Informed Consent Form Template
STUDY TITLE…
‘The research institution’s name … ‘ is (type
of) organisation that carries out medical research. Research is different from
normal treatment because research aims to find better ways of preventing and
treating illness in the future for everybody’s benefit. We are asking your
permission for you/your child to participate in a research study.
·
What is this research about?
You/ Your child has [XXX]/[XXX] is a common and serious
illness in this area. In this research we aim to find out [explain basic
research question e.g.] whether a new (drug/vaccine/intervention) will work as
well and be as safe as the one currently recommended in xxxx. In research so far, the new
drug/vaccine/intervention [XXX] has been shown to work at least as well, and to
be as safe, as the currently recommended one, [XXX] [or similar for
vaccines/interventions]. Both are given by injection/tablet/XX.
In this research we will give [XXX] children/adults [explain
selection e.g] who attend this clinic/live in this area the new drug/vaccine
and [XXX] children/adults the normal drug/vaccine for [disease name]. We will
find out if there is any difference between these drugs/vaccines by closely
watching the progress of everyone in this study. The decision on which
person/child gets which drug/vaccine will be decided by a system based on
chance, not by any of the research team. [Where study is blind or explain if
diifferent] To make sure the findings of this study are accurate, it is
important that no one knows which person/child is receiving which drug/vaccine
until the end of the research.
What will it involve for me/my
child?
1.
[Where 1st sample taken is
equivalent to standard care] We will use a small amount of the blood that has
been/will be taken as part of your/your child’s normal treatment to find out if
it is possible for you/them to participate in this research. This extra amount
will be less than ½ tsp (2ml).
[Where 1st sample taken is not equivalent to standard care]
We will take a small sample of blood from you/your child to find out why
you/they are sick; [explain research reasons for this sample] how your/their
body is reacting to XXX disease; and if it is possible for them to participate
in this research. This sample will be less than half a tsp (2ml) and will be
taken from your/your child’s arm.
2.
If you/your child fits the
requirements of this research, we will give you/them either the new
drug/vaccine [XXX] or the normal
drug/vaccine [XXX]
3.
[Explain
follow up procedures, including number, timing and place of follow up visits;
type, amount and site of sample removal; and any other procedures] We will
check/visit you/your child after xx days at this clinic/home to assess
your/their progress. This will include taking another small sample of blood
(less than half a teaspoon of blood) from your/your child’s arm. Altogether we expect the trial to have X visits for you/your child and take x
months.
Are there any risks or
disadvantages to me/my child of taking part?
[XXX] has been shown to be safe (if
this is true so any known/frequently occurring adverse effects must be
explained here) and to work in all the research already done in other places.
However there is a very small chance that there may be a reaction we do not
expect, but we will be monitoring your child very closely and it is considered
to be unlikely. If we learn anything new about [XXX] during this study, we will
tell you. If for any reason the doctors thinks you/your child should not be in
the trial for you/their best interest then you/they will be taken out and given
normal
standard of care.
Are there any benefits to me/my
child of taking part?
The benefits for you/your child
taking part are that they/you get close observation during the trial and in
taking part you/your child may help us improve the care of children/adults who
have xxx in the future. [Explain any
other benefits such as treatment during follow up but explain terms of access
to treatment and care]
You will be asked to bring your
child back for follow up at this clinic [where relevant], but we will pay for
the costs of your transport for this visit. Follow up visits will take some of
your time. [Explain any other /costs/re-embursements]
What will happen if I don’t agree to participate?
All participation in research is voluntary. You are free to
decide if you want/you want your child to take part or not. You/your child will
still receive the recommended standard
of care if you/they do not take part. If you do agree you can change your mind
at any time and withdraw your child from the research. This will not affect
your/their care now or in the future.
What
happens to the samples?
[Explain reasons for export] Some of the
tests that are needed as part of this research cannot be done in xxxx at the moment, so part of the samples will be
sent to laboratories abroad for these tests.
