Specimen ICF
v. 03Jan2014
SPECIMEN RESEARCH
INFORMED CONSENT
TITLE OF RESEARCH STUDY
Investigator(s) Name, Degree, University Department & address:
Sponsor(s) name & address: (if externally funded)
Site(s) where study is to be conducted:
Phone number for subjects to call for questions:
Introduction and Background Information
You are invited to take part in a research study because you have been diagnosed with ____. The
study is being conducted under the direction of _____ (list degree), Principal Investigator. About
____ local subjects will be invited to take part in this research. The total number of subjects across
all sites will be ___ (include if multiple sites are participating).
Purpose
The purpose of this research study is (describe)
Procedures
Your participation in this study will last for _____. You will have the following procedures while you
are in this study: (describe)
Risks
There may be some pain or discomfort during the procedure. It is possible there may be some
bleeding, bruising or infection at the puncture site. (If collecting tissue or other body fluids,
describe the risk(s) that might be associated with obtaining the specimen.)
Research Involving Genetic Information (include only if genetic testing is involved and the
samples are not anonymous (i.e. if they can be linked back to the subject by code, this
information must be included)
A new Federal law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it
illegal for health insurance companies, group health plans, and most employers to discriminate
against you based on your genetic information. This law generally will protect you in the following
ways:
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Specimen ICF
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1. Health insurance companies and group health plans may not request your genetic information
that we get from this research or use your genetic information when making decisions
regarding your eligibility or premiums.
2. Employers with 15 or more employees may not use your genetic information that we get from
this research when making a decision to hire, promote, or fire you or when setting the terms of
your employment.
Employers with 15 or more employees, health insurance companies, and group health plans must
follow this law. This new law does not protect you against genetic discrimination by companies that
sell life insurance, disability insurance, or long-term care insurance.
Benefits
The possible benefits of this study include ________(omit if there are no benefits to the subject).
The information collected may not benefit you directly; however, the information learned in this study
may be helpful to others.
Compensation
You will not be compensated for your time, inconvenience, or expenses while you are in this study.
<OR> (If the sentence above applies, remove the paragraph below. If the statement below
applies, remove sentence above.)
You will be paid (state the amount and form/method of payment: cash, gift card, other) for your
time, inconvenience, or expenses while you are in this study. (Payments to study subjects must
be pro-rated and distributed equally, if appropriate, or distributed according to time
commitment and potential discomfort for each visit.)
Costs
If externally funded, state what items the sponsor is paying for.
You or your insurance company will be billed for all office visits, tests, medications and procedures
that are part of your routine medical care outside of this research study. You will be responsible for
paying your co-pay that is associated with any office visit, test, medication or procedure.
HIPAA Research Authorization (include only if protected health information is being collected)
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) provides federal
safeguards for your protected health information (PHI). Examples of PHI are your name,
address, and birth date together with your health information. PHI may also include your
medical history, results of health exams and lab tests, drugs taken and results of this research
study. Your PHI may not be used or shared without your agreement, unless it meets one of
the HIPAA exceptions.
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State and federal privacy laws protect your health information. In most cases, health
information that identifies you can be used or shared by the research team only if you give
your permission by signing this form.
If you sign this form your health information will be used and shared to answer the research
questions described above and to make sure that the research was done correctly. The time
period when information can be used or shared ends when all activities related to this study
are completed.
Your access to your health information will/will not (choose will or will not) be limited during
this study. (If “will not” is chosen, delete the following sentence) When the study is over,
you will have the right to see your health information related to this research.
You do not have to sign this form. If you do not sign this form you may not participate in the
study and health information that identifies you will not be shared with the research team.
Site(s) where health information about you will be used or shared for this research:
In our research, the research team will look at and may share information about you and your
health. Federal law requires that health care providers and researchers protect the privacy
and security of health information that identifies you. We may ask for your health information
from the following: (list)
Revocation of Research Authorization for use of Protected Health Information
You may cancel the permission you have given us to use and share your protected health
information at any time. This means you can tell us to stop using and sharing your protected
health information. If you cancel your permission:
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We will stop collecting information about you.
You may not withdraw information that we had before you told us to stop.
o We may already have used it or shared it.
o We may need it to complete the research.
Staff may ask your permission to follow-up with you if there is a medical reason to do
so.
You may cancel your permission by writing to the investigator at the address on page one.
Confidentiality (Not necessary if samples are anonymous and cannot be linked back to the
donor)
Total privacy cannot be guaranteed. We will protect your privacy to the extent permitted by law. If
the results from this study are published, your name will not be made public. Once your information
leaves our institution, we cannot promise that others will keep it private.
Your information may be shared with the following:
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The sponsor (name the sponsor and CRO if applicable) and others hired by the sponsor to
oversee the research
The Wright State IRB and Office of Research and Sponsored Programs
The local research team
Researchers at other sites participating in the study (if applicable)
People responsible for billing, sending and receiving payments related to your participation in
the study
People who are responsible for research and HIPAA oversight at the institutions where the
study is conducted (include only if study conducted in a covered entity)
Government agencies, such as: (List all that apply)
o Office for Human Research Protections (OHRP),
o Office of Civil Rights (if PHI is being collected), and
o Other (please specify)
Others (please specify)
Security
Describe what methods will be used to ensure that the data collected is secured (e.g., locked
in a file cabinet, kept in a secured area, or kept in a password protected computer).
Conflict of Interest (if study is externally sponsored)
This study may involve a conflict of interest because the institution and/or the investigator will be
compensated for your participation in it. Please ask the investigator how the institution and/or
investigator will benefit by your participation in the study.
*Significant Financial Interests (external interests) must be disclosed to the Office of Research
and Sponsored Programs. If determined that a Financial Conflict of Interest exists, additional
restrictions and appropriate consent wording will be required. This applies to all investigators
and key personnel.
Voluntary Participation
Taking part in this study is completely voluntary. You may choose not to take part at all. If you decide
not to be in this study, you won’t be penalized or lose any benefits for which you qualify. If you decide
to be in this study, you may change your mind and stop taking part at any time. If you decide to stop
taking part, you won’t be penalized or lose any benefits for which you qualify. You will be told about
any new information learned during the study that could affect your decision to continue in the study.
Contact Persons
If you have any questions, concerns, or complaints about the research study, please contact:
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Research Subject’s Rights, Questions, Concerns, and Complaints
You may contact the principal investigator at ____________.
If you have any questions about your rights as a study subject, questions, concerns or complaints,
you may call the Wright State IRB Office (937) 775-4462. You may discuss any questions about your
rights as a subject with a member of the IRB or staff. The IRB is an independent committee
composed of members of the University community, staff of the institutions, as well as lay members
of the community not connected with these institutions. The IRB has reviewed this study. (Do not
state “approved”.)
Acknowledgment and Signatures
This document tells you what will happen during the study if you choose to take part. Your signature
means that this study has been discussed with you, that your questions have been answered, and
that you will take part in the study. This informed consent document is not a contract. You are not
giving up any legal rights by signing this informed consent document. You will be given a signed
copy of this consent to keep for your records.
________________________________________________________________________________
Printed Subject Name
Signature of Subject
Date Signed
________________________________________________________________________________
Legally Authorized Representative (Please Print) Signature of LAR
Date Signed
(if applicable)
___________________________________________
Relationship of Legally Authorized Representative to Subject
___________________________________________
Signature of Person Obtaining Consent
(if other than the Investigator)
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_____________________
Date Signed