Ethics

Obtaining Ethics Approval for your PhD Study


All health researchers should apply for ethical approval of a study before they may commence with research. A particular responsibility for oversight rests with the institution in the case of researchers in training, such as PhD candidates. Every FMHS PhD-candidate must apply for ethics clearance, whether by means of formal ethics approval or formal exemption, to the most suitable Research Ethics Committee (REC) within Stellenbosch University. To help make this process accessible and transparent up front, please see the Tygerberg Doctoral Office combined Ethics Application Guide for PhD students in the FMHS. A version more suitable for other SU postgraduate students is available here.

A student will be issued with a letter to facilitate their ethics application following successful completion of the proposal review process and submission of the review documents to the Tygerberg Doctoral Office. Our turnaround time is usually two workdays or less from receipt of the documents in good order. Most PhD projects can be assessed by one, particular REC, but some projects will straddle the domain of more than one REC. Stellenbosch University has five RECs, all functioning under the SU Senate Research Ethics Committee (SREC), as follows:

 

wooden blocks with icons for different ethics considerations

 

 

 

  1. Animal Care and Use (REC: ACU)
     
  2. Biological and Environmental Safety (REC: BES)
     
  3. Health Research Ethics Committee 1 (HREC1)
     
  4. Health Research Ethics Committee 2 (HREC2)
     
  5. Social, Behavioural and Education Research (REC: SBE)


A majority of doctoral research projects in the SU Faculty of Medicine and Health Sciences are considered by the respective RECs for Animal Care and Use, or Biological and Environmental Safety, or the respective Health Research Ethics Committees. Distinct rules and procedures apply to each of the RECs. Three months should be allowed for the ethics process of a doctoral study, from application to outcome. 

On receipt of the ethics approval letter bearing your name, this document should be submitted to the Tygerberg Doctoral Office at [email protected], right away. Ethics approval for an individual study, OR a letter adding a student as investigator to an existing, ethics-approved study, is acceptable. In case of the latter, we also request the original or most recent ethics approval of the larger study.

As soon as you have obtained ethical clearance, with no requirements for modifications remaining, your practical research may begin. Meanwhile, the Tygerberg Doctoral Office will submit your project to the Committee for Postgraduate Research on behalf of your academic environment. From there it is routed to the Faculty Board and Senate, for formal approval of your doctoral study. The relevant governance meetings are generally scheduled quarterly and the full process takes about three months.

Regardless of the details of a specific project or the stipulations of its ethics clearance, all research should adhere to the Policy for Responsible Research Conduct at Stellenbosch University. Also consult the Principles, Processes and Structures for Ethics in Health Research of the SA Department of Health.

 

Confirmation of the proposal review process

  • Before accepting a doctoral study for ethics review, the Health Research Ethics Committees (only) require a letter to confirm that the relevant faculty proposal review process was followed correctly, and the review completed successfully.

  • The Tygerberg Doctoral Office will provide confirmation that the Faculty of Medicine and Health Sciences proposal review procedures were followed in the case of all FMHS students. Turnaround is fast, but do submit your five review documents to [email protected] in good order, and in a single email, by three workdays prior to your ethics deadline. There is no need to request the letter - it will be issued automatically on receipt of your five review documents (and not before).

  • When applying for minor amendments with no title change implied, we rely on the domain-specific judgement and good ​faith of the supervisor and student. The same ​review confirmation letter provided previously may be uploaded in order to satisfy the HREC requirement for a document from our office. 

  • In the case of applications for major amendments, or amendments involving a title change, a revised set of review documents may​ be submitted to [email protected] as the basis for an updated review confirmation letter. For effective processing, the proposal should​ be edited using track changes.

  • Doctoral candidates from other faculties may obtain a formal letter from a suitable independent party in their own faculty - such as the HoD, but not the supervisor - to confirm the correct internal processes for scientific review were followed; in order to facilitate an ethics application to the HREC.​ Unfortunately, the Tygerberg Doctoral Office cannot assist in this regard.

 

Ethics Links & Documents

PhD Support

For clinicians

  • In the case of clinical trials, a separate ethics process governed by the Department of Health follows.
  • In addition, the trial may be registered on the South African National Clinical Trials Register (SANCTR), housed on the website of the Medical Research Council, at this link.

Equip Yourself for Ethics by Design

  • 👆 At this link, a number of core questions about health research ethics are answered. These resources were developed by Dr Debbie Marais.

  • 👆At this link, a number of useful videos on various aspects of health research ethics have been published by the FMHS Division for Research Development & Support and Internationalisation (RIDS). SU health professionals who watch these videos can also return to the same page to complete the relevant multiple choice quizzes in order to earn CPD points.

  • 👆 At this link, you can enrol for the SUNLearn Upskilling Learning Unit (ULU) on Responsible Conduct of Research. This course may soon become a prerequisite for ethics approval from an SU Research Ethics Committee.