Ethics Review Committee: review process
Principle investigators of protocols and interested parties can use this guide to demonstrate how ethics procedures work at WHO.
To whom do I submit my proposal?
All research proposals involving human participants need to be submitted by the WHO staff member to the ERC Secretariat, using an online submission portal, ProEthos.
Each proposal undergoes a preliminary screening by the Secretariat to confirm that all necessary documentation has been submitted – i.e. the study protocol, informed consent forms, study instruments, local ethics approval etc. Only when all required documentation has been duly submitted, will the Secretariat forward the study for review by the ERC. A study will only receive final approval from the ERC when all core documentation has been satisfactorily submitted, including local ethics approval.
After the initial screening, what next?
Only when all required documentation has been duly submitted, will the Secretariat forward the study for review by the ERC. A study will only receive final approval from the ERC when all core documentation has been satisfactorily submitted, including local ethics approval.
What types of review are there?
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 ERC members who present the proposal to the ERC followed by a general discussion and a consensus decision. WHO responsible officers 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 ERC members who are required to provide their feedback to the secretariat within 10 working days. As appropriate, the proposal is then either approved or returned to the technical officer for further action.
Exemption from ERC review
Proposals are exempt from ERC review when there is no possibility of harm arising as a result of the conduct of the research project or when the information being collected is available from the public domain.
In the event of a public health emergency, such as the investigation of a disease outbreak or a disaster relief operation, a protocol may be submitted for accelerated review.
Since ethics approvals are provided to studies for a limited time period, the ERC reviews the progress of the study at periodic intervals. In order to renew the approval, the WHO responsible officers should submit the necessary documentation to the ERC prior to approval expiry.
How is a proposal reviewed at an ERC meeting?
One of the two 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 to enable the primary reviewers to make their overall recommendations, which the rest of the ERC may or may not endorse.
In the event of the latter, a debate will take place until the ERC agrees in unison what the final recommendation should be.
What if the Committee cannot agree on a final recommendation?
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."
How is the outcome of the review communicated to the WHO responsible officer?
Whether a proposal has been submitted to a Full Committee or for an "expedited review", the outcome of the review will be communicated electronically to the Technical Unit. The Secretariat will provide an ERC Summary Review Form to the technical officer outlining the concerns, if any, raised by the ERC.
The ERC recommends that the responsible officer should not contact individual ERC 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.
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 rejected.
What do the ERC recommendations mean?
The ERC may give any one of the following recommendations on a proposal:
Approved as submitted
The proposal is approved and no modifications are required. In this case, the responsible officer should prepare the Technical Service Agreement (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.
Approved conditionally; requires amendments and/or clarifications
The proposal’s approval is contingent upon an adequate response by the Principal Investigator to the satisfaction of the reviewers or the Chair on behalf of the ERC.
If amendments are required, they should be included in the proposal and the amended proposal submitted to the ERC Secretariat. The proposal will either be scrutinized by the Secretariat or by the Primary Reviewers as decided by the ERC.
Not approved; requires additional information and/or rewriting
The proposal should be improved and the revised version of the proposal should be re-submitted by the WHO responsible officer as a new submission to the ERC for re-review by the Committee.
The proposal is ethically unacceptable and may not be approved by the ERC, or supported by WHO. The Principal Investigator may submit a new proposal that takes into consideration the ethical issues raised by the Committee.
What is the time frame for the review of proposals by the ERC?
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.
Once submitted for expedited review, the proposal is reviewed within 10 days. Consequently, a responsible officer can expect a response from the Secretariat within 2-3 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.