| 1. Improving the manuscript | Change title to better reflect the scope of the review. Ensure better acknowledgement of the rich bioethics literature and lack of grey literature in the review. Incorporate a reflexive section on the authors. Emphasise the value of qualitative research in addressing key research gaps.
| Reflexive note in online supplemental file 5; others incorporated in manuscript. |
| 2. Additional analysis and missed literature | Consider impact of the 2013 regulatory changes. Consider impact of studies’ funder/sponsor on the research landscape. Examine four missed articles for inclusion.
| Additional analysis undertaken (data extracted for year of data collection and funder). One article met inclusion criteria and was included; others, where relevant, have been mentioned in methods/discussion.
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| 3. Research gaps | There is insufficient empirical information on:Informed consent/assent processes for children in clinical trials/research. Models of informed consent to suit multiple contexts. Issues of equity and social justice in relation to clinical trials. Doctor-recruiter dual role and the arising conflicts of interest. Regulatory processes. Academic trials conducted in medical institutions and vaccine trials. Therapeutic misconception. Questionnaire validation processes.
| These gaps have either been highlighted separately within the review or incorporated within existing gaps. |
| 4. Reasons for paucity of research | Lack of funding initiatives to carry out nested studies within clinical trials and related methodological work is a major obstacle for researchers in India. Not all ethical issues are ‘researchable’ and are sometimes better captured through bioethics literature.
| Incorporated in discussion. |
| 5. Concerns | Most concerns expressed were in relation to ethics committees:Lack of awareness of principles underpinning clinical research and good clinical practice guidelines among committee members. Non-trial study designs encouraged by committees to avoid institutional liability for serious adverse events in clinical trials. Excessive workloads and undeclared roles and conflicts of interests among members.
| Noted here as this is a reflection of the large proportion of studies on ethics committees. |