University of Miami - Repository Informed Consent Form
EPROST # ___________________
Version Date _____________
Consent (Permission) to be part of a Research Repository
Title of Repository:
Principal Investigator:
Department:
Phone Number:
Email Address:
Study Contact Name:
Study Contact Telephone Number:
Study Contact Email:
READ THE FOLLOWING CAREFULLY
This consent form contains important information, so that you can decide if you wish (for your
child) to take part in this study. If you (or your child) have any questions that remain
unanswered, please ask the study doctor or one of his/her research study personnel before
signing this form.
You are being asked to give permission (for your child) to participate in a research repository
because [state general reason why the person was identified to participate]. Before you give
your consent (for your child) to be part of this repository, please read the following and ask as
many questions as necessary to be sure that you understand what your (your child’s)
participation will involve.
Revise this section to match the specifics of your repository. Provide explanation of medical or
technical terms so that the information is understandable to the lay person.
PURPOSE
A repository is also known as a tissue bank or data warehouse. A research repository provides a
way for researchers to store samples of tissues (for example, blood, urine, tissue specimens
obtained from biopsies, and tissues or organs removed during surgery) and medical information
(for example, information from your medical record about your condition) about a person for
future use in research studies. In this consent form, tissues of all types will be referred to as
“tissue” and private medical information will be referred to as “data”. Together, tissues and data
stored in a repository are referred to as “materials”.
Materials from a repository can be used in research to help find out more about the causes of
disease, how to prevent it, and how to treat it. Storing tissue and information about the person
who provided the tissue in a repository is one way that researchers plan for new research.
Your (your child’s) tissue, along with your (your child’s) medical information may be helpful
for research whether or not you have the disease or condition that is the focus of this repository.
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Future research studies using materials from this repository may include genetic testing. In some
cases, genetic testing of tissues can be used to indicate a risk for the development of certain
diseases or to discover possible changes in a person’s future health status or life expectancy, or
that of his/her children and family members.
Select either local or external repository:
Local repository
The research repository is maintained at [insert name and location of repository]. The study
doctor is responsible for the repository. Other researchers requesting tissue samples or
information from the repository must have the approval of the PI and also must have a separate
research protocol for any newly proposed study approved by an Institutional Review Board
(IRB, a committee responsible for protecting research subjects).
External repository
The research repository is maintained at [insert name and location of repository]. [Insert
name of organization or institution hosting repository] is responsible for the research
repository. Other researchers requesting tissue samples or information from the repository must
have the approval of the repository director and also must have a separate research protocol for
any newly proposed study approved by an Institutional Review Board (IRB, a committee
responsible for protecting research subjects).
PROCEDURES
If you decide to take part in this research repository, you will be asked to sign this consent form
[Explain how the tissue/data will be obtained].
Left over tissue (no additional tissue or procedure)
As part of your (your child’s) routine care, you are (your child is) scheduled to have a [insert
procedure] which will involve the removal of [list type of tissue, e.g., blood, spinal fluid, etc]
from your body. Frequently, extra tissue is “left over” after required tests have been done. Often
the left over tissue is discarded. The researchers are asking permission to obtain the remaining
tissue for the research repository. [note – generally the risks related to discarded tissues are
limited to issues of confidentiality. If there are additional risks, address these in the risks
section]
Additional tissue obtained during a routine procedure
As part of your (your child’s) routine care, you are (your child is) scheduled to have a [insert
procedure] which will involve the removal of [list type of tissue, e.g., blood, spinal fluid, etc]
from your (your child’s) body. The researchers are asking permission to obtain additional tissue
at the same time that the routine tissue is being obtained. The additional tissue will be for the
research repository. [Note – address the risks reasonably expected from obtaining the
additional tissue in the risks section]
Additional procedures to obtain tissue/information
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University of Miami - Repository Informed Consent Form
EPROST # ___________________
Version Date _____________
The researchers are asking permission to perform additional procedures to obtain a tissue or
information for the repository. The following is a description of the procedures that will be done
so that the tissue or information may be included in the research repository:
[insert description of each procedure, e.g., biopsy, venipuncture, or survey]
 Describe in lay language all procedures and their purposes.
