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Include the following section if the research protocol calls for storage

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Include the following section if the research protocol calls for storage
---------Consent for Storage and Future Use of Unused Samples
Additional Consent to [Name of Project]
Include the following section if the research protocol calls for storage and future use of samples
This Statement of Consent consists of two parts:
• Information Sheet (to share information about unused samples with you)
• Certificate of Consent (to record your agreement)
You will be given a copy of the full Statement of Consent
h
Part 1. Information Sheet
Explain that you are seeking permission to store their unused samples for possible future use in
either your own research or someone else's research. State that they need to make some decisions
about their blood/tissue/sperm/sputum sample because they gave you permission only to use it for
the current research.
Explain that sometimes people don't want their samples used for research into areas they might
not agree with, for example, research into birth control or reproductive technology. Use lay terms
to explain research possibilities. If genetic research is a possibility, explain what this is and any
implications for them. State that they can tell you if there is something they don't want their
sample used for, or if they don't want their sample used at all.
Inform the participant that at present, the researchers can trace which blood/tissue/sperm/sputum
sample belongs to the participant. In most cases, the participant must decide whether they want to
let the researchers keep the sample but get rid of all identifying information, or whether they are
comfortable with the researchers knowing whose sample it is. Explain the risks and benefits of
each of these options. Inform the participant of researcher obligations in cases where the sample
remains linked. These obligations include informing the participant of results which have
immediate clinical relevance.
Inform participants that their sample will not be sold for profit and that any research which uses
their sample will have been approved.
Right to Refuse and Withdraw
Explain that the participant may refuse to allow samples to be kept or put restrictions on those
samples with no loss of benefits and that the current research study will not be affected in any
way. Inform the participant that they may withdraw permission at anytime and provide them with
the name, address, and number of the person and sponsoring institution to contact.
Confidentiality
Briefly explain how confidentiality will be maintained including any limitations.
Page 1 of 3
Part II. Certificate of Consent
If any of the (TYPE OF SAMPLE i.e. blood, tissue) I have provided for this research project is
unused or leftover when the project is completed (Tick one choice from each of the following boxes)
†
†
†
I wish my [TYPE OF SAMPLE] sample to be destroyed immediately.
I want my [TYPE OF SAMPLE] sample to be destroyed after ____ years.
I give permission for my [TYPE OF SAMPLE] sample to be stored indefinitely
AND (if the sample is to be stored)
†
†
†
I give permission for my (TYPE OF SAMPLE) sample to be stored and used in future research but
only on the same subject as the current research project : [give name of current research]
I give my permission for my [TYPE OF SAMPLE] sample to be stored and used in future research of
any type which has been properly approved
I give permission for my [TYPE OF SAMPLE] sample to be stored and used in future research except
for research about [NAME TYPE OF RESEARCH]
AND
†
†
I want my identity to be removed from my (TYPE OF SAMPLE) sample.
I want my identity to be kept with my (TYPE OF SAMPLE) sample.
I have read the information, or it has been read to me. I have had the opportunity to ask
questions about it and my questions have been answered to my satisfaction. I consent
voluntarily and understand that I have the right to withdraw my consent without this affecting
the current research study or my medical care.
Print Name of Participant _________________________
Signature of Participant ___________________________
Date ___________________________
Day/month/year
If illiterate
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 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.
Page 2 of 3
Print name of witness_____________________
AND
Thumb print of participant
Signature of witness ______________________
Date ________________________
Day/month/year
I have accurately read or 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 Researcher________________________
Signature of Researcher _________________________
Date ___________________________
Day/month/year
Copy provided to participant _______ (initialed by researcher)
Page 3 of 3
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