Research Informed Consent Form
Study Title:
Principal Investigator:
Study Sponsor:
“You” refers to the subject. (Include only if adult study)
“You” refers to you and your child. (Include only if pediatric study)
“We” refers to ____________________. (Include organizations affiliated with the research, e.g. Mercy Health,
Mercy Health Physician Partners)
1. Introduction
Include the following language verbatim:
You are being asked to participate in a clinical research study. Clinical research is the study of
human diseases in an attempt to improve diagnosis and treatment. In order to decide whether or
not you should agree to be part of this research study, you should receive enough information about
its risks and benefits to make a judgment. This process is called informed consent.
This consent form gives detailed information about the research study, which will be discussed with
you. If you wish to participate in this study you will be asked to sign this form.
2. Purpose of This Research Study
 Explain the purpose of your study, including procedures, in easily understood language.
 Explain what you hope to learn (state what the study is designed to discover or establish).
 Include special conditions of participation, including inclusion or exclusion criteria.
 Clearly state why the participant is being asked to participate.
3. Registering Your Study on ClinicalTrials.gov
Under the new 21 CFR 50.25©, the following statement must be included verbatim (for applicable
clinical trials only):
“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 with Web site at any time.”
For applicable clinical trials, refer to the attached guidance sheet at the end of this template for
additional information.
 ATTENTION: Investigator or Sponsor enters version number and date of ICF in footer. 
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4. Length of Your Participation
 Explain the expected length of time of the subject’s participation. Include the number of required
study visits.
5. Where the Study is Being Done and Number of People Participating
 Explain where the study will be conducted and total number of subjects expected to be recruited
overall. Specify expected number of subjects to be recruited for your site only.
6. Study Procedures
 Include all study procedures, clearly explaining which procedures are considered standard of
care versus those that are being conducted solely for the purpose of this study.
 Provide explanation, in easily understood language, for:
o Randomization (if applicable)
o Blinding (if applicable)
o Placebo (if applicable)
 If specimens are required, describe:
o Type
o How and when obtained
o If drawing blood, specify amount of blood required in tablespoons or teaspoons
 If specimens are required for future research, explain how, where and length of time they will be
stored, and who owns them.
 If there are social behavioral consequences, identify potential risk and a plan to manage event
issues.
 If the research involves photographs, video or audiotaping, describe how subject’s identity be
protected.
7. What Will Happen When You Complete the Study
 Provide an explanation (e.g. When your participation in the study ends, you will no longer have
access to (the study medication/device).
8. Possible Risks or Side Effects of Taking Part in this Study
 If there are no known side effects or risks, state as such.
 Include a statement describing how participation may involve unforeseeable risks. If the study
drug is still being tested, inform subjects they may experience other side effects that have not yet
been reported (e.g. In addition to these risks, this research may hurt you in ways that are
unknown. If we learn of new risks that we think might affect your desire to stay in the research,
we will tell you. It is possible, if major risks are discovered after the study is finished, the sponsor
may attempt to contact you.)
 Include all known and potential risks or inconveniences of the study and any procedures required
solely for the purposes of this study (e.g. psychological risks, genetic, financial).
o If a blood draw is required, include a statement explaining there may be possible
bruising, minor discomfort, bleeding or infection at the site
 Describe each of the following risks/discomforts, if appropriate:
o Physical risks (e.g. medical side effect)
o Psychological risks/discomforts (e.g. embarrassment, fear or guilt)
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o
o
o
o


Privacy risks (e.g. potential loss of confidentiality)
Legal risks (e.g. legal prosecution or being reported for child abuse)
Social risks (e.g. social ostracism or discrimination)
Economic risks (e.g. having to pay money out of pocket for research or medical
expenses. Should you lose your health insurance during your involvement in this clinical
trial, you may have to pay money out of pocket.)
If specimens are retained for future genetic research, explain what is meant by genetic
information, how and where the specimens and genetic information will be stored, and who owns
the specimens and related genetic information (e.g. “Like all tissues and cells in your body, these
tissues/cells have genes. A ‘gene’ is the basic ‘instruction book’ for how to build a cell. Your
genes determine your physical characteristics, such as your height and hair and eye color. Your
genes can also help determine whether you have a chance of developing a certain illness or
medical condition.”) Describe the risks of this information being collected or misused.
At the end of this section, the following language must be included (for those studies
collecting specimens or bodily fluids):
o In accordance with Michigan Public Health Code MCL 333.5133, an HIV and hepatitis
test may be performed without written consent if a healthcare worker is exposed to your
or your child’s blood or other bodily fluids. If the test results indicate you or your child are
HIV or hepatitis positive, you or your child will be informed of these results and given
appropriate counseling.
