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Approval of the Institute Review Board, Ethics Committee and Registering with the Clinical Trial Registry

  • Zile Singh
  • P. Stalin
Chapter

Abstract

  • Submission of research protocol with necessary documents to the Institutional Ethics Committee (IEC) for approval.

  • Proposals with more than minimal risk where invasive and/or non-invasive procedures are carried out should be submitted for full ethics Committee Review.

  • Patient information sheet and written informed consent forms should be submitted in both English and local language for ethics committee review.

  • Registration of clinical trials at Clinical Trial Registry of India.

  • World Health Organization has developed International Clinical Trial Registry Platform (ICTRP), which is a network of Primary Clinical Trial Registers.

References

  1. 1.
    Ethical guidelines for biomedical and health research involving human participants. New Delhi: Indian Council of Medical Research; 2017.Google Scholar
  2. 2.
    Guidelines for preparing Standard Operating Procedures (SOP) for Institutional Ethics Committee for Human Research. Indian Council of Medical Research. http://icmr.nic.in/ethics_SOP.pdf. Accessed on 21st June 2017.
  3. 3.
    Recommended format for a Research Protocol. Research Policy. World Health Organization. http://www.who.int/rpc/research_ethics/format_rp/en/. Accessed on 30 June 2017.
  4. 4.
    Implementation research toolkit. Workbook on special Programme for research and training in tropical diseases. Geneva: World Health Organization; 2014.Google Scholar
  5. 5.
    Frequently Asked Questions. Clinical Trials Registry of India. National Institute of Medical Statistics. Indian Council of Medical Research. http://ctri.nic.in/Clinicaltrials/faq.php. Accessed on 10 July 2017.
  6. 6.
    Primary Registries. International Clinical Trials Registry Platform (ICTRP). World Health Organization. http://www.who.int/ictrp/network/primary/en/. Accessed on 17 October 2017.

Copyright information

© Springer Nature Singapore Pte Ltd. 2018

Authors and Affiliations

  • Zile Singh
    • 1
  • P. Stalin
    • 1
  1. 1.Department of Community MedicinePondicherry Institute of Medical SciencesPondicherryIndia

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