Annex 1: INFORMED CONSENT IN ENGLISH

1. BRIEFING NOTE FOR RESEARCH PARTICIPANTS

R-SWITCH: Research to improve the screening for wasting and the identification and
treatment of wasted children
Investigators : Tefera Belachew, Lieven Huybregts
Promotor : Ethiopian Public Heath Association, International Food Policy Research Institute

You have been invited to participate in a research study on acute malnutrition, which is very common
among young children in this region. This information note and consent form explain the purpose, tests,
benefits, risks, and potential harms of this study. They also state that you have the right to withdraw your
consent at any time and to ask questions, for example, about the possible benefits and risks of this study.
Your participation must be completely voluntary. You are free to talk about this research with anyone you
feel comfortable with and you can take as much time as you need to think about your decision. If you agree
to participate in the study, be sure to keep this background information throughout the study.

PURPOSE AND DESCRIPTION OF THE STUDY

This program evaluation is being conducted to gather more information on the prevention and treatment
of severe acute malnutrition. When a child is underweight for his or her height, he or she is more vulnerable
and susceptible to illness. Seere acute malnutrition prevents children from growing well and developing
their brains. In addition, the child becomes too fragile and easily catches diseases that can be costly and
can eventually die.
In certain randomly selected kebeles of the Kersa and Jeldessa woredas, UNICEF and the MoH are
collaborating with HEW, AFD and the community to conduct the R-SWITCH program. This program, aims
to better prevent severe acute malnutrition in children and to improve the screening (identification) and
follow-up of malnourished children so that more children can receive the free treatment provided by the
HEW at the health post and healthcenter level.

The partnership between EPHA and IFPRI will carry out the evaluation of this program in Kersa and Jeldessa
woredas. For this purpose, we will screen all children 6-59 months of age for severe acute malnutrition
(SAM) in both woredas. Households with a SAM child or a child enrolled into a SAM treatment program
will be invited to participate into this study. Your child is therefore possibly eligible to be part of the sample
for this survey.

CONDUCT OF THE STUDY

If you agree on participation and your child meets the conditions for participation, we will ask the
mother/guardian, father, and head of household questions about your household, your children, your
activities, and your family's diet. The interview will take maximal 2 hours. You will have the right to refuse
to answer certain questions if they make you too uncomfortable.
We will also ask questions about your child's diet, health and your contact with health services. If your child
has had a fever in the past 48 hours, we will draw a drop of blood from your child, to immediately do the
rapid diagnostic test for malaria. This is a procedure that is not very painful and will in no way harm your
child.

RISKS AND DISADVANTAGES

There are no particular risks for a child, his/her mother/legal guardian and household to participate in the
study. On rare occasions, the rapid diagnostic test for malaria may be painful and may, at times, result in
bruising instead of pricking. All precautions for asepsis, handling and treatment of biological waste will be
taken and samples will be taken by trained personnel, so the risk of infection will be minimal. In particular,
good clinical practices will be followed.

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Annex 1: INFORMED CONSENT IN ENGLISH

BENEFITS
With this survey, participants will be able to benefit from access to free screening for malaria and acute
malnutrition. All participants will be informed immediately of their test results.
In the event that your child is diagnosed with severe acute malnutrition or a danger sign during the
recruitment interview or a monthly follow-up visit, we will refer your child to the nearest health post to be
enrolled into SAM treatment.

COMPENSATION
There is no cost to you for the exams related to your participation in the study. Apart from the benefits
already described above, we offer a small compensation of 150 birr for your participation in this survey.

PROTECTING YOUR PRIVACY

We will take all possible steps to protect your privacy. All field staff, both interviewers and supervisors, will
be trained to maintain data confidentiality. The information we collect about you and your child's visits to
the health post or health center will not be shared with anyone except the study researchers. By assigning
a unique code to your personal information, your identity is kept secret. Your name will not appear in any
report or publication resulting from this study. Once the data collection is completed, any personal
information collected about you, your household and your child (name, address, telephone number) will
be erased in order to anonymize the data.

ETHICS COMMITTEE
The study protocol and the conduct of this study is arrpoved by the Institutinal Review Board (IRB) of the
Ethiopian Public Health Association and the IRB of the International Food Policy Research Institute These
Ethics Committees also exercise ongoing oversight to ensure that the study is conducted in the safest
possible manner.

VOLUNTARY PARTICIPATION
Your participation in this study must be completely voluntary. It is up to you to decide whether or not you
wish to participate. Your decision to participate or not will will not change your access to health and
nutrition services. You also have the right to stop your participation at any time, even after signing this
informed consent form. You are not required to explain why you wish to stop participating in the study.
The study investigator may also stop your participation at any time, even without asking your permission,
if he or she believes that it is in your own best interest or if you do not follow the instructions to participate
in the study.

CONTACT PERSON IF YOU HAVE ANY QUESTIONS ABOUT THE STUDY

If you have any questions about participating in this study, you can contact us now, during or after the
study:
- Study cotact: Prof Tefera Belachew, contact: +251917804072
- IRB of the Ethiopian Public Health Association: Mariamawit Sedika, Telephone: +2511416 60 86
- IRB of the International Food Policy Research Institute (Washington, DC). Attn: Olivette Burton-
1201 Eye Street, NW Washington, DC 20005-3915 E-mail: ifpri-irb@cgiar.org

Final remark
Finally, before you decide to participate in this study, we would like to ask you if you all understand what
has been explained to you. If you still have questions, now or later, please do not hesitate to ask us.

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Annex 1: INFORMED CONSENT IN ENGLISH

2. INFORMED CONSENT FORM

R-SWITCH: Research to improve the screening for wasting and the identification
and treatment of wasted children

Part reserved exclusively for the participant or his legal representative

I, the undersigned, certify that I have been informed about the study and have received a copy of the
information note for research participants and the informed consent form. I have read and understood the
information. I have received sufficient information about the conditions, duration and consequences of
the study. In addition, I was given sufficient time to reflect on the information provided to me and to ask
questions, to which I received satisfactory answers. I freely consent to participate in this study and agree
to cooperate in the required examinations/activities.

Date :

Name :

Signature (or fingerprint) of the participant (or his/her legal representative) :

…………………………………………...
__________________________________________________________________________________
Date :

Witness name (if necessary):…………………………….. .…… ... .

Signature of witness (if required) :

Part intended exclusively for the investigator's team

I, the undersigned, ………………………………………confirm that I have informed the participant (and/or his/her
legal representative) of all relevant aspects of this study. I confirm that he/she voluntarily consented to
participate in the study.

Date: ..... ……………………………

Signature :………………………….……

Revision history: Template version 1.0

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Annex 1: INFORMED CONSENT IN ENGLISH

INFORMATION NOTE FOR HEALTH EXTENSION WORKERS AND AFD LEADERS

R-SWITCH: Research to improve the screening for wasting and the identification and
treatment of wasted children

Investigators : Tefera Belachew, Lieven Huybregts

Promotor : Ethiopian Public Heath Association, International Food Policy Research

You have been invited to participate in a research study on acute malnutrition, which is very common
among young children in this region. Before deciding whether or not to participate in this study, it is
important that you understand the information in this form, which specifies your rights and responsibilities.
This information note and consent form explain the purpose, tests, benefits, risks, and potential harms of
this study. They also state that you have the right to withdraw your consent at any time and to ask
questions, for example, about the possible benefits and risks of this study. Your participation must be
completely voluntary. You are free to talk about this research with anyone you feel comfortable with and
you can take as much time as you need to think about your decision. If you agree to participate in the study,
be sure to keep this background information throughout the study.
PURPOSE AND DESCRIPTION OF THE STUDY
This program evaluation is being conducted to gather more information on the prevention and treatment
of severe acute malnutrition. When a child is underweight for his or her height, he or she is more vulnerable
and susceptible to illness. Seere acute malnutrition prevents children from growing well and developing
their brains. In addition, the child becomes too fragile and easily catches diseases that can be costly and
can eventually die.
In certain randomly selected kebeles of the Kersa and Jeldessa woredas, UNICEF and the MoH are
collaborating with HEW, AFD and the community to conduct the R-SWITCH program. This program, aims
to better prevent severe acute malnutrition in children and to improve the screening (identification) and
follow-up of malnourished children so that more children can receive the free treatment provided by the
HEW at the health post and healthcenter level.
The partnership between EPHA and IFPRI will carry out the evaluation of this program in Kersa and Jeldessa
woredas. For this purpose, we will screen all children 6-59 months of age for severe acute malnutrition
(SAM) in both woredas. Households with a SAM child or a child enrolled into a SAM treatment program
will be invited to participate into this study. Your child is therefore possibly eligible to be part of the sample
for this survey.

