**Executive Summary:**
This advisory notice, referencing Professor Ranjit Roy Chaudhury's recommendations, emphasizes the need for improved systems and procedures in Indian clinical trials to protect participant rights, safety, and well-being. It addresses various aspects of clinical trials, including consent processes, compensation, ethics committee accreditation, and stem cell treatments. The notice is intended to sensitize stakeholders and encourage compliance with ethical practices.
**Key Points / Main Content:**
* **Consent and Patient Rights:**
* Consent forms should be simplified for better understanding by laypersons and translated accurately into the patient's mother tongue.
* For children under 14, legal guardian consent is required, with the child's assent also necessary if they understand the information.
* For mentally challenged or schizophrenic patients, guardian consent can be considered.
* Informed consent is required if banked tissue from a patient is used for purposes beyond the original trial.
* Patients have the right to know if stem cell treatments are proven to work.
* **Ethics Committee and Accreditation:**
* Ethics committees should be accredited, with accreditation mandatory for operation.
* An accreditation body, potentially under the proposed National Council for Human Resources of Health, is envisaged.
* Independent ethics committees should be regulated to prevent unapproved trials.
* Ethics committee members, including lay members, should be better informed about the ethical implications of trials.
* **Clinical Trial Practices:**
* The number of clinical trials an investigator can handle should be limited.
* Clinical trial sites should be chosen randomly by the Drug Controller General India (DCGI), not by pharmaceutical companies.
* Institutes and investigators should be accredited.
* A medical devices agency should be established to regulate medical device trials.
* If a clinical trial is carried out in India, the resultant drug should be released here and the number of patients in India on whom the study is conducted needs to be sufficient enough to give information as to how the drug functions in Indian patients.
* **Compensation and Oversight:**
* Ethics committees should determine compensation for clinical trial participants in cases of unfortunate outcomes.
* There is a proposal to put the decision on the quantum of compensation to be paid in the ambit of ethics committees
* **Stem Cell Treatments:**
* Stem cell treatments, except for hematopoietic stem cells for specific hematological indications, should be conducted in an investigative mode only.
* A government-run fund (ICMR) should be created to support clinical trials for stem cell treatments.
* **International Collaboration:**
* Safeguards are needed for international collaborative research.
**Impact Analysis**
**Pharmaceutical Companies:**
* *Impact:* Increased transparency in site selection, potential limitations on trial numbers per investigator, and the need to release drugs developed in Indian trials in India.
* *Action Required:* Adapt trial site selection processes to comply with DCGI randomization, adhere to investigator limits, and consider domestic release of drugs developed in India.
**Investigators:**
* *Impact:* Potential limits on the number of clinical trials they can handle, need for accreditation, and adherence to ethical guidelines.
* *Action Required:* Seek accreditation, manage the number of trials to comply with potential limits, and stay informed about ethical implications.
**Ethics Committees:**
* *Impact:* Requirement for accreditation, potential involvement in compensation decisions, and need for better-informed members.
* *Action Required:* Pursue accreditation, develop expertise in compensation calculation, and provide training to members on ethical implications.
**Patients/Trial Participants:**
* *Impact:* Improved consent processes, potential for compensation in case of negative outcomes, and right to information about stem cell treatment efficacy.
* *Action Required:* Understand consent forms thoroughly and seek clarification when needed.
**Drug Controller General India (DCGI):**
* *Impact:* Responsibility for randomizing clinical trial site selection.
* *Action Required:* Establish a process for random site selection.
Key Entities Referenced
Professor Ranjit Roy Chaudhury: An eminent Scientist who advocated for proper systems and procedures for conducting clinical trials in India.
Drugs Controller General India: A regulatory authority mentioned in the context of choosing clinical sites.
Apollo Group of Hospitals, Delhi: Location where experts deliberated on quality and ethical practices in clinical trials.
Apollo Hospitals Educational Research Foundation AHERF: Institution where Dr. Ranjit Roy Chaudhury is the Chairman Task Force for Research.
Parliamentary Standing Committee: Entity that exposed the nexus between Pharma companies and those managing trial sites.
National Council for Human Resources of Health: Proposed council under which an assessment body for ethics committees may function.
Indian Council of Medical Research ICMR: An organization related to stem cell treatment guidelines and funding clinical trials for stem cell treatments.
China: Mentioned as a country fast taking over from India as a preferred destination for foreign MNCs regarding clinical trials.