Download SPARROW HEALTH SYSTEM

SPARROW HEALTH SYSTEM
Office of Human Research Administration IRB
Informed Consent Form - Guidelines and Basic Elements
Content
Consistent
 The content is consistent with the study protocol
Concise
 Be brief and to the point, express more with fewer words
Comprehendible
 Use simple language equivalent to an 8th grade reading level
 Written in second person so as to not be interpreted as suggestive or coercive
 Write out (define) abbreviations and acronyms with the first use
 Explain medical terms
Compliant
 Include all elements required by federal regulations
 Include any additional elements that apply to the study in appendices after
signature page
Clear
 Proof read the document for accuracy and completeness
 Ask “would this make sense to a potential subject?” and “is information
presented in a logical order?”
Yes
No
Format & Style
 Remove all non-applicable section headings and re-number them
 Page orientation is portrait
 Justification is left aligned
 Text size is at least 12 point
 Tables (If used) should be in portrait orientation
 Replace green text for investigator use with language to the subject as
described
 Populate yellow highlighted data fields as described
Yes
No
Informed consent is a process, not just a form. Information must be presented to enable persons to
decide voluntarily whether or not to participate as a research subject. It is a fundamental mechanism to
ensure respect for persons who may be willing to offer their bodies and experiences to assist investigators
in research without promise or benefit.
The informed consent document provides a summary of the clinical study and the individual’s rights as a
participant. The document acts as a starting point for the necessary exchange of information between the
investigator and the potential research participant. In addition, the consent form may be used as an
information resource and reference for the participant throughout the research trial. The document is not
a risk management tool for the investigator and/or the institution.
BASIC ELEMENTS:
Any information that is not a part of the required basic elements must be placed in an appendix at the
end of the form after the signature page. The consent form should include the following statements or
concepts:
Protocol #:
Subject ID:
Version #:
Version Date:
Approval Date:
Not to be used after:
Research Participant Informed Consent and
Authorization to Disclose Protected Health
Information for Research-Related Activities and
Treatment Form
Study Title:
Researcher and Title:
Department and Institution:
Address and Contact Information:
Sponsor:
Introduction
This document is designed to provide you with information about the risks and benefits
of this clinical trial as well as what might happen if you choose to participate. In
addition, your study doctor will explain the clinical trial to you. After you read this
document and have all of your questions answered, you will be asked to make a
decision whether or not you agree to be part of this research study. This process is
known as informed consent.
Take your time to decide. Feel free to discuss the study with your family, friends and
healthcare provider before you make your decision.
To help you decide if you want to take part in this study, you should know:
 Taking part in this study is completely voluntary
 You can choose not to participate
 You are free to change your mind at any time if you choose to participate
 Your decision will not cause any penalties or loss of benefits to which you are
otherwise entitled
 Your decision will not change the access to medical care you receive at Sparrow
Health System now or in the future if you choose not to participate or
discontinue your participation
Initial:
Sparrow Health System
Protocol #:
Subject ID:
Version #:
Version Date:
Approval Date:
Not to be used after:
Contact Information
You can contact…
At…
Principal Investigator(s):
Phone:
Study Team Contact:
Phone:
If you have questions about…



Address:

Sparrow Health System
Institutional Review
Board (IRB)
Phone:
517.364.2157
Email:
[email protected]






Study tests and procedures
Research-related injuries or
emergencies
Any research-related concerns or
complaints
Withdrawing from the research
study
Materials you receive
Research-related appointments
Rights of a research participant
Any research-related concerns or
complaints
Use of your Protected Health
Information (PHI)
Stopping your authorization to use
your Protected Health Information
Why is this study being done?
Points to include:
 Description of the study drug or procedure being done
 “You are being asked to take part in this medical research study because…”
 State what the Investigators hope to learn from this study
 State whether or not the Patients will be randomized and what it means (if
applicable) and state whether or not the Physician will know which drugs or
treatment the Patient will receive
How many people will take part in the study?
“A total of ____ people will take part in this research study around the world. About
____ Patients will take part in this study at your institution.”
What will happen if I take part in the research study?
Describe the procedures to be undergone by the Patient in the study. If you are
randomizing subjects, be sure to explain your randomization process. Use as much detail
as necessary to ensure that all study procedures and visits are spelled out clearly for the
Patient. Clearly identify which of these procedures is experimental and which is part of
Initial:
Sparrow Health System
Protocol #:
Subject ID:
Version #:
Version Date:
Approval Date:
Not to be used after:
the standard therapy. Indicate the approximate amount of time the Patient will need to
devote to study procedures. In complicated protocols it is very helpful to have a chart to
explain the procedures in more detail.
How long will I be in the study?
State clearly how long the Patient will be expected to participate in the study, including follow
up once they have completed their study treatment (if applicable).
What are the risks/side effects?
List the discomforts and risks that will or may result from participation in the study.
Include not the only the risks from individual drugs and treatments but the overall effect
of the combined drugs or treatments. If there is a risk to an unborn or nursing child,
these risks should be addressed in this section.
The consent form should indicate to the participant that any new information that bears
on the risks and/or benefits of the study would be made available to the participant.

