Director of Medical Education & Research
Tel: 02-3204-6500 Cell:0733-777680
Fax: 02-3204-6355
Email:[email protected]
[email protected]
Research Request Form
Date: ___________________
Principal Investigator: _________________________________________________________________
Address:____________________________ _______________________________________________
Mobile number:________________________________________________________________________
Email address: ________________________________________________________________________
Human Subjects Training Yes____________ No______________
Co- Investigator (if applicable): ____________________________________
Address:________________________________________________________________________
Mobile number:_________________________________________________________________
Email address: _________________________________________________________________
If other co-investigators, please attach information.
PI CV and Co-I CV(s) to be attached
Supervisors: External _______________________ Kijabe Hospital __________________________
PROTOCOL
Research Question:
Institution(s) where study to be done (Approval required from the institution(s) where it will be conducted):
Background/ significance: Please attach a relevant literature review.
Methodology
Study Design:
Study population: (including 1-- what department involved; 2-- are any of the population considered
vulnerable (such as children, minors, pregnant women, economically and educationally disabled, prisoners,
etc.)
How subjects will be recruited (include any flyers or other types of promotion):
Sampling method: (check if randomization used ____ )
Sample size:
Data collection method:
Study period:
Explain the Safety Monitoring Plan for the study:
Ethical issues addressed (including informed voluntary consent (attach any form used)):
o Consent form in plain (Grade 5) English and simpleKiswahili, including:
title of the research study
name of researcher (PI) with contact info
contact information for the KH IERC Office (if the subject has questions about
the subject’s rights as a research subject or to report research-related problems)
purpose of data collection/ research and its general value and individual benefits
for the participant
explanation of all procedures used in the research and why
participants’ part in the research including the amount of time and energy the
research/data collection will take.
any possible risk/ pain/ discomfort/ stress or loss of dignity that the participant
may experience.
how privacy, confidentiality and anonymity will be guarded.
manner in which the results will be used
participant’s right to refuse to take part and their right to withdraw without any
penalty at any point during the process.
o Any questionnaires used (required!) to be attached
o Conflicts of interest—Do any investigators have conflicts of interest (personal or
financial)? ______ No _______ Yes. If Yes, please explain in detail any financial or
personal relationships with the sponsor, product (drug, device, etc.) or institution such as
receiving financial compensation for conducting the research or an investigator or his/her
close family member having a financial interest in the product. Attach the explanation to
the research request form.
What benefit do you anticipate to the hospital or patient care?
o Consent documents approved by the KH IERC include information for
contacting the PI should the subject have questions or research-related
How will confidentiality and anonymity be maintained?
Source of Funding
Budget
Principal Investigator’s Signature __________________________ ____________
Date
CHECKLIST
Please make sure that ALL of the items below have been fulfilled. The KH IERC Committee will NOT
be able to review your proposal until all these items are completed.
1. For a research project that is NOT a thesis or an academic requirement:
□Research Request Form filled completely
□Required CVs, questionnaires, consent forms, conflict-of-interest, etc., attached
□Materials submitted in soft copy by email to
[email protected] or
[email protected] □LOCAL (Kijabe Hospital) research supervisor in addition to the external supervisor. This can be
any senior person in the respective department, who has previous research experience.
2. For a research project that is a thesis or an academic requirement:
□Research Request Form filled completely
□Required CVs, questionnaires, consent forms, etc., attached
□Study proposal/protocol and/or thesis proposal/protocol submitted in soft copy by email to
[email protected] or
[email protected] □The proposal MUST include the following headings:
o Literature review (if needed for academic requirement)
o Study aim and specific objectives
o Methodology, including design, sampling, and detailed statistical analysis
o Ethical considerations, incl. informed consent, confidentiality, anonymity
o Timeline and expenses
o Population
o References/Bibliography(if needed for academic requirement)
o Any questionnaires used (required!)
o Consent form in plain (Grade 5) English and Kiswahili
LOCAL (KijabeHospital) research supervisor in addition to the external supervisor. This can be
any senior person in the respective department, who has previous research experience.
TIMELINE: please note that the KH IERC Committee needs on average one month
advancenotice before a decision is made. DO NOT schedule your project to start less than
one month after the completed proposal is submitted!
