FPD RESEARCH ETHICS COMMITTEE (FPD - REC)

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Who We Are

About the FPD Research Ethics Committee

The Foundation for Professional Development Research Ethics Committee (FPD-REC) promotes the conduct of ethical research within FPD. The Committee provides ethical oversight to help ensure that research is conducted responsibly and with respect for the people and communities involved.

Our Purpose

Protecting the Rights and Well-being of Research Participants

The main aim of the FPD-REC is to safeguard the dignity, rights, safety and well-being of all actual or potential research participants and communities, while taking into account the interests and needs of researchers and the integrity of FPD.

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Participant Protection

Safeguarding the dignity, rights, safety, welfare and interests of research participants.

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Ethical Oversight

Reviewing research proposals and considering their ethical implications and participant safeguards.

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Scientific Integrity

Considering the scientific and methodological soundness of proposed research as part of ethical review.

Recognition and Accreditation

Registered with the National Health Research Ethics Council

The FPD-REC operates in terms of the National Health Act, 2003 (Act 61 of 2003), and the national research ethics framework overseen by the National Health Research Ethics Council (NHREC).

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National Health Act

The Committee operates within the legislative framework established by the National Health Act, 2003.

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NHREC Registration

The FPD Research Ethics Committee has been registered and audited by the National Health Research Ethics Council.

View Registration Certificate

The registration certificate currently published by FPD lists registration number REC-030711-033 and validity until 30 November 2027.

Understanding Research Ethics

What Type of Research Must Be Submitted?

Health research must be reviewed by a Research Ethics Committee in terms of the National Health Act. The Act defines health research broadly as research that contributes to knowledge in areas including:

01

Human Processes

Biological, clinical, psychological or social processes in human beings.

02

Health Service Delivery

Improved methods for the provision of health services.

03

Human Pathology

Knowledge and understanding of human pathology.

04

Causes of Disease

Research into the causes and contributing factors of disease.

05

Environmental Effects

The effects of the environment on the human body.

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Medicines and Health Technology

The development or new application of pharmaceuticals, medicines, related substances and health technology.

Important: Researchers should establish whether their proposed work requires ethical review before commencing research activities. If you are unsure whether your study falls within the FPD-REC's scope, contact the Secretariat for guidance.

The Review Journey

Application and Review Process

Applications are screened for completeness and scientific soundness before being considered by the full Committee. The process diagram below illustrates the review stages and the feedback or approval steps.

FPD Research Ethics Committee application and review process

Overview of the FPD-REC application and review process.

01

Submission

The Principal Investigator submits the required documents electronically to the Secretariat before the applicable deadline.

02

Initial Screening

The Secretariat checks the application for completeness and correct supporting documentation.

03

Scientific Review

Complete applications are considered by the scientific sub-committee for scientific soundness.

04

Committee Review

The full Committee reviews the proposal and considers its ethical implications.

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Outcome and Feedback

The Committee communicates its outcome. Changes or clarifications may be requested before approval is granted.

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Approval Certificate

Once approval has been granted, the approval certificate is issued.

Submission timing: The FPD-REC Protocol Submission Guidelines state that applications must be submitted at least 15 working days before the relevant Committee meeting. Please consult the Secretariat for the applicable submission deadline and meeting date.

For Researchers

First Applications and Required Documents

A complete application should include the research protocol and all supporting documents relevant to the proposed study. The proposal submitted for scientific or technical review must be the same as the proposal submitted for ethics review.

01

Research Proposal

A complete research proposal with the research methodology and ethical considerations, including how participants' welfare, rights and interests will be protected.

02

Research Team Details

Researchers' names, current CVs, qualifications, affiliations, addresses and contact details.

03

Organisation and Funding

Details of organisations or institutions involved in the study, together with sponsors and funders.

04

Protocol Summary

A summary, synopsis or diagrammatic representation of the research protocol.

05

Recruitment and Consent

Recruitment procedures, participant information, informed consent forms and assent forms where applicable.

06

Research Instruments

Questionnaires, interview guides, diary cards, computer-based surveys and other participant-facing research tools.

07

Study Sites and Permissions

Site details, relevant addresses, research team members and permission letters where applicable.

08

Risk and Participant Safety

Procedures for responding to adverse events, injury or harm attributable to participation in the study.

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Additional Information

Conflict-of-interest information, participant compensation, study budget and disclosure of previous ethics review where applicable.

Submission requirements: Applications must be submitted electronically in English to the FPD-REC Secretariat. The full protocol submission guidelines contain the detailed list of required documents and the application summary sheet.

After Initial Approval

Subsequent Submissions and Study Updates

Ethical oversight continues throughout the life of an approved study. Researchers must submit relevant changes, progress updates and reports to the FPD-REC Secretariat.

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Amendment Applications

Submit a cover letter from the Principal Investigator explaining the proposed changes and reasons for them, the amendment request form and applicable revised study documents. Highlight all additions and changes to previously approved documents in yellow.

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Annual Renewals

Submit a cover letter explaining why the study requires an extension, together with a progress report and the applicable renewal documentation.

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Protocol Deviations and Serious Adverse Events

The Principal Investigator must notify the FPD-REC Secretariat electronically within 24 hours after becoming aware of a protocol deviation and/or serious adverse event, using the applicable reporting documentation.

Study reports: Progress and final study reports must be submitted to the Secretariat as required. Use the study report form for six-month progress reports and final study reports.

Get in Touch

Contact the FPD-REC Secretariat

For questions about applications, submissions, amendments, renewals or the research ethics review process, please contact the FPD-REC Secretariat.

Telephone: 012 110 4080 Telephone: 087 821 1109 Email: liviav@foundation.co.za

Physical Address
Foundation for Professional Development
FPD Knowledge Park, 173 Mary Road
The Willows, Pretoria

Email the Secretariat