REGULATION AND GUIDELINES FOR ETHICS COMMITTEE IN INDIA

Module 1

The main purpose behind the constitution of Ethics Committee was to ensure that the rights, safety and well being of the trial subjects are maintained. The origin of Ethics Committee goes back to 1974 when National Research Act was passed by the 93rd United States Congress in response to the infamous Tuskgee Syphilis study. National Research Act created National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research which consequently, created and published Belmont Report in 1979.

The framework of the Belmont Report is presented in three discussion topics: boundaries between practice and research; basic ethical principles, and applications.

1. Boundaries between Practice and Research

  • The distinction between practice and research is blurred; often because they occur together
  • The IRB must ensure that the researcher (and the participant) distinguishes practice from research in both social science and biomedical research
  • Minimize the potential for therapeutic misconception – when one believes the purpose of clinical research is to treat rather than to gain knowledge

2.Fundamental ethical principles

  • Respect for persons: protecting the autonomy of all people and treating them with courtesy and respect and allowing for informed consent. Researchers must be truthful and conduct no deception
  • Beneficence: The philosophy of “Do no harm” while maximizing benefits for the research project and minimizing risks to the research subjects
  • Justice: ensuring reasonable, non-exploitative, and well-considered procedures are administered fairly — the fair distribution of risks and benefits to potential research participants — and equally.

3.Applications of the general principles

Consideration of the three general principles in the conduct of research, lead to the reflection of these three processes:

  • Informed Consent process
  • Risk/Benefits assessment
  • Selection of research participants

After registration process there is lot of awareness and responsibility on ethics committees. There is lot of training and awareness programs conducted for ethics committee’s members to make their process more efficient and uniform. Below links will be useful for ethics committee’s members for continuous training and development.

GCP training for ethics committees members:

The Good Clinical Practice (GCP) course is designed to prepare research staff in the conduct of clinical trials with human participants. The 12 modules included in the course are based on ICH GCP Principles and the Code of Federal Regulations (CFR) for clinical research trials in the U.S. The course is self-paced and takes approximately six hours to complete.

Free Online Courses related to Ethics Committee

Introduction to Bioethics

Introduction to Bioethics is e-learning course explores some of the most difficult – and fascinating – moral challenges we face in health, medicine, and emerging technologies.

Ethics of Human Subject Research

Ethics of Human Subject Research is offered by the Department of Health Policy and Management and Johns Hopkins Bloomberg School of Public Health and The Phoebe R. Berman Bioethics Institute, Johns Hopkins University. The course introduces students to the ethics of human subject research. Ethical theory and principles are introduced, followed by a brief history of research ethics. Topics covered in lectures and moderated discussions include informed consent for research participation, role and function of institutional review boards, just selection of research subjects, ethical aspects of study design, and privacy and confidentiality. Student evaluation will be based on participation in moderated discussions, an informed consent exercise and written case analysis.

Introduction to the Ethics of Human Subjects Research

Introduces students to ethics concepts as they apply to questions and challenges in conducting human subject research. The aim is to increase students’ knowledge and skills to recognize and consider ethical issues that arise in the conduct of human subject research. The course was designed for clinical investigators in India who will likely collaborate with US investigators; it therefore includes a discussion of US and Indian regulatory requirements relevant to the conduct of collaborative research.

Ethical Issues in Public Health

Lectures and small group discussions focus on ethical theory and current ethical issues in public health and health policy, including resource allocation, the use of summary measures of health, the right to health care, and conflicts between autonomy and health promotion efforts. Student evaluation based on class participation, a group project, and a paper evaluating ethical issues in the student’s area of public health specialization.

