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Institutional Review Board
13951 Terrace Road
Regional Institutional Review Board Cleveland, OH 44112
Euclid, Fairview, Hillcrest, Huron, Lakewood, Lutheran, Marymount, South Pointe
Consent Document Instructions & Template Phone: 216-761-8206
Fax: 216-761-2876
IRB Consent Document Instructions
Last update 10/18/07CCF
The purpose of the consent document is to provide research participants with a written document that presents the main
implications of research participation. It is part of the informed consent process – an ongoing process of communication
between the participant and the research staff.
The consent form should be used as a guide when conducting a consent interview to provide potential participants with
sufficient information to make an informed decision whether or not to participate in the research. The consent form
should be designed to inform potential participants to what will happen during the course of the study. It should be
written in “lay language”(i.e. nonscientific simple terms) so that the intended subject population can readily
understand the important information.
Please review IRB Policy # 40, Informed Consent Process. This policy provides information about the informed
consent process, consent document basic and additional elements, revisions or changes to the consent document,
consent involving vulnerable subjects, and use of the GCRC Research Subject Advocate.
Use the IRB Consent Format/Template below with your application. This form has been developed by the Cleveland
Clinic IRB in compliance with the federal basic elements and the additional elements when appropriate for human subject
protections and includes the core elements and general requirement for HIPAA authorization.
General Instructions:
Consent forms should be written in the second person (e.g., “You are invited to participate.”). Use of the first person
(e.g., “I understand that…”) can be interpreted as suggestive and can constitute coercive influence over a subject.
Consent forms may not include any exculpatory language through which the subject is asked to waive or appear to
waive any of his/her legal rights, or releases or appears to release the Investigator, the sponsor, the institution or its
agents from liability for negligence. Avoid using statements that require subjects to agree to terms or conditions as they
can be construed as being exculpatory (e.g. "I agree that I will not be paid for any research-related injuries." “I give up my
rights to future compensation.”)
Consent forms for studies involving pediatric subjects should include an assent statement for children above age 7 and
parents to sign. Avoid the format of “you/your child” throughout the document by stating up-front that “you” refers to
either you or your child.
Consent forms should use a 12 point font with one-inch margins, a version date and page numbers in the footer.
Each of the section sub-headings should be set-off in bold print. For studies expected to enroll visually impaired
individuals, a larger font size should be used.
IRB stamp-approved consent forms are to be signed and dated by the subject or the subject’s legally authorized
representative and the person conducting the interview. Maintain the signed original in the research study file and
give a copy to participants.
ITALICIZED TEXT SHOULD BE REMOVED FROM THE FINAL CONSENT DOCUMENT
CCR IRB Revised 9/5/08
__________Hospital, a Cleveland Clinic hospital
Consent to Participate in a Research Study
Study Title:
Principal Investigator:
Sponsor:
Carefully review this consent document. The purpose of a consent document is to provide you with information
to help you decide whether you wish to participate in research. Your decision is completely voluntary and will
not affect your medical care if you choose not to participate. It is important for you to ask questions and
understand the research risks, benefits and alternatives.
Please note:
You are being asked to participate in a research study
Carefully consider the risks, benefits and alternatives of the research
Your decision to participate is completely voluntary
Your doctor may be an investigator in this research study, and as a research investigator, is interested in both
your welfare and in the conduct of the research study. Before entering this study or at any time during this
research, you may ask for a second opinion about your care from another doctor who is not involved with the
research study. You are not under any obligation to participate in any research project offered by your doctor.
*************************************************************************************
The standard COI language below must be added if any investigator discloses a conflict within permissible
limits. COI’s that require management plans will be individually designed by the Conflict of Interest
Committee (COIC) and given to you from the IRB.
Conflict of Interest Disclosure:
One or more of the investigators conducting this study serve as paid speakers, consultants or advisory
committee members for the company that is paying for this research or a company that makes products used
in this study. These financial interests are within permissible limits established by the Cleveland Clinic
Conflict of Interest Policy. If you have any questions regarding conflicts of interest, please ask your study
doctor or call the Institutional Review Board at 216-761-7079.
*************************************************************************************
1. INFORMATION ON THE RESEARCH
Why Are You Being Asked To Take Part In This Research?
Required language: You are being asked to participate in this research study because you …
(ex. have been diagnosed with high blood pressure, are a normal healthy volunteer, etc.)
Why Is This Study Being Done?
Required language: The purpose of this study is to …
(ex. to investigate the effectiveness and safety of experimental drug, XXX, which has not yet been approved
for use by the U.S. Food and Drug Administration (FDA)
Do not use the term “new” to describe an “experimental” or “investigational” drug/device. “New” may
perceived as describing a drug/device that has been approved by FDA.
How Many People Will Take Part In The Study?
Required language: About ____ people will take part in this study.”
If the research involves a multi-center study, add: at ____different hospitals and approximately _____
people will take part at Cleveland Clinic.]
What Is Involved In The Study?
All study procedures and visits that occur during the protocol must be described.
A description of every visit and procedure including, but not limited to, blood draws, EKG’s, injections,
follow-up phone calls, pulmonary function testing, x-rays, MRI’s, or any other procedure done in
accordance with the protocol.
When describing what is involved in the research, consider using a table to outline the study activities. See
example below.
Visit What procedures/tests that will be What will need to be brought
done at this visit? and/or done for this visit?
Week 1/Visit 2 Blood tests for______ (__ tsp.) Ex. Bring diary cards and
all medication bottles
EKG a tracing of the electrical (both empty and full).
activity of the heart)
Do not eat after midnight
the night before the visit.
Week 2/Visit 3
Week 4/Visit 4
Every 6 Telephone follow-up call None
months after
Week 4 visit
When applicable, clearly describe all medical/technical terms in lay language:
Randomization: chance selection, like flipping a coin
Placebo: a substance with no active medication
Describe blood samples in amounts such as teaspoons, tablespoons, ounces, etc.:
5ml = 1 teaspoon; 15ml = 1 tablespoon; 30ml = 1 ounce; 500ml = 1 standard blood donation
Describe the dosage of the study drug including the method and schedule of administration of
medications
Identify the length of time to complete procedures, visits or questionnaires
HIV testing: “As part of this study a sample of your blood is being tested for the presence of
HIV(Human Immunodeficiency Virus). HIV is the virus that causes AIDS (Acquired Immunodeficiency
Syndrome). If your blood test results are positive and you live in the State of Ohio, the results of that
test, if positive, and demographic information about you will be reported to the Ohio Department of
Health as required by law. In addition, this information will be available on the hospital’s laboratory
reporting system. The results may influence your insurability and/or employability regarding your
health status.
Other Infections Diseases: refer to Policies and Procedures for Infection Control
How Long Will You Be In The Study?
Required language: Your participation in this study will last …
2. RISKS AND DISCOMFORTS
What Are The Risks Of The Study?
All known risks associated with the research must be listed in order of frequency, severity, and
consequences.
All research involves some risk therefore a risk statement must always be included.
Risks associated with standard care should be included in the consent form if they are integral to the
research design.
For placebo groups explain the risk of not receiving treatment. If you receive placebo, your condition may
go untreated and may worsen as a result.
Include all risks associated with the device including its insertion/implantation and potential need for
removal.
Include a statement indicating the research may involve unforeseeable risk to the participant for research
involving greater than minimal risk.
Minimal risk studies (such as questionnaires/surveys) may involve the risk of loss/breach of confidentiality,
psychological stress or inconvenience and should be included if applicable.
All potential risks should be described in terms of frequency, severity and consequences. The IRB recommends
the use of a table such as below to describe this information. Use the Investigator Brochure or the Protocol to
assemble this table.
Mild Moderate Severe
Likely Nausea and vomiting Nausea and vomiting
without consequence leading to dehydration
_____%
Less Abnormal liver
Likely functions which
improved after study
_____% drug was stopped.
Rare Cardiac arrest that
could lead to death.
_____%
Required language:
Unforeseeable risks:
There may be risks or side effects related to the study drug/device that are unknown at this time. You will be
notified of any significant new findings that become known that may affect your willingness to continue in
the study.
Pregnant women, fertile females/males:
There may be unforeseen risks to an unborn child associated with your taking Drug XXX. Therefore, if you
are capable of giving birth to or fathering a child, you and your sexual partner should use adequate birth
control measures while you are in the study. These measures may include abstinence, oral contraceptives
(birth control pills), IUD, diaphragm, approved hormone injections, condoms, or documentation of medical
sterilization. If you are unwilling to do this, we ask that you not participate in this study.
