General Research Process
CONTACT:
Geanine Hopley
Research Administrator (Paeds Research Office)
Department of Paediatrics and Child Health
Faculty of Health Sciences
University of Cape Town
email: geanine.hopley@uct.ac.za
ICH Building, Red Cross War Memorial Children's Hospital
A.1 The researcher submits electronically to our office:
- Cover letter addressed to the Departmental Research Committee (Paeds DRC) chair; a synopsis (maximum 4 pages) FHS014, full research proposal FHS015; application for ministerial consent for research with minors (if the research will involve any contact with children). Include any supporting documentation (e.g. consent form, information sheet, data collection sheet etc.)
- If applicable, a copy of the budget should be included in the submission and, if applicable, a contract should also be submitted.
- An electronic copy of the signed Ethics application form FHS013 should be included in the submission (please see Section B of this document). Please note: If the research is for degree purposes then the supervisor should be listed as the PI on this form.
- The researcher should also please include in their cover letter 2 - 4 suggestions for reviewers (please note that the suggested reviewer cannot be someone involved in the study, and should also be an expert in the field with an appropriate qualification). While the researcher’s reviewer suggestions will be considered, the DRC Chair will allocate reviewers and may choose people other than those recommended by the researcher. Please note that anonymity between PI and reviewer should be maintained.
A.2 The research office will send the proposal for departmental review, in order to ensure that only well-designed and scientifically sound research is submitted for review to the Faculty Human Research Ethics Committee (HREC). There are 3 kinds of Departmental Review:
- Primary review: This is for a new protocol, first time being reviewed. Detailed scientific review of study design, sample size, analysi plan, participant safety and confidentiality, before submission to HREC for ethical approval.
- Sub study review: For a secondary analysis of existing data from a previously approved study, or an extension of an existing study. Normally a quicker review, unless the new study involves extra patient contacts or risks to partipants that were not approved in the original parent study. Each sub-study will be issued unique DRC and HREC numbers which are linked to the parent study.
- Reciprocal review: Existing protocol has already been reviewed and approved by external (national or international academic, or pharmaceutical) scientific and ethics committee; the local principal investigator must submit a “local PI synopsis” to explain how the approved protocol will be implemented in the local context. This is a rapid review, should focus mainly on local implementation, participant safety and confidentiality.
Please note that the MINIMUM amount of time allocated for departmental review is 2-3 weeks and that the departmental review process may well take longer to finalize. Researchers are therefore encouraged to submit their proposals for departmental review well in advance of their selected FHS HREC submission date. (Please see FHS HREC submission and meeting dates.).
A.3 Once the proposal is approved by the reviewer, the Ethics application form (FHS013) is signed by the Paeds DRC chair/deputy chair.
A.4. Research office will then secure Dept of Paediatrics and Child Health HOD signature on the FHS013 form before informing the researcher via email that the proposal has been approved. The DRC and HOD signed FHS013 form will be attached to allow the researcher to submit to HREC.
Note: DRC signature or HOD signature cannot be that of a study investigator.
A.5. Signed FHS013 is sent to HREC (see contact details below). Once approval is obtained, proof of approval and HREC reference number must be provided to the Research office before research can commence. Investigators cannot proceed with a research study until they have submitted a copy of UCT ethics approval letter to the Paeds DRC via the Research office.
A.6. If the research will take place in a health facility (ie contact with patients or folder review) then requires hospital administration approval or Western Cape Department of Health and Wellness approval. See section C below.
A.7. If external funding is involved, please see process to follow on the UCT Research Support Hub page or see one-page PDF titled “Pre-Awards Module – Internal Review Process” (which includes who to contact for assistance with any queries around the eRA application process). Note that all external funding applications must link with the departmental research finance team to assist with / review the budgeting process.
- Please note only electronic submissions will currently be accepted.
B. Submission to the Faculty of Health Sciences Human Research Ethics Committee (FHS HREC)
Please see here for FHS HREC submission process and forms
- The researcher should make certain that the Ethics application form (FHS013) has been signed by their HoD before submitting to the FHS HREC. Please note that the PI and HoD signature cannot be the same.
- Please refer to the following link for details of the FHS HREC Admin Team
Animal Research Ethics Committee
NB: Protocols should be submitted as early as possible BEFORE the submission date. This is essential to facilitate assessment by the reviewers prior to the meeting. Any delay/late submission will require the protocol to be held over to a later meeting date.
C. Application to hospital administration
Obtain approval from the relevant hospital administration and regional Department of Health (online). Apply to the COO/Superintendent for approval and if applicable, see Western Cape Health Research approval process.
Please click here for the Red Cross Children's Hospital Research Requirements.
Please see NB memo.
* Please note: Only after the approval from hospital management has been obtained can the research project or clinical trial be conducted at Red Cross War Memorial Children’s Hospital.
D. Obtaining Permission to access UCT Staff or Students as part of Research Activities
PLEASE NOTE: Researchers are reminded that permission to access UCT staff or students is required from the relevant authorities before commencing recruitment: further information is available here.