ERC Review Process
- To whom do I submit my proposal?
- After the initial screening, what next?
- What types of review are there?
- How is a proposal reviewed at an ERC meeting?
- What if the committee cannot agree on a final recommendation?
- How is the outcome of the review communicated to the WHO Responsible Officer?
- What do the ERC recommendations mean?
- What is the time frame for the review of proposals by the ERC?
All research proposals involving human participants need to be submitted through the ERC Secretariat, using an online form (DataCol). Each proposal undergoes a preliminary screening by the secretariat to confirm that all necessary documentation has been submitted. This includes checking that all documents ticked on the coversheet are attached i.e. the study protocol, informed consent forms, study instruments, local ethics approval etc (submitting a proposal to the ERC?). A study will still be forwarded for review if local ethical clearance has not been obtained once assurances are given by the unit that clearance by the local/national ERC is being processed. However, a study will only receive final approval from the ERC when all core documentation has been satisfactorily submitted, including local ethics approval.
Once the ERC is in possession of all the necessary documentation, these are pre-reviewed at the secretariat level. Ethical and scientific concerns are raised by the staff scientist, usually through the exchanges of emails concerning the protocol, the informed consent forms, the scientific peer review process and the study instruments. Once the secretariat receives a satisfactory response to all queries and comments, the study is triaged for review purposes.
Based on certain set of criteria, a proposal is submitted for one of the following types of review:
Full Committee Review of Proposals
All research proposals that present more than minimal risk to human subjects are reviewed by two primary reviewers who present the proposal to the Committee followed by a general discussion and a consensus decision. The WHO technical officers responsible for the proposal under review are invited to respond to queries raised and to provide clarifications and/or justifications.
Expedited Review of Proposals
A proposal is circulated for expedited review when the research procedures present no more than minimal harm to the research participants or communities. In this case, the proposal is sent to two reviewers who are required to provide their feedback to the secretariat within 5 working days. As appropriate, the proposal is then either approved or returned to the technical officer for further action.
Exempt from Review
Proposals are exempt from review if there is no possibility of harm arising as a result of the conduct of the research project or if the information being evaluated is already available in the public domain.
Fast track review
The ethics approval is provided to a proposal only for a limited time period, usually for a period of one year. In order to renew approval the WHO TO is required to request for a Continuing Review of the proposal.
One of the 2 primary reviewers makes a brief presentation of the proposal under review, highlighting the ethical and other issues raised by the study and the documentation provided for review. The second primary reviewer supplements the presentation by his/her own review. After the presentation by the primary reviewers, the discussion is opened to the rest of the ERC members, who may raise additional questions. The Secretariat invites the WHO Responsible Officer to attend the segment of the ERC meeting when discussions on his/her proposal are taking place. The responsible officer is given the opportunity to respond to all the queries and comments, and there is often a lively discussion on the proposal. When all the queries have been answered, the Responsible Officer will leave the meeting so as to enable the Primary Reviewers to make their overall recommendations, which the rest of the Committee may or may not endorse. In the event of the latter, a debate will take place until the Committee agrees in unison what the final recommendation should be.
According to the ERC Rules of Procedure:
"A Committee decision on a research proposal shall be made by consensus. Where consensus cannot be reached, consideration of the proposal shall be postponed to a subsequent meeting in order to seek additional information or expert advice if so decided by a majority of members present and voting, or the proposal shall be considered not approved."
Whether a proposal has been submitted to a Full Committee or for an Expedited Review, the outcome of the review will be communicated to the Technical Unit within one week. The secretariat will provide an ERC Summary Review Form to the technical officer outlining the concerns, if any, raised by the Committee at the meeting. The ERC may give any one of the following recommendations on a proposal:
- Approved conditionally, subject to amendments: means that the proposal is approved subject to the incorporation into the proposal of the required amendments, to the satisfaction of the responsible WHO staff member, and the ERC. The responsible WHO staff member shall provide the Secretariat with a copy of the amended proposal, which shall be considered Approved when the Committee finds that the changes made fulfil the Committee’s request.
- Approved conditionally, subject to clarification: means that the proposal is approved if the clarifications requested by the Committee are provided by the responsible WHO staff member in writing to the Secretariat, and the Committee finds that the clarifications are acceptable.
- Approved conditionally, subject to submission of further documentation: means that the proposal is approved subject to receipt of some specific documents such as approval by another ethics committee, submission of translated informed consent forms, etc.
- Decision deferred: means that the proposal is not approved as submitted either because there is insufficient information to make a decision or the proposal is not ethically sound. However the proposal can be re-submitted after revision to address the reasons for the deferment and this should be reviewed by the Committee as a whole.
- Not Approved: means that the proposal is ethically unacceptable and may not be resubmitted to the ERC.
The review Summary is sent electronically initially and is followed by the hard-copy only after the proposal is fully approved or if it is deferred.
If a proposal is approved as submitted, the TO should prepare the TSA (if the study is being funded by WHO). If WHO is not funding the study, the Review Summary is the document required in order to begin the study.
If the proposal is approved subject to amendments and/or clarifications being made in the proposal, the amended proposal or informed consent form should be submitted to the ERC Secretariat. If the ERC has asked for clarifications, these should be provided in writing to the secretariat but do not necessitate a change or an amendment to the proposal. The proposal is not usually re-submitted to the full Committee, but in most cases, will either be scrutinized by the Secretariat or by the primary reviewers as decided by the Committee.
When decision on a proposal is deferred by the Committee, this will be communicated to the Responsible Officer who will be expected to provide substantial amendments and inputs. When the resubmission is deemed satisfactory by the Secretariat, it will be tabled for a discussion by the full Committee. If a project is deemed to be deferred on its second submission, then it should not be submitted to the ERC again, and it is Not Approved.
If the proposal is not approved, then it cannot be re-submitted to the ERC, and cannot be supported by WHO.
The ERC recommends that the Responsible Officer should not contact individual Committee members present at a meeting when their proposal was discussed. Any questions or concerns that a Responsible Officer might have with regard to his/her proposal should be referred directly to the Secretariat. Responsible Officers of a study under review will be cautioned in the invitation to the meeting to this effect.
The initial screening is done on the first day of receipt of the proposal to ensure that all the documentation has been submitted. A more detailed technical screening at the Secretariat level is then carried out within 5 working days. If you do not receive any information or acknowledgement of the proposal, do not hesitate to contact the Secretariat.
Expedited review - Once submitted for expedited review, the proposal is reviewed within 10 days. Consequently, a Responsible Officer can expect a response from the Secretariat within two-three weeks of the initial submission.
Full Committee review - If a proposal is sent for regular review, it will be discussed at the next meeting to the date of receipt of a satisfactory submission. As a general rule ERC meetings take place on a monthly basis. The cut-off date for receiving a proposal for discussion at a particular meeting is listed on the ERC Meeting dates and deadlines for submission of protocols.
The length of time for approval, with both expedited and regular reviews, depends on the promptness of the response from the Responsible Officers and the Principal Investigators' to ERC concerns.
The ERC secretariat is currently creating a system whereby you will be able to track the progress of the project through the review process.