o Describe what the subject will feel or experience
 Quantify procedures – for example
o Number of each procedure per visit and total for research
o Volume of blood samples only if:
 (a) exceeds 550 ml in an 8 week period from healthy, non-pregnant
adults, or
 (b) from other adults and children, the amount drawn exceeds the lesser
of 50 ml or 3 ml per kg in an 8 week period
 Address the risks reasonably expected from each repository driven procedure in the
risks section. If you feel you must include risks with the research procedure, you are
still required to provide ALL risk information in the risk section.
RISKS AND DISCOMFORTS
Describe in lay language, step-by-step, what risks may occur to the research subjects.
Standard language for studies that involve risk: In addition, there may be uncommon or
previously unknown risks that might occur. You (your child) should report any problems to the
research staff.
You (your child) have the right to ask any questions about the potential and/or known risks of
this study at any time.
Standard language for studies that involve no risks: There are no additional risks to you (your
child) from participating in this study.
Risk of an unintentional disclosure of private information/breach of confidentiality; select
either anonymous or identifiable material statement
Only anonymous repository materials
Privacy
Your (your child’s) tissue and medical information will not be stored with identifying
information (such as your name) or a code that is linked to your identifying information. The
materials in the research repository cannot be traced back to you as the participant. There is no
risk to you (your child) that your (your child’s) private information could be unintentionally
released. Once your (your child’s) tissue and/or data are entered into the repository, you (your
child) will not be able to withdraw them because the materials will not be traceable.
OR, identifiable/coded repository materials
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University of Miami - Repository Informed Consent Form
EPROST # ___________________
Version Date _____________
Privacy
Your (your child’s) tissue and medical information will be stored with identifying information
(such as your name). If this information were unintentionally (by mistake) released it could
harm you. The research repository is required to protect your private information to prevent
unintentional release of your data. Your (your child’s) name, address, phone number and other
identifying information will be taken off anything associated with your (your child’s) tissue or
data and replaced with a code. The key linking your identity to the code will be kept in a
separate, secure location, only accessible by the research repository staff. No identifying private
information will be given to researchers requesting use of the repository tissues or data.
Risk related to genetic testing; select either anonymous or identifiable material statement
Only anonymous repository materials
Future genetic research
Future research studies using materials from this research repository may include genetic
testing. Human tissue contains genes that determine many of a person’s physical characteristics,
such as the color of eyes and hair. In some cases, genetic testing of tissues can be used to
indicate a risk for the development of certain diseases. Genetic information is unique to each
individual and could potentially be used to discover possible changes in a person’s future health
status or life expectancy, or that of his/her children and family members. Even though your name
will not be connected to the tissue or blood sample, other information such as about race,
ethnicity, sex, your medical history, and so forth might be available to scientists studying your
tissue or blood samples. This information may be important for research or public health
purposes.
Or, for identifiable/coded repository materials
Future genetic research
Future research studies using materials from this repository may include genetic testing. Human
tissue contains genes that determine many of a person’s physical characteristics, such as the
color of eyes and hair. In some cases, genetic testing of tissues can be used to indicate a risk for
the development of certain diseases. Genetic information is unique to each individual and could
potentially be used to discover possible changes in a person’s future health status or life
expectancy, or that of his/her children and family members. Even if your tissues are used for this
type of research, the results will not be put in your health records. Also, there may be unknown
risks of genetic testing in the future.
Sharing your health information with others
Neither you (your child) nor your (your child’s) doctor will receive research information or test
results from the research. Research information and test results will not be placed in your (your
child’s) medical record or used in your care.
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University of Miami - Repository Informed Consent Form
EPROST # ___________________
Version Date _____________
Most research with your (your child’s) tissue/data is not expected to yield new information that
would be meaningful to share with you personally. There are no plans to re-contact you (your
child) or other research participants with information about research results.