Pregnancy tests will be performed on all women of child-bearing potential before beginning the study and
during the study every … If you or your spouse become pregnant while taking part in this study you must
notify the study doctor immediately. If birth control methods must continue after the study drug is
discontinued, this time period should be provided to subjects.
Marymount Hospital
Marymount Hospital is a Catholic Hospital sponsored by the Sisters of St. Joseph of the Third Order of St.
Francis. As a Catholic Hospital, Marymount Hospital does not promote or condone artificial methods of
birth control. There are various methods consistent with Catholic moral teaching including natural family
planning and abstinence. The IRB, however, recognizes the need to address birth control in the informed
consent document. This applies to all Marymount Hospital facilities, including physician offices located in
the Marymount Medical Building.
Acceptable birth control practices include abstinence and natural family planning. The adjectives reliable
and responsible are also acceptable. Samples of acceptable birth control language in an informed consent
document are: It is not known if this study drug may harm an unborn baby. If you participate in this research
study, you should avoid becoming pregnant. OR It is not known if this study drug may harm an unborn baby.
If you participate in this research study, you and your partner should use responsible and reliable natural
family planning to avoid becoming pregnant.
Unacceptable birth control practices include listing specific methods of birth control, such as hormonal
methods or barrier methods of birth control. Samples of unacceptable birth control language include It is
not known if this study drug may harm an unborn baby. If you participate in this research study, you and
your partner should birth control to avoid becoming pregnant. Methods of birth control include oral
contraceptives or birth control bills, depo-provera injections, IUD or double-barrier methods, for example a
diaphragm used with condoms.
In some instances, the study drug is proven to be harmful to fetuses and yet may be beneficial for the
research patient. In these instances, the informed consent document may contain explicit birth control
language which should be followed by the statement, As a Catholic institution, Marymount Hospital does not
endorse the use of birth control. Proof of teratogenicity or fetal harm must be provided prior to using this
statement. The IRB will consult with Marymount Hospital administration’s regarding the best way to
proceed with these studies. A sample is The study drug has been proven to harm unborn babies. If you
participate in this research study, you avoid becoming pregnant by using two reliable forms of birth control.
Reliable forms of birth control include oral contraceptives (birth control pills), depo-provera injections, IUD,
diaphragm, or condoms. Please discuss your birth control plan with the study doctors. As a Catholic
Hospital, Marymount Hospital does not promote or condone artificial methods of birth control. There are
various methods consistent with Catholic moral teaching including natural family planning and abstinence.
The following five risks may or may not apply to your protocol; include if relevant and delete if inapplicable.
Radiation:
The consent should identify the cumulative risks of radiation exposure from both standard of care and the
additional research related tests.
One of the risks associated with radiation exposure is cancer. The natural incidence of fatal cancer in the
U.S. is about 1 chance in 5. Everyday radiation exposure from natural occurring background radiation (sun,
radon exposure in the home) is approximately 3 mSv per year. In this research study, you will be receive
(identify the test(s) and the number of tests; for example, 2 CT scans) combined with (identify the test(s) and
the number of tests) performed for standard care. This radiation exposure risk is equal to an additional
(identify the time equivalent to natural background radiation; for example, 3 months) of natural background
radiation.
Consent language for repeated or prolonged interventional fluoroscopic procedures should include the risk of
hair loss, skin burns, cataracts, diminished fertility and bone marrow suppression, as appropriate.
Genetic Research: See IRB Policy #115 Human Genetic Research
Genetic studies may create psychosocial and economic risks, social stigma, and loss of privacy, insurability
and employability, therefore additional elements beyond the required elements are to be included. They
are:
A. Information about the DNA samples to be taken, including whether cell lines will be established.
B. If data are to be shared, how will it be provided and when it will be disclosed.
C. If disease risk is disclosed, discuss how it is quantified, including limits on the certainty of the
test, and the availability of genetic counseling and related costs.
D. Risks should include statements regarding:
1. The information may contain things about themselves and their family that they
did not want to know, or may make them uncomfortable in knowing.
2. The information about themselves may be learned by other family members
3. Risk the information may affect their insurability and employability
4. Resulting actions due to the genetic information may expose them to additional
risks; e.g. submitting insurance claims for genetic counseling.
E. Limits to and consequence of the subject’s right to withdraw from the research, withdraw data,
withdraw DNA.
