New Ethics Application

Kindly note: (1) Nelson Mandela University researchers (staff and/or students) of umbrella and/or undergraduate/Honours group studies making use of human participants are required to comply with the procedure for New Umbrella and/or Undergraduate/Honours Group Project Ethics Application; (2) Researchers external to Nelson Mandela University, wishing to make use of Nelson Mandela University staff and/or students as participants in a study, are required to comply with the procedure for External Parties wishing to Conduct Research using University Staff and/or Students.

 

All applicants (PI and PRP) 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.
     

All applications must be submitted online on MEOS (Mandela Ethics Online System). Only researchers from the Faculty of Health Sciences may choose to submit their application using the offline process.

Submitting through MEOS

  1. Refer to the MEOS How-to Manuals/Videos on the REC-H website.
  2. Log into the Mandela Ethics Online System (MEOS) using your Nelson Mandela University username and password.
  3. Students are advised to share the form with their supervisors.
  4. Complete the application form.
  5. Sign the application form.
  6. Request the signature of the PRP (Primary Responsible Person).
  7. Once signed by all relevant parties, the form will be automatically submitted for review.

 

Submitting using the offline process

Only applicants from Health Sciences may opt to use the ethics application process outlined below. Please note that if ethics approval is received using the offline process, any amendment or extension applications, progress or closure reports must also be submitted using the offline process.

Kindly note that the application form should be submitted in English. Where information will be provided to participants in translated form, the translated versions AND the English versions should be included as appendices to the application.

  1. Download a copy of the RECH-001 Application Form template. Any application not submitted on the correct and most recent version of the application form will not be reviewed. It is also suggested that the Guideline to Completing RECH-001 is downloaded and consulted to assist in providing inclusive respponses with a view to preventing delay in the review and approval process. This guideline provides an overview of the specific elements that reviewers look for in an ethics application.
     
  2. Applicants are required to familiarise themselves with the instructions and terminology provided on pages 1 – 3 of the application form template. 
     
  3. Complete the risk assessment for the proposed study (pp 6-10). Watch the "Assssing the Risk of a Study" video (Duration 4:44) for assistance.
     
  4. Complete the application form in full – refer to the provided definition of terms on pages 1 – 3 of the application form for assistance. Incomplete or incorrectly completed application forms will result in a delay of the review and approval process.
     
  5. 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 10: Data collection instruments (mandatory) 
    7. Appendix 11: Recruitment information (mandatory) – written and/or oral 
    8. Appendix 12: Enrolment information (mandatory) – written and/or oral 
    9. Appendix 13: Consent form(s) (mandatory) 
    10. Appendix 14: Assent forms(s) (if applicable for minors) 
    11. Appendix 15: Budget for reimbursement/remuneration/incentives (if applicable)
       
  6. Prepare the application for submission as per the instructions in the application form information block on page 1.  
     
  7. Remove the information block (pages 1 – 3) from the application form.
     
  8. Complete the inventory of Supporting Documentation on page 5.
     
  9. Submit the application to the relevant faculty administrator/manager.