WHO works with Member States and partners to promote ethical standards and appropriate verification systems for all human research. Within WHO, the Research Ethics Board (REC) ensures that WHO supports research only to the highest ethical standards. The CEE reviews all research projects involving human participants that receive financial or technical support from WHO. The work of the ERC is based on the World Medical Association`s Declaration of Helsinki (1964), which was last updated in 2013, and the International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS 2016). It has become increasingly clear that most members of the general population and health professionals are unaware of genetics, genetic engineering and the potential ethical, legal and social implications of genetic information. This became all the more clear as the results of a number of ELSI-funded surveys became available. New information generated by HGP and human genetics research is transforming biomedical research, medical practice, and public perception of genetic information and technologies. It is imperative that the public adequately understand the importance of newly discovered genetic information. It is also important that health professionals in our country have the knowledge, skills and resources to effectively integrate this new knowledge and technologies into the diagnosis, prevention and treatment of disease. Without skilled health professionals and the public, advances in genetic research will not be fully realized. A fourth high-priority area identified for the ELSI programme is public and professional training in genetics. A second major initiative was undertaken by the NHGRI in 1994 in anticipation of the discovery of a number of genes predisposing to cancer.
This initiative (also a call for applications) was co-funded by the National Cancer Institute, the National Institute of Mental Health (NIMH) and the National Institute of Nursing Research (NINR). He has invited applications for studies to investigate the psychosocial and clinical implications of using gene-based diagnostic tests in families with inherited forms of breast, ovarian and colorectal cancer to identify people who are at increased risk of developing cancer and those who do not. Knowledge and attitudes towards genetic testing for cancer risk will also be assessed and information gathered to establish clinical protocols for the optimal use of these risk assessment technologies in the future. These projects are now entering their second year and preliminary results are available. Once completed, these projects will provide valuable, experience-based guidance for genetic testing of cancer susceptibility genes. A fourth funded project (MCET-Texter) aims to develop and test a one-semester high school course to be distributed over a public service broadcasting network using multiple telecommunications networks, including satellite, computer, audio and print materials. An important step was taken in 1986 when the Council of Europe adopted the Pact for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes. This obliged its parties to ensure “an effective system of control and supervision” of the rules set out in the Convention. In the same year, similar duties were imposed on the Member States of the European Community by Council Directive 86/609/EEC (Council Directive of 1986).
It calls on each Member State to set up an authority to review the basic legal standards laid down in the Directive. In addition, the Authority should be informed in advance of any research project involving animals in order to be able to effectively monitor compliance with the principles of animal testing in daily laboratory practices. As the results of ELSI projects and activities have been collected and analyzed, ELSI has been able to more clearly articulate its highest research, policy and education priorities and has recently issued a revised program announcement that will serve to better target future program activities. Under the Cystic Fibrosis Initiative, the projects were initiated only two years after the cystic fibrosis gene was discovered, at least in part, because the ELSI program was not yet established at the time the gene was discovered. Genetic studies of cancer were undertaken shortly after the discovery of several colorectal cancer genes and before the discovery of breast cancer genes. Anticipating such scientific discoveries allows these questions to be addressed in a timely manner before problems arise, rather than after they have already arisen. The formation of such research consortia is a practice that has recently been considered an effective means of achieving the above objectives. The concept of procedural justice, or fairness, has been developed for centuries in legal thought (Cane 2016).
Nevertheless, the serious discussion of procedural justice theory is quite new. The locus classicus for the modern theoretical presentation of the concept is the seminal The Theory of Justice by John Rawls. The author has distinguished the idea of pure, perfect and imperfect procedural justice. Pure procedural justice implies that there is no independent test for a fair result other than that of obtaining it through a fair trial. Alternatively, the idea of perfect procedural justice assumes that there are independent criteria for determining the fairness of the outcome, but the procedure ensures that the correct result is actually achieved. The idea of imperfect procedural justice, in turn, implies that procedural conditions do not guarantee the right outcome, but offer the best possible chance of achieving it (Rawls 1999, 74). Respect for standards of procedural justice appears to be particularly important in conflicts based on inevitably plural ethical attitudes, where the pluralism of values makes it almost impossible to reach agreement on the substance of the issue in question (Ceva 2008). A third project, funded by the University of Virginia-Fletcher (ELSI) program, aims to educate appellate judges and journalists about HGP and its implications for the future. As part of this project, an integrated manual, a casebook and a pedagogical manual adapted to each group will be developed and educational workshops will be offered. As mentioned above, impartiality is considered one of the two fundamental principles of “natural” procedural justice.
For a collective body such as an ECA, this extends to all its members and includes the obligation to exclude anyone with a conflict of interest from the body deciding the case. However, the majority of VAC members tend to be active researchers, often professionally associated with the institutions from which the projects reviewed originate (Schuppli & Fraser, 2007; Russell, 2012; Johnson, 2013). If an AEC is institutional, it is even possible that all of its decisions relate to projects submitted by colleagues and staff members of committee members.