Guidance to Principle Investigators for submissions of documents
Submission of new research proposals
Protocols of research projects that involve human participants are submitted to ERC for ethical review by the Technical Officer (TO) in WHO in charge of the project. The TO works closely with the Principal Investigator (PI) in order to facilitate the ethics review. This site provides guidance for both the TO and PI on requirements for submission to the WHO ERC.
In cases where proposals are developed by PIs and submitted to WHO for funding, the PIs submit the research protocol, study instruments, informed consent forms and other associated documents to the WHO TO, who then submits all these documents to the WHO ERC for review.
The ERC requires that submission be made using an online form (DataCol). Each of the indicated document should be attached separately at the place indicated in the datacol form, either as a word document or a pdf doc. A new datacol form should be used for each submission. The form can be saved, either for completing at a later stage, or for future reference.
- Covering memo (to be prepared by TO)
- Research Protocol (this must be the version approved by the peer review group and include the changes recommended by the peer-reviewers either in track change or in highlighted mode). View recommended format for writing a research protocol
- Informed Consent form in English (It is preferable to submit the local language informed consent form after the English version has been approved by the ERC. Therefore, only the English version is initially required for review by the ERC. However, the local language consent documents should be provided before a final approval by the ERC. The ERC will not give final approval without these documents being on file). See templates for informed consent forms
- Associated study instruments (e.g. questionnaires, focus group discussion guides, in-depth interview guides). These should eventually be developed in the local language. The same considerations apply as for the informed consent forms.
- Data Collection Forms, Case Report Forms, Patient diaries, etc.
- Patient recruitment materials
- Final Approval by the scientific/technical review committee, or peer reviewers
- PI's Response to the peer review - point-by-point. In the reply, the PI should indicate which changes have or have not been made and where in the revised protocol these can be found.
- Comments made by the scientific peer review group
- A letter from the local/national ethics committee acknowledging receipt of submission for review OR an approval from them. (Scanned and sent electronically)