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Frequently Asked Questions

Registration and Suspension of Research Ethics Committees (RECs)

To register with the NHREC, RECs must follow the official registration process outlined by the Council. This includes submitting a formal application and meeting the specified criteria for registration and ongoing compliance.

A REC (HREC or AREC) of an organisation/institution, may apply for registration with NHREC, provided that:

  • The REC and institution comply with Section 73 of the National Health Act (Act 61 of 2003).
  • The REC adheres to the South African Ethics in Health Research Guidelines (NDoH 2024 or latest version).

 

For ARECs, compliance with SANS 10386:2021 (3rd ed.) is also required.

RECs must:

  • Demonstrate ongoing compliance with the Ethics in Health Research Guidelines.
  • Submit annual reports.
  • Address NHREC feedback and implement improvements as required.
  • Promptly inform NHREC of any changes to membership, Terms of Reference (ToR), or Standard Operating Procedures (SOPs), to name a few.

A complete and updated register of South African RECs is publicly available on the NHREC website.

ARECs must comply with both documents, as they complement each other.

  • SANS 10386:2021 applies to all scientific use of animals (i.e., any discipline or scientific application, for research, education, testing etc.).
  • NDoH 2024 applies to animal research specifically for human health purposes and governs all research approved by NHREC-registered ARECs.

Suspension may occur if:

  • A REC fails to comply with required guidelines.
  • Issues arise during annual reporting or 5-yearly audits.
  • There is failure to respond to required improvements or falsified reporting.
  • Ongoing non-compliance presents risk to participants or research animals.
Complaints and Queries

Download and complete the complaint form from the NHREC website and submit it electronically. Verbal or telephonic complaints are not accepted.

Yes. NHREC offers a query management system. The handling process may differ depending on the nature of the query.

The NHREC Secretariat communicates feedback to the complainant in a timely manner.

Conflict of Interest and Independence 

Members must disclose any real, potential, or perceived conflicts of interest immediately. A formal process, governed by NHREC’s Code of Conduct, manages such disclosures. Members may be recused from specific deliberations if necessary.

Independence of RECs means:

  • That the committees must be free to do their work as described in the South African Ethics in Health Research Guidelines and the governing statutory framework (NHA and regulations), without interference from others within the institution.
  • However, RECs must not regard themselves as functioning completely autonomously from their institutional governance systems. Autonomy of RECs applies with regards to the review of clearance applications.
  • Institutions should recognise that RECs necessarily have a dual governance model.
  • On the one hand, they are institutional committees and are expected to comply with the usual institutional committee reporting lines, whilst on the other hand, RECs are also a national research integrity instruments (in terms of the NHA) and must comply with the prescripts and reporting expectations, as outlined in the statute and associated regulations and national guidelines.

Conflicts between REC SOPs and institutional policies should be resolved internally. RECs have a dual accountability—both to their institution and to the NHREC—and must align their SOPs accordingly.

Ethical Clearance and Gatekeeping

Ethical clearance must be granted before research begins.

  • Retrospective clearance of research protocols is not permitted.  The REC’s mandate is protection of study participants. If the study has already been conducted, then the REC’s oversight of the study falls away.
  • In instances student receives retrospective clearance by his/her institution in order to graduate, this could pose serious legal and ethical consequences for the institution concerned.

Institutions should have gatekeeping policies in place. Where RECs are involved, there must be clear coordination to ensure requests are supported by valid ethics clearance.

Governance, Compliance and Oversight

All clinical/preclinical animal research related to health products must be registered with SAHPRA. ARECs must confirm that researchers provide proof of this registration.

In multi-institutional or international studies:

  • Each REC approving a study holds full oversight responsibility.
  • Where Research Animal Facilities (RAFs) are shared, a formal MoU/MoA must define responsibilities and access rights.
  • AREC must verify compliance with both the NDoH 2024 and the SANS 10386:2021.  Both regulatory documents respectively indicate topics for the theoretical ethics education, who should be trained and even minimum duration of training.
  • The requirements of the NDoH 2024 and the SANS 10386:2021 are complimentary and not contradictory.  Important is to consider that the SANS 10386:2021 distinguishes the theoretical ethical education, hands-on training in techniques, and achievement plus verification of competence of the researcher/student (i.e., when the absence of direct veterinary/para-veterinary oversight does not add risk to animal wellbeing).
  • The four-yearly independent external review required by the SANS 10386 is required by Council only in as far as the NDoH 2024 endorses the SANS 10386. Council does not have the capacity or mandate to monitor all requirements of the SANS 10386.  Therefore, it may be sufficient for the AREC for indicate in its annual report to the NHREC that the required review has been done, and during the full NHREC audit to make such documents available.
  • The report of the four-yearly independent external review includes a reflection on the functioning of the AREC and its relation to the institution at large, and this will be of interest to the NHREC. A copy of the report may therefore be a valuable supporting document of things the AREC reports on to Council.

SOPs, templates and forms should be regarded as living documents, to be reviewed, revised, and updated at regular intervals as well as be accessible online to its research community. REC members should ensure that they use the most recent versions of documents.

Yes. The report must be signed by the individual with overall responsibility for the institution’s research activities. This ensures institutional awareness and accountability.

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