Qualitative and numerical descriptors must be included with each category of
risk. Please be advised if this is not incorporated into the consent form it
will delay your research project approval. Examples of common definitions
include:
 Likely (occurs in more than 25% of people – more than 25 out of
100 people)
 Common (occurs in 10-25% of people – 10 to 25 out of 100 people)
 Infrequent (occurs in 1-10% of people – 1 to 10 out of 100 people)
 Rare (occurs in less than 1% of people – less than 1 out of 100)
Note: If the level of specificity is not feasible, explain why in the application
form.
What are the benefits of taking part in the study?
State the potential benefits of the study to the Patient, where appropriate, and to others
who may benefit from the research.
What other choices do I have if I do not take part in the study?
State all alternative treatments available to the Patient and indicate, where appropriate,
which treatments are currently the standards of care for the Patient’s problem. Where
appropriate, tell the Patient that no additional treatment is also an option.
Initial:
Sparrow Health System
Approval Date:
Not to be used after:
Protocol #:
Subject ID:
Version #:
Version Date:
What are the costs of taking part in this study?
In the case that there are likely to be additional costs to the Patient, investigators must
incorporate a statement specifying the nature of these costs in their consent forms. A
statement should be included to the effect that either: (Select only one option that
applies)
Option 1
All doctors’ visits, tests, ______________ that are required during the study are similar
to those you would receive during standard treatments of your disease and will be
billed to you or your medical insurance. Your health insurance company may or may not
pay for these charges. Unless otherwise stated in this consent form, you will be
responsible for all of the costs linked with this study that are not covered by other
payers (HMO, health insurance company, etc.) Procedures that are done only for the
study will be paid by __________. However, you or your insurance carrier must provide
payment for hospital, clinical and other medical costs related to this study and
associated with standard medical care provided to you during your participation in this
study.
Option 2
The participation of the subject in this research project will not involve any additional
costs to the subject or the subject's healthcare insurer.
Option 3
Your participation in the research project may involve additional costs to you (specify
the additional procedures, tests, etc. that occasion the costs). Your health insurance will
not cover all of the additional costs. An estimate of total costs is $_________. If actual
costs exceed the estimate, you will remain responsible for the costs.
What happens if I am injured because I took part in this study?
Specify that if an injury occurs as a direct result of the research study, emergency
medical care required to treat the injury will be provided by (indicate the payee). The
statement should also specify whether reimbursement would be sought from the
Patient’s insurance company for the emergency care and any other medical expenses
incurred as a result of the injury.
The following injury clauses have been provided as suggested language to incorporate in
the informed consent form (select only the appropriate clause):
Initial:
Sparrow Health System
Protocol #:
Subject ID:
Version #:
Version Date:
Approval Date:
Not to be used after:
Option 1 - No costs will be paid
If you are injured as a result of your participation in this research project, Sparrow
Hospital 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 medical insurance, any costs that are not
covered or in excess of what are paid by your insurance, including deductibles, will be
your responsibility. The Hospital’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.
Option 2 - Third party will pay
If you are injured as a result of your participation in this research project, Sparrow
Hospital 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. Any costs that are not covered or in excess of what are
paid by your insurance, including deductibles, shall be paid by [name of payee]. The
Hospital’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.
Option 3 - Used forcContracts with the Army or where Army personnel are involved
and the research study is funded by the Department of Defense
If you are hurt or get sick because of this research study, you can receive medical care at
an Army hospital or clinic free of charge. You will only be treated for injuries that are
directly caused by the research study. The Army will not pay for your transportation to
and from the hospital or clinic. If you have questions about this medical care, talk to the
Principal Investigator. If the issue cannot be resolved, contact the U.S. Army Medical
Research and Materiel Command (USAMRMC) Office of the Staff Judge Advocate (legal
office) at 301.619.7663/2221.
Termination of the study
Indicate the circumstances under which the investigator or Patient’s doctor may
terminate the study without the consent of the patient.
Initial:
Sparrow Health System
Approval Date:
Not to be used after:
Protocol #:
Subject ID:
Version #:
Version Date:
What are my rights if I take part in this study?
It is up to you to decide whether or not being on this study is the right choice for you, and if
you decide to participate you can change your mind at any time.
You have the right to say no and the right not to sign this form. If you do not sign the form,
you cannot take part in this research study. However, this decision will not affect your
relationship with the hospital, it will not affect your present or future healthcare, nor will it
cause any penalty or loss of benefits to which you are otherwise entitled.
Will my medical information be kept confidential?
Sparrow Health System is committed to protecting the confidentiality of information
obtained about you in connection with this research study.

