Download Please prepare your consent form using the

INSTRUCTIONS FOR PREPARING INFORMED CONSENT
Please prepare your consent form using the format below.
Each research proposal (if not exempted) is required to be accompanied by an informed consent. If changes in
format are necessary, please include a written explanation for any deletions, additions, or revisions prior to IRB
review. Please see suggested/required text in italics.
SAMPLE OF INFORMED CONSENT
HUSSON UNIVERSITY
1 College Circle
Bangor, Maine 04401
Subject Information
CONSENT FOR RESEARCH
INVITATION TO PARTICIPATE:
You are invited to take part in the research project identified below because [for example, you are an adult and
have been having chest pains due to heart disease. If, however, you are pregnant or expect to become pregnant
soon, you may not take part in this study.]
Research Protocol Name:________________________________________________________________
Investigator(s):________________________________________________________________________
PURPOSE OF STUDY:
[Describe in simple language, what is being studied and why, including the approximate number of
participants and expected duration of the study.]
PROCEDURES:
1. Describe the study design (double-blind, randomized, etc).
Actual procedure or methods to be followed and medications to be used. Identify any medications, devices, methods
or
procedures which are experimental.
3. Who will perform procedures.
4. Types and numbers of tests, amount of blood to be withdrawn, questionnaires, follow-up studies,
etc.
5. Where will study be conducted.
6. Duration of subject's participation - per session and in total (days, months, years).
RISKS AND DISCOMFORTS:
[Describe in simple language the reasonably foreseeable risks and discomforts to the subject.] [When research
studies document that a drug or treatment procedure utilized in a research protocol indicates that the risk of
death to subjects in the study is higher than 9%, the following warning should be included in the Informed
Consent]:
This drug or treatment procedure has been shown through clinical trials to present a 10% or greater risk of death in
those patients using the drug or procedure. I have discussed my concerns with my physician.
PREGNANCY:
[The following statement (as is or amended as appropriate) must be included in the informed consent ONLY
if the study drug/device could affect women of childbearing age, an unborn fetus or a woman breast-feeding a
child.]:
Because of the effects of this drug/device, there could be serious harm to unborn children (or children who are
breast-feeding).
It could also endanger the health of the mother. Also it is possible that harmful side effects that are not yet known
could occur to both the mother and unborn or breast-feeding child.
For this reason, if you are pregnant, we want you to tell us and we will not include you in the study. If you are still
able to become pregnant, you will be given a pregnancy test prior to entry into the study.
Understand that while you are taking this drug/device you should not become pregnant, and if you do become
pregnant, you must stop the drug/device and consider ending the pregnancy.
POTENTIAL PSYCHOLOGICAL RISKS :
[Should be included in informed consent as worded. Researchers may use their discretion in modifying this
statement, however any modifications will be critically appraised by the IRB.]:
Taking part in this study involves interventions/treatments not usually used. Although you may experience some
benefits from the intervention(s)/treatment(s), to date there are no proven benefits associated with it/them. There
may be small psychological risks, and it is possible that there may be some stress because of the
intervention/treatment. If there is psychological stress from this study and if it interferes a lot with your usual
ability to function, you have the following options:
1. When and if available, a clinical consultant may be contacted to help you cope with your emotional stress or
2. A referral to a psychologist, or other mental health worker in the area can be made with the help of our study
team.
You will be responsible for payment of any costs associated with psychological consultation or counseling.
BENEFITS:
[An unbiased statement of reasonably expected benefits must be included. This should describe personal
benefits (ranging from none to some) and may include societal benefits.]
FINANCIAL COMPENSATIONS:
[Describe any fees to be paid to the subject for participation, describe partial payment or no payment for
early termination or bonus for completion. Or state that there will be no financial compensation for
participation.]
CONFIDENTIALITY:
Any information gathered for this project and which could be identified with you will be kept strictly confidential.
Representatives of the United States Department of Health and Human Services, the United States Food and Drug
Administration, the Husson Institutional Review Board, or the sponsor [include sponsor’s name] of the research
may look at your research records to review the results of this research.
The information gathered in this study may be published in scientific magazines or presented at scientific meetings,
but your identity will be kept strictly confidential.
[If applicable: This study has been developed in cooperation with a nationally recognized research group and
copies of your research records will be made available to this group for purposes of data collection regarding
your treatment course.]
[If the study deals with HIV/AIDS, drug/alcohol abuse, or psychiatric care you must also obtain the subject's
specific Authorization to Release Information on Form MR-2N-15 for each person to receive information. If
you have any questions regarding this requirement, consult the Chair, IRB.
COMPENSATION FOR INJURY:
[The following statement does not need to be included if the study involves no more than minimal risk.]:
No payment will be provided for injury resulting from the experimental nature of the research.
You should contact the investigator to explain to you what treatments are available if you are injured.
Any medical treatment will be your responsibility. This does not take away your rights in the event of negligence.
VOLUNTARY PARTICIPATION:
Your participation in the study is voluntary.
You may refuse to take part in the study and you are also free to withdraw from the study at any time. Neither of
these actions will influence your physicians against you in any way.
You may stop taking part in the study without penalty or any loss of benefits to which you are entitled. Significant
new findings developed during the course of the research will be provided to you.
You may take back this consent at any time whether there has been a change in circumstances or not.
[If there are any significant new finding(s) that may potentially influence a subject's decision to continue
participating in the study, the investigator must provide the subject and the IRB with a written statement of
those findings and the investigator must renegotiate informed consent.]
WITHDRAWAL FROM THE STUDY:
[The following statement does not need to be included if the study is a non-treatment study.]
If necessary, for your safety or for other good reason, the principal investigator may drop you from the study at any
time. He/She will explain why you may no longer take part, if it becomes necessary.
[If withdrawal from participation requires assistance from the investigator, e.g., weaning from a medication
or removal of a device, or other follow-up, then describe the consequences of withdrawal and procedures for
orderly termination of participation.]
QUESTIONS:
If you have any questions, please ask.
If you think of questions later or if you think you have a research-related injury, please contact the investigator(s)
[Include Investigator name, address and a phone number to be reached at any time].
If you have any questions regarding your rights as a research subject, please contact the Institutional Review Board
at Husson College (207) 941-7049.
in
-
You are voluntarily making a decision whether or not to take part [allow your child/legal ward to take part]
the research study described above.
No guarantees are made to you about the result of the study or your care.
Your signature indicates that you have agreed to take part in the study [permit your child/legal ward to
participate] having read the information provided above.
You will be given a copy of this consent form and a statement of your research subjects' rights to keep.
__________________________________
Signature of Subject
__________________________________
Date
__________________________________
Legally Authorized Representative
(i.e. parent, legal guardian, or
individual with durable power of
attorney for health care of subject)
__________________________________
Date
__________________________________
Signature of Investigator
__________________________________
Date
__________________________________
Signature of Witness
__________________________________
Date
Original Date:
Revision Date: