Respect for Persons
Acknowledging autonomy and protecting those with diminished autonomy through informed consent processes
Beneficence
Maximizing potential benefits while minimizing risks and harms to research participants
Justice
Fair distribution of research burdens and benefits across all populations
Confidentiality
Protecting participant privacy and ensuring secure handling of sensitive information
Informed Consent Requirements
Guidelines for obtaining valid informed consent from research participants
- Use language at class 6/8 level
- Avoid exculpatory language
- Include information sheet and consent certificate
- Provide copy of full ICF to participants
- Obtain witness signature for illiterate participants
Vulnerable Populations
Special protections for research involving vulnerable groups
- Children: Parental consent + child assent (7-18 years)
- Pregnant women: Additional safeguards
- Prisoners: Independent advocate required
- Mentally disabled: Surrogate consent with witness
- Economically disadvantaged: Avoid undue influence
Risk-Benefit Assessment
Framework for evaluating risks and anticipated benefits
- Identify all potential risks and discomforts
- Describe plans to prevent/mitigate risks
- Specify care available for harm
- Clearly state benefits (individual/community/society)
- Ensure risks are justified by potential benefits
Data & Sample Management
Guidelines for handling research data and biological samples
- Secure storage of consent forms
- Password-protected electronic data
- Limited access to authorized personnel
- Specify sample storage duration
- Obtain separate consent for sample storage
Adverse Event Reporting
Procedures for reporting and managing adverse events
- Minor AEs: Report within stipulated period
- Serious AEs: Report within 24 hours
- Include action taken details
- Document occurrence date and relationship to study
- Submit copies of adverse reports
Protocol Modifications
Requirements for amending approved research protocols
- Obtain SERC approval before implementation
- Submit revised proposal with tracked changes
- Provide clean copy of revised proposal
- Justify reasons for modifications
- Report changes in investigators
All research proposals submitted to TMU-SERC must include the following documentation:
- Fully completed application form with all sections filled
- Research protocol detailing objectives, methodology, and analysis plan
- Informed consent form(s) in appropriate language(s)
- Data collection tools (questionnaires, interview guides, etc.)
- Curriculum vitae of principal investigator and co-investigators
- Approval from relevant departmental/school committees
- For clinical trials: Investigational brochure, insurance documents
- For externally sponsored research: Material Transfer Agreement (MTA)
- Evidence of scientific review and approval
Language Requirements
All documents should be submitted in English. Consent forms must be available in languages understood by participants (English, Kiswahili, or local languages).
The SERC review process follows a structured timeline to ensure thorough evaluation:
- Submission & Initial Screening (3-5 days): Administrative check for completeness of documentation
- Primary Review (7-10 days): Assignment to primary and secondary reviewers
- Committee Review (14-21 days): Full committee discussion at scheduled meeting
- Decision Communication (3-5 days): Notification of approval, revisions required, or rejection
- Resubmission Review (7-14 days): Expedited review for revised applications
Expedited Review: Available for minimal risk studies or minor amendments (7-10 days total).
Full Board Review: Required for greater than minimal risk studies, vulnerable populations, or clinical trials.
Approved studies require ongoing monitoring and reporting:
- Annual Progress Reports: Submit within 30 days of approval anniversary
- Self-Assessment Form: Complete with each progress report
- Study Completion Report: Submit within 90 days of study completion
- Renewal Applications: Submit at least 60 days before approval expiry
- Protocol Deviations: Report within 7 days of occurrence
- Unanticipated Problems: Report within 24-48 hours
Site Monitoring Visits
SERC may conduct periodic site visits to verify compliance with approved protocols. Researchers must maintain all study documents for at least 5 years after study completion.
Guidelines for participant compensation and reimbursement:
- Reimbursement for actual expenses (travel, lost wages) is permissible
- Compensation should be reasonable and not constitute undue influence
- Clearly state compensation details in the consent form
- Research-related injury treatment: Specify who provides and pays
- Insurance coverage required for clinical trials
- No exculpatory language waiving legal rights for compensation
Prohibited Practices
Avoid excessive or inappropriate rewards that may coerce participation. All compensation must be approved by SERC and documented in the consent form.
Requirements for externally sponsored or collaborative research:
- Must have local co-investigator from Kenya
- Approval from ERC/IRB in sponsoring country required
- Justification for conducting research in Kenya
- Post-research benefits to Kenya must be acceptable
- Intellectual property sharing provisions must be fair
- Material Transfer Agreement (MTA) for biological samples leaving Kenya
- Compliance with local laws and cultural sensitivities
- Responsive to local health needs and priorities
Data Transfer
If data or biological materials are transferred overseas, provisions must safeguard participant interests and protect intellectual property rights.
NACOSTI Compliance
TMU-SERC operates under the regulatory framework of the National Commission for Science, Technology, and Innovation (NACOSTI). All research conducted at Tom Mboya University must comply with the Science, Technology and Innovation Act (2013) and NACOSTI guidelines.
Visit NACOSTI Website
ICH Good Clinical Practice Guidelines
Principal investigators are advised to always refer to the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines when developing research protocols and informed consent forms.
ICH GCP Guidelines
