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It is essential for investigator to obtain HMSC clearance

Dr Arun Bhatt
Wednesday, September 6, 2023, 08:00 Hrs  [IST]

Is it necessary to get the Health Ministry’s Screening Committee (HMSC) clearance for the international collaborative study where patient clinical data is transferred into the online registry platform which is maintained and managed by the investigator of the Host University?
Dr Sreevatsa

Ministry of Health and Family Welfare (27th  June 2022) has mandated need for HMSC clearance for all projects with foreign collaboration.  
ICMR 2017 ethical guidance for biomedical research mandates that HMSC approval is required even if there is no financial assistance, and the project is only a research collaboration. As per ICMR, legal expert/s of Ethics Committee are responsible for review of HMSC approval.
All biomedical and health research proposals involving foreign assistance and/or collaboration should be submitted to the Health Ministry’s Screening Committee (HMSC) for consideration and approval before initiation.

As per the requirements of HMSC, all research involving international collaboration – either technical, financial, laboratory or data management must be submitted to HMSC.

Health Ministry’s Screening Committee requirements mention some critical aspects of projects which require special consideration by the principal investigator (PI) (https://main.icmr.nic.in/content/health-ministry-screening-committee-hmsc)  
iv. Relevance to India’s national health priorities.
iii. Risk (relative) from the defence and internal security point of view of the country.
iv. Intellectual Property Rights issues, if any.
v. Potential for commercial exploitation, such as by development of vaccines, diagnostics, therapeutics, drugs, etc.

Sharing of raw data by Indian principal investigator with the foreign agency in any form is not permitted. Only the identified/anonymized/analysed data can be shared. An MoU on data sharing/clinical trial agreement is to be submitted, wherever applicable.

It is essential for the investigator to obtain Health Ministry’s Screening Committee  clearance. Failure to do so might create problems, e.g., government inquiry for the institution, Ethics Committee and the investigator, and loss of registration for Ethics Committee.

In drafting patient information for informed consent, GCP recommends inclusion of reasonably foreseeable risks or discomforts? What should we include in the risks or discomforts?
Dr Deepak Dedhia
The US FDA’s August 2023 guidance on Informed Consent recommends inclusion of:
    • Risks or discomforts of tests, interventions and procedures required by the protocol, protocol-specified standard medical procedures, exams, and tests, with a particular focus on those that carry significant risk of morbidity or mortality.
    • Risks or discomforts due to changes to a subject’s medical care e.g., changing/stopping the medication regimen or randomizing them should also be addressed.
    • Possibility of unintended disclosures of private information and be provided with an explanation of measures to protect a subject’s privacy and data, and limitations to those measures.
    • Reasonably foreseeable discomforts to the subject e.g., claustrophobia-like symptoms during an MRI
    • Significant risks and discomforts of the standard of care, if used as comparator therapy
    • Risks that are more likely to occur and those that are serious
    • Whether a risk is reversible, and the probability of the risk based on existing data.
    • What may be done to mitigate serious risks.
    • Potential for risk to “others” e.g., radiation therapy.
    • Unforeseeable risks of particular treatment or procedure to the subject or foetus.

The explanation of potential risks of the test article and control, if any, and an assessment of the likelihood of these risks occurring should be based on reliable and accurate information presented in the protocol, investigator’s brochure, labelling, and/or previous research reports. must also be described.

Regulatory guidance recommends that the participants should be informed about significant new findings? What does this mean?
Dr Renu Nadkarni

The health authorities would expect that the patient information sheet should include significant new findings e.g. an unexpected adverse event, an adverse event occurring at greater frequency or severity than previously stated in the consent process, results from interim analyses (in some cases), additional alternative procedures or courses of treatment that become available during the course of the clinical investigation, and information from other clinical trials about the effectiveness of the investigational product, the comparator, or other products for the same indication.

Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com

 

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