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Using 1 central EC for non-interventional study would be non-compliance

Wednesday, March 1, 2023, 08:00 Hrs  [IST]

We have been encouraging AV consent on studies with vulnerable population groups only and those where the trial is with NCE/NME and not for all studies, however we have seen this being contested citing we need it for all studies by different regulatory teams associated with sponsors.  Would you have any perspective on this please?

Srilakshmi Dhabbala

The definition of vulnerable population is quite broad and include many diverse categories of clinical trial participants.

ICH GCP 1.61. vulnerable subjects
Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

ICMR 6.2 examples of vulnerable populations or groups:
  • economically and socially disadvantaged (unemployed individuals, orphans, abandoned individuals, persons below the poverty line, ethnic minorities, sexual minorities – lesbian/gay/bisexual and transgender (LGBT), etc.);
  • unduly influenced either by the expectation of benefits or fear of retaliation in case of refusal to participate which may lead them to give consent;
  • children (up to 18 years);
  • women in special situations (pregnant or lactating women, or those who have poor decision-making powers/poor access to healthcare);
  • tribals and marginalized communities;
  • refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster situations;
  • afflicted with mental illness and cognitively impaired individuals, differently abled – mentally and physically disabled;
  • terminally ill or are in search of new interventions having exhausted all therapies;
  • suffering from stigmatizing or rare diseases; or
  • have diminished autonomy due to dependency or being under a hierarchical system (students, employees, subordinates, defence services personnel, healthcare workers, institutionalized individuals, under trials and prisoners).
When you apply these definitions, majority of clinical trial participants in India would be considered vulnerable. All ethical guidelines e.g. ICMR expect that the investigator and the sponsor ensure additional protection to the vulnerable participants.

Since 2015, the investigator sites are now used to recording AV consent. So, advising them not to record AV consent in certain population may lead to errors. It would be ethically pragmatic  to do AV recording in all vulnerable participants

Can we take a one approval from a central EC for non-interventional observational studies?
Shilpa Raut

If the study is for regulatory purpose, NDCTR 2019 would apply, which mandate:
  • where a clinical trial site does not have its own Ethics Committee, clinical trial at that site may be initiated after obtaining approval of the protocol from the Ethics Committee of another trial site; or an independent Ethics Committee for clinical trial constituted in accordance with the provisions of rule 7:
  • Provided that the approving Ethics Committee for clinical trial shall in such case be responsible for the study at the trial site or the centre, as the case may be:
  • Provided further that the approving Ethics Committee and the clinical trial site or the bioavailability and bioequivalence centre, as the case may be, shall be located within the same city or within a radius of 50 kms of the clinical trial site;
If the study is a academic clinical trial, ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, would apply.

ICMR 4.2.2 recommends that An institution that does not have its own EC (user institution) may utilize the services of the EC of another institution (host institution) preferably in the adjoining/nearby area.

In view of the above, using one central EC for non-interventional observational studies, would be non-compliance to NDCTR 2019 and ICMR Guideline.

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


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