Choice for Future Research Use and Future Contact
The statements below provide a sample of what you may ask participants to consider. If you
plan to use the specimens/data with identifiers, you need to give the participants a chance to
choose among several choices, so that the decision to permit use with identifiers for certain
purposes is clear.
Please read each statement below and think about your choice. Check either yes or no for each
statement.
My (my child’s) tissue/data may be used for future research on <<identify specific disease or
condition under study>>.
_____ Yes
_____ No
My (my child’s) tissue/data may be used for future research on any health related issue (for
example, cancer, diabetes, or genetic research on alcoholism).
_____ Yes
_____ No
My (my child’s) tissue/data may be shared with other investigators outside of the University
of Miami.
I agree to be contacted for future studies regarding the future use of my (my child’s)
tissue/data, when appropriate. I understand that in certain circumstances, the PI will not need
to recontact me (my child) to use my (my child’s) tissue/data in future studies.
_____ Yes
_____ No
BENEFITS
Choose or modify ONE of the following groups of sentences as appropriate to the specific
study:
Research is designed to benefit society by gaining new knowledge. You (your child) will not
benefit directly from participating in this research repository. The use of your (your child’s)
tissue/data in future research could help us learn more about human health and how to improve
it. We hope the information learned from research using the research repository materials will
benefit other people with similar conditions in the future.
The benefits to your (your child’s) participation in this research repository may be
.
We hope the information learned from research using the repository materials will benefit other
people with similar conditions in the future.
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University of Miami - Repository Informed Consent Form
EPROST # ___________________
Version Date _____________
ALTERNATIVES
Choose ONE option below
Option 1: You (your child) do not have to participate in this research repository. There are other
options available to you (your child). Your (your child’s) other choices may include:
[insert options]
You (you child) can choose to participate in one, some or all the research repository procedures
listed in this consent form. Please initial next to the procedures you agree to take part.
_____ [insert first optional procedure]
_____ [insert second optional procedure]
Option 2: You (your child) have the alternative not to participate in this repository. You (your
child) can decide to stop participating in this research repository at any time. Not participating
in this research repository will not affect your (your child’s) medical care.
COSTS
You (your child) will not have to pay any money to take part in this research repository or for
the storage and use of the tissue/data for research purposes.
For research repositories involving medical intervention(s), clearly explain which costs will be
billed to the subject's insurance company, and who (the subject? the study sponsor?) will be
responsible for payment of any costs not covered by the insurance.
You (your child) or your insurance company will be responsible for medical costs of
participating in this research repository. If you (your child) have insurance, your (your child’s)
insurance company may or may not pay for these costs. If you (your child)do not have
insurance, or if your (your child’s) insurance company refuses to pay, you (your child) will be
billed.
Use this section to list any additional costs

List the additional tests/visits/procedures to be performed for research repository
purposes only. Describe who will be responsible for paying the cost of research tests,
procedures, visits, etc. that are not standard of care or routine care.

Clearly explain what the likely costs will be for participation in this research
repository, and who will be responsible for those costs e.g. “… billed to you and/or
your insurance.” Or “… paid by the sponsor”. Or “…estimated costs to be paid by
you”.
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University of Miami - Repository Informed Consent Form
EPROST # ___________________
Version Date _____________

Describe specific items or procedures that may/may not be covered. Include clinic fees,
transportation, and parking fees (if known).
INCENTIVES/PAYMENTS TO PARTICIPANTS
Choose ONE applicable sentence.
Describe payment or gift and schedule for their receipt. Address how payment will be prorated
in the event the subject withdraws from the study prior to completion. Include information
about any reimbursement for parking, transportation, etc.
You (and your child) will not be paid for taking part in this repository.
You (and your child) will be receiving (payment)
for taking part in this repository.
COMPENSATION FOR STUDY-RELATED INJURY
Studies that involve minimal to no risks:
Although risks are unlikely, if injury should occur, treatment will in most cases be available. If
you have insurance, your insurance company may or may not pay for these costs. If you do not
have insurance, or if your insurance company refuses to pay, you will be billed. Funds to
compensate for pain, expenses, lost wages and other damages caused by injury are not routinely
available.
