Understand the NORSU Research Ethics Committee clearance process—from the initial Letter of Intent and submission requirements through review, revisions, final verification, and issuance of Research Ethics Clearance.
Research involving human participants is submitted to the REC for ethical review before study implementation. The application materials state that research involving human participants shall not commence without prior REC approval and issuance of Research Ethics Clearance.
Start here: The operational flow chart begins with submission of a Letter of Intent and initial form at the NORSU-REC office.
The sequence below follows the supplied NORSU-REC Research Ethics Clearance Process Flow Chart.
View Flow ChartThe applicant visits the NORSU-REC office, submits a Letter of Intent (LOI), and fills out the initial form.
The REC Secretary sends the Research Ethics Clearance application and list of required documents. The researcher completes the application, research protocol, and other requirements.
The Ethics Chair reviews the submitted research proposal or assigns it to an ethics committee member for review.
The review process takes a maximum of seven (7) working days, excluding holidays and weekends.
The REC Secretary sends the review results and recommendations to the researcher.
The researcher submits the needed documents and responses to reviewer feedback and recommendations.
The Ethics Chair conducts final review and verification of the submitted revisions.
The process concludes with issuance or release of Research Ethics Clearance following satisfactory final review and verification.
The Research Ethics Manual and current application materials identify documents and information used for initial ethics review. Requirements may vary depending on the study.
The supplied NORSU-REC process flow chart states that the review process takes a maximum of seven working days, excluding holidays and weekends. This refers specifically to the review-process step and should not be interpreted as a guaranteed total end-to-end clearance time.
The supplied application and reviewer materials identify key scientific and ethical considerations examined during protocol review.
Study rationale, objectives, methodology, participant selection, recruitment, data collection, instruments, and analysis are considered as part of protocol review.
The review considers whether consent is appropriately documented and whether participation is voluntary and adequately informed.
Researchers should explain what participant information will be obtained and how privacy, confidentiality, and research data will be protected.
The protocol should identify risks and benefits and explain measures intended to reduce or manage research-related risks.
Studies involving vulnerable participants require appropriate ethical safeguards and special protection.
The application addresses researcher expertise and qualifications. For student researchers, the current form instructs that only the adviser's CV be attached.
The supplied Reviewer’s Guide includes review classifications and a structured assessment of ethical and scientific considerations.
One of the classifications identified in the reviewer guide.
One of the classifications identified in the reviewer guide.
One of the classifications identified in the reviewer guide.
The reviewer material also provides recommendation options including approval, minor modification, major modification, and disapproval. Classification and decision are determined through REC review; researchers should not self-classify a submission as a substitute for REC assessment.
REC oversight does not necessarily end when clearance is issued. The Research Ethics Manual describes continuing responsibilities for approved research.
Protocol amendments or revisions should be appropriately reported and reviewed in accordance with REC requirements.
Protocol deviations and unanticipated problems affecting ethical conduct or participant protection require appropriate reporting.
The REC monitors ongoing approved research and the Manual provides for progress, termination, end-of-study, and final reporting.
Study files and required reports form part of REC documentation and recordkeeping after review and approval.
Download the Letter of Intent, application form, informed-consent templates, process flow chart, and Research Ethics Manual from the Forms & Documents page.