Maramraj, Kiran Kumar
Subbalakshmi, G.
Ali, Mohammed Shahed
Dikid, Tanzin
Yadav, Rajesh
Sodha, Samir V.
Jain, Sudhir Kumar
Singh, Sujeet Kumar
Article History
Received: 20 June 2019
Accepted: 22 January 2020
First Online: 14 February 2020
Ethics approval and consent to participate
: The investigation was a public health response to an outbreak as part of the India Epidemic Intelligence Service Program, undertaken with the purpose to identify source of contamination for immediate control of outbreak and intended for benefit of the community at large. Ethical approval is not applicable as part of public health response. It did not involve any human laboratory sample collection for research purpose and there were no invasive investigations or medical interventions / experiments. Laboratory results of two stool samples which are mentioned in the manuscript pertain to the samples collected by the treating physician of government health-care facility for treatment purposes.All ethical principles and guidelines by government of India were adopted during the outbreak response. Investigation was aimed at achieving public good (beneficence) and collective welfare (solidarity), no harm done to any individual (non-maleficence), fair, honest and transparent (accountability and transparency) and participants’ data was de-identified prior to analysis (confidentiality).The outbreak response followed a two-stage process: Firstly, requisite approval was obtained from both national and state health authorities with involvement of key stakeholders from the community. Secondly, informed verbal consent was obtained from the participants after providing information about the purpose for answering the questionnaire of the outbreak investigation. As the community was mostly illiterate, participant information was provided in the presence of state health department officials, district health officer, tribal welfare officer and village / community head (<i>Sarpanch</i>). National Ethical Guidelines for Biomedical and Health Research involving Human Participants, Section 8, Indian Council of Medical Research Guidelines 2017 ExternalRef removed.
: Not applicable.
: The authors declare that they have no competing interests.