FACULTY OF HEALTH SCIENCES UNIVERSITY OF CAPE TOWN

FACULTY OF HEALTH SCIENCES UNIVERSITY OF CAPE TOWN Research Ethics Sidney Engelbrecht Manager: Research Ethics OMB, GSH cutting edge research world class training and education partnering for patient-centred health services

Overview • Overview of FHS Ethics Office • Submission processes for the Human Research Ethics Committee • Specific questions/issues University of Cape Town Faculty of Health Sciences

Ethics Office* Human Ethics Animal Ethics Biosafety Committee * Ethics Office reports to the Deputy Dean: Research University of Cape Town Faculty of Health Sciences

Ethics Office* Human Ethics Animal Ethics Biosafety Committee * Ethics Office reports to the Deputy Dean: Research University of Cape Town Faculty of Health Sciences

Office Staff & Contact details Lamees Emjedi (Human) lamees. emjedi@uct. ac. za Tel 021 406 6338 Shuretta Thomas (Human) shuretta. thomas@uct. ac. za Tel 021 406 6626 Sumayah Ariefdien (Human &Animal) Sumayah. ariefdien@uct. ac. za Tel 021 406 6492 University of Cape Town Faculty of Health Sciences

Office Staff & Contact details Admin Assistants Theresa (Terry) Rossouw (Human & Office Admin) terry. rossouw@uct. ac. za Tel 021 404 7682 Jakobet (Jako) Mfundisi (Human Admin Assistant) jako. mfundisi@uct. ac. za Tel 021 650 1236 University of Cape Town Faculty of Health Sciences

Office Staff & Contact details Sidney Engelbrecht (Ethics Compliance & Biosafety) sidney. engelbrecht@uct. ac. za Tel 021 650 5057 Location: E 53. 46 (E-floor) Old Main Building University of Cape Town Faculty of Health Sciences

Ethics Office Website http: //www. health. uct. ac. za/fhs/research/humanethics/adminteam University of Cape Town Faculty of Health Sciences

HREC EXCO http: //www. health. uct. ac. za/fhs/research/humanethics/about Backbone of the HREC! University of Cape Town Faculty of Health Sciences

Submission Processes related to the submitting applications to the: Human Research Ethics Committee University of Cape Town Faculty of Health Sciences

Submission process: HREC http: //www. health. uct. ac. za/fhs/research/humanethics/about University of Cape Town Faculty of Health Sciences

Submission process: HREC http: //www. health. uct. ac. za/fhs/research/humanethics/about University of Cape Town Faculty of Health Sciences

Submission process: HREC Forms http: //www. health. uct. ac. za/fhs/research/humanethics/forms University of Cape Town Faculty of Health Sciences

Submission process: HREC What is needed for a COMPLETE submission? • Help Documents: FHS 013 and FHS 015 – see website • DRC processes and signature • Cover letter • Most updated form (FHS 013) – see website • Submit 2 hard copies to Ethics Office University of Cape Town Faculty of Health Sciences

Submission process: HREC What is needed for a COMPLETE submission? • Signatures: PI, DRC, Ho. D and student • Supervisor = PI (Principal Investigator) • Addenda: - Consent form and Information booklet - Synopsis and Protocol - Questionnaire/Instrument/Datasheets University of Cape Town Faculty of Health Sciences

Submission process: HREC • Submission dates are on our website. • Please ensure annual approval (FHS 016) 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. University of Cape Town Faculty of Health Sciences

Submission process: HREC - dates University of Cape Town Faculty of Health Sciences

Specific questions Questions / FAQs related to the submitting applications to the: Human Research Ethics Committee University of Cape Town Faculty of Health Sciences

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 University of Cape Town Faculty of Health Sciences

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. University of Cape Town Faculty of Health Sciences

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. University of Cape Town Faculty of Health Sciences

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 researchive? • 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. • • University of Cape Town Faculty of Health Sciences

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. University of Cape Town Faculty of Health Sciences

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 (Do. H, 2015)? • Retrospective approval is not permitted (Do. H, 2015) • Please submit APR one month of expiry date. University of Cape Town Faculty of Health Sciences

Specific questions Renewal: • Ethics approval is for one year (Do. H, 2015) • Retrospective approval is not permitted (Do. H, 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 (FHS 013). University of Cape Town Faculty of Health Sciences

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 (FHS 006). • We require: track changes version and clean copy. • Auditing purposes. University of Cape Town Faculty of Health Sciences

Thank You Questions? University of Cape Town Faculty of Health Sciences

University of Cape Town Faculty of Health Sciences