F. Confidentiality and Privacy protections.
G. DNA storage and sharing; secondary uses and third party uses of tissue sample and/or data.
Sharing of subject identity.
H. Compensation for specimen and future product development.
Depression/Suicidal Ideation:
In previous studies depression, thoughts of suicide and suicide attempts have been identified as risks
associated with this medication. If you experience sadness or depression or are troubled by thoughts of
harming yourself in any way, please seek immediate help by calling your doctor, going to the nearest
emergency room or health care facility, or calling 911. Also, at your earliest convenience, please notify the
study investigator or study nurse that you have experienced a change in your mood.
Blood Draw:
The risks of drawing blood from a vein includes discomfort at the site of the needle stick, possible bruising
and swelling around the site of the needle stick, rarely an infection, and uncommonly feeling faint from the
procedure.
Questionnaire/Survey Research:
There are no physical risks associated with this study. There is, however, the potential risk of loss of
confidentiality. Every effort will be made to keep your information confidential, however, this can not be
guaranteed. Some of the questions we will ask you as part of this study may make you feel uncomfortable.
You may refuse to answer any of the questions and you may take a break at any time during the study.
3. BENEFITS
Are There Benefits To Taking Part In The Study?
Suggested language:
Participation in this study may help to improve your condition, but it is also possible that your condition may
worsen. There is no guarantee that you will personally benefit by participating in this research study. Your
participation in this study may provide information that may help other people who have a similar medical
problem in the future.
OR
There is no personal benefit to you by participating in this research study.
The knowledge to be gained from this research may be beneficial for other patients, society or science.
4. ALTERNATIVES
What Other Options Are There?
If other therapies are available besides the experimental treatment, subjects should be told about those
therapies and the comparative advantages and disadvantages including other investigational studies.
The alternative of no treatment (comfort care) should be included, as applicable.
If the research is a non-interventional study and there are no options the alternative is not to participate.
5. PRIVACY AND CONFIDENTIALITY
Required language: note you need to insert specific information as identified below
The medical and research information recorded about you for this research will be used within the
Cleveland Clinic and/or disclosed outside the Cleveland Clinic. Tests and procedures done solely for this
research study may be placed in your medical record to indicate your participation in this study. The
information recorded about you as part of this research will be maintained in a confidential manner.
Upon completion of the study, you may have access to the research information if contained in the medical
record. During the study, your access to research information about you will be limited. Preventing this
access during the study keeps the knowledge of study results from affecting the reliability of the study. This
information will be available should an emergency arise that would require your treating physician to know
this information to assist in treating you.
Federal regulations require that you authorize the release of any health information that may reveal your
identity. The persons and entities that you are authorizing to use or disclose your individually identifiable
health information may include the study doctor, the study staff, Cleveland Clinic monitors/auditors and
IRB, the study Sponsor and its agents, the U.S. Food and Drug Administration (FDA), the Department of
Health and Human Services (DHHS), other governmental agencies from foreign countries, and (insert other
parties as appropriate). Because of the need to release information to these parties absolute confidentiality
cannot be guaranteed. The Cleveland Clinic also may use and disclose this information for treatment and
payment reasons. The Cleveland Clinic must comply with legal requirements that mandate disclosure in
unusual situations. Once your personal health information is released it may be re-disclosed and no longer
protected by federal privacy laws. The results of this research may be presented at meetings or in
publications; however, your identity will not be disclosed in those presentation.
Your research information may be used and disclosed indefinitely, but you may stop these uses and
disclosures at any time by writing to (insert name of PI) at (insert address of PI). If you do so, your
participation in the research will stop, but any information previously recorded about you cannot be
removed from the records and will continue to be used as part of the research. Also, information already
disclosed outside the Cleveland Clinic cannot be retrieved. Even if you ask us to stop outside disclosures,
information collected about you will be disclosed as required by state and federal law.
The Cleveland Clinic will not use or disclose the information collected in this study for another research
purpose without your written permission, unless the Cleveland Clinic Institutional Review Board gives
permission after ensuring that appropriate privacy safeguards are in place. The Institutional Review Board
is a committee whose job is to protect the safety and welfare of research subjects.
By signing this informed consent form, you are authorizing such access to your medical records. If you
choose not to sign this consent form, you will not be permitted to participate in this research study.
