Information and Instructions for Researchers for the Request for an Amendment to a Currently Active Study

Nelson Mandela University researchers (staff and/or students) of currently active studies making use of human participants who require an amendment to a currently active study in terms of data collection activities are required to complete and submit a request for the review and approval of such an amendment PRIOR to implementing the amendment, except where it is essential to prevent and/or exclude immediate hazards and/or risks to currently enrolled participants (in case of the latter situation, please alert Imtiaz.Khan@mandela.ac.za for advice on the required procedure to follow). Failure to request an amendment prior to implementation thereof may result in the immediate suspension or termination of all data collection activities linked to the study.

Amendments to studies include but are not limited to changes in research protocol, written/oral information/consent documents and/or data collection instruments.  If the amendment involves only a change to the primary responsible person (PRP), primary investigator (PI) or any other researchers collaborating with the study, the procedure described in menu item Request for Change in Study Researchers must be followed.

Unless there are extenuating circumstances, continuous applications for amendments to a particular study will not be viewed in a favourable light.  This procedure described below is NOT for requesting approval for an  extension/renewal of a previously approved protocol (for this purpose please make use of form RECH-005).


Minor Amendments

Minor amendments to a currently active study are reviewed by REC-H at the monthly REC-H meetings.  Minor amendments are restricted to the following:

  • 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;
  • Modifying data collection points or volume of data collected as long as any safety regulations/constraints are retained;
  • Changes in compensation and/or reimbursement with adequate rationale;
  • Any editorial modifications that serve to clarity but not alter the existing meaning of a document; and
  • Any translations of documents previously reviewed and approved by REC-H.

The procedure for requesting approval for a minor modification is by means of written communication on a signed letterhead to Imtiaz.Khan@mandela.ac.za citing the study reference number and providing a detailed description of each change, supported by a rationale for each change as well as any and all relevant revised documentation for each change.  One copy of each amended study document which clearly highlights the changes must be submitted (highlighting of changes can be implemented by means of tracked changes, striking through “old text” and showing the “new text” in bold, underlined or in italics, or similar).  Additionally, one clean copy of the each amended document should accompany the written request.  Failure to submit both copies of modified documents and/or rationale for proposed modifications will delay the review and approval process.


Major Amendments

Major amendments to a currently active study are subject to full REC-H review.  Examples of major amendments include but are not limited to the following:

  • Increasing the inclusion criteria;
  • Reducing the exclusion criteria;
  • Emergence of new and/or serious 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 by REC-H; and
  • Any other change that does not qualify as a minor amendment (see list above).

A progress report is required to accompany the request for any major amendment to a study. 


The procedure for requesting a major amendment to a study is:
 

  1. Download a copy of both the application for an amendment to study form and the progress report. 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 of the request.
     
  2. Researchers are required to familiarise themselves with the instructions and terminology provided on the first page of each form.
     
  3. Complete the forms in full.  Provide suitable responses to each item on the forms.  Incomplete or incorrectly completed forms might result in a delay of the review and approval process, and ultimately on the ability of the study to continue.


The completed application form, progress report and the original signed approval letter must be submited to RECH Imtiaz.Khan@mandela.ac.za