Application procedures

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Hello Everybody,

I just missed out on conveying my New Year wishes in my very first post. Anyway, better late than never.

“Wish you all and your families a Very Happy, Healthy and Prosperous New Year 2010â€

Coming back to the discussion-

For a thorough and complete review, all research proposals should be submitted with the following documents :

1. Name of the applicant with designation

2. Name of the Institute/ Hospital / Field area where research will be conducted.

3. Approval of the Head of the Department / Institution

4. Protocol of the proposed research

5. Ethical issues in the study and plans to address these issues.

6. Proposal should be submitted with all relevant enclosures like proformae, case report forms, questionnaires, follow - up cards, etc.

7. Informed consent process, including patient information sheet and informed consent form in local language(s).

8. For any drug / device trial, all relevant pre-clinical animal data and clinical trial data from other centres within the country / countries, if available.

9. Curriculum vitae of all the investigators with relevant publications in last five years.

10. Any regulatory clearances required.

11. Source of funding and financial requirements for the project.

12. Other financial issues including those related to insurance

13. An agreement to report only Serious Adverse Events (SAE) to IEC.

14. Statement of conflicts of interest, if any.

15. Agreement to comply with the relevant national and applicable international guidelines.

16. A statement describing any compensation for study participation (including expenses and access to medical care) to be given to research participants; a description of the arrangements for indemnity, if applicable (in study-related injuries); a description of the arrangements for insurance coverage for research participants, if applicable; all significant previous decisions(e.g.those leading to a negative decision or modified protocol) by other ECs or regulatory authorities for the proposed study (whether in the same location or elsewhere) and an indication of the modification(s) to the protocol made on that account. The reasons for negative decisions should be provided.

17. Plans for publication of results – positive or negative- while maintaining the privacy and confidentiality of the study participants.

18. Any other information relevant to the study

All proposals should be submitted in the prescribed application form.

Required number of copies of the proposal along with the application and documents in prescribed format duly signed by the Principal Investigator and co-investigators / Collaborators should be forwarded by the Head of the Departments / Institution to the ethics committee.

The date of meeting should be intimated to the researcher, to be present, if necessary to offer clarifications.

Prescribed fee if any, should be remitted along with the application.

Dr. Smita

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