KABARAK UNIVERSITY RESEARCH ETHICS COMMITTEE

ADULT INFORMED CONSENT FORM (TEMPLATE)

(The form is written in English language but can be translated to Kiswahili or any other
appropriate language)
STUDY TITLE______________________________________________________________
PI_________________________________ Affiliated Institution________________________
Co-investigator(s)____________________ Affiliated Institution(s)
________________________

INTRODUCTION
You are invited to participate in this research study being undertaken by the above listed
investigators. This form will help you gather information about the study so that you can
voluntarily decide whether you want to participate or not. You are encouraged to ask any question
regarding the research process as well as any benefit or risk that you may accrue by participating.
After you have adequately been informed about the study, you will be requested to either agree or
decline to participate. Upon agreeing to participate in the study, you will be further requested to
affirm that by appending your signature/thumbprint on this form. Accepting or declining to
participate in this study does not in any way waive the following rights which you’re entitled to:
a) Voluntary participation in the study;
b) Withdrawing from the study at any time without the obligation of having to give an
explanation and;
c) Access to services which you’re entitled to
A copy of this form will be provided to you for your own records
Should I continue YES/NO __________
This study has been reviewed and approved by Kabarak University Research Ethics Committee
(KUREC)
What is the Purpose of the Study?
The main reason(s) for conducting this study is to answer the following questions:
1…………………………………………………………………………………………..
2…………………………………………………………………………………………..
3…………………………………………………………………………………………..
(In order to answer these research questions, you are requested to voluntarily answer
question(s) and/or accept some procedures performed on you)
Who can Take Part in the Study?
Outline the inclusion and exclusion criteria
Specify the sample size
In Case You Agree to Participate in the Study, What Will Happen?
This is what is going to happen once you have agreed to participate in the study:
 First, include a statement about the time commitments of the research for the participant
including both the duration of the research and follow-up, if relevant.
__________________________________________________________________________
__________________________________________________________________________
_______________________________________________________________
 Second, a qualified and well-trained interviewer will ask you questions in a private place
where you will feel comfortable. In case there is any question you feel uncomfortable
responding to, you will not be coerced to respond. The questions will be on the following
areas: (list the areas below)
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
_________________________________________
● Third, after the interview, the following procedures will be done {detailed information on any
procedures to be undertaken by the investigator(s)}
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
● Last, you are requested to provide your contact details (phone number or any other reliable
form of contact). This will help reach you in case new information regarding the study
emerges. Other reason(s) for requesting your contact details is (are)
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
● The contact details you will provide shall remain confidential to the lead researcher (PI).

What Potential Risks are Associated with Participation in this Study?

Any research involving human subjects has the potential of imposing a number of risks/harms or
discomfort including psychological, physical, emotional, environmental, cultural etc.
{The risks depend upon the nature and type of study and the interventions. State and explain the risk to
the participant. Explain to the participant how this risk will be mitigated}
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
Privacy & Confidentiality
Privacy is the right of an individual to have some control over how his or her personal
information/data is collected, used, and/or disclosed. Confidentiality is the duty to ensure
information (data) is kept secret only to the extent possible/reasonable. {Explain to the participants
how privacy and confidentiality will be upheld. Explain to the participant any extra precautions,
you will take to ensure safety and anonymity. How well data will be handled and after how long
will the data be discarded and how the data will be discarded}
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
In case you aren’t comfortable answering any of the questions during the interview because of
feeling embarrassed or uncomfortable, it will be within your rights to decline. Otherwise every
measure has been taken to ensure that the interview is conducted in a private area with minimal
to no interference so that you feel comfortable.

In case of clinical procedures: You may experience some discomfort/pain after {State the
procedure} _______________________. This may even cause some {state the effects of the
procedure}
If at all you suffer any injury, illness or complication(s) by participating in this study, kindly
contact us immediately using the contact details provided at the bottom of this form. you will be
attended to by the study clinician and if there is need for further assessment or treatment you will
be referred accordingly
What Benefits are you Going to Accrue by Participating in the Study
{Benefits may be divided into benefits to the individual, benefits to the community in which the
individual resides, and benefits to society as a whole as a result of finding an answer to the
research question. Mention those that will be actual benefits not entitlements}
{Highlight the significance of the study}
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
What Will it Cost You to Participate in the Study?
{Will the participant incur any cost in order to participate in the study? Explain it clearly to the
participant}
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________

Will Any Expenditure that You Incur by Participating in the Study be Refunded? Or will
you be Paid for Participating in the Study? {Explain clearly to the participant whether or not
they will be reimbursed}
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
In Case I Have any Further Questions/ Concerns in Future Whom Should I Contact?
In the event that you need further clarification or questions regarding your continued participation
in the study feel free to contact the PI {Provide the contacts of the PI}. In case of concerns
regarding your rights and/or obligations as a research participant do not hesitate to contact the
secretary, KUREC on {KUREC contact}

What Alternative Options are Available to Me?

The decision on whether to participate or not is absolutely voluntary. You will be free to withdraw
from the study at any point during the study without providing any explanation.
How Will the Findings of this Study be Communicated or Shared?
{Provide a detailed plan of how feedback of the study findings will be given}
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________

Statement of Consent
I have comprehensively read the consent form or/the information has been comprehensively read
to me by the researcher. I have understood what the study is about and all the questions and
concerns that I had have been responded to in a clear and concise. The study benefits and
foreseeable risks have been explained to me. I totally understand that my decision to participate in
this study is voluntary and I have the right to withdraw at any point during the study.
I freely consent to participate in this study
Signing this form does not in any way imply that I have given up the rights am entitled to as a
participant
I agree to participate in this research YES___________ NO____________
I agree to provide my contact details for follow-up YES___________ NO ___________
Participant’s Name ___________________________________________________________

Participant’s Signature/Thumb print___________________ Date ______________________