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Research procedures

General MMED |  MPhil |  PhD

All research undertaken is done under the auspices of the Department of Paediatrics and Child Health and before a protocol can be submitted to the UCT Ethics Committee for ethics approval, it first needs to go through the Department of Paediatrics and Child Health Research Committee for scientific review approval.  Please click on the links above for more info ......


General Research Process

All research undertaken is done under the auspices of the Department of Paediatrics and Child Health and before a protocol can be submitted to the UCT Ethics Committee for ethics approval, it first needs to go through the Department of Paediatrics and Child Health Research Committee for scientific review approval.


CONTACT:
Geanine Hopley
Research Administration
Department of Paediatrics and Child Health
Faculty of Health Sciences
University of Cape Town
email: geanine.hopley@uct.ac.za 
ph: 021 - 686 0086
fax: 021 - 689 1287
Room 3.16, 3rd Floor, ICH Building, Red Cross War Memorial Children's Hospital


1.  The researcher submits to our office: 

  • 1 hard copy of the covering letter addressed to the departmental research committee (Paeds DRC) chair, Prof. Kirsty Donald; a synopsis and research proposal, as well as any supporting documentation (e.g. consent form, information sheet, data collection sheet etc.)

  • 1 electronic copy of the above documentation.
  • If applicable, a hard copy and electronic copy of the budget should be included in the submission and, if  applicable, a contract should also be submitted.

  • A hard copy of the signed Ethics application form 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.

  • If funding is involved, please see process to follow on the UCT Research Support Hub page    http://www.researchsupport.uct.ac.za/rsh/era/internal-approvals-how-to or see attached notice (which includes who to contact for further assistance / additional support). Finally, please note that all external funding applications must link with the departmental research finance team to assist with / review the budgeting process.

  • The researcher should also please include in their submission 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 we will consider the researcher’s reviewer suggestions, the DRC Chair allocates reviewers and may choose other people than those recommended by the PI. Please note that anonymity between PI and reviewer should be maintained.

2.  Our office will then send the proposal for departmental review. 

    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.
).

 
3.  Once the proposal is approved by the reviewer, the Ethics application form is given to the Paeds DRC chair/deputy chair to sign
     off.
 
4.  Our office will then contact the researcher to advise that the proposal has received Paeds DRC approval and that they may now
     collect the Paeds DRC signed form from our office and submit to the FHS HREC for ethics review and approval.

NB:

  • INVESTIGATORS CANNOT PROCEED WITH A RESEARCH STUDY UNTIL THEY HAVE SUBMITTED A COPY OF THE UCT ETHICS APPROVAL LETTER TO THE PAEDS DRC VIA THE PAEDS RESEARCH OFFICE.

  • If external funding is involved, please see process to follow on the UCT Research Support Hub page http://www.researchsupport.uct.ac.za/rsh/era/internal-approvals-how-to or see attached notice (which includes who to contact for assistance with any queries around the eRA application process). Finally, please 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.


2.  Submission to the Faculty of Health Sciences Human Research Ethics Committee (FHS HREC)

Please submit the completed FHS013 form together with the supporting documents by hand delivery or registered mail to – 

FHS Human Research Ethics Admin Office 
c/o the secretary – HREC Office Address: 
Human Research Ethics Committee
E 53, Room 46, Old Main Building, Groote Schuur Hospital, Observatory
Office Contacts:
021 406 6492; 021 404 7682; 021 406 6626

Electronic copy of your submission to be emailed to: hrec-enquiries@uct.ac.za

Researchers must ensure that they check the Administrative Forms web page to make certain that they are using the current version of the forms:  http://www.health.uct.ac.za/fhs/research/humanethics/forms

      2.1  The researcher should make certain that the Ethics application form has been signed by their HoD before submitting to the
             FHS HREC. Please note that the PI and HoD signature cannot be the same.

      2.2  Please refer to the following link for current version of forms checklist: 
             http://www.health.uct.ac.za/fhs/research/humanethics/forms


3.  Submission to Hospital (RXH)

  • The applicant should email the office of the Hospital Research Review Committee Chair, Dr Tamara Kerbelker, at G2 Management Suite via her assistant, Ellen Thomas (ellen.thomas@westerncape.gov.za OR 021-658 5383) advising that they would like to request hospital approval from RXH to undertake research.

  • Dr Kerbelker’s office will send the researcher a Research Requirements Form for completion which will need to be returned to that office.

  • 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.

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