Ethics approval and consent to participate
DELHI, EYE
The Ethics Committees of L V PRASAD Eye Institute, Hyderabad, India (LEC 02–16–008) and London School of Hygiene and Tropical Medicine (LSHTM Ethics Ref: 10482) have approved the trial protocol. We have obtained the necessary approvals from the Indian Council of Medical Research, New Delhi and the Government of Madhya Pradesh to conduct this trial in Satna district. The trial complies with the Declaration of Helsinki, local laws, and the International Conference on Harmonisation Good Clinical Practice (ICH-GCP). Any protocol modifications will be communicated to both the Ethics Committees, and consent will be re-obtained at the village and individual (woman or caregiver) level at that point if deemed necessary.For this trial, we received approval from the Indian Medical Council of Research (ICMR), New Delhi, India. At the state level, approval of the protocol was obtained from the Department of Health & Family Welfare of the government of Madhya Pradesh.This trial employs multiple tiers of consent: village, individual, and individual on behalf of the child. Agreement to approach eligible villages was first obtained from the Once the trial was accepted at the village meeting, the villages were considered eligible for baseline enumeration. During the process of baseline interview, each head of household, each potentially eligible woman and one parent or caregiver of each potentially eligible child was informed in the local language (Hindi) about the trial and their participation and asked for a signature or thumbprint to indicate their consent to join the trial. Only people who agreed to participate were enumerated. Women and caregivers of enumerated children have the right to withdraw consent at any time during the trial. This process of consent is compatible with current standards for cluster randomised trials [