University of the Free State UFS Ethics Committee

RIMS

IMPORTANT NOTICE: All applications (except Contract Research) will henceforth only be accepted via the online application platform, RIMS.

Scope of practice

The Health Sciences Research Ethics Committee (HSREC) is responsible for managing and facilitating the ethical and governance review processes for all health research. This involves coordinating scientific and ethical review of research. In addition, the HSREC is responsible for compliance governance, including research monitoring, the provision of researcher support and advice, and risk management.

All health research, as defined by the National Health Act, must be reviewed and approved by a research ethics committee registered with the National Health Research Ethics Council (NHREC). Thus, all health-related research requires the approval of the HSREC BEFORE the research study commences.

The HSREC:

• Reviews research studies to ensure that investigators and other parties involved follow appropriate ethical guidelines as stipulated in the Constitution of the HSREC;
• Ensures that research participants are protected against unethical behaviour by investigators during any kind of research; and
• Performs other functions as stipulated in the Constitution.

Target Group

The scope of practice of the HSREC is applicable to:

1. Members of the Faculty of Health Sciences:

Any research to be conducted by members of the Faculty of Health Sciences must be submitted to the HSREC for review and approval.

• Research conducted abroad by members of the Faculty of Health Sciences must be submitted to the relevant Ethics Committee for approval as stipulated. This letter of approval should be forwarded to the HSREC, which will take note of the approval.
• Should the researcher prefer to submit the application to the HSREC of this university, such protocol will be dealt with according to the Standard Operating Procedures.

2. Students (under- and postgraduate) of the Faculty of Health Sciences.

3. Any other member of a faculty or department at the University of the Free State.

4. Any other person or institution seeking ethical approval for research studies, including:

• Private organisations/individuals;
• Pharmaceutical companies;
• Governmental departments;
• NGOs (non-governmental organisations);
• Other higher-education institutions;
• Other research institutions/organisations.

Administrative Team

Mrs Maré Marais (Head of Ethics Administration)
T: +27 51 401 7795

Mrs Jemima du Plessis
T: +27 51 401 7794

Ms Abigail Mulondo
T: +27 51 401 7794

Please direct all correspondence to:

The Chairperson: Health Sciences Research Ethics Committee (HSREC)
For Attention: Mrs MGE Marais
Block D, Room 104
Francois Retief Building
PO Box 339 (G40)
Nelson Mandela Drive
Faculty of Health Sciences
University of the Free State
Bloemfontein 9300
E: EthicsFHS@ufs.ac.za

Submission and Meeting Dates

HSREC Submission and Meeting Dates (HSREC Dates)

HSREC Review Fees (HSREC02.2)

Initial Applications

Important notice: All new applications for undergraduate and postgraduate/other research will henceforth only be accepted via the online application platform, RIMS.

New applications for Contract Research will remain status quo until further notice.

HSREC Administration reserves the right to not accept applications for review that are submitted in hard copy at the HSREC office, which should be submitted through RIMS.

Preparation Guides:

These documents are mandatory reading in preparation for your submission to the HSREC:

• RIMS Undergraduate Preparation Guide (HSREC20)
• RIMS Postgraduate and Other Research Preparation Guide (HSREC21)
• New applications for Contract Research will remain status quo until further notice. The General Submission Guidelines for Contract/Clinical Research still apply (HSREC02)
  • Contract/Clinical Research New Protocol Application (HSREC03)

Other initial application documents

Please read through the RIMS Preparation Guide document (above) to determine if you require any of the following documents in your application. These forms must be printed, completed, scanned, and uploaded to RIMS in the Documents Checklist at the time of your application:

• Approval from UFS Authorities (HSREC17)
• Form A: Application for ministerial consent for non-therapeutic research with minors (GL24)
• RIMS Undergraduate Student Research Investigator Declaration (HSREC18) (mandatory for all undergraduate applications)
• RIMS Postgrad and Other Research Investigator Declaration (HSREC19) (mandatory for all postgraduate/other applications)
• RIMS Case Studies/Series Investigator Declaration (HSREC22) (mandatory for all Case Studies/Series applications)

RIMS User Training Manuals

Please refer to the following generic manuals when applying. Fir RIMS related queries, please cal (051)401-9451 :

• How to apply for ethical clearance on RIMS (RIMS01)
• How to make modifications that are required on a RIMS application (RIMS02 )
• How to respond when an Application has received Conditional Approval (RIMS03)

Informed Consent – Templates and Guidance

• Informed consent and information leaflet (EC31)
• Assent form for children in research (EC39)

Guidance Documents

• Guidelines for advertisements (EC36)
• NHREC registration (EC32)
• Criteria of Approval (HSREC23)
• Format of Curriculum Vitae (EC45)

Links

The HSREC functions in compliance with, but not limited to, the following documents and guidelines:

• The SA National Health Act, No 61 of 2003 (GL03)
• Department of Health: Ethics in Health Research: Principles, Structures and Processes, 2015 (GL04)
• Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa. Second Edition, 2006. Department of Health, Pretoria, South Africa (GL05)
• Declaration of Helsinki (GL06)
• The Belmont Report (GL07)
• US Common Rule Subparts A-E 2009 (GL08)
• 21 CFR Part 50 – Protection of Human Subjects (GL09)
• 21 CFR Part 56 – Institutional Review Boards (GL10)
• Council for International Organisations of Medical Sciences (CIOMS). International Ethical Guidelines for Biomedical Research Involving Human Subjects (GL11)
• ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice E6 (R1) 1996 (GL12)
• ICH Harmonised Tripartite Guideline: Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH Tripartite). (GL13)
• ICH Harmonised Tripartite Guideline: Clinical Investigation of Medicinal Products in the Paediatric Population E11 2000 (GL14)

National Research Ethics Guidance

• Department of Health: Application for Ministerial Consent for Non-Therapeutic Research with Minors (GL15)
• NHREC Payment of trial participants in South Africa (GL16)
• Conducting Research in Public Health Institutions Guidelines for Approval of Health Research in the Free State Department of Health June 2015 (GL17)
• Free State Department of Health Scheduled meetings: protocol review committee (GL18)
• National Health Research Database (NHRD) User Manual: How to submit an Online Research Proposal (GL19)

Online Research Ethics Training

• Training and Resources on Research Ethics Evaluation (TRREE)
• Global Health Trials
• Family Health International Research Ethics Training Curriculum Second Edition
• Family Health International Research Ethics Training Curriculum for Community Representatives
• NIH Office for Extramural Research Protecting Human Research Participants
• ERECCA Enhancing Research Ethics Capacity and Compliance in Africa
• Human Research Ethics Training for the Social Sciences and the Humanities
• Research Ethics Online Training developed by the Global Health Network e-Learning Centre

Animal experiments

Guidelines – animal research projects

• Guide to the care and use of animals in research and teaching
• Evaluation of protocols (SOP aec-001)
• Submission of protocols, modifications, amendments, reports, and reporting of adverse events (SOP aec-007)
• Emergency procedures and adverse events (SOP aec-008)

IRB Registration

Federal wide assurance (FWA) number of the Health Sciences Research Ethics Committee.

The HSREC is registered as an institutional review board (IRB) with the Office for Human Research Protections (OHRP) of the USA Department of Health and Human Services;

IRB organisation identifier: IRB00006240
Unique Assurance Number: FWA00012784
Unique Organisation Number: IORG0005187