Can an investigator delegate consent process to a designee during audio visual (AV) recording of consent?

ICH GCP 4.8.5 describes that the investigator, or a person designated by the investigator, should fully inform the subject, or his/her LAR of all pertinent aspects of the trial.

However, Indian GCP does not describe delegation of consent process to a designated person. Also Schedule Y Appendix V Informed Consent has provision for the signature of the investigator, but no provision for signature of a designated person.

As per the draft guidelines on AV recording of informed consent process in clinical trial, the investigator has the duty to communicate to the subjects/LAR/IW, all the information necessary for informed consent. The investigator has to record the consent of the subject for AV recording. At the beginning of the video recording process, the investigator will identify the protocol, the subject/LAR/IW and the language understood by the subject/LAR/IW. If the Investigator does not know the language of the subject/LAR/IW a member of the study team who understands the language, would become the interpreter. If the investigator does not know the language of the subject/LAR/IW a member of the study team who understands the language, would become the interpreter.

Hence, this guideline mandates that the investigator has to conduct the consent process during AV recording.

However, he/she can delegate the AV recording to another person.

What is the effective date for formula to determine quantum of compensation in cases of trial related serious adverse events of deaths occurring during trials

This formula is developed by the expert committee set up as per the Rule 122 DAB of 30 Jan 13. Hence, this will be applicable to all serious adverse events of deaths occurring during clinical trials after 30 Jan 13.

Is ethical approval is needed for research studies in public health studies?

The need for EC approval depends on the assessment of risk to participants. It is desirable to seek EC opinion on whether the study protocol requires approval or not. Please see ICMR 2006 guidance for EC review process categories based on risk assessment - excerpts:

Minimal risk would be defined as one which may be anticipated as harm or discomfort not greater than that encountered in routine daily life activities of general population or during the performance of routine physical or psychological examinations or tests.

The proposals which present less than minimal risk may be expected for review or may be subjected to expedited review. All research presenting with more than minimal risk, proposals/protocols which do not qualify for exempted or expedited review and projects that involve vulnerable population and special groups shall be subjected to full review by all the members.

How can we ensure proper documentation of eligibility criteria in source documents?

The regulatory inspectors expect that adherence to all individual inclusion and exclusion criteria should be documented in the source data. The inspectors also want documentation that the investigator has assessed each individual eligibility criteria from all sources – medical history, physical examination, investigations etc - and has taken the final decision to include the subject in the trial. A single statement that the subject satisfies all study entry criteria is not adequate.

What is the qualification of clinician to become a member of independent ethics committee? Can a paediatrician with MD degree become member (clinician) of independent EC?

As per 122DD, the clinician should have a post-graduate qualification. Hence, an MD pediatrician can serve as a clinician on the ethics committee.