Information and Instructions for Applicants* for a New Application for Ethics Review and Approval

* The term “applicants” refers to both the primary investigator (PI) and the primary responsible person (PRP) as a collective


Nelson Mandela University researchers (staff and/or students) of studies making use of human participants are advised to familiarise themselves with these guidelines and instructions prior to completing and submitting an application for review.  Failure to do so might result in a delay in the review and approval of the application. 
 


Any application not submitted on the correct and most recent version of the application form, or any incomplete submission will not be reviewed.  The version of the application form found on this page will be the only application form accepted for review as from 1 April 2021.  This form has specifically been designed with the intention of requiring responses directly in line with the review criteria used by the committee to ensure ethical compliance with national standards and norms.  It is the intention that this form will now serve to expedite the review and approval processes.

  1. Applicants are expected to have familiarised themselves with the contents of the following documentation with the intention of applying said knowledge to the completion of the application form:
    1. REC-H Standard Operating Procedures, with emphasis on the section on the responsibilities of the primary responsible person (PRP) and primary investigator (PI);
    2. Department of Health Research Ethics Guidelines (2015), with emphasis on consideration for the mental and physical well-being of all human participants;
    3. Any and all relevant documentation regarding ethical and legal aspects of research studies making use of human participants (refer to pp 12 of document b. above);
    4. The Belmont Report summarised for your convenience by a 3rd party and available as video presentation;
    5. Summary of the Protection of Personal Information Act (POPIA);
    6. Nelson Mandela University Code of Conduct for Researchers and
    7. Nelson Mandela University Research Ethics Policy.
       
  2. Download a copy of the application form template.  The form is intended to be comprehensive in order to assist you with inclusive responses with a view to prevent any delay in the review and approval process.
     
  3. Applicants are required to familiarise themselves with the instructions and terminology provided on pages 1 – 3 of the application form template.  It is advised that the instructions are followed carefully.
     
  4. Complete the risk assessment for the proposed study (available as a component of the application form template).
     
  5. Complete the application form in full – refer to the provided definition of terms on pages 1 – 3 of the application form for assistance as and when required.  Provide suitable responses to each item on the application form.  Incomplete or incorrectly completed application forms might result in a delay of the review and approval process.
     
  6. Draft all required supporting documentation and label each Appendix correctly.
    1. Appendix 1: Research proposal (mandatory)
    2. Appendix 2: Gatekeeper/Permission for access/Institutional permission draft letters (mandatory)
    3. Appendix 3: Evidence of Researcher Competence (if applicable) 
    4. Appendix 4: International Ethics Approval Process (if applicable) 
    5. Appendix 5: Restrictions/conditions applicable to publication of results (if applicable) 
    6. Appendix 11: Data collection instruments (mandatory) 
    7. Appendix 12: Recruitment information (mandatory) – written and/or oral 
    8. Appendix 13: Enrolment information (mandatory) – written and/or oral 
    9. Appendix 14: Consent form(s) (mandatory) 
    10. Appendix 15: Assent forms(s) (if applicable for minors) 
    11. Appendix 16: Budget for reimbursement/remuneration/incentives (if applicable) 
       
  7. Ensure that the Synopsis of the Study (Appendix 10) has been correctly completed.
     
  8. Prepare the application for submission as per the instructions in the application form information block.  Incorrect preparation and labelling of Appendices might result in a delay of the review and approval process.
     
  9. Remove the information block (pages 1 – 3) from the application form.
     
  10. Complete the inventory of Supporting Documentation.
     
  11. Submit the application for review to your Faculty Contact Person.


Audio-visual assistance:

  1. Assessing the Risk of the Study (Duration 4:44 - audio-visual assistance to complete the Risk Assessment Form pp 6 – 10)