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Indian investigator can conduct international survey approved by EC

Thursday, July 2, 2020, 08:00 Hrs  [IST]

An Indian investigator wants to collaborate with foreign collaborators in different countries to conducting a survey on COVID pandemic in their respective countries. Can Indian investigator collect information during this pandemic through his international collaborators and publish? Can EC approve his proposal? Does he require approval from HMSC?
Dr Sreevatsa

An Indian investigator can conduct a survey which can be reviewed and approved by EC. However, if the survey locations are outside India, the Indian EC cannot approve these locations. If there is a foreign collaboration, HMSC approval is a must.

Please see below ICMR 2020 guidance for review of research during COVID-19 pandemic.  
Collaboration in research
•    Existing guidelines on collaboration for sharing biological samples, data and intellectual property including publication related issues will be applicable. Collaborations to address possible inequity of expertise, access between partnering institutions /funding relationships.
•    Rapid data sharing while safeguarding the above is critical during public health emergency.
•    An appropriate MoU and/or MTA to safeguard the interests of participants and ensure compliance (addressing issues of confidentiality, sharing of data, joint publications, etc.).
•    Biomedical and health research proposals involving foreign assistance and/or collaboration be submitted to Health Ministry’s Screening Committee (HMSC) for approval before initiation.

Can patient consent be waived for clinical trials during COVID-19 pandemic?
Manisha Desai
ICMR 2020 guidance for review of research during COVID-19 pandemic permits waiver of consent in following situations:
For seeking waiver of consent, the researchers should give the rationale justifying the waiver which EC can approve a waiver after careful discussion in the following situations:
•    Research cannot practically be carried out without the waiver and the waiver is scientifically justified like, cluster randomization trials.
•    Retrospective studies, where the participants are de-identified or cannot be contacted
•    Research on anonymized biological samples/data
•    Certain types of public health studies/surveillance programs/programme evaluation studies
•    Research on data available in the public domain; or
•    Research during humanitarian emergencies and disasters when the participant may not be able to give consent.
•    When consent of the participant/LAR/assent is not possible due to the emergency situation, informed consent can be administered at a later stage, when the situation allows for it, and if it is so envisaged, prior permission must be obtained from the EC.

What are regulatory expectations about attributability of source data and documents?
Dr Ananthakrishnan
Regulatory authorities would expect forms, questionnaires, and diaries completed by study participants to be attributable to the individual completing them. However, there is no regulatory guidance about how validation of this attributability should be accomplished. Questions of attributability would be asked if during monitoring, audit, or inspection something in the documents raised a question as to who completed and/or modified them. For example, if the inspector finds different handwriting in different parts of the document, or extensive modifications made in a different handwriting, or if the handwriting in all such documents appeared same. Regulatory inspector may would request documentation of who performed which task during a study, when GCP noncompliance is observed.

Dr Arun Bhatt is a Consultant - Clinical Research & Development,

Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com


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