Do Fair and Just Systems Require Compensation for the Disadvantages of the Natural Lottery? A Discussion on Society's Duties on the Provision of Gene Therapy.

Genetic diseases have been thought to be acquired as a result of sheer bad luck. However, recent advances in medical science have demonstrated the mechanisms of genetic disorders, which enable us to intervene with their occurrence and treatment. Today, gene therapy, once considered too risky, has become safer and can save the lives of patients with previously untreatable and lethal genetic diseases. However, the positive expectations from gene therapy are overshadowed by their extremely high prices. Thus, the duty of society in the provision of gene therapies has been frequently discussed. The discussions mainly focus on how to meet the genetic treatment needs of patients without violating the notion of justice and fairness in society. This study discusses the theoretical grounds for society's duty to compensate for genetic disease patients' disadvantages by providing them with appropriate genetic treatment. The main question is whether a fair and just system requires society to provide available lifesaving gene therapy to patients in need. The discussion is constructed on the crucial notion of the fair equal opportunity principle in a just system and the plausibility of including disadvantages emerging from bad luck in the natural lottery in the domain of justice.

Inconsistencies in institutional review board decisions: A proposal to regulate the decision-making process.

Medical sciences and medical technologies are developing in an enormous pace. The number of multi-site and multi- cultural clinical trials is increasing in line with this development. Yet, the increase in number brought about a problem, namely that of inconsistencies in institutional review board (IRB) decisions. The efforts to develop a comprehensive and systematic framework for the decision-making procedure of IRB members were ineffective and ended up in form of lists containing general principles of research ethics. The increase in multi-site, multi-cultural clinical research together with the initiation of new institutional review boards in countries involved in these researches emphasize the importance of defining the sine qua non criteria for considering a proposed research study to be ethical, as well as for avoiding inconsistencies in institutional review board decisions. The aim of this study is to prepare a toolkit for IRB members to regulate the ethical decision-making process while minimizing inconsistencies in institutional review board decisions. The objective is to minimize the effect of subjective factors and to ensure that all issues in key international documents and guidelines are covered prior to the point of reaching a conclusion for the proposed research protocol. By providing a comprehensive review of the Declaration of Helsinki, Council For International Organizations of Medical Sciences Guidelines, International Conference on Harmonization Guidelines, Standards and Operational Guidance for Ethics Review of Health-related Research with Human Participants of World Health Organization, and Medical Ethics Manual of the World Medical Association, this study aims at developing a standard evaluation sheet for institutional review board members to evaluate the ethical appropriateness of proposed trial protocols (Tab. 1, Ref. 35). Keywords: clinical research, ethics review committee, human subjects, informed consent, institutional review board, research ethics.