ICMR in Medical Research

ICMR IN MEDICAL RESEARCH

·       The Indian Council of Medical Research (ICMR) has established comprehensive guidelines addressing medical research involving death, dying, and incurably ill patients.

·       These guidelines emphasize ethical considerations, patient autonomy, and the importance of palliative care.

1. Definitions Related to End-of-Life Care: ICMR provides clear definitions to standardize understanding and practices concerning end-of-life care:

• Terminal Illness: An irreversible or incurable condition expected to result in death in the foreseeable future.
• Actively Dying: The period, typically hours or days, preceding imminent death during which physiological functions decline.
• Life-Sustaining Treatment: Medical interventions that artificially support or replace essential bodily functions.
• Do Not Attempt Resuscitation (DNAR): A directive not to initiate cardiopulmonary resuscitation (CPR) in patients with terminal illness, based on prior expressed wishes of the patient or their surrogate.
• Palliative Care: A holistic approach aimed at improving the quality of life for patients and their families facing life-threatening illnesses, focusing on the prevention and relief of suffering.
• Advance Directives: Statements made by individuals with decision-making capacity regarding their preferences for treatment or non-treatment in situations where they may lose such capacity.

2. 'Do Not Attempt Resuscitation' (DNAR) Guidelines: ICMR's consensus guidelines on DNAR decisions emphasize the following:

• Scope of DNAR: A DNAR order specifically pertains to refraining from CPR in cases of cardiorespiratory arrest and it does not imply the withdrawal or withholding of other medical treatments aimed at cure or supportive care.
• Clinical Situations for DNAR Discussions: Discussions regarding DNAR should be considered in scenarios such as:
• Imminent death expected within hours or days.
• Advanced, progressive, incurable conditions.
• Existing conditions where sudden death may occur as an acute complication.
• Life-threatening acute conditions resulting from sudden catastrophic events or patients in a persistent vegetative state.
• Decision-Making Process: The treating physician assesses the appropriateness of a DNAR order and discusses it with the patient or their surrogate. Good communication is essential, conducted in a simplified and understandable manner, allowing time for discussion in privacy and the option to seek a second opinion if desired.
• Role of Surrogates: A surrogate is a person accepted as representing the patient's best interests, making decisions on behalf of the patient when they lose decision-making capacity. This can include spouses, children, parents, siblings, close friends, or caregivers.

3. Ethical Guidelines for Biomedical Research: ICMR's ethical guidelines for biomedical and health research involving human participants outline the following principles:

• Respect for Persons (Autonomy): Acknowledging the dignity and autonomy of individuals, ensuring informed consent is obtained.
• Beneficence: Obligation to act in the best interests of the patient, maximizing possible benefits while minimizing potential harms.
• Non-Maleficence: Duty to not inflict harm intentionally.
• Justice: Ensuring equitable distribution of the benefits and burdens of research.

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