Review Process and Timelines

The Tenwek Hospital Institutional Scientific and Ethics Review Committee (ISERC) follows a structured process for the scientific and ethical review of research submissions. The process is intended to ensure that applications are complete, appropriately reviewed, and considered in a timely and consistent manner.

1. Submission of Application

Researchers submit their research protocol and all applicable supporting documents through the Tenwek Hospital ISERC Protocol Review System.

Before submitting, applicants should review the Submission Guidelines and ISERC Submission Checklist to ensure that all required documents have been prepared.

Each submission is assigned a unique study identifier. Researchers should retain this identifier for subsequent submissions relating to the same study.

2. Initial Completeness Check

Following submission, the application undergoes an initial check by the ISERC administrative team.

This check confirms that:

  • The required application information has been provided.
  • The research protocol is included and sufficiently complete for review.
  • Applicable supporting documents have been submitted.
  • Required forms have been completed.
  • The submitted documents are appropriately identified and internally consistent.

If required information or documentation is missing, the applicant will be notified of the outstanding items. Where the submission is declined because it is incomplete, the applicant should address the outstanding requirements and start a new submission once the all documents have been duly filled and are complete.

3. Assignment to ISERC Reviewers

Once the submission has passed the initial completeness check, appropriate ISERC member(s) are assigned to review the application.

Reviewers use a standardized template to assess the submission with consideration to:

  • Scientific merit and methodological appropriateness
  • Study population and recruitment
  • Informed consent and participant information
  • Risks, benefits, and participant protection
  • Privacy and confidentiality
  • Data management and security
  • Regulatory and institutional requirements
  • Conflicts of interest and other relevant ethical considerations

Reviewers submit their comments and recommendations through the Protocol Review System.

4. ISERC Consideration

The Committee considers the research submission together with the reviewers' comments and recommendations and any other relevant information. Meeting consideration is subject to completion of the required review process by the assigned reviewer(s).

ISERC ordinarily meets on the third Tuesday of each month.

To allow sufficient time for the initial completeness check and reviewer assessment, applications intended for consideration at a particular month's meeting should be submitted and complete by the second Tuesday of that month.

5. Committee Decision

Following consideration, ISERC may issue one of the applicable decisions, including:

Approved
The study meets the Committee's requirements and may proceed subject to any stated conditions and other required regulatory approvals.

Provisional Approval
The research is considered acceptable in principle but requires specified conditions, clarifications, or minor revisions to be addressed before final approval is granted.

Deferred Approval
The Committee requires substantive revisions, additional information, or further clarification before a decision on approval can be made. The applicant will be required to address the Committee's comments and resubmit the relevant documents for further review.

Not Approved
The Committee has determined that the study does not meet the requirements for ethical approval.

The applicant will be notified of the Committee's decision and any associated comments or required actions through the Protocol Review System.

The Committee’s decision will typically be communicated to the researcher in writing within one week of the monthly ISERC meeting. The communication will include the Committee’s decision and, where applicable, specific comments or recommendations arising from the Committee’s review and reviewer feedback.

6. Responding to Reviewer and Committee Comments

Where revisions are required, applicants should respond to each comment individually and clearly indicate how the concern has been addressed.

A revised submission should generally include:

  • A revised protocol with tracked changes
  • A clean version of the revised protocol
  • A point-by-point response to the reviewers' and/or Committee's comments
  • Revised consent forms, data collection tools, or other supporting documents where applicable
  • Any additional documentation specifically requested by ISERC

Applicants should ensure that any changes made to the protocol are reflected consistently across all affected supporting documents.

7. Resubmission and Further Review

Revised applications should be submitted through the existing study record, using the study identifier originally assigned to the application.

The revised submission will undergo a further review before being reconsidered by ISERC. Applicants will subsequently be notified of the Committee's decision and any further actions required.

8. Amendments and Other Subsequent Submissions

Once a study has been approved, subsequent submissions relating to that study should be made through the existing study record. These may include:

  • Protocol amendments
  • Annual renewal/continuing review
  • Serious adverse event (SAE) or safety reports
  • Study closure/final reports
  • Other submissions requested by ISERC

The specific requirements for each submission type are provided in the relevant sections. See: Submission Guidelines, Forms and Templates, and Service Delivery Charter.