6. RESEARCH RELATED INJURIES
What Happens If An Injury Occurs?
Standard language: refer to the research contract to determine if the sponsor will cover
In the event you are injured as a result of participation in this research, medical care is available to you and
will be billed to your insurance company. The cost of such medical care that is not covered by your medical
insurance shall be paid by the study sponsor, (insert sponsor name), if the injury is not attributable to a
known risk of the research or the natural progression of an underlying pre-existing condition or failure to
follow the study protocol or instructions. There are no plans to provide compensation for lost wages, direct
or indirect losses. You are not waiving any legal rights by signing this form. Further information about
research related injury is available by contacting the Institutional Review Board at 216-761-7079.
OR
In the event you are injured as a result of participation in this research, medical care is available to you. The
costs of such medical care will be billed to you or your insurance company. There are no plans to provide
compensation for lost wages, direct or indirect losses. The Cleveland Clinic will not voluntarily provide
compensation for research related injury. You are not waiving any legal rights by signing this form.
Further information about research related injury is available by contacting the Institutional Review Board
at 216-761-7079.
If the research is deemed minimal risk, there is no requirement to include injury language.
7. COSTS
What Are The Costs?
Suggested language: refer to the research contract and study budget to identify applicable costs
There are no additional costs to you for participation in this research study. The cost for routine tests and
services that would normally be performed even if you don’t participate in the study will be billed to you or
your insurance provider.
OR
The study drug/device or other study related tests/procedures/visits will be provided at no cost to you. The
cost for routine tests and services that would normally be performed even if you don’t participate in the study
will be billed to you or your insurance provider.
OR
The cost of study drug or other study related tests/procedures/visits that are not covered by your insurance
will be paid by the study sponsor The cost for routine tests and services that would normally be performed
even if you don’t participate in the study will be billed to you or your insurance provider.
Required language if this research leads to potential commercialization:
There are no plans to provide financial compensation to you in the event the results from this research lead to
the development of new products.
If participants compensated for participating in the research identify the specific amount and prorated
payment schedule. See IRB Policy 55, Recruitment, Advertising and Subject Compensation
8. VOLUNTARY PARTICIPATION
What Are Your Rights As A Participant?
Required language:
Taking part in this study is voluntary. You will be told of any new, relevant information from the research
that may affect your health, welfare, or willingness to continue in this study. You may choose not to take
part or may leave the study at any time. Withdrawing from the study will not result in any penalty or loss of
benefits to which you are entitled. If you decide to withdraw from the study you should discuss with your
study doctor your decision to ensure a safe withdrawal.
Specify any circumstances that may result in early withdrawal from the study without participants’ approval,
such as an investigator’s determination of deteriorating health or other conditions that might make
continued participation harmful, serious adverse reactions to study drugs, pregnancy, or the termination of
the study by the sponsor. Information about a safe withdrawal should be included.
9. QUESTIONS
Whom Do You Call With Questions Or Problems?
Required language:
If you have any questions, concerns or complaints about the research, or develop a research-related problem,
contact (insert name and phone number of investigator and identify who they should call after non-
business hours). If you have questions about your rights as a research subject, you should contact the
Institutional Review Board at 216-761-7079.
10. SIGNATURE (Format so this section and the signature lines are not on a page by themselves)
Statement of Participant
I have read and have had verbally explained to me the above information and have had all my questions
answered to my satisfaction. I understand that my participation is voluntary and that I may stop my
participation in the study at any time. Signing this form does not waive any of my legal rights. I
understand that a copy of this consent will be provided to me. By signing below, I agree to take part in this
research study.
_____________________________
Printed name of Participant
_____________________________ ___________
Participant Signature Date
Statement of Person Conducting Informed Consent Discussion
I have discussed the information contained in this document with the participant and it is my opinion that
the participant understands the risks, benefits, alternatives and procedures involved with this research
study.
_____________________________
Printed name of person obtaining consent
_____________________________ ___________
Signature of person obtaining consent Date
If this study involves a child assent, the following signature format should be added:
Permission of Parent/Legal Guardian
You and your child have had the above research study explained to you and your child, in language that
you and your child can understand, and you give permission for your child’s participation.
______________________________________________ ___________
Parent/Guardian Signature Date
I have had the above research study explained to me in language I understand and I agree to participate.
__________________________________________________ ___________
Child Signature Date
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