9. Acceptable Birth Control Language
 Include one of the following sample statements (exactly as written) if applicable to your study.
These choices are accepted within the Ethical and Religious Directives for Catholic Health Care
Services (Directives 38-54).

"If you are pregnant or breastfeeding, you cannot take part in this study. You may be
required to have a blood and/or urine test to see if you are pregnant before you begin this
study treatment. If you are sexually active, it is important that you not become pregnant
because this medication may be harmful to your unborn child. You must discuss your
pregnancy plans with your doctor before enrolling in this study; you must also
agree to use the type and duration of precautions approved by your doctor for the
entire time you receive this study treatment. For women, if you become pregnant or
have reason to believe you might be pregnant, please inform your doctor immediately.
Once you are no longer receiving this study treatment, discuss with your doctor when it
might be safe to become pregnant or become a new father."

"If you are pregnant or breastfeeding, you cannot take part in this study. You may be
required to have a blood and/or urine test to see if you are pregnant before you begin this
study treatment. If you are sexually active, it is important that you not become pregnant
for this medication may be harmful to your unborn child. You must discuss your
pregnancy plans with your doctor before enrolling in this study and agree that you
will take the appropriate precautions not to become pregnant while enrolled in the
study. For women, if you become pregnant or have reason to believe you might be
pregnant, please inform your doctor immediately. Once you are no longer receiving this
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study treatment, discuss with your doctor when it might be safe to become pregnant or
become a new father."
10. Costs for Taking Part in this Study
 Explain any additional costs to the participant or their insurance that may be incurred by their
participation in the study. If the study treatment is provided free of charge, state as such (e.g.
There is no cost to you for participation in this clinical trial). Clearly differentiate those
procedures considered standard of care and those that are solely for the purpose of the study.
Following is sample language you may use:
The study drug/device will be supplied free of charge.
Use the following language verbatim:
(The following information regarding patient care and research costs is reproduced language
originating from the National Cancer Institute, www.cancer.gov)
As you think about taking part in this research study, you will need to consider how to cover the
costs of your care. Even if you have health insurance, your plan may not cover all of the costs
related to receiving treatment in a clinical trial. Some health plans will not pay these costs for people
taking part in research studies. You may want to verify this with your health plan or insurance
company to find out what they will pay for (your medical social worker may be able to help you with
this, if needed).
There are two types of costs associated with a clinical trial: patient care costs and research costs.
Patient care costs are the costs related to treating your disease or medical issue even if you don't
participate in a clinical trial. These costs are often covered by health insurance. They include:
 Doctor Visits
 Hospital Stays
 Lab Tests
 X-Rays and other Imaging Tests
Research costs are those specifically related to taking part in a clinical trial. Often these costs are
not covered by health insurance, but they may be covered by the sponsor of the clinical trial.
Examples include:
 The study drug or device
 Lab tests performed solely for research purposes
 Additional x-rays and imaging tests performed solely for this clinical trial
 You should also consider that you may have extra doctor visits that you would not have
with standard treatment. These extra visits can add costs for transportation and child
care.
If you are injured as a result of your participation in this research project, Mercy Health will assist
you in obtaining emergency care, if necessary, for your research related injuries. If you have
insurance for medical care, your insurance carrier will be billed in the ordinary manner. As with any
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medical insurance, any costs that are not covered or are in excess of what are paid by your
insurance, including deductibles, will be your responsibility. Mercy Health's policy is not to provide
financial compensation for lost wages, disability, pain or discomfort, unless required by law to do so.
This does not mean that you are giving up any legal rights you may have. You may contact [insert
Principal Investigator’s name and phone number] with any questions or to report an injury.
11. Payment for Taking Part in this Study
 Explain any compensation the participant may receive, including the amount and any conditions
of payment. Please state that “Payment will be in the form of a store card to a local retailer.” If
no compensation will be given, please state as such.
12. Possible Benefits to You for Taking Part in the Study
 Describe any potential benefits to the participant that may be reasonably expected.
 If no direct benefit, state as such. (e.g. You will not directly benefit from your participation in the
study. However, your participation in this study may contribute to the understanding of…..)
13. About Participating in this Study
Following is sample language to be included in this section:
Your health care provider may be an investigator of this research protocol and, as an investigator, is
interested both in your clinical welfare and in the conduct of this study. Before entering this study, or
at any time during the research, you may ask for a second opinion about your care from another
doctor who is in no way associated with this research study. You will be responsible for any costs
associated with obtaining a second opinion. You are not under any obligation to participate in any
research project offered by your doctor.
