*9000301*
Study Title
Principal Investigator
BMH # ____________
Bronson Methodist Hospital
Informed Consent Template
INSTRUCTIONS:
INFORMED CONSENT (S) should be no more than 8th grade reading level.
FONT SIZE – No smaller than 12-point font.
MARGIN-Minimum of .75” on all sides (main text, header/footer at approximately .5”).
Exception for signature page – leave a 3” wide X 1.5” high margin at the bottom of the signature page for
the IRB approval stamp.
BRACKETS [ ] indicated that your specific study information needs to be filled in
DELETE THESE AND ALL ITALIZED INSTRUCTIONS BEFORE PRINTING THE CONSENT.
Informed Consent to Participate in Research
[Name of Institution (if applicable)]
[Study Title]
[Principle Investigator Name, with Credentials]
Introduction:
You are being asked to take part in a research study. Taking part in this study is your choice. This form gives
you important information about the study. It describes the purpose of the study, along with the risks and
possible benefits of being in the study.
You don’t have to be in this research study. You can agree to be in the study now and change your mind later.
Your decision will have no effect on the quality of [medical care, academic standing, job status, etc. (whatever
phrase is appropriate)]. Please ask questions if there is anything you do not understand. If you decide to take
part in the study, you will be asked to sign this form.
Why is this research being done?
The purpose of this study is to:
 Describe the purpose of the study;
 Clearly state why the patient is being asked to participate;
 Include the number of subjects expected to participate..
Suggested conclusion wording (if applicable):
Date
Version
1 of 8
IRB Template Approved 05/2004, Revised: 12/2006, 11/2008, 06/2010, 01/2012, 06/2012, 09/2013, 07/2014
*9000301*
Study Title
Principal Investigator
BMH # ____________
Bronson Methodist Hospital
Informed Consent Template
In order to learn about [disease/condition/etc.], half the people in this study will receive
[drug/device/etc.] and half the people in this study will receive a placebo (no drug, like a ‘sugar
pill’).
What does this study involve?
If you agree to be in this study, you will be asked to do the following:
 Describe the procedures, in order and in detail;
 Use lay language;
 Use short sentences and short paragraphs;
 Use subheadings and bulleted items;
 Describe which procedures are experimental and which are standard clinical treatments
 Describe time required to participate and length of study
When applicable, describe:
 Whether or not the drugs or devices are being used in ways that are not FDA approved
 The use of placebo and how individuals would be assigned to a group
 Whether or not all participants will receive the same therapy
 The process of randomization (i.e. flipping a coin, 50/50 chance)
If there are multiple study groups, clarify this by listing the groups as follows:
If you decide to be in this research study you will be assigned by chance (like the flip of a coin) to one of the
following groups:
Group A –receives [name of drug, device, etc.]
Group B—receives [placebo or other drug, device, etc.]
Neither you nor your doctor can decide or will know into which group you will be assigned.
For Clinical Trials:
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by
U.S. Law. This Web site will not include information that can identify you. At most, the Web site will
include a summary of the results. You can search this Web site at any time.
What are your options if you do not want to be in the study? 


Explain alternative treatment in lay language.
Explain whether or not the research can be obtained off study.
Date
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IRB Template Approved 05/2004, Revised: 12/2006, 11/2008, 06/2010, 01/2012, 06/2012, 09/2013, 07/2014
*9000301*
Study Title
Principal Investigator
BMH # ____________

Bronson Methodist Hospital
Informed Consent Template
Include a list of the tests/procedures to be performed for research purposes only
If you take part in this study these additional tests or procedures will be performed:
Study Criteria:
Inclusion Criteria:
 [list in bullet format]
Exclusion Criteria:
 [list in bullet format]
Participant Responsibilities:
You will be expected to:

[ ]

[ ]

[ ]
Are there benefits to being in this study?
State the direct benefits, or the possibility of direct benefits, that are likely for research participants.
If there are no direct benefits, state:
 There is no direct benefit to you from being in this study.
Describe the general and social benefits, such as:
 If you take part in this study, you may help others with [disease/condition, etc] in the future.
What are the risks involved with being in this study?
If you decide to be in this study, you should know there might be risks. You should talk about these risks
before you decide to be in the study. The known or expected risks are:
 List in bullet format
As with any research study, there may be additional risks that we did not expect.
 With drug studies involving a multi-drug regimen, list the problems associated with the entire
regimen rather than providing separate information for each individual medication. Whenever
possible, you should estimate the probability that a problem will occur. Words such as
“common,” “likely,” “unlikely,” “occasionally,” or “rare” may be used when it is not desirable
to use numerical estimates (i.e., you will likely experience some bruising and soreness at the
place where the blood is taken).
Date
Version
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IRB Template Approved 05/2004, Revised: 12/2006, 11/2008, 06/2010, 01/2012, 06/2012, 09/2013, 07/2014
*9000301*
Study Title
Principal Investigator
BMH # ____________


