Ndebele comments the topic saying that “Firstly, the DOH does not provide a definition of who is vulnerable. It simply states that the vulnerable have an increased likelihood of being wronged or of incurring additional harm. This is true. The DOH also states that all groups and individuals who are considered vulnerable should be accorded adequate protection. The DOH does not state the kinds of protection. The WMA left this to be decided on by the researchers and the RECs. The issue of fair benefits was included in the draft that was sent out for consultations and it was left out from the final version. I agree that those vulnerable to exploitation, should receive fair benefits”.
Bibliography
Ndebele P. The Declaration of Helsinki, 50 years later. JAMA. 2013 Nov 27;310(20):2145-6
Emanuel EJ. Reconsidering the Declaration of Helsinki. Lancet. 2013 May 4;381(9877):1532-3.
WMA DECLARATION OF HELSINKI – ETHICAL PRINCIPLES FOR MEDICAL RESEARCH INVOLVING HUMAN SUBJECTS
The principal new or changed paragraphs are listed below.
15. Adequate compensation and treatment for subjects who are harmed as a result of participating in the research must be ensured. 17. All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation Measures to minimise the risks must be implemented. The risks must be continuously monitored, assessed and documented by the researcher.
19. Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm. All vulnerable groups and individuals should receive specifically considered protection.
20. Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.
RESEARCH ABOMINATIONS
Do you think that research abominations as the ones made by Nazis “scientists” are still possible?
Parsa-Parsi point of view: At the time of the atrocities carried out by National Socialist physicians in the name of medical science in the 1930s and 1940s there was no code of ethics regulating research involving human subjects. Since then, the World Medical Association has developed the Declaration of Geneva in which doctors pledge that the health of their patient will be their first consideration, to maintain the utmost respect for human life and not to use their medical knowledge to violate human rights. This was followed by the Declaration of Helsinki in 1964. As the first international regulation of research ethics written by physicians for physicians, it sets out clearly the ethical responsibilities of physicians regarding the protection of study participants. The World Medical Association now has 106 members worldwide; however the Declaration is aimed at all physicians and is intended to provide guidance to all who carry out research. The principles contained within the Declaration, for example approval by ethics committees and the necessity of obtaining informed consent, have been echoed in many other guidelines and laws since. Nevertheless, we should not become complacent. The development of statements of ethical principles have certainly set a benchmark for what is and is not ethically acceptable, meaning that gross violations of human rights may be less likely today, however it remains important to ensure that such guidelines are implemented in practice.
Ndebele point of view: In my opinion it is still possible for researchers to engage in abominations such as those committed by the Nazis. Countries have different research oversight systems. Remember the virodene and trovan studies in Africa were conducted recently. There are several abominations that go unreported in developing countries. There are numerous studies being conducted without the approval of well constituted Research Ethics Committees. All countries need to have some research oversight mechanisms to ensure that their citizens are protected. It is a well known fact that some drug studies that cannot be conducted in rich countries, end up being conducted in poor countries with weak research oversight systems.