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Can an investigator enrol her own child in a paediatric clinical trial?
Dr Shivani Kulkarni
There is no regulatory prohibition against an investigator’s family member participating in a trial, if they meet the inclusion/exclusion criteria outlined in the study protocol. However, both the sponsor and the Ethics Committee (EC) have some responsibility over the recruitment of subjects so /both can impose restrictions on whether an Investigator’s family member can participate in a trial. The sponsor may include restrictions in the study protocol; and the EC may establish written policies in this area.
Enrolment of a family member raises the issue of conflict of interest, and potential coercion or undue influence. The EC should review a) whether the family member's participation in the study truly voluntary? b) Does the investigator’s family member feel pressured to enrol when he/she otherwise would not ordinarily have taken part in a trial?
Do regulatory authorities accept alternative methods of obtaining informed consent to traditional face-to-face interview based informed consent? Dr Radha Tiwari
Recent FDA guidance on informed consent describes situations/process where alternative methods of obtaining informed consent would be acceptable.
In the context of paper consent forms, there may be certain circumstances when an alternative to a face-to-face consent discussion may be appropriate. For example, such an alternative may be appropriate when the subject or the subject’s LAR is unable to visit the investigational site to sign the consent form, or if the screening procedures for the clinical investigation require prior activity, such as fasting, that requires consent but does not require a visit to the investigational site.
Methods other than a face-to-face consent discussion may be acceptable if those methods allow for an adequate exchange of information and documentation, and a method to ensure that the signer of the consent form is the person who plans to enrol as a participant in the clinical trial or is the LAR of the participant. For example, the consent form may be sent to the participant or the participant’s LAR by e-mail, and the consent discussion may then be conducted by telephone/videoconference when the participant or participant’s LAR can access the consent form during the discussion. After the consent discussion, the participant or participant’s LAR can manually or electronically sign and date the consent form and return the document to the clinical investigator through a secure electronic method, such as by scanning the consent form and returning it through a secure e-mail account, or by posting it to a secure internet address. Alternatively, the participant may bring the signed and dated consent form to their next visit to the clinical site or mail it to the clinical investigator. In situations in which the signed document cannot be retrieved for filing in the study records (e.g., because the participant is in strict isolation due to a highly transmissible infectious disease), and electronic consent is not available, it is acceptable to retain for the study records a photographic image of the signed consent form along with an attestation by the person entering the photograph into the study records that states how the photograph was obtained and that it is a photograph of the informed consent form signed by the participant.
If a site accepts transfer of a clinical trial participant from another site, will the site and PI be held responsible for these errors and deviations e.g., a consent error, randomization error, dosing error, that might have occurred at the transferring?
Chetan Anekar
The regulatory authorities - FDA may identify such deviations identified during inspection. However, if these are based on the participants participation prior to their transfer, they would not be the responsibility of the new clinical investigator/site. The new site/clinical investigator will only be held responsible for the participant after they are transferred to the new site.
Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com
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