Introduction on Ethics
The World Medical Association (WMA) has developed the Declaration of Helsinki, Finland as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. The Declaration of Geneva of the WMA binds the physician with the words, “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient's best interest when providing medical care.” It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician's knowledge and conscience are dedicated to the fulfilment of this duty. IHEC has to work under the guidelines issued by regulatory bodies i.e. Declaration of Helsinki, DCGI (Drug Controller General of India) and Drugs and Cosmetics Act, 1945, CDSCO (Central Drug Standard Control Organisation),Indian Council of Medical Research (ICMR), and International Council for Harmonization of Technical requirements for pharmaceuticals for human use (ICH). IHEC has to make recommendations keeping in mind the concept of right and wrong conduct.
[Institutional Ethics Review Board (IHEC ), Chitkara University would be following these norms as defined under the Drugs and Cosmetics Act, 1945.]
The mandate of Institutional Ethics Review Board (IHEC ) is to function independently for maintaining consistent ethical framework in research, and in the integration of ethical values into practice, policy relationships, and organizational activities. The purpose of IHEC is to cultivate a pluralistic and democratic exchange of ethical values, concerns and to critically analyse them looking for opportunities to enhance the ethical integrity of the Institution. The mandate of IHEC essentially targets ethical aspects of research and education.The terms of reference for the IHEC are as follows:
To ensure that all proposed research projects conform to standard national and international ethical guidelines and that dignity, right and wellbeing of research participants is protected.
Continuing education in research bioethics and ethical aspects of clinical practice by seminars, workshops and interactive discussions for IHEC members, investigators, study coordinators, research staff, and officials of Bioethics cell.
The committee does not address or interfere in matters of an administrative nature, nor does the committee function as a grievance cell for staff members.
IHEC has responsibility within the institution with the following objectives:
- To ensure the competent review and evaluation of all ethical aspects of research projects received, to ensure compliance with the appropriate laws and safeguard welfare of participants.
- Continuing education and training programs to ensure that IHEC members are qualified to perform their specific duties, by education of professional, administrative, and support staff about ethical issues and current ethical standards and guidelines.
- Creation, developing revising and implementing ethical guidelines (SOPs).
- The committee consists of members who collectively have the qualifications and experience to review and evaluate the scientific, medical, ethical and legal aspects of a proposed research project/Clinical Trials.
- In collaborative research, the IHEC recognizes that the protocol it approves has to be approved by national and/or institutional ethics committees prior to implementation/start of study.
- In evaluating protocols and ethical issues, the IHEC is aware of the diversity of laws, cultures and practices governing research and medical practices in various countries around the world.
- The IHEC also seeks to be informed, as appropriate, by national/other local ethics committees and researchers of the impact of the research it has approved.
- The ethical principles expressed in WMA Declaration of Helsinki (Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964, and finally amended by the 64th WMA General Assembly, Fortaleza, Brazil, October 2013).
- It makes further reference to the International Ethical Guidelines like. The Nuremburg Code (1945), the Belmont Report 1979, the CIOM International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva 1993), European Convention on Human Rights and Biomedicine 1997, Standard and Operational Guidance for Ethics Review of Health-Related Research with Human Participants (WHO 2011), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP 2016).
- The IHEC establishes its own Standard Operating Procedures taking recognition of Indian Good Clinical Practice Guidelines (2001) by Central Drugs Standard Control Organization (CDSCO) for clinical trials (and revised Schedule Y of the Drugs and Cosmetics Act, 1940, in the year 2005 with several amendments in the Rules under Drugs and Cosmetics Act in the year 2013), National Ethical Guideline for Biomedical and Health Research Involving Human Participants by the Indian Council of Medical Research (ICMR 2017) National Ethical Guideline for Biomedical Research Involving Children (ICMR 2017),NABH Guidebook to standards for accreditation of Ethical Committees (1st ed., 2015) and Helsinki Declaration (Oct., 2015).
The IHEC seeks to fulfil the requirements for international assurances and is established and functions in accordance with the national law and regulations.
In view of the tremendous growth of research in the institution, the HoI, Chitkara University has accepted a SOP prepared by IHEC to facilitate the work of IHEC and maintain high standard of ethical review.
Members shall also be conversant with the provisions of research using human subjects, clinical trials and Good Clinical Practice Guidelines in India and other regulatory requirements to safeguard the rights, safety and well-being of the trial participants. Members are expected to be aware of local, social and cultural norms, as this is the most important social control mechanism.
Qualities sought in Chitkara University IHEC members:
- Interest and motivation
- Time and effort
- Commitment and availability
- Experience and education
- Respect for divergent opinions