Consultation
Under the direction of DG ICMR, the ICMR Bioethics Unit has formulated a consensus policy statement to address the ethical concerns related to the conduct of Controlled Human Infection Studies in India. The statement has been developed through a process of rigorous engagement with experts in the last few months. These studies may play a crucial role in advancing the scientific understanding of infectious diseases and thereby accelerating the development of treatment strategies. However, being a very specialized type of research involving deliberately infecting healthy volunteers with a specific pathogen under controlled conditions, these may have a lot of ethical challenges and an attempt has been made to address these issues in this document. The document was posted on ICMR website for Public Consultation for a period of one month from 17th July 2023 to 16th August, 2023.
ICMR has appointed an expert committee to draft a position paper on ‘Do Not Attempt Resuscitation (DNAR)’ which would guide treating physicians to take the decision whether or not to perform the Cardiopulmonary Resuscitation (CPR) on the background of incurable disease where the patient’s chances of survival are extremely low. The purpose of the document is to suggest a mechanism to not prolong the suffering of the patient and to preserve the dignity in death by avoiding medically non-beneficial CPR while providing compassionate care. The patient/s undergoing the treatment for incurable disease with least/no probability of survival often impose themselves and their families to increased psychological, emotional and economic burden. The document also highlights how the treating physician should provide complete information to the patient/surrogate(s) regarding DNAR and suggests a form for the purpose that can be used by clinical facilities.
Multicentre research collaborations offered opportunities to engage diverse scientific expertise to answer important research questions among wider population groups. Every biomedical and health research study had to be reviewed by an Ethics Committee before its conduct. At that time in India, all centres were required to obtain approval from their respective ECs, which considered the local needs and requirements of the population and safeguarded the dignity, rights, safety, and well-being of the participants. In order to streamline the review process and improve coordination in multicentre research, a process for common ethics review had been suggested in the ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017. Accordingly, the ICMR Bioethics Unit had formulated the draft guidelines for Common Ethics Review of Multicentre Research after a series of consultations with stakeholders. The guidance was intended to address a variety of issues related to common ethics review so that research could proceed expeditiously without compromising ethical principles and ensuring protection for human research participants. This method could be adopted as an option by ECs engaged in multicentre research. The ICMR had invited feedback and comments on the draft ICMR guidelines for Common Ethics Review of Multicentre Research from stakeholders involved in multicentre research
In continuation to the release ‘Definitions of terms used in limitation of treatment and providing palliative care at end of life’, ICMR Bioethics Unit took up the initiative to develop a format for Advance Health Care directive document. A consultation meeting with experts were organized to finalize the format of Advance Health Care Directives and guidance for Withdrawal and Withholding of Life Support in Terminal Illness. The expert group has drafted two sets of documents namely.
1. Advance Medical Directives
2. Withdrawal and Withholding of Life Support in Terminal Illness
ICMR Bioethics Unit organized a consultation meeting with experts and relevant stakeholders to discuss issues related to Reuse of Cardiovascular Catheters. The group discussed issues related to safety and scientific concerns, sterilization process, quality of product, reprocessing procedures, cost implications, ethical and legal issues related to reuse of cardiovascular catheters.
To streamline the review processes of ethics committee submissions and improve coordination in multicentre research, an expert consultation was organized to develop a guidance document and Standard Operating Procedures (SOP) for common ethics review of multicentre research to improve EC coordination between various ECs, quality and credibility of the research conducted.
ICMR-Bioethics Unit, NCDIR, Bengaluru organized a symposium to discuss the Draft New Drugs and Clinical Trial Rules 2018 at NCDIR, Bangalore on 12th March, 2018. The consultation meeting was attended by stakeholders from government agencies, universities, research institutes, non- governmental organizations, private practitioners, legal experts, basic scientists, social scientists and others.
