|Round||Submission Deadline Date||Full Committee Meeting Date|
All required documents for application should be emailed to email@example.com on or before the submission deadline. Serious adverse events (SEA), amendment requests, study reports and annual renewals must also be submitted to the email address mentioned above.
Please refer to the FPD REC Submission Guidelines for a full list of documents to be submitted for application:
Documents for application include:
The Complete research proposal. The proposal which is submitted for scientific or technical review must be the same as that submitted for ethics review. A statement of the ethics considerations involved in the proposed research must be included. The Committee must be satisfied that the research protocol gives adequate consideration to participants’ welfare, rights, beliefs, values, customs and cultural heritage. The process of obtaining informed consent and assessing understanding of the consent information should be included in the protocol.
Researchers’ names, current Curricula Vitae, affiliations, addresses and contact numbers
Detail of organisation(s) or institution(s) involved in the study and of any sponsors or funders
A summary, synopsis, or diagrammatic representation (flowchart) of the protocol.
Other pertinent information such a conflict of interests.
Participant recruitment procedures, education material (e.g. advertisements) and any other written information to be provided to participants.
Description of the process for obtaining informed consent together with the Information Leaflet.
Written Informed Consent Form or Assent Form (if applicable) in English and in the language of the potential participant as well as the written version of the Verbal Informed Consent Form (if applicable).
A list of site details, including the site address and names of the PI, sub-investigators, study coordinators and all other research team members.
Description and/or amounts of compensation including reimbursements, gifts or services to be provided to participants as well as a description of any financial costs to participants (if applicable).
Description of steps to be undertaken in case of adverse event or when injury or harm is experienced by the participants attributable to their participation in the study.
Statement agreeing to comply with ethical principles set out in the FPDREC SOP’s.
Disclosure of any previous ethics review action by other ethics review bodies (if applicable)
Research instruments such as questionnaires, interview guides, diary cards, computer-based surveys intended for research participants and similar documents
Letter(s) of permission from relevant bodies (if applicable)
A copy of the study budget (if applicable)
Detail of funder(s) of study
Please note that it is the researchers’ responsibility to determine which document are relevant to the specific study which seeks approval. If you are not sure, please contact the FPD REC Secretariat Livia van Wyngaardt for more information. Contact Us: