MHS VERSION 06-01-2013
MHS - PART B
WILL YOU BE PAID FOR TAKING PART IN THIS STUDY?
Indicate if subject reimbursement is included as participation in the study. Information should include the
amount of per-visit reimbursement, the total amount possible, when reimbursements will occur, and what
form of payment will be received (check, cash, or gift card). Then add the following standard statement:
If you receive $600 or more in one calendar year, MemorialCare Health System accounting is required to
report such payments to the Internal Revenue Service and provide you with a 1099-MISC form. No
income tax will be withheld and you will be responsible for any tax liability. If this occurs, your anonymity
cannot be maintained.
WHAT ARE THE COSTS OF TAKING PART IN THIS STUDY?
(Depending on Funding Source):
You or your third party payer (health insurance, Medicare, Medi-Cal or other) must provide payment for
hospital, office and other medical costs unrelated to this study. You will receive no financial gain for your
participation in this study.
If project is sponsored by an outside source such as a pharmaceutical company or is a national protocol,
and the following, or a modified version of it, is applicable:
There will be no additional costs to you. All research related medications will be provided free of charge
by the sponsor of the study.
WHAT HAPPENS IF YOU ARE INJURED BECAUSE YOU TOOK PART IN THIS STUDY?
(Compensation for illness or injury arising from participation in study):
If you experience a physical injury or condition directly arising from your participation in this study and
you require medical care that cannot be billed to a third party payor, the study sponsor will cover the
reasonable and customary costs for acute medical treatment without cost to you. The sponsor will only
cover such costs if you follow the instructions of the investigator. Financial compensation for participation
in the study for things such as loss of wages, disability, or discomfort due to injury is not available. If you
sustain an injury, you should contact (Principal Investigator) at (phone number) immediately.
If the study is a Clinical Trial where subjects are recruited for a particular study, compensation for
subjects' time statement may be added (this statement should be modified to fit the study protocol).
Who Will Have Access to Your Study Data?
Any information about you obtained from this research will be kept confidential and your name will never
be identified in any report or publication unless you sign a release. Information regarding your medical
records, just like hospital records, may be subpoenaed by court order. You consent to the publication of
study results so long as the information is anonymous and/or disguised so that identification cannot be
made. Authorized representatives of (SPONSORS NAME, if any), the Food and Drug Administration
(FDA), the Office of Human Research Protections (OHRP) and the MHS Institutional Review Board (IRB)
may examine your medical records, and there will be no breach of confidentiality.
Investigator Financial Conflict of Interest
(TO COMPLETE AS APPLICABLE)
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MHS VERSION 06-01-2013
DO YOU AGREE TO PARTICIPATE IN THIS STUDY?
I certify that I have read the preceding or it has been read to me, that I have reviewed its contents, and
that any question I have pertaining to the preceding have been, or will be answered by my doctor and
that my permission is freely given. I have been given a signed copy of this consent form along with a
copy of the “Rights of Human Subjects in Medical Research,” and I consent to participate in this study.
__________________________________
Printed Name of Subject
___________________________________ __________ ________
Subject’s Signature
Date
Time
If the subject is a minor, or otherwise unable to sign, complete the following:
a)
Reason subject is unable to sign: ______________________________
_________________________________________________________
b)
________________________________
Printed Name of Authorized Person
_________________
Date
________________________________
Signature of Authorized Person
_________________
Time
_________________________________
Relationship and Basis of Authorization
to Give Consent
Certificate of Person Obtaining Consent:
I have provided an explanation of the above research study and encouraged the subject to ask questions
and request additional information regarding the study, its risks and complications and possible
alternatives. A copy of this consent form has been given to the subject.
____________________________________________________________________________
Signature of Person
Printed Name of Person
Date
Obtaining Consent
Obtaining Consent
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