Principal Investigators, Co-Investigators and Supervisors where applicable

  -Their addresses and signatures should be included

  -Role of investigators/supervisors as applicable

  -The committee may require their curriculum vitae

Funding agency where applicable

-The committee may require their curriculum vitae   

Literature review including conceptual/theoretical framework

Study questions, hypothesis where applicable

Objectives/Aims:

   a. Broad objective(s)/overall goals

   b. Specific objectives

   c. Secondary objectives if applicable

Methodology:

  a. Study design

  b. Study area description

      -Specific study site

  c. Study population

      -Population characteristics

      -Definition of cases/controls if applicable

      -Inclusion/exclusion criteria

   d. Sample size determination and formula/computer programme used (assumptions  and reference)

   e. Sampling procedure/screening/selection of study participants   

   f. Recruitment and consenting procedures

  g. Variables – dependent, independent, confounders where applicable

  h. Data collection procedures (qualitative and quantitative data, field data collection

     instruments, laboratory procedures etc)

  i. Materials – equipment, supplies etc

  j. Training procedures where applicable

  k. Quality assurance procedures

References 

- Use internationally accepted format e.g. Vancouver, Harvard, American Psychological Association (APA) etc. must maintain format consistency

Budget and budget justification

-Consider coverage of such areas as Personnel, Salaries and Salary disbursements, Training costs, Participants service costs, Supplies and equipment, Animal acquisition where  applicable, Travel and accommodation, Transport – vehicles – repair, fuel, Operating expenses – postage, report writing etc., Consultancy if applicable, Dissemination, Miscellaneous, Contingency (%)

Appendices for example:

A. Informed Consent/ Assent Explanation and Consent Form

1. Consent explanation (to include details on the following):

1. Title of study
2. Investigators, their contacts and roles
3. Study introduction,
4. Purpose of the study 
5. Study procedures
6. Role of the participant
7. Type of specimens and amount to be obtained where applicable
8. Possible storage of specimen for further analysis  with the permission from the KNH-UoN ERC
9. Follow up schedules if applicable/expected time in the study
10. Benefits
11. Risks and discomforts
12. Confidentiality
13. Study participants should consent for storage, transportation of their samples between laboratories and use of the samples for future research (specific areas require consent)
14. Research related injuries and compensation (where applicable)
15. Reimbursement mechanism
16. Alternative treatments (where applicable)
17. Voluntary participation
18. Information on researchers and telephone numbers in case of any questions
19. KNH-UoN ERC Secretary Contact telephone numbers  2726300 ext. 44102, email uonknh_erc@uonbi.ac.ke
20. Any other necessary information about the study

(Click for the consent explanation template)

II) Consent form to include investigators and participant statement with signature page

(Click for consent form template)

More information to researchers

1. Severe Adverse Events (SAE) should be reported to the KNH-UoN ERC within 72 hours as per the approved format. 

(Click for the SAEs form)

2.Protocol violations/deviations should be reported to KNH-UoN ERC as soon as they occur.

(Click for the update form)

3.KNH-UoN ERC approval is required for transfer of materials from one laboratory   to another for analysis.

(Click for  the transfer of materials form)

4.The KNH-UoN ERC approval is given for one year only.  The researcher is required to officially request for renewal at least 60 days to the expiry of the current approval and provide a detailed progress report for the preceding year.

(Click for the update form)

5. KNH-UoN ERC will make study site visits as and when deemed necessary.

6. The Principal Investigator must provide the executive study summary and a list of publications to KNH-UoN ERC of the at the end of study. 

7. The Principal Investigator must provide study closure report if the study ceases to continue for whatever reason.

Click for the Study Closure Application Form

Click for the study closure policy form

Guidelines for protocol development and submission.pdf