Ethics in Medical Research: General Principles with Special Reference to Psychiatry Research

Article excerpt

Byline: Ajit. Avasthi, Abhishek. Ghosh, Sidharth. Sarkar, Sandeep. Grover

Ethics is an understanding of the nature of conflicts arising from moral imperatives and how best we may deal with them. Ethics in medical research deals with the conflicts of interest across various levels. Guidelines have been proposed for standardized ethical practice throughout the globe. The four fundamental principles of ethics which are being underscored are autonomy, non-maleficence, beneficence, and justice. Some special ethical issues have particular relevance to psychiatric research arising primarily from the specific vulnerabilities of those with mental illness and the risks posed by some research methodologies. Accordingly, sensitivity is required in the design of psychiatric research. It is suggested that though the value of published guidelines and the help that may be available from research ethics committees is quite great, the primary responsibility for maintaining high standards of practice in research rests with research workers themselves.

Introduction

The word "ethics" is derived from the Greek word, ethos, which means custom or character. Ethics is an understanding of the nature of conflicts arising from moral imperatives and how best we may deal with them. [sup][1] It deals with the choices we make and our actions in relation to those choices. It deals with the choices made by both clinicians and patients and the duties and obligations of clinicians to their patients. Medical ethics also deals with the choices made by society, the distribution of resources, and access to health care, and the dilemmas arising from them. [sup][2] An issue, mainly for the developing countries, has been the extent to which ethical principles are considered universal or as culturally relative - the universalist versus the pluralist view. The challenge to international research ethics is to apply universal ethical principles to biomedical research in a multicultural world with a multiplicity of health-care systems and considerable variation in standards of health care. [sup][3]

History

History is unfortunately peppered with stories of abuse carried out in the name of medical research. The most dreadful of all atrocities was possibly conducted by Nazi doctors who used convicts for human experimentation. The discovery of these experiments stunned the whole world which led to the formulation of Nuremberg code [sup][4] to prevent recurrence of such episodes. It was the first international code for ethics in clinical research laying down the guidelines for research on human subjects. It laid down 10 clear principles to be followed by researchers and made voluntary consent essential, allowed subjects to withdraw from the experimentation at any time, banned experiments that could result in major injury or death of the subjects, and made mandatory to have preclinical data before experimenting on humans. Even Nuremberg code failed to terminate unethical research practices. Eventually a set of guidelines was adopted by the 18 [sup]th World Medical Association (WMA) [sup][5] General Assembly, which was called the Declaration of Helsinki. It contained 32 principles, which stress on informed consent, confidentiality of data, vulnerable population, and requirement of a protocol, including the scientific reasons of the study, to be reviewed by the ethics committee. Though Declaration of Helsinki had created a stir in the medical community, medical atrocities continued. The malpractice in the Tuskegee Syphilis Study in the US was possibly the next eye opener which ushered the Belmont Report [sup][6] in 1979 and laid the foundation for regulations regarding ethics and human subjects' research in the US. With the increasing interest of pharmaceutical industries in carrying out research experiments in the developing and the underdeveloped countries, the Council for International Organizations of Medical Sciences (CIOMS) [sup][3] in association with World Health Organization (WHO) developed "International Ethical Guidelines for Biomedical Research Involving Human Subjects" in 1982. …