<\/p>\n
0. Introductory<\/strong><\/p>\n 1. Preparing Standard Operating Procedures (SOPs): Writing, Reviewing, Distributing and Amending SOPs<\/strong><\/p>\n 2. Constitution of Institutional Ethics Committee (IEC), Selection, Roles and Responsibilities of Members of the IEC<\/strong><\/p>\n 3. Handling Confidentiality and Conflict of interest among Ethics Committee Members<\/b><\/p>\n 4. Selection and Responsibilities of Independent Consultants<\/strong><\/p>\n 5. Procedures for allowing Guest\/Observer to visit Institutional Ethics Committee or attend IEC meeting<\/strong><\/p>\n 6. Management of Submission of Research Study Protocol and Study Related Documents<\/strong><\/p>\n 7. Categorization of Submitted Protocols for Ethics Review<\/strong><\/p>\n 7A. Initial Full-Board Review of Research Study Protocols<\/strong><\/p>\n 7B. Expedited Review of Research Study Protocols<\/strong><\/p>\n 7C. Exemption from Ethics Review of Research Study Protocols<\/strong><\/p>\n 8. Agenda Preparation, Meeting Procedures and Recording of Minutes<\/strong><\/p>\n 9. Review of Amended Protocol, Protocol-related Documents and Resubmitted protocol<\/strong><\/p>\n 10. Continuing Review of Study Protocols<\/strong><\/p>\n 11. Review of Protocol Deviations\/Violations\/Non-compliance<\/strong><\/p>\n 12. Review of Serious Adverse Events (SAE) Reports<\/strong><\/p>\n 13. Review of Study Completion Reports<\/strong><\/p>\n 14. Management of Premature Termination\/Suspension\/Discontinuation of the Study<\/strong><\/p>\n 15. Request for Waiver of Written Informed Consent and Waiver of Consent<\/strong><\/p>\n 16. Site Monitoring and Post-Monitoring Activities<\/strong><\/p>\n 17. Dealing with Participants\u2019 Requests and Complaints Coming to Ethics Committee<\/strong><\/p>\n 18. Maintenance of Active Study Files, Administrative Records of the Ethics Committee, Archival of Closed Files and Retrieval of Documents<\/strong><\/p>\n 19. Reviewing Proposals involving Vulnerable Populations<\/strong><\/p>\n 20. Preparing for Ethics Committee Audit\/Inspection<\/strong><\/p>\n 21. Training and Assessment of Ethics Committee Members<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":" Standard Operating Procedure (SOP) for Bio Medical and Health Research involving Human participants 0. Introductory 1. Preparing Standard Operating Procedures (SOPs): Writing, Reviewing, Distributing and Amending SOPs 2. Constitution of Institutional Ethics Committee (IEC), Selection, Roles and Responsibilities of Members of…<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"ngg_post_thumbnail":0,"footnotes":""},"class_list":["post-2003","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/nischennai.org\/main\/wp-json\/wp\/v2\/pages\/2003","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nischennai.org\/main\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/nischennai.org\/main\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/nischennai.org\/main\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/nischennai.org\/main\/wp-json\/wp\/v2\/comments?post=2003"}],"version-history":[{"count":2,"href":"https:\/\/nischennai.org\/main\/wp-json\/wp\/v2\/pages\/2003\/revisions"}],"predecessor-version":[{"id":2006,"href":"https:\/\/nischennai.org\/main\/wp-json\/wp\/v2\/pages\/2003\/revisions\/2006"}],"wp:attachment":[{"href":"https:\/\/nischennai.org\/main\/wp-json\/wp\/v2\/media?parent=2003"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}