How does the ethics committee review process work

New applications

New applications are for research that has not yet been carried out and is not an amendment to a previous application. The procedure for a new application is as follows:

Submitting

• An application is submitted via mail to ec.pp@ugent.be. The application includes the completed Specific Ethical Protocol (SEP), and all necessary documents as ticked in the SEP. All documents and attachments (e.g. DMP, ICF) are submitted as separate documents.
• A review cycle always starts on the 15th of each month. There is no review cycle in July: all applications submitted between 16 June and 15 August are processed in September.
  Before a file is forwarded to the reviewers, it is screened for completeness and admissibility. Applications that are incomplete on the 15th of the month will be postponed to the next cycle.
• The EC therefore encourages applicants to submit well before the start of the review cycle so that any deficiencies can still be remedied in time.
• Each file is assigned to a review panel of 3 reviewers and an editor.

Only complete dossiers are admissible. To avoid unnecessary delays in cases of uncertainty (about what the EC expects; about issues that might raise ethical concerns; about specific questions from the SEP), researchers are invited to contact ec.pp@ugent.be prior to submitting an ethics application

Review cycle

• The review panel represents the EC and provides feedback to the application autonomously. The reviewers' comments are compiled by the editor into a feedback report, which is then transmitted to the applicant.
• Feedback on an application normally follows around the 15th of the following month. The EC may approve the application, request additional information or suggest changes.
• Whenever it suits the applicant, the latter submits the revised application along with a rebuttal letter.
• The EC may approve the revised application, request additional information or suggest changes. In normal circumstances, this feedback follows one to two weeks after submission.
• The review cycle can be repeated if necessary.

The EC makes every effort to make the procedure as smooth as possible. The approval of a file can sometimes, depending on the difficulty of the reviewers' questions and comments, take longer than the predetermined month per review cycle. Also, if there are additional steps for complex ethical issues, the procedure will take longer. Keep this in mind when planning!

Approval

The applicant will receive an approval letter after the relevant editor has completed the last round of review and the final file incorporating all comments has been submitted to ec.pp@ugent.be.

Complex Ethical Issues

• For applications with complex ethical issues, the review panel may, after consultation between the panel members and the Chair, decide to submit the file to the full EC.
• The applicant will be informed if the submitted application includes a complex ethical issue that requires discussion in the full EC and further additional steps.
• The discussion by the full EC of complex ethical issues may reveal that additional steps are necessary to reach a decision. These additional steps may include:
  • Consulting experts.
  • A consultation between the EC and the applicant, at the suggestion of the EC or the applicant.
• When the EC does not reach a unanimous decision when discussing a complex ethical issue, a vote is taken. A project is approved if more than half of all voting members support the project. A vote resulting in disapproval is valid only if the number of absentees is less than the number of votes missing to approve the project. Voting via email is allowed provided all members have all relevant information.

Amendements

Amendments are applications for follow-up studies that are very similar to applications previously approved by the EC and do not contain ethically relevant changes (see GEP, section 3.4). The procedure for an amendment is as follows:

Submitting

• Amendments may always be submitted via email to ec.pp@ugent.be. Clearly state in the email that the submission concerns an amendment and briefly describe how it differs from the original application.
• Add all documents from the original application to the file and indicate all changes.
• Check that you are using the latest ICF templates.

Review cycle

• The review cycle for amendments is not periodic, but is completed as soon as possible.
• The secretary checks whether the application meets the definition of an amendment as in the GEP (i.e. closely related to a project that has already been approved and the proposed changes have no ethical implications). If not, the amendment is treated as a new application.
• For complex files, the secretary appeals to a review panel or to the full EC. The remainder of the procedure follows the same procedure as for new applications.

Approval

In the case of an evident file, the secretary may approve the amendment immediately. The applicant will receive an approval letter after the final files incorporating all comments has been transmitted to ec.pp@ugent.be.

Waivers

Waivers are applications for already completed research not previously submitted to the EC.

Submitting

• Applications for waivers may always be submitted via email to ec.pp@ugent.be. Please state clearly in the email that the submission concerns a waiver request.
• The application includes the completed Specific Ethical Protocol (SEP), and all necessary documents as ticked in the SEP. All documents and attachments (e.g. DMP, ICF) are submitted as separate documents.

Review cycle

The procedure for a waiver is identical to that for a new application except for one difference: because the study has already been conducted, there is only one review cycle. So there is no possibility of revision.

Approval

If the research meets the prescribed rules of the General Ethics Protocol, the EC will confirm this via a waiver (this is not the same as an approval).