Your participation in this study is voluntary. You may stop participating in this study at any time. Your
decision not to take part in this study or to stop your participation, will not affect your medical care or
any benefits to which you are entitled. If you decide to stop taking part in this study, you should tell
the investigator.
Your doctor, the investigator and/or the Sponsor may stop your participation in the study at any time
if they decide that it is in your best interest. They may also do this if you do not follow instructions. If
you have other medical problems or side effects, the doctor and/or nurse will decide if you may
continue in the research study.
If you wish to take part in this study, we expect that you will:
 Keep your study appointments. If you cannot keep an appointment, contact the investigator
or research study staff to reschedule as soon as you know that you will miss the
appointment.
 Tell the investigator or research study staff about any medications you are taking so they can
check how the drug being studied and your medications may interact. If you need to start on
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
any new medications while you are in the study, please check with the investigator before
you do so.
Tell the investigator or research study staff about any side effects, doctor visits, or
hospitalization that you may have whether or not you think they are related to the study
therapy.
If you decide to leave the research, the consequences of your decision are (describe the adverse
consequences – e.g. participants on a drug may experience worsening of their disease or
withdrawal problems without substituting another drug or tapering the study drug.). If you decide to
leave the research, contact the investigator so that the investigator can (describe the procedures for
orderly termination by the participant.)
14. Compensation for Injury
 If sponsor agrees to pay for expenses resulting from research related injury or illness, include the
sponsor’s statement.
 If no compensation is available from any source, insert the following statement:
If you are injured as a result of your participation in this research project, medical care and/or
hospitalization will be provided, if necessary. If you have health insurance, your insurance
carrier will be billed in the ordinary manner. As with any health insurance, any costs that are not
covered or are in excess of what is paid by your insurance, including deductibles, will be your
responsibility. No funds have been set aside to pay you in the event of a study related injury.
By signing this consent form, you will not waive any of your legal rights or release the parties
involved in this study from liability for negligence.
15. Confidentiality of Study Records and Medical Records
 If data for this project is being collected anonymously and researchers nor anyone else can link
the data to the participant, state as such.
 If data is being coded and a key maintained separately, inform participants of the process.
 Explain how you will maintain the participant’s privacy throughout the project.
Sample statement:
Information collected for this study is confidential. However, the investigator and his/her study
staff, delegated representatives of Mercy Health and Mercy Health Regional Institutional Review
Board (IRB), the sponsor and/or their representatives, the Food and Drug Administration (FDA)
and other government agencies involved in keeping research safe for people may look at your
medical records when necessary, either in person, by mail, fax or electronically.

Discuss how you will keep the participant’s information confidential
o Where will the data be stored and how will it be protected
o Who will have access to the data?
 Researchers and research staff
 Institutional Review Board (IRB)
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

Sponsor
Government agencies (e.g. FDA)
16. Release of Personal Information
Include the following statement:
We will do our best to ensure that your personal information is kept confidential and private to the
maximum extent required by law. We cannot guarantee absolute confidentiality and privacy. Your
personal information may be disclosed if required by law. If information from this study is published or
presented at scientific meetings, your name and other personal information will not be used.
17. Financial Conflict of Interest
 If there is a conflict of interest, the researcher should disclose this on the consent form.
o Significant financial interest
o Affiliation with study sponsor
18. HIPAA Authorization
Include all of the language in this section verbatim:
As part of this research study, you are being asked to release your health information. The Health
Insurance Portability and Accountability Act (HIPAA) permits a hospital or doctor’s office to use or
release protected health information (PHI) for the purposes of treatment, payment or health care
operations. A HIPAA authorization gives permission from you to use or release PHI for research
purposes, and is in addition to your consent to participate in this research study.
In working with the sponsor, the investigator, (enter investigator’s name), will use and share personal
health information about you. This is information about your health that may also include your name,
address, telephone number or other facts that could identify the health information as yours. This
includes information in your medical record and information created or collected during the study. This
information may include your medical history, physical exam and laboratory test results. Some of these
tests may have been done as part of your regular care. The investigator will use this information about
you to complete this research.
In most cases, the investigator will use your initials and assign a code number to your information that is
shared with the sponsor. The sponsor and its representative may review or copy your personal health
information at the study site. Regulatory authorities and the Mercy Health's Institutional Review Board
may also review or copy your information to make sure that the study is done properly or for other
purposes required by law.
