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Annex C – Informed Consent for Client Exit Interview (FP counseling, Oral, Injectable

and Implant contraceptive clients)

Complete Informed Consent Information for Client Exit Interviews


Hello, my name is ____________________. I was given your phone number by the CP/PPMV
named ______________________ who works at the premise/shop _______________________
you visited recently for family planning services. You may recall that when you received the
services, the CP/PPMV told you about a study that is trying to understand women’s experiences
receiving family planning services from CPS/PPMVs.

Do you recall giving permission to the CP/PPMV for us to call you?


Yes No

(If NO,) I am sorry that you did not expect to receive this phone call from us today. Now
that I have you on the phone though, would you like to hear more about the study and then
decide whether you would like to participate in a survey? Yes No

I work with the Population Council, an international, non-profit, nongovernmental research


organization. You are invited to take part in a research study that is led by the IntegratE project
funded by Bill & Melinda Gates Foundation. Before you choose if you want to take part, we
need to explain this study, so you understand why it is being done and what you would do.
Please take the time to listen as I read the following information. You may talk to others about
the study if you wish. Please ask me if there is anything that is not clear, or if you would like
more information. When all your questions have been answered and you feel that you understand
this study, we will ask you if you want to take part. If you do, then you will provide verbal
consent to participate in the study and I will record your answer.

Purpose of the Study and Study Requirements


What is the study? The purpose of the study is to assess CPs and PPMVs in the delivery of
family planning services. We are particularly interested in your reasons for coming to
CPs/PPMVs for family planning services and your general experience for the family planning
service you received.

Why have I been invited to take part? You have been invited to take part because you opted to
receive family planning services at this CP or PPMV.

What will happen if I take part? If you agree to participate in the study, we will ask you to
provide verbal consent to participate in this study. You will be asked to answer questions in a
survey. I will ask you questions and will record your answers to these questions on a
tablet/computer. We will read the questions in English or [LOCAL LANGUAGES] and record
your answers in the computer. The survey contains questions about your age, marital status, and
education level. In addition, we will ask questions around family planning. Your opinions are
important for improving family planning services and for supporting our ability to identify gaps
in quality of services and improving the services clients receive.
We will contact you again in 6 months to conduct a similar survey over the telephone. If you
agree to participate, we would like to interview you once every 6 months for the year.

How long will the survey last? The survey today will last about 25-30 minutes.

Risks
What are the risks of the study? We believe that this study is safe and do not expect that you
will suffer any harm because of your participation in it. An inconvenience may be the time and
effort you take to be a participant. There is a slight risk that some of the questions that we ask
you are personal and may make you feel uncomfortable however, you may skip any questions
that you do not want to answer. Please note that we will not include your name or any other
information that could identify you in reports about this study. Furthermore, nobody will know
how you answer our questions, so please feel comfortable answering our questions honestly.

Benefits
What are the benefits of participating? There are no benefits to your participating in the study.
However, you may indirectly benefit from the opportunity to ask questions and discuss your
feelings and concerns. You will also have the opportunity to share what you know and your
experiences as a client. You may find an indirect benefit in knowing your participation has
generated knowledge and data that could be used to improve the availability of family planning
services to women like yourself.

Confidentiality
Will my participation in the study be kept confidential? The information that is collected
during the study is strictly confidential. The study team will make every effort to protect your
privacy and maintain the confidentiality of all the information that you provide. We will not
record your name and no one else except the research, monitoring and evaluation advisors will
be able to link the information to you. The following steps will be taken to promote your safety
and ensure that the information you provide to us is confidential:
1. The interview will take place in a private place, where no one else hears what you discuss
with me the interviewer.
2. Your name will not appear anywhere on the survey. Instead we will use identification
numbers to ensure anonymity and that your responses cannot be linked to you.
3. The name associated with the number assigned to each file will be kept under lock and
key and will not be disclosed to anyone except staff working on this study.
4. While information from this study may be used in publications or presentations, your
name and identifying information will never be shared with anybody. Any personal
information that could identify you will be removed before data files are made public.
5. You may talk to the leader of the research team in case you have any concern or
questions at any time.
6. The questionnaires will be destroyed within five years.

Additional Information
What will happen to the results of the research study? The results of the study will be
discussed with the Pharmacist Council of Nigeria, the regulatory body for PPMVs for
Ministry of Health and funders of family planning programs in Nigeria and will be
presented at other meetings and conferences. The results may be published in scientific
reports.

Who has reviewed the study for ethical issues? This study has been reviewed by the
National Health Research Ethics Committee, Nigeria and the Population Council’s
Institutional Review Board.

What if I need more information? If you have any concern about any aspect of the
study, you should ask to speak to the researchers who will do their best to answer your
questions. You can also contact Mr. Sikiru Baruwa, Population Council, Abuja, Nigeria
at 08033900631.
Any complaint about the way you have been treated during the study or any possible
harm you might suffer will be addressed. Please contact the IRB Secretariat at National
Health Research Ethics Committee, Nigeria (NHREC).; phone number: 08065479926.

Question: Do you have any questions? Yes No


(Please note the questions and provide responses.)

Consent to interview: Do you agree to participate in the interview? Yes No

Subject Statement: I have read the Informed Consent for this study. I have received an
explanation of the planned research, procedures, risks and benefits and privacy of my personal
information. I understand that my responses will be recorded and that my participation in this
study is my choice, and I agree to take part in this interview.

Your name:

Your signature: Date:

Investigator or person who conducted Informed Consent discussion: I confirm that I have
personally explained the nature and extent of the planned research, study procedures, potential
risks and benefits, and confidentiality of personal information.

Name of person obtaining consent:

Signature of person obtaining consent: Date:

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