Documents Required for IHEC Application Download Application Form
Applicants may include all required documents relevant to their study
- Duly filled in application for review by the IHEC (all sections must be complete)
- Declaration form with Signature
Project Timeline/ Gantt Chart showing week-wise activities for the whole study period - Copy of Letter granting funds / Studentship / Scholarship / Fellowship (if applicable)
- Permission letter from the head of the institution from where data is to be collected
- Informed Consent Form in English with due signatures and date. (If study participants are minors, Parental Consent form will be required)
- Informed Consent Form translated into the relevant language(s)
- Patient Information Sheet in English, if applicable
- Patient Information Sheet translated into the relevant language(s), if applicable
- Confidentiality Statement
- Data collection Questionnaire/ Tool in English in English [Enclose sample copy]
- Data collection Questionnaire/ Tool in local language of the respondents [Enclose sample copy]
- Current CV of the Principal Investigator and / or Supervisor
- All relevant pre-clinical animal data
- Compensation for study participation
- Relevant documents for special criteria samples (see page 2)
- Any other information relevant to the study (Provide list)
Additional Documents Required for Special Criteria Study Applications involving studies that involve the following special criteria of study group must include the relevant documents as indicated below:
S.No. |
Special Criteria in Proposal | Additional Documents to be Submitted |
1. | Involves study participants from institutions like schools, orphanages, special needs institutions etc. | Approval letter from the head of the institution |
2. | Involves tribal people (including tribal children) | Approval letter from tribal chief [If study is from a different geographic location other than Coimbatore, a letter from the District Collector should also be enclosed] |
3. | To be executed in a geographic location other than Coimbatore and its suburbs | Approval letter from the IHEC in the area of study execution |
4. | Involves a study group, who do not comprehend English | A translation of the ICF in the local language of the area where the study is being conducted |
5. | Involves any kind of supplementation | Evidence for online registration with CTRI |
6. | Involves any kind of biological sample collection | Acceptance letter from a qualified medical doctor, familiar with the area of research, to act as a member in the study panel (Please ensure that the Registration Number of the medical practitioner is present in the seal or the letter head) |
7. | Any kind of special group as study sample ( e.g. infants,toddlers, very young children, transgenders, mentally compromised individuals (from mild to severe), autistic children, differently- abled individuals, individuals with signs of depression, participants afflicted with sensitive conditions like HIV infection, etc., terminally ill patients, unstable patients, individuals who have suffered second or third degree burns, individuals with multiple medical conditions, etc.) | Acceptance letter from a qualified medical doctor, familiar with the area of research, to act as a member in the study panel (Please ensure that the Registration Number of the medical practitioner is present in the seal or the letter head) |