CONDUCT OF THE STUDY

If you agree to participate in this study and meet the conditions for participation, we will ask you questions
about your activities, training, knowledge and satisfaction as a HEW. The interview will last approximately
45 minutes. You will have the right to refuse to answer certain questions if they make you too
uncomfortable.

RISKS AND DISADVANTAGES

There are no risks or disadvatanges associated with study participation.

BENEFITS AND COMPENSATION

We will not compensate you for your participation in this survey. However, with the project, community
health workers in all villages will benefit from UNICEF’s technical and material support to the health system

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Annex 1: INFORMED CONSENT IN ENGLISH
and the community to improve the prevention, detection and treatment of child malnutrition. This support
will benefit children throughout the health district.

PROTECTING YOUR PRIVACY

We will take all possible steps to protect your privacy. All field staff will be trained to maintain data
confidentiality. The information we collect about you will not be shared with anyone except the study
researchers. Through the assignment of a unique code to your personal information, your identity is kept
secret. Your name will not appear in any report or publication resulting from this study.

ETHICS COMMITTEE
The study protocol and the conduct of this study is arrpoved by the Institutinal Review Board (IRB) of the
Ethiopian Public Health Association and the IRB of the International Food Policy Research Institute These
Ethics Committees also exercise ongoing oversight to ensure that the study is conducted in the safest
possible manner.

VOLUNTARY PARTICIPATION
Your participation in this study must be completely voluntary. It is up to you to decide whether or not you
wish to participate. World Vision's support at the community level will not be influenced by your decision
to participate or not, it will remain the same.
You also have the right to stop your participation at any time, even after signing this informed consent
form. You are not required to explain why you wish to stop participating in the study. The study investigator
may also stop your participation at any time, even without asking your permission, if he or she believes
that it is in your own best interest or if you do not follow the instructions for participating in the study.

CONTACT PERSON IF YOU HAVE ANY QUESTIONS ABOUT THE STUDY

If you have any questions about participating in this study, you can contact us now, during or after the
study:
- Study cotact: Prof Tefera Belachew, contact: +251917804072
- IRB of the Ethiopian Public Health Association: Mariamawit Sedika, Telephone: +2511416 60 86
- IRB of the International Food Policy Research Institute (Washington, DC). Attn: Olivette Burton-
1201 Eye Street, NW Washington, DC 20005-3915 E-mail: ifpri-irb@cgiar.org

Final remark
Finally, before you decide to participate in this study, we would like to ask you if you all understand what
has been explained to you. If you still have questions, now or later, please do not hesitate to ask us.

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Annex 1: INFORMED CONSENT IN ENGLISH

INFORMED CONSENT FORM HEALTH EXTENSION WORKERS AND AFD LEADERS

R-SWITCH: Research to improve the screening for wasting and the identification
and treatment of wasted children

Part reserved exclusively for the participant or his legal representative

I, the undersigned, certify that I have been informed about the study and have received a copy of the information
note for research participants and the informed consent form. I have read and understood the information. I have
received sufficient information about the terms and duration of the study. In addition, I had sufficient time to reflect
on the information provided to me and to ask questions, to which I received satisfactory answers. I freely consent to
participate in this study.

Health Post area: ______________________

Date :
Name :

Participant's signature: ………………………………………….

Name of signatory :

Part intended exclusively for the investigator's team

I, the undersigned, ………………………………………confirm that I have informed the participant (and/or his/her
legal representative) of all relevant aspects of this study. I confirm that he/she voluntarily consented to
participate in the study.

Date: ..... ……………………………

Signature :………………………….……

Revision history: version 1.0

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