The application for IEC review can be submitted through an email. All the relevant documents (please refer to the section below) should be completed and submitted in pdf format and sent to the following email address: iec@tech4health.org.in
Following your email, you will receive an acknowledgement email from the Tech4Health Foundation’s IEC team with instructions on paying the relevant application fee.
| S.No | Documents |
|---|---|
| 1 | Cover letter to the Member Secretary |
| 2 | Application form for initial review |
| 3 | Proforma |
| 4 | Case report forms |
| 5 | Survey tools |
| 6 | Follow-up cards |
| 7 | Permission of using copyrighted proforma/ questionnaire |
| 8 | Complete protocol |
| 9 | CVs of all the investigators with relevant publications in the last five years |
| 10 | Informed consent document (ICD) in English as well as local language(s) (please refer to Annexure 3 of Tech4Health Foundation's SOP) |
| 11 | Case record form/questionnaire |
| 12 | In case of HIV testing/genetic screening, pre-test and post-test counselling forms |
| 13 | Recruitment procedures: advertisement, notices, if applicable |
| 14 | Patient instruction card, diary, etc., if applicable |
| 15 | Investigator’s brochure (as applicable for drug/biologicals/device trials) |
| 16 | Details of the funding agency or sponsor and allocation of funds, if applicable |
| 17 | A statement on CoI (Conflict of Interest), if there isn’t any conflict, it should state so in the CoI |
| 18 | GCP training certificate (preferably within the last five years) of investigators (in case of sponsored clinical trials) |
| 19 | Any other evidence relevant for research ethics, if applicable |
| 20 | List of all ongoing research studies under the PI supervision, if applicable |
| 21 | Undertaking with signatures of investigators |
| 22 | Regulatory permissions, as applicable |
| 23 | Relevant administrative approval(s) |
| 24 | MoU in cases of studies involving collaborations with other institutions, if applicable |
| 25 | Clinical trial agreement between the investigator and sponsors of the study, if applicable |
| 26 | Insurance policy, if applicable |
Sponsored projects:
Non-sponsored projects:
Please note that 18% GST is not included, and it should be paid over and above the mentioned IEC base fee. Furthermore, the applicant would be charged 25% more than the base IEC fee to fulfil an expedited review request.
The IEC meets on as needed-basis to review all the submitted applications. Following the meeting, the IEC approval letter is provided to the applicant within two-three weeks.