KENYATTA NATIONAL HOSPITAL/UNIVERSITY OF NAIROBI ETHICS AND RESEARCH COMMITTEE GUIDELINES FOR PROTOCOL DEVELOPMENT

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  1. Title

2 Investigators, co-investigators and supervisors where applicable.

Their addresses and signatures should be included.

The committee may require their curriculum vitae

3  Any collaborating institution(s).

4  Funding agency where applicable

5  Summary (Approximately 200-300 words, one paragraph)

6  a) Introduction/background

b) Literature review

7. Rationale

8. Hypothesis/Hypotheses/ study questions

9. Objectives

a)  Broad objective(s)

b)  Specific objectives

c)  Secondary objectives if applicable

10. Study design and Methodology

a)  Study design

b)  Study area description

c)  Study population (source and reference)

-Inclusion/exclusion criteria

d)  Sample size determination and formula used

e)  Sampling method

f)  Definition of cases/controls if applicable

g)  Recruitment and consenting procedures

h)  Data collection procedures (clinical and non clinical, field, data collection instruments)

i)  Variables – Dependent, Independent, Confounders

j)  Materials – equipment, suppliers, personnel

k)  Training procedures if any

l)  Quality assurance procedures

m)  Data collection instruments

n)  Study limitation

11. Ethical consideration

a) Consent explanation

·  Title

·  Introduction

·  Objectives of the study

·  Benefits

·  Risks

·  Compensation mechanism if any

·  Alternative treatments

·  Voluntarism

·  Type of specimens and amount to be obtained

·  Follow up schedules if applicable/expected time in the study

·  Information on researchers and telephone numbers in case to be contacted

·  Information on the KNH/UON/ERC in case they need to contact the committee (telephone numbers)

·  Any other necessary information about the study

·  Possible storage of specimen for further analysis with the permission form the KNH/UON/ERC

b) Consent form with signature page for the participant and witnesses

12. Data management and statistical analysis plans.

13. Study limitations and how to minimize them

14. Timeline/time frame

13. References

Use authors – Date system i.e. (Use internationally accepted format e.g. Vancouver format)

Note: If more than three authors, use et al after the third author.

14. Budget

  1. Personnel – salaries and salary disbursements
  2. Patient costs e.t.c
  3. Supplies and equipment
  4. Animal acquisition
  5. Travel and accommodation
  6. Transport – vehicles – repair, fuel.
  7. Operating expenses – postage, report writing e.t.c
  8. Consultancy if applicable
  9. Miscellaneous
  10. Contingency (%)

15. Appendixes for example:

·  Consent/assent explanation and consent form

·  Study instruments

·  Curriculum vitea

·  Funding information

·  Clinical procedures and references

·  Laboratory procedures and references

·  Maps where applicable

·  Special information e.g. educational materials

·  Others according t the study e.g. processes of pre-testing and post test counseling for special tests e.g. HIV

NOTE:

1.  KNH/UON/ERC would like you to report Severe Adverse Events (SAE) as soon as they occur not more than 72 hours. Contact the KNH/UON/ERC for further details.

Contact the KNH/UON/ERC for further details.

3. It is requirement that you get permission for transfer of materials from one lab to another for analysis – Material Transfer Agreement (MTA) between the laboratories involved.

4. The permission is given for one year only a renewal is necessary after receiving a satisfactory progressive report

5. A letter indicating the stoppage of the project and reasons

6. The committee might ask you to provide more information as need will arise.

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