Submissions

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Author Guidelines

The Tenwek Hospital Institutional Scientific and Ethics Review Committee (ISERC) receives research protocols for scientific and ethical review through this online submission system. Researchers are required to provide complete and accurate documentation to facilitate efficient review.

1. Acceptable Research Categories

Research submitted through the Tenwek Hospital ISERC Protocol Review System should fall within the scope of research that can be reviewed by the Committee. This may include:

  • Clinical and biomedical research
  • Public health and epidemiological research
  • Health systems and implementation research
  • Nursing, allied health and other health sciences research
  • Community and population health research
  • Qualitative and social/behavioural research related to health
  • Medical education and health professions education research
  • Research involving Tenwek Hospital patients, staff, services, records, facilities, or other institutional resources

If you are unsure whether your proposed research falls within the scope of ISERC review, please contact the ISERC Chairperson: ierc@tenwekhosp.org for guidance before submitting.

2.  The Research Protocol

The research protocol should provide sufficient information for the ISERC to assess the scientific merit, ethical considerations, risks and benefits, participant protections, and feasibility of the proposed research.

The protocol should generally include:

  • Title
  • Background and rationale
  • Problem statement
  • Research question(s) and/or objectives
  • Study design, setting and period.
  • Study population and eligibility criteria
  • Sample size and sampling procedures
  • Study / Data collection procedures
  • Data management and confidentiality
  • Ethical Considerations (Informed Consent, Protection of vulnerable populations where applicable, Potential risks and benefits of the study, Compensation of study Participants where applicable)
  • Plans for dissemination of findings
  • Funding and conflicts of interest
  • References
  • Relevant appendices and research instruments.

Applicants should use clear headings and consistent formatting throughout the protocol and ensure that all documents are internally consistent.

3. Supporting Documents

Depending on your study, supporting documents may be needed. These may include:

  • Application Forms
  • Participant information sheets and informed consent / assent forms
  • Data collection tools, questionnaires, or interview guides
  • Recruitment materials
  • Investigator CVs and relevant training documentation
  • Letters of permission or access, where applicable
  • ISERC Fee Payment Receipt
  • Other documents relevant to your study

Participant-facing documents should be written in clear, simple language appropriate for the intended participants. Where applicable, provide translated versions in the languages that will be used during recruitment and consent.

Please ensure that all supporting documents are complete, legible, and consistent with the information provided in the protocol.

Required forms and templates are available below. Please download and complete the form applicable to your submission type.

4. Forms and Templates

5. Existing Studies and Subsequent Submissions

For studies submitted through the Tenwek Hospital ISERC Protocol Review System, each submission will be assigned a unique study identifier. Subsequent submissions relating to the same study should be made through the existing study record rather than creating a new submission.

This applies to protocol amendments, annual renewals/continuing reviews, safety reports, study closure, and other subsequent submissions, where applicable. Using the existing study record helps maintain all related documents, correspondence, reviews, and decisions under the same study.

This process applies to studies submitted through the new online system. For studies previously submitted or approved through another process, please follow the instructions provided by ISERC.

6. File Preparation and Submission:

Please upload documents in Microsoft Word format, unless otherwise indicated. Documents requiring version control should clearly indicate the document title, version number, and date.

Please use clear file names, for example:

Protocol_MainStudy_v1.0.docx
ConsentForm_English_v1.0.docx
Questionnaire_v1.0.docx

 

 

Submission Preparation Checklist

ISERC Submission Checklist

1. New Protocol Application

Before submitting, please confirm that you have attached:

  • Complete research protocol, with all required sections completed as outlined in the Submission Guidelines.
  • Duly filled ISERC application form.
  • Participant information and informed consent forms, where applicable.
  • Assent forms, where applicable.
  • Data collection tools/instruments, where applicable.
  • Investigators’ CVs attached.
  • Relevant letters of permission/access, where applicable.
  • ISERC Fee Receipt Attached.

2. Protocol Amendment

  • Revised protocol with all proposed changes incorporated.
  • Point-by-point response to the previous ISERC comments/requests, where applicable.
  • Revised supporting documents, where applicable.
  • Revised consent/assent forms, where applicable.
  • Completed amendment application/form, where applicable.

3. Annual Renewal / Continuing Review

  • Completed continuing review/renewal application or report.
  • Current approved protocol or protocol version details.
  • Progress/status report, including recruitment status where applicable.
  • Relevant adverse event/safety information and protocol deviations, where applicable.
  • Any other documents required for the continuing review.

4. SAE / Safety Report

  • Completed SAE/safety report.
  • Relevant protocol/study details and current approval information.
  • ISERC approval letter, where applicable.
  • Relevant supporting clinical or safety documentation, where applicable.
  • Any other documents relevant to the reported event.

6. Study Closure

  • Completed study closure form/final report.
  • Current protocol/approval details.
  • Summary of the final study status, where applicable.

7. Expedited Review

  • Complete research protocol.
  • Completed ISERC application/submission form.
  • Justification/request for expedited review.
  • Participant information and consent/assent documents, where applicable.

Privacy Statement

Tenwek Hospital Institutional Scientific and Ethics Review Committee (ISERC) is committed to protecting the privacy and confidentiality of information submitted through the ISERC Protocol Review System.

Information collected through the system, including researcher details, research protocols, supporting documents, correspondence, and review records, will be used solely for the submission, review, management, and oversight of research applications.

Access to submissions and related records is restricted to authorized personnel, ISERC members, reviewers, and others who require access for legitimate review or administrative purposes.

Researchers should not upload identifiable participant information unless it is necessary for the ISERC review.

For questions regarding privacy or confidentiality, please contact the ISERC Secretariat at ierc@tenwekhosp.org or +254 728 091 900 Ext. 1680.