By signing this Authorization, you allow the investigator to use your personal health information to carry
out and evaluate this study. You also allow the investigator to share your personal health information
with:
 the sponsor and its representatives
 the Mercy Health Regional Institutional Review Board
 the U.S. Food and Drug Administration (FDA)
 Other regulatory agencies - e.g. National Institutes of Health (NIH) and Department of Health
and Human Services (DHHS)
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Your personal health information may be further shared by the groups above. If shared by them, the
information will no longer be covered by the Privacy Rule. However, these groups are committed to
keeping your personal health confidential.
You have the right to see and get a copy of your records related to the study for as long as the
investigator has this information. However, by signing this Authorization you agree that you might not be
able to review or receive some of your records related to the study until after the study has been
completed.
You may choose to withdraw this Authorization at any time, but you must notify the investigator in
writing. Send your written withdrawal notice to (enter investigator’s name and address). If you
withdraw from the study and withdraw your Authorization, no new information will be collected for study
purposes unless the information concerns an adverse event (a bad effect) related to the study. If an
adverse event occurs, your entire medical records may be reviewed. All information that has already
been collected for study purposes, and any new information about an adverse event to the study, will be
sent to the study sponsor.
If you withdraw from the study but do not withdraw your Authorization, new personal health information
may be collected until this study ends.
Include one of the following statements:
1. This authorization does not have an expiration date.
2. This authorization expires on _____________.
If you do not sign this Authorization, you cannot participate in this research study or receive studyrelated treatment. If you withdraw this Authorization in the future, you will no longer be able to participate
in this study. Your decision to withdraw your Authorization or not to participate will not involve any
penalty or loss of access to treatment or other benefits to which you are entitled.
19. Names of Contacts for Questions about the Study
Include the following statement:
If you have any questions about taking part in this study, or in the event of a research related illness or
injury, contact (insert investigator’s name and contact number). If you have any questions about your
rights as a research participant, you may contact:
Brenda Hoffman, Mercy Health Regional Institutional Review Board (IRB) Chairperson
200 Jefferson Ave. SE – Grand Rapids, MI 49503
Telephone: 616-685-6198
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DOCUMENTATION OF INFORMED CONSENT
By signing this consent form and HIPAA authorization and by initialing each page, you certify
you have read this form, you have had the opportunity to ask questions about this study and
this form, and you have received answers that fully satisfy those questions. You are
voluntarily signing this consent form and HIPAA authorization as evidence of your decision to
participate in this research study and you are giving authorization for release of all your
protected health information relative to this research.
You are aware you may withdraw your consent and HIPAA authorization in writing at any time
without harming my future medical care or losing any benefits to which you might be otherwise
entitled. You have been advised that the investigator in charge of this study may discontinue
your participation in this study if it is felt to be in your best interest, if you do not follow the
study requirements or if the study is stopped.
You will receive a signed copy of this Research Informed Consent Form and HIPAA
Authorization.
By signing this consent form, you have not waived any of your legal rights or released the
parties involved in this study from liability for negligence.
Signature of Study Participant
Date
Printed Name of Study Participant
Signature of Person Obtaining Consent
Date
Signature of Principal Investigator
Date
The following is optional. Remove if not applicable to your study.
Signature of Witness
Date
Witnessed entire consent process
Witnessed participant’s signature only
Printed Name of Witness
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Include the following only if applicable to your study.
Signature Block for Adult Unable to Consent
I certify that under state law I am the legally authorized representative of the study participant
named below, and that I am authorized to sign consent to his/her participation in this research
study and to the use and disclosure of this person’s personal health information. [Remove latter
part of this statement if there is no HIPAA authorization.] You will receive a signed copy of this
complete form.
_______
Printed Name of Study Participant
___________________________________________
Signature of Legal Authorized Representative
____________________
Date
___________________________________________
Printed Name of Legal Authorized Representative
________
Signature of Person Obtaining Consent and Assent
_
Date
[Remove “and Assent” if assent will not be obtained]
____________________________________________
Printed Name of Person Obtaining Consent and Assent
[Remove “and Assent” if assent will not be obtained]
[Add the following block if you will document verbal assent of the participant on this
consent form. If you will be documenting written assent, add an assent signature line,
date line and printed name line to this form – OR – complete a separate assent form.]
Verbal Assent was:
Obtained
Not obtained because the capability of the participant is so limited that the participant
cannot reasonably be consulted
[Add the following signature block if an impartial witness is required for a LAR that is a
non-reader.]
I witnessed:
 The entire consent discussion and attest that the information in the consent document
and any other written information were accurately read to the participant.
 That all of the participant’s questions were addressed.
 The participant freely giving consent to participate in this clinical trial.
