ICMR-Central Ethics Committee on Human Research (CECHR)

Common Forms for Central Ethics Committee on Human Research (CECHR)

General instructions	Instruction to fill the word form

Index	Download
Initial Review
Annexures
1. Expedited Review
2. Exemption from Review
3. Continuing Review / Annual report format
4. Application/Notification form for Amendments
5. Protocol Violation/Deviation Reporting form (Reporting by case)
6. Serious Adverse Event Reporting Format (Biomedical Health Research)
7. Premature Termination/Suspension/ Discontinuation Report Format
8. Clinical Trials
9. Serious Adverse Event Reporting Format (Clinical trials)
10. Human Genetics Testing Research
11. Socio-Behavioural and Public Health Research
12. Study completion/Final report format
13 .Format for Curriculum Vitae for Investigators
14 .Format for Project extension

Background

* Multidisciplinary and multi-sectoral in composition, and functions as per ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017.
* Appointed by Director General, ICMR to work at the national level for development and updating of National Ethical Guidelines, to address emerging ethical aspects of Biomedical and Health Research, to guide ICMR Ethics Policy, review research of national importance with complex ethical issues being led by ICMR or referred to it by the government ministries and departments.
* ICMR Bioethics Unit, NCDIR, Bengaluru serves as the Secretariat for the CECHR.

PROCEDURES FOR EC REVIEW & RESPONSIBILITIES

Comments/Suggestion

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I. General feedback:

The content of the common EC forms captures all the necessary information required by ECs to review a protocol

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The common EC forms will be easy to use and implement for all types of basic medical and health research

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Have you used Common Ethics Forms as provided? Or have you modified the form as per your requirements.

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II. Provide Section wise detailed comments on Initial review form: If you have any comments or specific questions in any section of the Initial review form, please provide feedback with reference to the section and question number.

III. Provide comments on other forms (Annexure 1-13): If you have any comments or specific questions in any annexures, please provide feedback with reference to the annexure and question number.

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Common Forms for Central Ethics Committee on Human Research (CECHR)

General Instructions

Instruction to fill the word form

Background

PROCEDURES FOR EC REVIEW & RESPONSIBILITIES

Comments/Suggestion