Sample
Informed Consent
This
is a generic sample form to help you address most situations. Please adapt as
appropriate for your research protocol and institution. Pending rulemaking
for classified human subject research will require additional elements of
consent.
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Project
Information
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Project Title:
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Project Number:
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ERC Ref No:
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Sponsor:
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Principal Investigator:
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Organization:
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Location:
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Phone:
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Other Investigators:
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Organization:
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Location
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Phone:
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Consent document must be
clearly written and understandable to subjects.
The language must be nontechnical (comparable to the language in a
newspapers or general circulation magazine), and scientific, technical or medical
terms must be plainly defined.
Informed Consent, whether oral or written, may not include language that appears to waive subjects’ legal rights or appears to release the investigators or anyone else from liability for negligence.
1. PURPOSE OF THIS RESEARCH STUDY
o
Include 3-5 sentences written
in nontechnical language. “You are being asked to participate in a research
study designed to...”
2. PROCEDURES
o
Describe procedures: “You
will be asked to do...”
o
Identify any procedures
that are experimental/investigational/non-therapeutic.
o
Define expected duration of
subject's participation.
o
Indicate type and frequency
of monitoring during and after the study.
3.
POSSIBLE RISKS OR
DISCOMFORT
Note that
these include not only physical injury, but also possible psychological, social
or economic harm, discomfort, or inconvenience.
o
Describe known or possible
risks. If unknown, state so.
o
Indicate if there are
special risks to women of child bearing age; if relevant, state that study may
involve risks that are currently unforeseeable, e.g., to developing fetus
o
If subject's participation
will continue over time, state: “any new information developed during the study
that may affect your willingness to continue participation will be communicated
to you.”
o
If applicable, state that a
particular treatment or procedure may involve risks that are currently
unforeseeable (to the subject, embryo or fetus, for example.)
4. POSSIBLE BENEFITS
o
Describe any benefits to
the subject that may be reasonably expected. If the research is not of direct
benefit to the participant, explain possible benefits to others.
5. FINANCIAL CONSIDERATIONS
o
Explain any financial
compensation involved or state: “There is no financial compensation for your
participation in this research.”
o
Describe any additional
costs to the subject that might result from participation in this study.
o
Please indicate any
financial benefits to the subjects including therapeutic or diagnostic costs
being covered by the study.
6. AVAILABLE TREATMENT ALTERNATIVES
o
If the procedure involves
an experimental treatment, indicate whether other non-experimental
(conventional) treatments are available and compare the relative risks (if
known) of each.
7. AVAILABLE MEDICAL TREATMENT FOR ADVERSE EXPERIENCES
o
“This study involves
(minimal risk) (greater than minimal risk).” In the event that greater than
minimal risk is involved, provide the subject with the following information.
o
If you are injured as a
direct result of taking part in this research study, emergency medical care
will be provided by [name] medical staff or by transporting you to your
personal doctor or medical center.
Indicate who will pay for this treatment.
8. CONFIDENTIALITY
o
Describe the extent to
which confidentiality of records identifying the subject will be maintained.
“Your identity in this study will
be treated as confidential. The results of the study, including laboratory or
any other data, may be published for scientific purposes but will not give your
name or include any identifiable references to you.”
“However, any records or data
obtained as a result of your participation in this study may be inspected by
the sponsor, or by AKU ERC members”.
In addition, list steps to protect
confidentiality such as codes for identifying data.
9. TERMINATION OF RESEARCH STUDY
You are free to choose whether or
not to participate in this study. There will be no penalty or loss of benefits
to which you are otherwise entitled if you choose not to participate. You will
be provided with any significant new findings developed during the course of
this study that may relate to or influence your willingness to continue
participation. In the event you decide to discontinue your participation in the
study,
o
These are the potential
consequences that may result: (list)
o
Please notify (name, telephone
no., etc.) of your decision or follow this procedure (describe), so that your
participation can be orderly terminated.
In addition, your participation in the study may be terminated
by the investigator without your consent under the following circumstances.
(Describe) It may be necessary for the sponsor of the study to terminate the
study without prior notice to, or consent of, the participants in the event
that (Describe circumstances, such as loss of funding.)
10. AVAILABLE SOURCES OF INFORMATION
o
Any further questions you
have about this study will be answered by the Principal Investigator:
Name:
Phone Number:
Phone Number:
o
Any questions you may have
about your rights as a research subject will be answered by:
Name:
Phone Number:
Phone Number:
o
In case of a
research-related emergency, call:
Day Emergency Number:
Night Emergency Number:
11. AUTHORIZATION
I have read and understand this
consent form, and I volunteer to participate in this research study. I
understand that I will receive a copy of this form. I voluntarily choose to
participate, but I understand that my consent does not take away any legal rights
in the case of negligence or other legal fault of anyone who is involved in
this study. I further understand that nothing in this consent form is intended
to replace any applicable Federal, state, or local laws.
Participant Name (Printed or Typed):
Date:
Date:
Participant Signature:
Date:
Date:
Principal Investigator
Signature:
Date:
Date:
Signature
of Person Obtaining Consent:
Date:
Date:
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