Umbrella Project Ethics Application

What is an Umbrella Project?

An umbrella project may be defined as a large (un)sponsored, national/international research project in which human participants are the subjects of research. 

An umbrella research project:

• is a broad research project under which a number of smaller, independent research projects fall.

• is a project in which a number of individual Masters (treatise and research) and Doctoral students collaborate, with each individual Masters and Doctoral student conducting research to realise at least one objective of the umbrella research project. An umbrella project (RECH-003U) can be approved, stating that there will be a certain number of Masters and Doctoral students involved (names as yet unknown). An application for an umbrella research project (form RECH-003/U) is required with an umbrella proposal that provides an overview of recruitment and sampling procedures. The overview should contain sufficient details for the review of the protocol. Specific details will need to be included in each individual Masters and doctoral research proposal.

• requires that the individual Masters and Doctoral students who are involved in the umbrella project complete the RECH-003/S** (sub-studies) form to link to the existing RECH-003U approved project, for their parts of the umbrella project (i.e independent proposal, data collection instruments etc.). This could therefore happen concurrently with or after approval of an existing umbrella project.

• is also advised for groups of undergraduate, PGDip and/or Honours students undertaking small research projects. An application for an umbrella research project (form RECH-003/U) is required. In this case, individual sub-studies must be submitted for approval on a form RECH-003/S as supporting documentation for form RECH-003/U, either individually or as a group submission of sub-studies (the latter only if data collection procedures and instruments of such studies are significantly similar).

**the RECH-003/S merely serve for the purpose of obtaining an independent ethics number per student.

Please note that:

• Nelson Mandela University researchers (staff and/or students) of individual studies should follow the procedure for a New Ethics Application.
   
• Researchers external to Nelson Mandela University, wishing to make use of Nelson Mandela University staff and/or students as participants in a study, should complete the relevant process for External Parties wishing to Conduct Research using University Staff and/or Students.

 

Application Process for an Umbrella Project:

Failure of researchers to familiarise themselves with the guidelines and instructions below prior to completing and submitting an application for review 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 a 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 the umbrella project application form as well as the sub-study application form (if applicable) for every study related to the umbrella study.  These forms are 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 umbrella/group application form template).
    
5. Complete the application form in full – refer to the provided definition of terms in the information block 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, as indicated on the form.
    
7. 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.
    
8. Remove the information block from the application form.
    
9. Complete the inventory of Supporting Documentation.
    
10. 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)