[Explain archiving] After the
research has been done, a small portion of the blood/other samples will be
stored. In the future, new research may be done on these samples about [XXX illness, or indicate if any illness].
Future research must first be approved by a national independent expert
committee in Nairobi to ensure that participants’ safety and rights are
respected. Individual names will be removed and replaced by codes, so that
information cannot be linked to the participants.
Who will have access to information about me/my child
in this research?
All our research
records are stored securely in locked cabinets and password protected
computers. Only a few people who are closely concerned with the research will
be able to view information from participants.
Who has allowed this
research to take place?
All research at XXX is approved by national independent
expert committees in XXX and a committee in XXX to make sure the research is conducted
properly and that participants’ safety and rights are respected.
What if I have any
questions?
You may ask any of our staff
questions at any time. You can also contact those who are responsible for the
care of your child and this research:
Dr ……………………… contact
details
This research is
supported by the (name of sponsor) who will pay for any treatment or
compensation in the unlikely event of any injury resulting from this trial.
Xxx
(institution) Consent Form.
Study title
1.
I, (Or
add ‘ being a guardian of’’)_________________________________ (name of child),
have had the trial explained to me. I have understood all that has been read and
had my questions answered satisfactorily. I understand that I change my mind at
any stage and it will not affect the benefits due to me/my child.
ÿ please tick I agree to ( allow my child to ) take
part in this research
ÿ please tick I agree to samples being stored
ÿ please tick I agree to samples being exported
Parent/Guardian’s
Signature:
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Date:
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Parent/Guardian’s
Name:
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Time:
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(please print name)
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2.
I
certify that the above was explained verbally to the parent/guardian by
_______________________________ (Name of person taking consent), and that s/he
understands the nature and the purpose of the study and consents to the
participation of the child in the study. S/he has been given opportunity to ask
questions which have been answered satisfactorily.
Investigator’s
Signature:
Or Designee
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Date:
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Name:
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Time:
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(please print name)
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Only necessary if
the Participant / Parent/Guardian cannot read:
3.
I*
attest that the information in this consent form was accurately explained to,
and apparently understood by, the parent/guardian, and that informed consent
was freely given by the parent /guardian
Witness’
Signature:
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Date:
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Witness’ Name:
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Time:
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(please print name)
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*The witness should be independent from trial or a member of
staff who was not involved in gaining the consent.
Thumbprint of the parent as named above if they cannot
write: ______________________
THE PARENT/GUARDIAN SHOULD NOW BE GIVEN A
SIGNED COPY TO KEEP
Take time to understand
A recent survey of 672 study volunteers offers insight into the informed consent process and whether or not it is working to help volunteers understand their roles and responsibilities. Some key takeaways from the study are:
- Nearly 98% of volunteers said they received the informed consent form and 90% said they read the form completely.
- The vast majority of volunteers said they understood the expectations of the study, including additional risks and their ability to withdraw at any time.
- More than three-quarters understood that they could contact someone outside the study if they had additional questions about their rights during the trial.
- More than half the volunteers were unaware that neither their doctor nor they would know what medication they would receive during the study; more than two-thirds understood that they could receive a placebo in the trial.
- Nine out of 10 volunteers said that the information received prior to the trial matched their actual experience during the trial.
- Approximately 75% of the volunteers indicated that the main reason for participating in a study was to help themselves or others and to advance science.
Research studies are very involved so it is important to learn as much as possible about the study you may participate in before you consent. The U.S. Food and Drug Administration (FDA) guidelines state that study volunteers should understand the risks they're taking, which may mean spending additional time with the research staff to make sure you get the information you need. If you want to know details, such as any documented side effects of a particular drug observed in earlier clinical trials, you must ask for that information as well as any other information you may want to know.
The decision to participate in a clinical trial is a personal one and one that you are entitled to make freely, without influence or coercion. Being properly informed so that you fully understand the responsibilities of becoming a study volunteer is the best way to ensure that you are making the right decision for you.
