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ICMR allows use of electronic process during COVID-19 pandemic


Saturday, June 6, 2020, 08:00 Hrs  [IST]

In view of COVID-19 situation, our Ethics Committee (EC) is planning to use electronic systems for conduct of meeting and documentation. Is there any regulatory guidance for compliance?
Dr Ramesh Ghia

ICMR 2020 has released guidelines for EC review of biomedical and health research during COVID-19 pandemic. It allows use of electronic process.

Electronic documents may be accepted for review and timelines shortened for accelerated procedures. Virtual or Tele/Video conferences should be attempted to ensure social distancing as face-to face meetings may not be suitable. Use suitable virtual software platform, preferably a video conference to enable face to face discussion or teleconference if connectivity is an issue.
However, there is no guidance about compliance for electronic documentation.

US FDA recommends 21 CFR Part 11 compliance mandates as follows: Records required for clinical investigations of medical products that are maintained in electronic format in place of paper format, including all records that are necessary for US FDA to reconstruct a study must be validated to be compliant with 21 CFR Part 11. US FDA expects that electronic systems supporting IRB activity should be compliant with 21 CFR Part 11.

Is there any mandatory language as per US FDA new consent regulation?
Dr Ganesh Parmar

US FDA has revised PART 50 - PROTECTION OF HUMAN SUBJECTS Subpart B - Informed Consent of Human Subjects.
Section 50.25 Elements of informed consent are revised to include the following text:

When seeking informed consent for applicable clinical trials, as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be provided to each clinical trial subject in informed consent documents and processes. This will notify the clinical trial subject that clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank under paragraph (j) of section 402 of the Public Health Service Act. The statement is: "A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by US Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time."

US FDA mandates that any applicable clinical trial, including applicable clinical trials conducted outside the United States, must comply with the new regulation (21 CFR § 50.25(c)) and include the statement regarding www.ClinicalTrials.gov in informed consent forms.

We are planning a study which will include multiple satellite sites. Can we consider the role of physicians as co-investigators?
Dr Mina Rameshwar

If the physician’s role is to refer patients to primary site without any specific screening, their role may be considered as referring physicians.
As per Indian GCP, co-investigator is a person legally qualified to be an investigator, to whom the investigator delegates a part of his responsibilities. ICH GCP does not use the term co-investigator, but considers such persons as sub-investigators.

The physicians at satellite site cannot be considered co-investigators or sub-investigators, who are supposed to assist the investigator conduct the study at a specific site. They should be qualified to perform the tasks delegated to them, but not to substitute for the investigator at satellite site.

If the satellite site is the location of study where the physician will conduct and/or supervise all aspects of a clinical study, then the physicians should be considered as the investigators and should comply with all regulatory and good clinical practice responsibilities.


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

 

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