Method of Decision Making

Method of Decision Making

The NREB will promote open communication by all members (through building consensus). Final determinations shall be reached following the NREB SOPs.

The NREB may seek opinions from content experts regarding designated research protocols and/or issues, as long as the experts have no conflict of interest (CoI), including participation in the research, financial interest in the outcome, and/or involvement in competing research, among others.

Decision Type

After the review of applications by the NREB, the decision types to be communicated by the Secretariat shall be one of the below categories:

  1. Approved: The submission satisfies all requirements in accordance with the NREB SoP and Good Clinical Practice (GCP), including country-specific ethical and regulatory principles, and the protections of human subjects.
  1. Not Approved: The submission failed to satisfy all requirements in accordance with the NREB’s SoPs and GCP.
  1. For Consideration
  1. Provisional Approval: an approval requiring the investigator to commence the study while addressing minor concerns.
  1. Pending Approval: The submission partially satisfied the requirements in accordance with the NREB’s SoPs and GCP. In such a situation, stipulations and/or concerns will be generated and submitted to the PI or approved designate for redress. The stipulations and/or concerns must be addressed to the satisfaction of the NREB prior to the granting of approval for the commencement of the study.