Follow-Up Consent Form - Pilot

PILOT STUDY
INFORMED CONSENT FORM FOR FOLLOW-UP VISITS
SUPPLEMENT
Updated 25 January 2016
You will be given a copy of the full Informed Consent Form.
Introduction
Thank you for participating in the Pilot of the Virus Persistence Study. At the beginning of the study, we
explained all the procedures of the study and you signed an informed consent form. You also received a
written copy of the informed consent form. In the months that have passed since that time, there are a few
additional things that we are planning to do to understand better the disease and that we wanted to inform you
of and ask if you would be willing to participate in.
Please feel free to ask any questions to me, the main investigator (Dr. Deen from the Ministry of Health and
Sanitation), or anyone else at any time so that you can feel comfortable making a decision to participate in
this research study or not.
Type of Research Intervention
In addition to the testing of semen which has already taken place, we would also like to access your
records from the laboratory and ETU clinic from the time you were treated for Ebola. Access to the
information will permit to check the information we have from the questionnaires you have completed with
the nurse, to ensure we have the right information. To sign the informed consent will imply that you grant us
access to your records from the laboratory and ETU clinic from the time you were treated for Ebola
The tests for Ebola virus pieces that we performed are very reliable, however it may be possible that virus
could still be present in the body but not able to be found in semen. There have been a very small number of
survivors who became seriously ill after they recovered, and so we would like to ensure that you are well
even after finishing the study and document health events that may have happened between your last
negative results and the 3 and 6 months visit.
If you agree, we would like to invite you for a new visit at 3 and 6 months after your second negative
sample. We will assess your health status by asking you questions about your health and will test your
semen again at these time points. Only semen samples will be collected. In case your semen tests positive
at one of these two visits, then the same protocol as before when enrolled in the study will be observed, and
we will follow you-up until you have two consecutive negative test results in a row for semen. As before,
the semen test results will be kept confidential.
Do you agree to have a 3 and 6 month visit?

Yes

No

The samples obtained will only be used for the here described Ebola testing, and will be safely and
respectfully destroyed after this research is completed. The Ebola virus grown in the laboratory may be
saved and used for future scientific studies should you agree. The scientific use of any virus kept for
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additional studies, would be decided upon by the group of study responsible persons from the Ministry of
Health and Sanitation, Sierra Leone, the WHO, US-CDC and Chinese-CDC.
You can decide if you allow for future study of the virus that might be produced from your samples or if you
prefer that it is destroyed.
If you do not want the laboratory to keep any Ebola virus isolates that stem from your body fluids you may
say so now, we will record it, and no virus will be stored.
Agree for laboratory to store virus:
(Circle appropriate answer)

yes

no

Who to Contact
You can always contact the main study investigator, Dr. Deen, Director of Clinical Studies at Connaught
Hospital, Freetown – Tel: 076865597. In addition, each participant will be given the name and contact
telephone number of the study physician for the sites of enrollment and follow-up.
This proposal has been reviewed and approved by an ethical review board linked to the Ministry of
Health in Sierra Leone, which is a committee whose task it is to make sure that research participants
are protected from harm. It has also been reviewed by the Ethics Review Committee of the World
Health Organization (WHO), which is funding/sponsoring/ and supporting the study.
Do you have any questions? Are you willing to participate in this research study?
Certificate of Consent
I have received the foregoing information, and it has been read to me. I have had the opportunity to
ask questions about it and any questions that I have were answered to my satisfaction. I consent
voluntarily to participate as a participant in this research.
Print Name of Participant:
Signature/Thumbprint/Mark of Participant:
Date:
DD/MM/YYYY
If illiterate
Participants who are illiterate should include their thumb-print or mark, and a witness who is literate
should also sign (if possible, this person should be selected by the participant).
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:
Signature of Witness:
Date:
DD/MM/YYYY

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Statement by the researcher/person taking consent
I have accurately read out the information sheet to the potential participant, confirm that the
participant was given the opportunity to ask questions about the study, and all 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 form has been provided to the participant.
Print name of Researcher:
Signature of Researcher:
Date:
DD/MM/YYYY

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