____________________________________
Signature of Impartial Witness
____________________________________
Printed Name of Impartial Witness
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____________________
Date
Include the following only if applicable to your study.
Signature Block for Children
Your signature below documents your permission for the child named below to take part in
this research study and to the use and disclosure of this child’s protected health information.
[Remove latter part of this statement if there is no HIPAA authorization] You will receive a signed copy
of this complete form.
___________________________________
Printed Name of Child Participant
___________________________________
Signature of Parent or Guardian
_________________________
Date
___________________________________
Printed Name of Parent or Guardian
Parent
Guardian (See note below)
Note on permission to guardians: An individual may provide permission for a child only if that
individual can provide a written document indicating that he or she is legally authorized to consent to
the child’s general medical care. Attach the documentation to the signed document.
[The following second parent or guardian block is required if your study is greater
than minimal risk with no prospect of direct benefit but likely to yield generalizable
knowledge about the child’s disorder or condition (45 CFR 46.460 & 21 CFR 50.53)]
___________________________________
Signature of Second Parent or Guardian
__________________________
Date
___________________________________
Printed Name of Second Parent or Guardian
Second Parent
Second Guardian (See note above)
If signature of second parent was not obtained, indicate why (select one):
Second parent is deceased
Second parent is unknown
Second parent is incompetent
Second parent is not reasonably available
Only one parent has legal responsibility for the care
and custody of the child
[Add the following block if you will document verbal consent of children on this consent
form. If you will be documenting written assent, add an assent signature line, date line
and printed name line to this form – OR – complete a separate assent form.]
Verbal Assent was:
Obtained
Not obtained because the capability of the child is so limited that the child cannot reasonably
be consulted
________
Signature of Person Obtaining Consent and Assent
[Remove “and Assent” if assent will not be obtained]
____________________________________________
Printed Name of Person Obtaining Consent and Assent
[Remove “and Assent” if assent will not be obtained]
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_
Date
Registering Your Study on ClinicalTrials.gov
In the Federal Register (FR) of January 4, 2011 (76 FR 256), FDA published a final regulation
(21 CFR 50.25 (c)) amending the current informed consent regulations to require that
informed consent documents and processes for applicable drug (including biological products)
and device clinical trials include a specific statement that clinical trial information will be
entered into a databank. The databank referred to in this final rule is the clinical trial registry
databank maintained by the National Institutes of Health/National Library of Medicine
(NIH/NLM) which was created by statute. The submission of clinical trial information to this
data bank also is required by the statue. The amendment to the informed consent regulations
was required by the Food and Drug Administration Amendments Act of 2007 (FDAAA), Public
Law 110-85 (September 27, 2007) and is designed to promote transparency of clinical
research to participants and patients.
For applicable clinical trials initiated on or after March 7, 2012, informed consent
documents must be in compliance with the new requirement in 21 CFR 50.25(c) and
include a specific statement that refers to the trial’s description on
www.ClinicalTrials.gov.
Definition of “Applicable Clinical Trial”:
Food and Drug Administration Amendments Act of 2007 provided a definition of “applicable
clinical trial” in 42 U.S.C 282(j)(1)(A). “Applicable clinical trials” generally include controlled
interventional studies (with one or more arms) of drugs, biological products, or devices that
are subject to FDA regulation, meaning that the trial has one or more sites in the United
States, involves a drug, biologic, or device that is manufactured in the United States (or its
territories), or is conducted under an investigational new drug application (IND) or
investigational device exemption (IDE). Trial sponsors and investigators have the
responsibility of determining whether or not a trial is an “applicable clinical trial”. Definitions
vary for applicable device and drug trials including biologics.
The trial is an “applicable clinical device trial” if: (I) the trial prospectively compares a devicebased intervention subject to FDA regulation against a control in human subjects: or (II) the
trial is a pediatric post-market surveillance trial. 42 U.S.C. 282(j)(1)(A)(ii).
The trial is an “applicable clinical drug trial” if the trial is a controlled clinical investigation,
other than a phase I clinical investigation, of a drug subject to FDA regulation. 42 U.S.C.
282(j)(1)(A)(iii)(1). For the purposes of this definition, a “clinical investigation” is “any
experiment in which a drug is administered or dispensed to, or used involving one or more
human subjects. 21 CFR 312.3
For drugs, phase I clinical investigations (defined in 21 C.F.R. 312.21) are not categorized as
“applicable clinical trials”. 42 U.S.C. 282(j)(1)(A)(iii). Uncontrolled clinical investigations of
drugs or devices also are not considered “applicable clinical trials”.