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Protection of rights & safety of trial subjects are important


Friday, May 8, 2020, 08:00 Hrs  [IST]


Is there any guideline regarding continuation of the ongoing clinical trial and precaution to be taken during Covid-19 pandemic? Sponsor is putting pressure on the investigator to carry on the project as per approved protocol.
Dr Sreevatsa
The Drugs Controller General India has issued a notice about conduct of clinical trials during outbreak of COVID-19. The notice mandates that protection of rights, safety and well-being of trial subjects are of paramount importance. The sponsor cannot take unilateral decisions. The sponsor in consultation with the investigator and the EC should decide whether to continue the trial in interest of the patient or to take decisions about the need for any protocol deviations/amendments. The sponsor in consultation with the investigator and the EC take decisions and ensure protection of rights, safety and well-being of trial subjects, data integrity and documentation of changes.

Can an EC conduct a virtual meeting during COVID-19 pandemic?
Dr Suresh Shahani
ICMR ethical guidelines 2017 recommends: 
Research during humanitarian emergencies and disasters can be reviewed through an expedited review/scheduled/ unscheduled full committee meeting. This may be decided by the Member Secretary on a case-to-case basis depending on the urgency and need. If an expedited review is done, full ethical review should follow as soon as possible.

Measures such as virtual or tele-conferences should be attempted when face-to-face meetings are not possible.

However, these provisions are not applicable for other types of research e.g. clinical drug trials for non-emergency therapy projects. 

FDA’s regulations do not provide specific requirements regarding how IRB meetings may be conducted, but participation by videoconferencing/telephone has been acknowledged previously by FDA. In general, virtual meetings should follow the same process as “in person” meetings. Documentation of the IRB meeting procedures and attendance should follow regulatory requirements as well as IRB SOPs and any hospital/local requirements for holding IRB meetings.

FDA’s Minutes of Institutional Review Board (IRB) Meetings Guidance for Institutions and IRBs provides the following information regarding documentation of IRB meeting attendance: However, the minutes must clearly document which IRB members were present at any given convened meeting (45 CFR 46.115(a)(2); 21 CFR 56.115(a)(2)). IRB members may participate in a convened meeting of the IRB via telephone or video conferencing when those members have received in advance of the meeting a copy of the documents for research proposals that are to be reviewed at the meeting. The minutes should make clear which members, if any, participated in the convened meeting via an alternative mechanism, such as telephone or video conferencing.

How should EC conduct a virtual meeting?
Dr Suresh Shahani
The University of Utah has provided a detailed SOP on Virtual IRB Meetings. 
Some critical aspects are:
  • Selection and checking IT platform/app
  • Conflict of interest issues
  • Members should pay attention and audibly announce when she leaves the room and return
The secretary’s responsibility as the meeting host include:
  • Display of the agenda and relevant information.
  • Muting and unmuting members 
  • Asking the members about any question or comment.
  • Managing voting process 
  • On-line virtual process  
  • Opening the EC meeting 
  • Review and discussion on projects 
  • Voting process 
  • EC member’s conflicts of interest 
  • Closing the meeting.

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

 

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