Page 19 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

Policy Statements
iii. During the conduct of the research (recruitment of subjects and/or data collection).
a. Any subsequent changes or additions to research that has received prior ethical
approval by MREC will require that such changes be submitted, reviewed, and
approved by MREC before it can be incorporated into the research. These changes
or additions include those affecting the i) research protocol and methodology, ii)
research sites, iii) investigators, and iv) related documents.
b. Applications for renewal of ethical approval should be made on a yearly basis and
should be submitted prior to the expiry of the ethical approval.
c. Research status or progress should be notified and updated in the NMRR.
d. The Closure/Suspension/Termination of research should be notified to MREC (for
research that had already received ethical approval from MREC).
e. Investigator needs to submit an End of Project or Final report upon research
completion (report can be uploaded in the NMRR). For research receiving MRG, the
report should be submitted to the MRG Secretariat as well.
3.4 Roles and Responsibilities of the Institutional/Facility Director, Head of Department
(HOD), Clinical Research Centre (CRC) Unit and Research Review Committee (Panel/
Reviewers and Secretariats)

Institutional/Facility Director, Head of Department (HOD), Clinical Research Centre (CRC)
Unit
Monitoring of research conducted at MOH institutions/facilities is under the responsibility of
respective Institutional/Facility Director, Head of Department (HOD) and Clinical Research
Centre (CRC) Unit (if available)

Research Review Secretariat (JPP-NIH)
i. Examine for completeness of all submitted research applications and documents;
ii. Assign and distribute the research application to the JPP-NIH Panel or Reviewers for
review and recommendation; and
iii. Forward the completed reviewed research application with recommendations from the
JPP-NIH Panel or Reviewers to MREC for further action and consideration.

Research Review Committee (JPP-NIH Panel or Reviewers)
i. Review the scientific merit of the research applications; and
ii. Propose recommendations to support or reject the research applications based on the
review.
iii. For research with MRG application
a. Propose recommendations to support or reject the MRG application; and
b. Evaluate and monitor the progress of the MRG awarded research.

Research Review Secretariat (JPP-CRC)
i. Examine for completeness of all research applications and documents;
ii. Assign and distribute the research application to relevant HRRCs;
iii. Coordinate between all HRRCs.

NIH Guidelines for Conducting Research in MOH, 2021 03