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

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

helb disbursement 2016/17  - 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
a.    Personnel – salaries and salary disbursements
b.    Patient costs e.t.c
c.    Supplies and equipment
d.    Animal acquisition
e.    Travel and accommodation
f.    Transport – vehicles – repair, fuel.
g.    Operating expenses – postage, report writing e.t.c
h.    Consultancy if applicable
i.    Miscellaneous
j.    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. 


With the information we provide about   helb disbursement 2016/17

, We hope you can be helped and hopefully set a precedent with you . Or also you can
see our other references are also others which are not less good about CURRICULUM VITAE


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