4.04 Informed Consent

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RESEARCH SUBJECT INFORMATION AND CONSENT FORM
TITLE:
Impact Evaluation of Health Results-Based Financing Program
SPONSOR:
World Bank
Washington, District of Columbia
United States
INVESTIGATOR:
Name
Address
City, State Zip
Country
SITE(S):
Name
Address
City, State Zip
Country
STUDY-RELATED
PHONE NUMBER(S):
Name
Telephone
This consent form may contain words that you do not understand. Please ask the study staff to explain any words or
information that you do not clearly understand. You may have a copy of this consent form and contact the study staff with
future questions.
PURPOSE
You are asked to participate in a research study. The study is conducted by the World Bank in cooperation with the
Government of XXX and Firm XXX. The purpose of the study is to better understand the conditions within your
community and household in order to improve available health programs and the health of individuals in your
community and household. You are being asked to participate in this study because you live in one of the communities
selected for the present study.
PROCEDURES
The study staff will come to your home to talk to you. You will give answers to a confidential questionnaire. The
questionnaire is designed to collect information about you and your family, your economic status and activities, your
family’s health, your mental well-being, and related topics.
The questionnaire also includes an anemia test, height and weight measurements for children under five years old. The
questionnaire will take approximately 2 hours of your time to complete.
About one year from now, someone will visit your house again to ask questions. This will take about 2 hours.
RISKS
You may feel uncomfortable answering some of the questions, which may gather information that is private.
BENEFITS
We hope to have a better understanding about current government services designed to improve community and
household wellbeing through your participation in the study. However, there may be no other direct personal benefits
for you from this research. However, the anemia test and height/weight results may provide information about your
child’s health.
PAYMENT FOR PARTICIPATION
You will not be paid for being in this study.
ALTERNATIVES
Your alternative is to not participate in this study.
CONFIDENTIALITY
Any information that is obtained in connection with this study and that can be identified with you will remain
confidential and will be disclosed only with your permission. Your responses can be linked to your personal
information only through a numeric code that will be kept secure and encrypted by the survey administrator. The study
will focus on the average answer within your community and not on individual answers. The honesty of your answers
is very important.
SOURCE OF FUNDING
Funding for this research study is provided by the World Bank.
VOLUNTARY PARTICIPATION AND WITHDRAWAL
Your participation in this study is voluntary. You may decide not to participate or you may leave the study at any time.
Your decision will not result in any penalty or loss of benefits to which you are entitled.
Your participation in this study may be stopped at any time by the study staff or the sponsor without your consent for any of
the following reasons:

if it is in your best interest;

or for any other reason.
QUESTIONS
If you have any questions, please feel free to ask the interviewer at any time during the interview.
Contact
at
if you have any questions about your participation in this study,
Do not agree to be in this research unless you have had a chance to ask questions and have received satisfactory
answers to all of your questions.
CONSENT
I willingly agree to participate. I may withdraw my consent at any time and stop participation without penalty. All my
questions about the study and my participation in it have been answered.
By agreeing to be in this research, I have not given up any of my legal rights.
Your signature or mark indicates your acceptance to voluntarily participate in this study.
Participant name:
Date:
Day / Month / Year
Signature or Mark:
Person Conducing Informed
Consent Discussion Name:
Date:
Day / Month / Year
Signature:
RESEARCH SUBJECT INFORMATION AND CONSENT FORM
PARENTAL CONSENT FOR CHILD ANEMIA AND MALARIA TEST
TITLE:
Impact Evaluation of Health Results-Based Financing Program
SPONSOR:
World Bank
Washington, District of Columbia
United States
INVESTIGATOR:
Name
Address
City, State Zip
Country
SITE(S):
Name
Address
City, State Zip
Country
STUDY-RELATED
PHONE NUMBER(S):
Name
Telephone
This consent form may contain words that you do not understand. Please ask the study staff to explain any words or
information that you do not clearly understand. You may have a copy of this consent form and contact the study staff with
future questions.
PURPOSE
You are asked to participate in a research study. The study is conducted by the World Bank in cooperation with the
Government of XXX and Firm XXX. The purpose of the study is to better understand the conditions within your
community and household in order to improve available health programs and the health of individuals in your
community and household. You are being asked to participate in this study because you live in one of the communities
selected for the present study.
PROCEDURES
Your child will be tested for anemia and malaria. This requires a prick on the finger (one or two drops of blood). Your
child will also be weighed and measured.
RISKS
There may be discomfort during the finger prick. There is also a risk of bruising, or temporary change in skin color and
possibly infection.
BENEFITS
There is no guarantee that your child will receive any medical benefits from being in this study. Your child may benefit
from learning about the results of the tests involved in this study. We also hope to have a better understanding about
current government services designed to improve community and household wellbeing through your participation in
the study.
PAYMENT FOR PARTICIPATION
You will not be paid for being in this study.
ALTERNATIVES
Your alternative is to not be in this study.
CONFIDENTIALITY
The results will only be given to others with your permission. The test results can be linked to your child’s information
only through a numeric code that will be kept secure and encrypted by the survey administrator. The study will focus
on the average answer within your community and not on individual answers. The honesty of your answers will be
very important in ensuring the validity of the study.
SOURCE OF FUNDING
Funding for this research study is provided by the World Bank.
VOLUNTARY PARTICIPATION
Your child’s participation in this study is voluntary. You may decide not to participate (allow your child to participate)
or you may leave the study at any time. Your decision will not result in any penalty or loss of benefits to which
you/your child are entitled.
QUESTIONS
If you have any questions, please feel free to ask the interviewer at any time during the interview.
Contact
at
if you have any questions about your participation in this study,
Do not agree to be in this research unless you have had a chance to ask questions and have received satisfactory
answers to all of your questions.
CONSENT
I willingly agree to allow my child to participate. I may withdraw my consent at any time and stop participation
without penalty. All my questions about the study and my/my child’s participation in it have been answered.
By agreeing to be in this research, I have not given up any of my/my child’s legal rights.
Your signature or mark indicates your acceptance to voluntarily participate in this study.
Child name:
__________________________________________________
Legally Authorized
Representative Name:
Date:
Day / Month / Year
Signature or Mark:
________________________________________________________________________
Authority of Subject’s Legally Authorized Representative or Relationship to Subject
Person Conducing Informed
Consent Discussion Name:
Date:
Day / Month / Year
Signature:
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