Are there any restrictions or guidelines on chairman holding position in 2 or 3 Ethics Committees in organizations specialized different discipline?
There is no guideline or restriction about a chairperson chairing 2 ECs of 2 institutions with different specialties. As the EC composition mandates need for clinicians in different disciplines, the chair need not be knowledgeable about different specialty medical conditions. However, there would be ethical issues when a person chairs 2 or more ECs e.g. conflict of interest, maintenance of privacy and confidentiality of discussions in the Ecs.
What are present SAE reporting timelines to DCGI?
Dr Nitin Kulkarni
The SAE reporting timelines to DCGI are:
• Investigator - 24 hours of occurrence of SAE and follow-up 14 calendar days from occurrence of SAE
• Sponsor - 14 calendar days from occurrence of SAE
Are there specific GCP certification requirements from regulatory agencies for investigators?
There are no international regulations e. g. FDA or guidance on how often GCP training should be completed and by whom and who can perform the training. US FDA does not require or provide certification.
The regulators expect that investigators, sub-investigators, and study staff should be knowledgeable about GCP including human subject protection, data integrity, record keeping, etc.
NABH accreditation requirements require that investigators are adequately qualified, experienced, and knowledgeable in trial processes, ethical issues and applicable rules and regulations for conduct of clinical trials ensuring data integrity and protection of subject rights, safety and wellbeing. Criteria for qualifications and experience of an investigator to qualify for accreditation are as follows:
a) Should have a medical degree registered with the Medical Council of India (MCI)/State Medical Councils or a dental degree registered with the Dental Council of India/State Dental Councils.
b) Should have training in Good Clinical Practice and be aware of regulatory requirements for clinical trials.
c) Should be well-versed with principles and procedures of informed consent process.
d) Should have a clear understanding of ethical issues involved in clinical trials including rights of subjects.
e) Should have knowledge and expertise in the area being studied in a particular trial and also should have experience of minimum two years in clinical trial/research.
Accreditation requirements also demand that initial and ongoing training should be conducted for the investigator/relevant site staff at regular interval.
We plan to use a website for recruitment. If the content is amended requiring additional IRB approval, when can the changes be made to website?
Dr Srinivas Subramanian
The Ethics Committee should give approval for initial content of the website prior to its launch. As per regulatory requirements, the EC should review methods and materials used to recruit subjects. The EC could require that individuals who contact the site about the study be informed about the duration and location of storage of the information they provide and, how confidentiality of the information will be maintained, and how the information may be used in the future. If the study is multi-centric the changes on website cannot be made until all of the ECs have approved them.
We have a study where subjects recruitment is from age 16-45 years. Does the EC require a paediatrician while approving the study protocol?
Dr Samir Prabhudesai
US FDA 21 CFR 56.107 recommends that if the IRB regularly reviews research that involves children, consideration should be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with children.
Schedule Y section (2) paediatrics specifies following requirement
- (viii) For clinical trials conducted in the paediatric population, the reviewing Ethics Committee should include members who are knowledgeable about paediatric, ethical, clinical, and psychosocial issues.
Hence, a paediatrician should be included in the EC review meeting as an invited expert.
Dr Arun Bhatt is a Consultant - Clinical Research & Development,
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