Students/researchers who are external to the Central University of Technology who have obtained ethics approval from an NHREC-accredited research ethics committee, and who are requesting access to CUT staff, students, documents, etc., are required to complete and submit a request for such access. Retrospective approval of such requests will not be granted.

Send a copy of the following documents to reic@cut.ac.za to request access to CUT staff, students or documents:

1. Survey purpose /research proposal.
2. Ethical considerations include privacy legislation.
3. Questionnaire
4. Sampling procedure
5. Ethical clearance from the appropriate Ethics Committee – your provisional ethical clearance will do here (must be included in your submission)

Once you submit these documents to the Research Ethics Office, you will be provided access and credentials to the Converis system. Ensure you capture your application on the system immediately as your credentials as an external applicant will expire in two days.

Should you require an extension to complete your data collection activities, you must apply for an extension 4-6 weeks before the current ethics approval period expires.

Failure to do so may result in suspending or terminating all data collection activities linked to the study upon the expiry of the approval period.

To apply for an extension, download and complete the extension template and send it to reic@cut.ac.za

Extension template (docx) | 29 August 2023

 Note the following:

• The CUT HSREC will not grant an extension on a lapsed protocol.
• If you submit an extension application after the expiry date of the current ethics approval period, you will be required to submit a new ethics application.
• New applications will be submitted via the faculty and will be sent to reviewers.
• Data collection may not commence or continue if ethics approval has lapsed.
• Any data collected without ethics approval may not be used for research purposes.
• Only through a substantial circumstance will the CUT HSREC review the extension of studies submitted after a protocol has lapsed.

Amendments are planned changes to an approved study and may be classified as either major or minor.

Examples of Major amendments:

• Increasing the inclusion criteria
• Reducing the exclusion criteria
• Emergence of new and/or serious risks and/or significant risks to either participants and/or researchers
• Requirement for new and/or additional study documentation to be distributed to or viewed by participants that include information and/or data collection items significantly different to that in materials previously approved.

Example of Minor amendments:

• Any modification that would not significantly affect the assessment of the risks and/or benefits of the study.
• Any change that does not significantly affect the aims and/or design of the protocol for the study.
• A decrease/increase in sample size, supported by relevant statistical motivation.
• Administrative changes such as researcher contact details, the removal/addition/replacement of research personnel and/or study sites;
• Reducing the inclusion criteria;
• Increasing the exclusion criteria.
• Change in study title.
• Modifying data collection points or volume of data collected if any safety regulations/constraints are retained.
• Changes in compensation and/or reimbursement with adequate rationale.
• Any editorial modifications that serve to clarify but not alter a document's meaning.
• Any translations of documents previously reviewed and approved.

Unless there are extenuating circumstances, continuous applications for amendments to a particular study will not be viewed in a favourable light.

An event is defined as an untoward or unfavourable experience or response such as the following.

1. Physical
2. Emotional
3. Psychological
4. Breach in Confidentiality

The principal investigator is responsible for reporting any adverse event experienced by the participant/researcher/non-participant. The CUT HSREC must be notified about the occurrence of the adverse event as soon as possible but no later than one business day following the event.

Procedure to Report SAE:

Download SAE template (docx) | 29 August 2023

• Complete the form in full.
• Provide suitable responses to each item on the form.
• Submit the completed report approved CUT HSREC letter and send it to reic@cut.ac.za

A closure report may be submitted on the conclusion of data collection activities as long as it is known that no further interaction with participants will be conducted.

For discontinuation of a study, submit the following documents:

1. Data collection for which ethical approval was granted
2. Discontinuation report
3. Ethics approval letter

For closure of study:

1. Updated progress report
2. Signed ethics approval letter

Send an email to reic@cut.ac.za consisting of the following documents.

• Motivational letter stating the purpose of the amendment
• CUT HREC approval number
• Copies of amendment document(s) (consent forms, information sheets etc.)
• Additional permission letters
• Which section of the application you want to make amendments on

Your application will be forwarded to the reviewers who approved the original applications. If the reviewers approve of the amendments, the applicant will be notified via email that the system has been opened and they can attach or make the required amendment to the system.

The NHREC requires students/researchers to submit a progress report on an annual basis. An active protocol is one for which an ethics closure report has not been submitted and approved.

The deadline for submission of progress reports is 15 November each year.

Note: failure to do so may result in the immediate suspension or termination of data collection activities linked to the study.

Progress report template (docx) | 30 August 2023 
Complete all the required sections and email to reic@cut.ac.za