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Institutional Ethics Committee (IEC)

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Aims

The SCTIMST-IEC aims to protect the dignity, rights and well being of the potential research participants with emphasis on human rights. Its other objective includes ensuring that universal ethical values and international scientific standards are expressed in terms of local community values and customs. It also will assist in the development and education of a research community responsive to local health care requirements.

Address for Communication

All the proposals for Institutional Ethics Committee (IEC) is to be addressed to "The Chairman, IEC" and submitted to Ms. Sreepriya, Ethics Committee Coordinator, (e-mail iec@sctimst.ac.in Phone: 2524501).

For any technical clarifications please contact Dr. Srinivas G, Member Secretary, I E C, SCTIMST, & Scientist - G, Department of Biochemistry, SCTIMST, (email iec.mem.sec@sctimst.ac.in).

Submission of Proposals to Institutional Ethics Committee

Notice - Submission of Proposals to Institutional Ethics Committee (IEC), dated 03.09.2022

Submission Requirements

A covering letter addressed to the Chairman, IEC, summarizing the proposed work and the list of Documents Submitted (with reference numbers and dates)
IEC application form along with the proposal
Informed Consent forms including patient/participant information sheet
C V of all researchers (For practitioners of modern medicine, while submitting the CVs, please ensure that the Indian Medical Council/State Medical Council Registration Number is included). All submissions to IEC-SCTIMST should use prescribed format for the CV for all affiliated researchers. This format (word document) is available in the IEC Website. CV format (pdf) (doc)
Receipt of Processing Fee if any
Please avoid use of abbreviations in the title of the study
For all abbreviations used, please provide an accompanying document listing the expanded forms.
Ongoing Trials, adverse events if any to be reported, may be submitted in the Adverse Event Reporting Form available in the SCTIMST web site.
Please note that no extension studies will be reviewed by IEC without the data from the earlier studies. If the final report is not available, at least preliminary data need to be submitted.
Investigators may give an all inclusive covering letter if they are submitting materials to IEC in part.
For other requirements, see Checklist

Notes

The requirements for TCMC Registration by Medical Practitioners/ Researchers is a mandatory requirement for submission. 'For those who have applied for TCMC registration and have not yet obtained the same, proof of application or copy of provisional registration is sufficient.'

Adverse event reporting to IEC

Investigator should report all adverse events in clinical trial. (Including the one that happened in other centers if it is a multicentric study) to the Director SCTIMST and to the Institutional Ethics Committee immediately without delay. SAE form (pdf) (doc)

The investigator should give his/her own expert opinion on the adverse event occurred and justification for continuing the study". On the completion of each proposal the investigator should submit a report to the IEC. SAE form (pdf) (doc)