The Procedure for Screening ERC

Submission of Application

Researchers submit a completed Ethics Application Form, along with supporting documents such as:

• Research proposal
• Participant information sheet
• Consent forms
• Data collection tools (e.g., questionnaires, interview guides)
• Institutional approvals (if applicable)

Administrative Screening (Preliminary Review)

Acknowledgement of the receipt of application.

Ethics Review Committee checks for:

• Completion of the application
• Proper formatting
• Required documents attached
• Eligibility of the researcher and project

Classification of Risk Level

The application is assessed to determine the risk level and classified accordingly:

• Exempted (minimal or no risk)
• Expedited Review (minimal risk, can be reviewed by a subcommittee or designated reviewers)
• Full Committee Review (more than minimal risk, vulnerable populations, sensitive topics)

Review by Ethics Committee

Depending on risk level:

• Expedited Review: Reviewed by three (03) designated members.
• Full Committee Review: Discussed at a scheduled Ethics Review Committee (ERC) meeting.

Decision and Feedback

The committee may issue one of the following:

• Approval: No further changes needed.
• Conditional Approval: Minor revisions required (e.g., wording of consent form).
• Deferred: Major revisions required; must be resubmitted.
• Rejection: Ethical concerns cannot be resolved, or the study is unethical.

Communication of Outcome

A formal letter is sent to the Principal Researcher with:

• The decision
• Any required revisions
• Justifications for changes (if any)
• Approval reference number and date (if approved)
• Date of expiry (if approved)

Resubmission (if applicable)

• Researcher revises and resubmits the application or documents as requested.
• Resubmitted materials undergo review again (expedited or full, depending on changes required and completed).

Monitoring and Continuing Review

For approved studies, the researcher may be required to:

• Submit progress reports
• Report adverse events or protocol deviations
• Apply for renewal if the study continues beyond the approval period (submit an application for renewal before the previous approval period elapses)
• Submit a brief final report upon study completion