Health Sciences Research Ethics Committee (HSREC): Assessment Questions Survey

Please provide your details below before starting the assessment:

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* 1. Name and Surname:

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* 2. Staff / Student Number (if you are not a UFS staff member or student, you can enter "NA"):

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* 3. Department Name (if you are not with a department at UFS, you can enter "NA"):

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* 4. Email Address:

Navigating the HSREC Application Process at the UFS: A Guide for University Researchers

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* 5. What is the primary role of the Health Sciences Research Ethics Committee (HSREC)?

To recruit participants for university studies

To safeguard the rights and well-being of research participants

To provide funding for health research projects

To publish research findings on behalf of researchers

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* 6. Which legislation provides the legal mandate for the HSREC?

Research Integrity Act of 2001

National Health Act No. 61 of 2003

Higher Education Act of 1997

Protection of Personal Information Act of 2013

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* 7. Where should researchers submit their HSREC ethics applications?

On the UFS main website

Via email to the HSREC chairperson

Through the faculty administrative office

Through the RIMS online portal

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* 8. Which of the following is NOT a possible HSREC review outcome?

Full approval

Request for modifications

Automatic approval without review

Conditional approval

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* 9. Which document is mandatory for an HSREC submission?

A letter of recommendation from a colleague

The final research protocol

A summary of previous research projects

A personal motivation letter

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* 10. Which of the following must be included if personal information will be processed?

A project marketing plan

A media release form

A participant rewards schedule

A data management plan

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* 11. Which of the following must be included if personal information will be processed?

A data management plan

A participant rewards schedule

A media release form

A project marketing plan

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* 12. When may a researcher begin collecting data for their study?

Immediately after submitting the application

Only after formal HSREC approval has been granted

After receiving verbal approval from a supervisor

After addressing feedback but before final approval

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* 13. What is a common issue that causes delays in HSREC application processing?

Submitting applications early

Using outdated or missing forms

Submitting too many supporting documents

Including a detailed study budget

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* 14. Who should researchers contact for technical assistance with the RIMS platform?

The HSREC chairperson

The UFS library

The faculty dean

The RIMS support team

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* 15. Where can researchers find additional materials and resources related to HSREC applications?

On the HSREC website

In the university cafeteria

Through student organisations

On social media platforms

Part 1: Approach to Ethics Application in Health Sciences

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* 16. According to the NHREC, which of the following best defines research?

Any activity conducted within a health facility

A systematic investigation contributing to generalisable knowledge

Routine operational or service delivery work

A once‑off quality improvement activity

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* 17. Which situation would require submission to a research ethics committee (REC)?

A quality improvement project with no intention to publish

An internal audit for service delivery

A study involving interviews with human participants

A project using only anonymous public‑domain data

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* 18. Who should apply to a UFS research ethics committee (REC)?

Researchers who already have ethics approval elsewhere

UFS students or staff members conducting research

Only external researchers with national projects

Any researcher working in South Africa

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* 19. Which type of study may qualify for a minimal risk review?

Research requiring informed consent for new genetic testing not covered in the consent form

Studies using public‑domain documents

Any study involving biological samples

Case studies involving Department of Health patients

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* 20. When is Free State Department of Health (FS DOH) approval required for a case study or case series?

Only when the researcher is not affiliated with the UFS

When the patient is from the Free State Department of Health

Only when the study involves genetic testing

Only when the NHREC guidance document requires it

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* 21. Which statement about gatekeeper approval is correct?

Gatekeeper approval is optional if ethics approval is granted

Gatekeeper approval is separate from the HSREC process

Gatekeeper approval is only needed for clinical trials

The HSREC acts as the primary gatekeeper for all studies

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* 22. When is it advisable to submit different components of a project as separate applications?

When the project is very short

When components have different ethics risk levels

When the researcher prefers fewer documents

When the study involves only secondary data

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* 23. Which of the following requires written informed consent?

Any study conducted outside the Free State

Any study using anonymised datasets

Any study involving direct or virtual participant contact

Any study using only public‑domain documents

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* 24. What is required for non‑therapeutic research involving minors in South Africa?

Only verbal assent from the child

Only parental consent

Ministerial consent and parental written consent

No consent if the child is older than 16

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* 25. What factors determine appropriate participant remuneration according to the TIE principle?

Task difficulty, involvement, and expertise

Travel, income, and employment

Time, inconvenience, and expense

Training, interest, and education

Part 2: Training

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* 26. What proof of training must all researchers submit before applying to the HSREC?

Proof of attendance at a research conference

Proof of ethics training as mandated by the NHREC

A letter from their supervisor

A certificate of data analysis training

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* 27. Which statement about Good Clinical Practice (GCP) certification is correct?

GCP is optional for all researchers

GCP is required for investigators in clinical trials and must be less than three years old

GCP certificates are valid indefinitely

GCP replaces the need for all other ethics training

Part 3: Avoiding Common Pitfalls in the HSREC Application Process

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* 28. What proof must accompany each HSREC application according to the NHREC?

A summary of previous research by the investigator

A draft version of the research protocol

Proof of independent scientific review

A letter of support from the supervisor

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* 29. Which of the following is a common error that causes delays in HSREC applications?

Submitting an itemised budget

Submitting documents with track changes or comments

Submitting only final, clean versions of documents

Submitting documents signed in wet ink

Part 4: Outcomes

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* 30. What does a ‘conditional approval’ outcome mean in the HSREC review process?

The modifications must be presented to the full committee

The application has been rejected

The HSREC Admin Office can manage the required administrative or gatekeeper modifications

No further action is required

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* 31. What does it mean when an application is ‘held over’?

The modifications must be presented to the full committee due to major issues or missing documentation

The reviewers will manage the modifications outside the meeting

Only minor administrative changes are needed

The study has been fully approved

Part 5: Post-HSREC-approval Phase

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* 32. What must happen before any amendments to an approved protocol can be implemented?

Amendments can be implemented immediately after the pilot study

Amendments only need supervisor approval

Amendments must first be approved by the HSREC

Amendments can be implemented if they are minor

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* 33. How long is HSREC approval valid before a continuation application is required?

Until the study is completed

Eighteen months

Twelve months

Six months

Part 6: POPIA and How it Relates to the HSREC Application Process

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* 34. Which of the following is one of the eight POPIA principles?

Open public access

Unlimited data retention

Accountability

Data monetisation

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* 35. What does personal information include according to POPIA?

Only a person’s name

Only medical and financial records

Any data that can identify or describe an individual

Only biometric information

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* 36. What is the correct definition of anonymous data?

Data collected without any identifiers ever linked to it

Data collected with a study number and code list

Data collected with identifiers and later stripped of them

Data collected with identifiers but kept confidential

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* 37. What is pseudonymised data?

Data that is publicly available

Data collected with a study number and a separate code list

Data collected with identifiers but stored confidentially

Data that has been permanently stripped of identifiers

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* 38. What does deidentification mean?

Data that contains only opinions and preferences

Data shared openly with third parties

Data was collected with identifiers but later stripped of them

Data was collected without identifiers

A minimum score of 70% is required to pass. If you achieve less than 70%, kindly retake the quiz to ensure successful completion.