Describe methods used to safeguard the confidentiality of subjects’ data (e.g. coding
data or samples with numbers, storing data in encrypted sparrow.box.com cloud
application, etc.
During this research, information about your health will be collected. Under Federal law,
called the HIPAA and HITECH Rule, health information is private. However, there are
exceptions to this rule and you should know who may be able to see, use, and share your
health information for research and why they may need to do so. Information about you and
your health cannot be used in this study without your written permission. By signing this
form, you are providing that permission.
Health information may be collected about you from:
 Past, present, and future medical records
 Research procedures, including research office visits, tests, interviews and
questionnaires
Why will this information be used and/or given to others?
 To do the research
 To report the results
 To see if the research was done correctly
If the results of this study are made public, information that identifies you will not be used.
Who may use or share your health information?
 Sparrow Health System research staff involved in this study
 Other (please list Sponsor’s name if applicable)
Initial:
Sparrow Health System
Protocol #:
Subject ID:
Version #:
Version Date:
Approval Date:
Not to be used after:
With whom may your health information be shared?
 The Sparrow Institutional Review Board that oversees the research
 Other Sparrow Health System Physicians involved in your clinical care (Omit if
research test results will NOT be put in medical records)
 Researchers involved in this study at other institutions
 Federal and State Agencies (such as the Food and Drug Administration, the
Department of Health and Human Services, the National Institutes of Health and
other United States agencies) or government agencies in other countries that
oversee or review research
 The Sponsor(s) of this study and the people or groups it hires to help perform this
research
 A group that oversees the data (study information) and safety of this research
Information disclosed may contain mental healthcare records (except psychotherapy notes that are not kept
within the medical records) alcohol/substance abuse treatment records, and any AIDS/HIV status. Limited data
gathered could imply this type of treatment; such as a medication list with medications used to treat the above
conditions. (This sensitive information has special protections under title 42 of the Code of Federal Regulations
Part II and the 1989 Public Act 174)
Is your health information protected after it has been shared with others?
Sparrow Health System asks anyone who receives your health information from us to protect
your privacy; however, once your information is shared outside Sparrow Health System, we
cannot promise that it will remain private and it may no longer be protected by the Privacy
Rule.
Your Privacy Rights
You do not have to sign this form, but if you do not, you cannot take part in this
research study.
If you cancel your permission to use or share your health information, your participation
in this study will end and no more information about you will be collected; however,
information already collected about you in the study may continue to be used.
If you chose not to take part or if you withdraw from this study, it will not harm your
relationship with your own doctors or with Sparrow Health System.
The following statement must be added to the Informed Consent if your study is an FDA
regulated Clinical Trial.
A description of this clinical trial will be available on www.ClinicalTrials.gov, as
Initial:
Sparrow Health System
Protocol #:
Subject ID:
Version #:
Version Date:
Approval Date:
Not to be used after:
required by U.S. Law. This website will not include information that can identify you. At
most, the website will include a summary of the results. You can search this website at
any time.
Enrollment and Permission Signature
Before signing this form below, make sure that you:
 Have read the entire consent form
 Know that your participation is voluntary
 Know that you may choose to discontinue your participation at any time
 Have taken your time to think about your decision to participate
 Have had all of your questions answered by your study doctor
Special provisions apply in the case of cognitively impaired persons. For a discussion of
these provisions, please contact the IRB office 517.364.2157.
If the subject is a minor, provisions should be made for obtaining parent or guardian's informed consent
(signature) and the minor's assent. An assent form must be written in language that can be read and
understood by the child based on their age, maturity, and degree of literacy. For additional guidance
contact the IRB office.
Your Signature documents your permission to take part in this research.
Printed Name
/ /
Date
:
Time
a.m./p.m.
Signature
Legally Authorized Representative (LAR) signature if applicable below:
(LAR) Printed Name
/ /
Date
:
Time
a.m./p.m.
(LAR) Signature
Initial:
Sparrow Health System
Protocol #:
Subject ID:
Version #:
Version Date:
Approval Date:
Not to be used after:
Person obtaining consent
 I have explained the research study to the participant
 I have answered all questions about this research to the best of my ability
Printed Name and Title
/ /
Date
:
Time
a.m./p.m.
Signature
IRB Approved Revisions: 10/08/01; 1/27/03; 04/11/05; 11/14/05; 2/13/06, 7.14.08, 02.15.11, 05.09.11, 12/31/14, 5/4/2015
Approved: IRB, 05/07/01, 05/09/11, 1/12/15, 10/12/15
Initial:
Sparrow Health System