Ethics and health

Guidance for submissions of documents

This is for Technical Officers and Principle Investigators

Submission of new research proposals

Protocols of research projects that involve human participants are submitted to ERC for ethical review by the Responsible Officer in WHO in charge of the project. The Responsible Officer works closely with the Principal Investigator (PI) in order to facilitate the ethics review. This site provides guidance for both the Responsible Officer O and PI on requirements for submission to the 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 Responsible Officer, who then submits all these documents to the ERC for review.

The ERC requires that submission be made using an online submission process, ProEthos, which has been developed in collaboration with the Pan American Health Organization and the Pontifícia Universidade Católica do Paraná.

Submission of response to the ERC review

  • In a cover memo, please address your response to each of the queries in sections 1 and 2 of the ERC 'review summary' POINT BY POINT.
  • Submit a revised amended protocol incorporating all the requested amendments. All changes should be marked either in bold or highlighted or they should be in track changes.
Upon approval from the ERC
  • Please submit a final protocol without track changes or highlighting. If the requested changes are only to the informed consent documents or the study instruments, then only these may be re-submitted.

Submission of proposals for 'continuing review'

ERC approval is provided to a project only for a limited time period, usually for a period of one year. In order to renew approval the WHO TO is required to submit the following documents:

  • A memo to the ERC for a renewal
  • A coversheet for 'continuing review' completed by the WHO Technical Officer
  • 'Continuing review' form to be completed by the P.I.
  • 'Progress report' of the project for the past recruiting period, highlighting the activities of the project and any deviation from the approved activities including any change to the proposal or to the informed consent documents.
  • An approval from the technical unit or the peer review group. (Some departments submit the progress report of the project to the peer reviewers or a technical group or the Steering Committee for their approval before releasing funds for another year. ERC recommends this as a best practice and encourages technical teams to adopt this process.)
  • Report from a DSMB/ DSMC, if it was established for the monitoring of the study.
  • Copies of any amended or modified documents or new documents.

Requesting an 'amendment to an approved protocol'

To request amendments to an approved protocol, the WHO TO is required to submit the following documents:

  • A memo to the ERC requesting for an amendment(s), explaining why the amendment is required.
  • A copy of the protocol (with the date or the version number on the title) with the amendment(s), the amendment(s) being in track change mode or highlighted.
  • Where significant changes have been made in the study design, the amendment should be accompanied by proof that the amendment has been approved by the original peer review group.

Please give the protocol ID of the proposal in the subject line of the e-mail. This is provided in the ERC 'review summary' that you receive at the end of a review.

Project closure

Upon completion/closure or upon cancellation of a project, the PI should submit the following documents to the ERC:

  • A final report of the project, including a summary of study results, and an outline of the dissemination of these results.
  • Project closure form
  • Progress report since last approval
  • The monitor's report, DSMB report (where applicable)

Please note: once a 'project closure form' has been completed, no more data may be collected from any of the subjects in the study. Even if new enrollment of subjects has ended, projects must remain open if the follow-up of subjects will continue.