Far Eastern University

Institute of Nursing
Graduate Studies

[Informed Consent Form for male patients with Systemic Lupus Erythematosus]
This informed consent is for male patients with systemic lupus erythematosus and who are invited to
participate in research, titled Lived Experiences of Men with Systemic Lupus Erythematosus: A
Qualitative Study
This Informed Consent Form has two parts:
Information Sheet (to share information about the study with you)
Certificate of Consent (for signatures if you choose to participate)
You will be given a copy of the full Informed Consent Form
Part I: Information Sheet

I am, Hearty Joy A. Que, a masters student of Far Eastern University specializing in
Medical Surgical Nursing, Manila. I am doing research on the disease systemic lupus
erythematosus among male patients which is an emerging in this country. I am going to
give you information regarding the study and invite you to be part of this research. You
may take time to decide whether or not to participate in the research. You may talk to
someone that you feel comfortable to talk with about the research before you decide. In
this consent form you may find words that you do not understand. Please, ask for my
assistance and I will be glad to take time to explain. If you have questions to ask later,
you can ask me about it or you can ask another researcher.
Systemic Lupus Erythematosus or lupus is a disease that is can affect few people,
affecting women more than men. By means of telling us your experiences about living
with the disease, I believe that you can help me by means of telling me what you
experience having the disease. Your experience will be a basis to lead us to know about
what to do, what we should know about male patients with lupus.
This research will involve one-on-one interview with you by me that will take for about
45minutes to one hour.

This research wants to know the experiences of male patients with lupus; you are invited
because I believe that you are of much understanding of living with the disease.
Your entire participation would be voluntary; any changes in your choice will
be respected whether you choose to continue or not.

I am inviting you to be part of this research study. If you accept, you will be asked to

describe what is your experiences living with the disease, what are your feelings, and
thoughts regarding the disease.
The one that will be conducting the interview will be me. During the interview
I will accompany you to a comfortable place that you will choose and will be
sitting down with you. If you think it is better and you feel comfortable at
your home or with a friends home, the interview will take place in there. You
and I will only be present in the interviews place. If you are not comfortable
without someone by your side it is possible to bring someone with you. You
can ask questions if the questions being asked are not clear. If in case I ask
uncomfortable questions to you and you dont want to share about it, then I
will not ask you to share about it. Personal beliefs and practices or stories will
not be ask if sharing it will make you uncomfortable sharing it. The entire
interview will be recorded using audio-recorder, no name will be placed in the
CD. The CD will be kept in a locker that only I can access. The collected
information will be kept confidential by the researcher and no one else. The
CDs will destroyed after 12 weeks after the data collection.

The researcher takes place over 2 and a half months in total. During that time, I will visit
you 4 times in a month and the interview will last for 45 minutes to 1 hour each.
I may have asked you to share with me some of the very personal and confidential information,
and you may feel uncomfortable talking about some of it. If in case you may encounter some that
you dont want to answer, it will be respected. You are not obliged to tell the reason for not
answering to the question, or even if you refused to be part of the interview.

The benefit of this research to you may not beneficial, but participating is likely to help
me give meaning to your experiences that may help to provide a basis to the
understanding of your experiences in our field.
You may not have any incentive in taking part in the research. Nevertheless, I will give you
money for giving me your time to be involved in the research, and travel expenses.

Information that will be collected will kept privately and I will not be sharing information
to anyone. Instead of using your name in the information about you, I will be using
numbers to represent you. Only me will know everything about you and will be lock in a
locker with lock and key. It will not be shared to anyone except for your rheumatologist.
Everything you shared to me will not be shared with anyone except your rheumatologist.
The knowledge that will be gathered in this research will only be made available to the
public. You will receive a summary of the results and this is applicable to all of the
participants. I will publish the results to other interesting people so that they will gain
knowledge about the research.
You will not take part of the research if you will do not want to; choosing to participate will not
affect your job. If you wish to stop from participating in the interview at any time you wish. At
the end of the interview, I will give you opportunity to review your remarks, and you can change
or remove portions that are not agreeable to you my notes.

If there are questions, you can ask them now or later. If in case you want to ask questions
later, you can contact any of the following: [Hearty Joy A. Que, Sampaloc, Manila/
09261815896/ heartyjoyq@yahoo.com]. This proposal has been reviewed and approved by FEU
local ethics board, which is a committee whose task it is to male sure that research
participants are protected from harm. If you wish to find about moer about the IRB,
contact
.
This proposal has been reviewed and approved by [name of
the local IRB], which is a committee whose task it is to make
sure that research participants are protected from harm. If
you wish to find about more about the IRB, contact [name,
address, telephone number.]). It has also been reviewed by the
Ethics Review Committee of the World Health Organization
(WHO), which is funding/sponsoring/supporting the study.

Part II: Certificate of Consent

(This section is mandatory)

I have read the foregoing information, or it has been read to me. I have
had the opportunity to ask questions about it and any questions I have
been asked have been answered to my satisfaction. I consent
voluntarily to be a participant in this study

Print Name of Participant__________________

Signature of Participant ___________________
Date ___________________________
Day/month/year
If illiterate

I have witnessed the accurate reading of the consent form to the

potential participant, and the individual has had the opportunity to ask
questions. I confirm that the individual has given consent freely.
Print name of witness____________

Thumb print of participant

Signature of witness _____________

Date ________________________
Day/month/year

Statement by the researcher/person taking consent

I have accurately read out the information sheet to the potential participant, and to
the best of my ability made sure that the participant understands that the following will
be done:
1.
2.
3.
1 A literate witness must sign (if possible, this person should be selected by the participant and should have no
connection to the research team). Participants who are illiterate should include their thumb print as well.

I confirm that the participant was given an opportunity to ask

questions about the study, and all the questions asked by the
participant have been answered correctly and to the best of my
ability. I confirm that the individual has not been coerced into
giving consent, and the consent has been given freely and
voluntarily.
A copy of this ICF has been provided to the participant.
Print
Name
of
Researcher/person
taking

the

consent________________________
Signature

of

Researcher

/person

taking

the

consent__________________________
Date ___________________________
Day/month/year

A literate witness must sign (if possible, this person should be selected by the participant and
should have no connection to the research team). Participants who are illiterate should include
their thumb print as well.