Bronson Methodist Hospital
Informed Consent Template
Be sure to include risks of being in a placebo or observation group.
Sample wording:
We cannot be sure how your body may respond to the [drug, placebo, procedure, etc.] used in
this study. The researchers will discuss possible problems and the chances that they will
happen. Problems we did not expect may happen. Problems may range from minor discomfort,
or may be so severe as to result in death (indicate highest severity level if death is not
applicable). You should tell your doctor the investigator of this study [PI name and phone
number] about any problem.
Are there risks related to pregnancy or reproduction?




Describe foreseeable risks to a fetus.
Describe any required pregnancy testing and actions that may be taken if the participant becomes
pregnant.
Describe any affect participation in the study could have on sperm or egg production.
If the research involves pregnant women or women capable of becoming pregnant, and the risk profile
of the research procedures on an embryo or fetus are not well known, end with the statement:
This research may hurt an embryo or fetus in ways we do not expect.
New Information:
We may learn new things during the study that you may need to know. We will tell you if this happens. You
can decide if you want to stay in this study.
What Conflict of Interests are Involved in this Study?
Identify consultative or financial interests, if applicable, by referring to the Informed Consent Financial
Disclosure Model Language form that can be found at
http://www.bronsonhealth.com/system/asset/document/1864/InformedConsentFinancialDiscolsureModelLangu
age.pdf
What are your Rights as if you take part in the Study
You have the right:
 To be told about the nature and purpose of the study
 To know exactly what will be done in the study
 To know the possible risks, discomforts, or benefits that can reasonably be expected
 To be told about any appropriate alternatives to the study, including any drugs or devices that might help
you. You will be told about any risks, discomforts, and benefits
 To ask any questions you have about the study
 To decide whether or not to be in the study without anyone misleading or deceiving you
 To receive a copy of this consent form once all signatures are on it
Date
Version
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IRB Template Approved 05/2004, Revised: 12/2006, 11/2008, 06/2010, 01/2012, 06/2012, 09/2013, 07/2014
*9000301*
Study Title
Principal Investigator
BMH # ____________

Bronson Methodist Hospital
Informed Consent Template
To stop taking part in the study at any time
If you sign this form, you will not give up any legal rights you may have as a research participant. You may
choose not to take part in the study or leave it at any time. If you choose to not take part in or leave the study,
your [regular care, employment status, academic standing] will not change. You will not lose any of the
benefits you would normally receive.
What if you want to stop taking part in the Study
You can decide to leave the study at any time. No harm will come to you if you decide to leave.
The researchers may decide to take you out of the study if:
 Your condition changes
 The researchers believe that it is not in your best interest to stay in the study
 You are no longer eligible for any reason
 You do not follow instructions
 The study is stopped
Costs, Payment, Compensation for Study Participation (if applicable):
Describe any additional costs to the participant or their insurance that may incur by their participation in the
study. Clearly delineate between “standard of care” and what is required solely for purposes of the study.
If the participant will not receive payment for their participation, please clearly state as such. If study
participants will be provided payment, the amount and conditions of payment (including subjects that withdraw
early) must be described. The payment should be appropriate for the level of risk, population recruited, and
commitment/time involved.
There may be risks to you that the researchers did not expect. You will receive emergency care if you are
injured during the study. You will not be paid for the additional treatment unless it is covered in this consent
form.
An injury is study-related if it is caused by study activities. The activities must be different from procedures or
treatment you would receive if you were not in the study. Your insurance company may be billed.
Bronson Healthcare Group, and its subsidiaries, will not pay for the medical treatment of other injuries or
illnesses, or pay any other type of compensation. You will not receive money if you are injured. You will not
receive any money for wages lost because you were:
 Hospitalized
 In physical therapy
 Getting other recovery services.
You will not receive any money for pain, suffering, or for any other loss of income.
Date
Version
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IRB Template Approved 05/2004, Revised: 12/2006, 11/2008, 06/2010, 01/2012, 06/2012, 09/2013, 07/2014
*9000301*
Study Title
Principal Investigator
BMH # ____________
Bronson Methodist Hospital
Informed Consent Template
Release of Protected Health Information for Research Purposes:
This section explains how we may use your personal health information that is collected for this study. The law
lets us use and share health information for research, if you agree to let us do this. The law requires us to
protect the health information that you agree to let us use and share.
What information are you asking me to release?
The health information that may be used or released for this study includes
[Complete as appropriate; provide a description of information to be used or disclosed for the research project.
This may include, for example, all information in a medical record, results of physical examinations, medical
history, lab tests, or certain health information indicating or relating to a particular condition]
What will be done with this information?
Your information may be used and shared with others:
 To do the study and evaluate the results
 To make sure the study is correctly performed
 To meet the reporting requirements of government agencies or for legal actions
Who may use or share your protected health information for this research study?
If you sign this document you are giving permission to [covered entity] to use and share your health information
for this research.
This information may be shared with: [complete as appropriate-see examples below]:
 The Research team including the Principal Investigator, study coordinator, research nurses, and all
other members of the research team; Do not list names because they may change over the course of the
study; instead list them by title or category only]
 Research teams at other institutions (if a collaborative project)
 Sponsor of the study and/or its agents
 Contract Research Organization
 Outside Laboratories
 Data Analysis, Data Coordinating Centers
 Study Safety Monitors
 Drug Safety Monitoring Board
 The medical staff who are taking care of you
Others who may see your health information during this study include:
 The Bronson Methodist Hospital Institutional Review Board and its staff;
 Agencies of the federal, state, or local government. This includes the Food and Drug Administration
(FDA), Department of Health and Human Services (DHHS) and the Office for Human Research
Protection.
Date
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IRB Template Approved 05/2004, Revised: 12/2006, 11/2008, 06/2010, 01/2012, 06/2012, 09/2013, 07/2014
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Study Title
Principal Investigator
BMH # ____________
Bronson Methodist Hospital
Informed Consent Template
If the information is shared with others and leaves [Institution], we cannot promise that others will keep it
private. The information will be shared only if necessary.
If the results of this study are published, or presented at medical meetings, you will not be identified in any way.
How long will this authorization last?
[List a specific time period, at the completion of the research project, or state that you do not know when the
information will no longer be used therefore the information will be kept for an indefinite length of time]
What happens if you do not give authorization or want to stop a past authorization?
You can refuse to release your personal health information for this study. If you decide not to permit the release
of your information:
 You will not be able to take part in the study
 Your medical care outside of this study will not change
 Your medical care benefits will not change
You can change your mind and decide to withdraw your consent for the release of this information. You can
stop collection of the information for the study by contacting [PIs name, phone number, and address]. If you
decide to withdraw your consent for the release of this information:
 We will stop collecting your medical information, and
 Any information that was collected before you withdrew your consent will be used and seen as
described above.
Contact Information:
If you have any questions about this study, you should call the principal investigator, [name of investigator], at
[phone number]. The Bronson Methodist Hospital Institutional Review Board (IRB) has approved this consent
form and study. The IRB is a group of scientific and non-scientific people. The IRB reviews, approves, or
disapproves research involving people by following the Food and Drug Administration (FDA) rules. If you
have any questions about your rights as a participant in this research study, you should contact James W. Carter,
MD, Chairman, Bronson Methodist Hospital Institutional Review Board at:
 Address:
301 John Street (Box 92)
Kalamazoo, MI 49007
 Phone:
269-341-7898 between the hours of 8:00 a.m. and 4:30 p.m.
It is preferred that the remaining information be kept on the same page. If a break
occurs in the middle, insert a page break at this point. Delete this paragraph before final printing
Date
Version
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IRB Template Approved 05/2004, Revised: 12/2006, 11/2008, 06/2010, 01/2012, 06/2012, 09/2013, 07/2014
*9000301*
Study Title
Principal Investigator
BMH # ____________
Bronson Methodist Hospital
Informed Consent Template
Signatures:
Research Participant:
I have read this form or had it explained to me in words I can understand. All my questions about the study and my
participation in it have been answered. I have been told of my rights as a research subject. I can decide not to be a part of
this or withdraw my consent. This will not affect my treatment in any way. I know that I will receive a copy of this
signed and dated consent form. By signing this consent form, I have not waived any of the legal rights I would have as a
subject in a research study. If my ability to consent for myself changes, either my legal representative or I may be asked to
give consent again before I can continue to take part in this study.
Name (Print legal name): ________________________________
Signature of Participant: _________________________________
Date: _____________
Legally Authorized Representative (if applicable):
Name (Print legal name): _________________________________
Signature of legally authorized representative: ____________________________
Date: _____________
Check Relationship to Subject:
 Parent  Spouse  Child
 Sibling
 Legal Guardian
 Other:___________________
Principal Investigator (or Designee):
I have given this participant (or his or her legally authorized representative, if applicable) information about this study that
I believe is accurate and complete. This participant indicated that he or she understands the nature of the study and the
risks and benefits of participating.
Name (Print legal name): ____________________________
Title: _______________________
Signature of Primary Investigator or Designee: __________________________
Date
Version
Date: ____________
8 of 8
IRB Template Approved 05/2004, Revised: 12/2006, 11/2008, 06/2010, 01/2012, 06/2012, 09/2013, 07/2014