1. Sidney Engelbrecht Manager: Research Ethics OMB, GSH

2. Overview Overview of FHS Ethics Office Submission processes for the
Human Research Ethics Committee
Specific questions/issues

3. Ethics Office Ethics Office* Human Ethics Animal Ethics
Biosafety Committee
* Ethics Office reports to the Deputy Dean: Research

4. Ethics Office Ethics Office* Human Ethics Animal Ethics
Biosafety Committee
* Ethics Office reports to the Deputy Dean: Research

5. Office Staff & Contact details
Lamees Emjedi (Human) Tel Shuretta Thomas (Human) Tel Sumayah Ariefdien (Human &Animal) Tel

6. Office Staff & Contact details
Admin Assistants Theresa (Terry) Rossouw (Human & Office Admin) terry. Tel Jakobet (Jako) Mfundisi (Human Admin Assistant) jako. Tel

7. Office Staff & Contact details
Sidney Engelbrecht (Ethics Compliance & Biosafety) Tel Location: E53.46 (E-floor) Old Main Building

8. Ethics Office Website

9. HREC EXCO Backbone of the HREC!
Backbone of the HREC!

10. Submission Processes related to the submitting applications to the:
Human Research Ethics Committee

11. Submission process: HREC

12. Submission process: HREC

13. Submission process: HREC Forms

14. Submission process: HREC
What is needed for a COMPLETE submission?
Help Documents: FHS013 and FHS015 – see website
DRC processes and signature
Cover letter
Most updated form (FHS013) – see website
Submit 2 hard copies to Ethics Office

15. Submission process: HREC
What is needed for a COMPLETE submission?
Signatures: PI, DRC, HoD and student
Supervisor = PI (Principal Investigator)
Addenda:
- Consent form and Information booklet
- Synopsis and Protocol
- Questionnaire/Instrument/Datasheets

16. Submission process: HREC
Submission dates are on our website.
Please ensure annual approval (FHS016) is up to date each year until the research is completed.
Any amendments to the protocol must be submitted for approval.
Research CANNOT take place without formal ethics approval letters.

17. Submission process: HREC - dates

18. Specific questions
Questions / FAQs related to the submitting applications to the:
Human Research Ethics Committee

19. Specific questions Timeline:
Expedited vs Full committee – Postgraduate students
Normally 4-6 weeks, but could be quicker contingent on a number of factors
Factors delaying process:
Expertise required (internal or external)
Good quality
Incompleteness
TIP: Help/Guidance document

20. Specific questions Expedited vs Full Committee review:
Studies by postgraduate students = expedited
Risk: minor, moderate and high
SOP: Criteria for Expedited Review
Selection of reviewers:
Expertise required
Could be an internal or external reviewer
Normally 2 reviewers assigned expect for expedited reviews = 1 reviewer
NB: identity of reviewers are ALWAYS kept confidential unless revealed at their request.

21. Specific questions Number of people reviewing an application:
Admin Office for completeness
EXCO for reviewer allocation
Reviewers
Criteria for awarding ethics approval
Pointers for reviewers – highlight the following:
Could be an internal or external reviewer
Normally 2 reviewers assigned expect for expedited reviews = 1 reviewer
NB: identity of reviewers are ALWAYS kept confidential unless revealed at their request.

22. Specific questions Histology slide as a control
Was ethics approval obtained?
How were they collected
Was consent obtained that included future use
Has the archive been converted into a research archive?
Is it adequately de-identified?
Using a histology slide to illustrate a talk on histology would be OK, but to use for research purposes is complicated.

23. Specific questions Histology slide as a control
‘Repository’ means a collection, storage and distribution system for human biological materials for research purposes including blood, urine, faeces, bone marrow, cell aspirates, diagnostic specimens, pathology specimens and so on. Usually demographic and medical information about the donors is included in the repository as are codes that link the material to the donors.

24. Specific questions Advertisement Ethics approval is required?
2 situations:
(1) submit advert with initial submission; or
(2) after approval is obtained.
NB: Ethics approval is required BEFORE advert is placed.
Renewal:
Ethics approval is for one year (DoH, 2015)?
Retrospective approval is not permitted (DoH, 2015)
Please submit APR one month of expiry date.

25. Specific questions Renewal:
Ethics approval is for one year (DoH, 2015)
Retrospective approval is not permitted (DoH, 2015)
Please submit APR one month of expiry date and while study is active.
Non-compliance – use deviation form.
Non-registered student?
Ethics approval is linked to UCT staff and student.
Student has to be registered at UCT.
Submission in name of supervisor as PI. Student name is listed on the application form (FHS013).

26. Specific questions Conflicting reviews:
HREC review process is thorough and robust
Comments to applicants and PIs are screened
Reviewer comments are evaluated and assessed by the HREC EXCO before circulation/sign-off.
Amendments:
Amendments are requested by PI (FHS006).
We require: track changes version and clean copy.
Auditing purposes.

27. Thank You
Questions?