Organization supporting training for Ethics Committee

Clinical Development Services Agency (CDSA)

CDSA is an autonomous not-for-profit research society to facilitate development of affordable healthcare products primarily for public health diseases. CDSA has set up processes, tools and systems for a program commissioned to train a cadre of clinical researchers (including physicians, study site coordinators, nurses and data managers) to conduct clinical trials using global standards for developing public health products that may be drugs, vaccines, biologics, medical devices or healthcare technologies. Visit their training page for programs offered for Ethics Committee and workshop material – http://cdsaindia.in/training-clinical-research

GUIDANCE DOCUMENT FOR IEC by CDSA

CDSA with support from experts has developed a “Guidance Document for Institutional Ethics Committee (IEC) that Review Clinical Trials on Human Participants”. This document provides guidance for functioning of an institutional ethics committee involving review of study protocol of a regulated clinical trial. The document could also be a useful resource for those who plan to involve, start an IEC and/or understand what an IEC does.

This document provides general guidance but does not define regulatory expectations in this area. This guidance document should not be regarded as a definitive interpretation of any Act or Guidelines. Anyone in doubt should refer to applicable rules and regulations, and guidelines. The document does not establish any rights for any person and is not binding on CDSA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. In no event shall CDSA be liable for any claim, damages or other liability arising from the use of this document.

http://www.cdsaindia.in/guidance-iec

The Forum for Ethics Review Committees in India (FERCI)

FERCI is a registered society (Maharashtra State, Reg No. 865/2006 200 GBBSD) set up as the national chapter of FERCAP (Forum for Ethics Review Committees in Asia-Pacific), the latter being an initiative undertaken by WHO TDR. The idea that such a national forum was needed in India to improve understanding and implementation of ethical review of biomedical research in India, with relevance to local cultural values. FERCI operates in close collaboration with important institutions like the World Health Organization (WHO), Indian Council of Medical Research (ICMR), Central Drugs Standard Control Organization (CDSCO), FERCAP, SIDCER (Strategic Initiative for Development of Committees for Ethics Review)etc. Membership of FERCI is open to everyone involved with ethics review committees and those interested in the process of ethics review of biomedical research in India. A lot free training material provide related to Guidelines, Conference and informed consent training videos.

The Indian Council of Medical Research (ICMR)

ICMR, New Delhi, the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest medical research bodies in the world. Visit their publication page for the guidelines and other training material offered by them. Also visit the ICMR page Ethics in Human Experimentation

Ethics Committee members should have understanding of all basic guideline on human protection during participation in a clinical trial. Guidelines on human protection during research are as below:

  1. THE NUREMBERG CODE
  2. THE DECLARATION OF HELSINKI
  3. THE BELMONT REPORT
  4. 21 CFR PARTS 50 AND 56
  5. 45 CFR PART 46
  6. INTERNATIONAL CONFERENCE ON HARMONIZATION GOOD CLINICAL PRACTICES
  7. WHO OPERATIONAL GUIDELINES FOR ETHICAL REVIEW COMMITTEE THAT REVIEW BIOMEDICAL RESEARCH
  8. ICMR’S ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS, ICMR
  9. SCHEDULE Y (DRUGS AND COSMETIC ACT 1940; AMENDMENT 20TH JANUARY 2005)
  10. GUIDELINE FOR COMPENSATION TO RESEARCH PARTICIPANT
  11. GOOD CLINICAL PRACTICES FOR CLINICAL RESEARCH IN INDIA
  12. REGISTRATION OF ETHICS COMMITTEE
  13. SYSTEM FOR THE PRE-SCREENING OF THE APPLICATIONS FOR REGISTRATION OF ETHICS COMMITTEE
  14. LIST OF REGISTERED ETHICS COMMITTEE – STATE WISE
  15. ACCREDITATION OF ETHICS COMMITTEE, SITES AND INVESTIGATORS

Now, Every research, based on humans should first be reviewed and approved by Ethics Committee, taking into considerations all the ethical principles governed by the Belmont Report. The most important parts of any proposal to an ethics committee for any clinical trial are the informed consent process and document, risks and benefit assessment and subject selection criteria. The main motto of ethics committee is to ensure whether the proposed trial is ethical or not. The prime focus is on the welfare of subjects and it is ensured that they obtain the maximum benefit from the trial.