Strengthening of Ethical Guidelines in Clinical Research
The global clinical research enterprise is rapidly progressing and thus putting forth new challenges to ethical standards so that the rights and health of human subject can be protected. Human experimentation has always been dogged by controversy
Recently published articles in scientific journals and popular press have accused scientific researchers for using humans as guinea pigs and using double stranded policies in conducting research in developing countries compared to developed countries. To ensure that the research is conducted in the most ethical way it is necessary to abide all the ethical guidelines and to oversee maintaince of the law and ethical review mechanism. It is necessary to have a responsible, well functioning ethics committee with validated standard operating procedures in order strengthen its function.
The horrifying experiments of the past that were conducted on vulnerable subjects, such as the Nazis’ experiments or be it the Tuskegee experiment in which syphilis affected men were left untreated for decades even after the availability of the treatment, and many other incidents have led to the development of the ethical guidelines for the conduct of clinical trials . The present scenario has definitely improved as compared to the past and clinical trials are conducted more ethically under international guidelines. Be as it may, it will be too overoptimistic to believe that ethical problems have been completely solved. At any given time, the strategy a company employs depends on factors such as: in-house expertise in the conduct of clinical trials, identification of the company’s business requirements, leveraging “specialized” providers that are functional experts rather than hiring drug development experts, depends on internal/external “bandwidth” or scalability, quality control and consistency, and cost benefits.After internal assessment, the sponsor selects the outsourcing strategy and the appropriate service provider for the same.
The constant development and refinement of international ethical guidelines is a positive step towards safeguarding the human subjects’ rights and safety, and thorough implementation of these guidelines is required as an urgent need. There are fewer than 40 properly constituted ethics committees in India according to a report by the World Health Organization. This is a matter of concern for many companies that engage themselves in conducting clinical trials in India. Moreover there is no legal requirement for the members of ethics committee and the investigator to declare a conflict of interest; these issues raise concerns over the transparency and accountability of the clinical trial results.Large pharmaceutical companies prefer the following outsourcing models for various trial management and data management services, supportive manpower and infrastructure.
First and foremost it is important to ensure the implementation of guidelines in the functioning of ethics committee. Efforts are to be made in the direction of educating research professionals through workshops on ethics in clinical research. It is important to have institutional ethics committees for research institutions which function according to local and international ethical guidelines and regulations. The criteria for ethical research should include fair selection of subjects, properly conducted inform consent process, favorable risk benefit ratio and independent review of the functioning of the ethics committees.
Registration of the clinical trial is an important step to maintain transparency in conducting clinical trials .There are number of clinical trial registries in place but none are truly comprehensive. In 2005 World Health Organization established the International Clinical Trial registry platform for registering clinical trials and as a one stop search portal for existing registries. India has in recent years become an ever increasing hub for clinical trials and the fear of conduct of clinical trials in an unethical manner has been one of the major issues which brought the urgent need for registration of clinical trials in India.Clinical trial registry of India has been set up by Indian Council of Medical Research (ICMR) to ensure that all trials conducted in India are registered and identifiable. Clinical trial registry is an online system which helps to set up unbiased, scientific public record of clinical trial while maintaining transparency and accessibility of clinical trials.
Ethical issues have multidisciplinary roles to play during the conduct of clinical trials. These roles spread from a broad range – from matters pertaining to the design of the study till the actual attainment of the objective. Each of these activities is to be carefully addressed and should be executed in relation to the international and national principles and guidelines. It is also mandatory that ethics committees be established for the governance of the clinical trials to ensure that all the conformities are met by following the principles, laws, guidance and processes that have been prescribed for the conduct of clinical trials globally.