IF the research sponsor has provisions for covering costs of treating research related
injuries, describe those here.
VOLUNTARY PARTICIPATION / WITHDRAWAL FROM STUDY
Your (your child’s) participation in this research repository is voluntary. You (your child) may
refuse to participate, or withdraw from the repository at any time, without penalty or loss of
benefits to which you (your child) are (is) otherwise entitled. This will not affect the medical
care you (your child) receive from the study doctor or University of Miami/Jackson Health
System. You must tell the study doctor if you wish (your child) to stop taking part in the
repository. Your (your child’s) participation in this repository may be discontinued, without
your consent, at any time if information is no longer needed. The Institutional Review Board
(IRB), regulatory authorities, or the sponsor may also discontinue your (your child’s)
participation in the study.
If you cancel your permission after you (your child) have (has) started in the research
repository, the repository staff and the study doctor will stop collecting your (your child’s) data
or tissue. However, they may need to use the information and tissue they have already collected.
If you do not make such a request, the tissue may be stored indefinitely. The researchers may
choose to destroy the tissue at any time.
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University of Miami - Repository Informed Consent Form
EPROST # ___________________
Version Date _____________
REFERENCE: Boilerplate Language for student and employee rights.
CONFIDENTIALITY
Indicate how privacy and confidentiality will be protected: Briefly but as clearly as possible
describe the key procedures for protecting the privacy and confidentiality of the individual’s
data.
By signing this consent form, you authorize the Investigator(s) and his/her/their staff to access
your (your child’s) medical records, obtain your tissue, and associated information as may be
necessary for purposes of this research repository. (If sponsored – This information will also be
shared with the Sponsor of this study, and persons working with the Sponsor to oversee the
study.) Your records and results will not be identified as pertaining to you in any publication
without your expressed permission. The Investigator and his/her collaborators, staff (and the
sponsor) will consider your records confidential to the extent permitted by law. The Food and
Drug Administration (FDA) and Department of Health and Human Services (DHHS) may
review these research records. Your records may also be reviewed for audit purposes by
authorized University of Miami employees or other agents who will be bound by the same
provisions of confidentiality.
[if applicable] Information from your medical records will be stored along with your tissue.
You will be asked to sign a separate form (“HIPAA authorization”) to allow researchers to
review your medical records.
[if applicable] Your (your child’s) tissue may be shared with researchers at this or other
institutions (include name of other institutions, if known). Research studies may be done at
many places at the same time. Your personal identifying information will not be sent to other
researchers.
[include if genetic research] A 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. GINA does not
protect you against genetic discrimination by companies that sell life insurance, disability
insurance, or long-term care insurance. GINA also does not protect you against discrimination
based on an already-diagnosed genetic condition or disease.
For studies having a federal Certificate of Confidentiality addressing long term storage:
Insert language provided by the federal agency that issued the certificate or ask your IRB for
appropriate language.
Significant new findings
Discuss policy regarding willingness to inform subjects if later tests have clinical relevance.
The study site personnel may use your (your child’s) information to notify you of appointments,
send you appointment reminders, or schedule additional appointments.
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University of Miami - Repository Informed Consent Form
EPROST # ___________________
Version Date _____________
Who owns the tissue (s)Insert any contract, grant or agreement language related to specimen
ownership or modify the following boilerplate.
Any blood, body fluids, or tissue specimens obtained for this purpose become the exclusive
property of (specify organization that owns, e.g. the University of Miami, name of sponsor, etc.
Individual researchers do not own specimens, and should not be listed.) This organization may
retain, preserve or dispose of these tissues and may use these tissues for research that may result
in commercial applications. There are no plans to compensate you for any future commercial
use of these tissues.
Who is sponsoring this research
This research repository is funded by (name of Drug Company, the National Institutes of
Health, etc.). This means that the research team is being paid by the sponsor for doing the study.
The researchers do not, however, have a direct financial interest with the sponsor or in the final
results of the study.
When appropriate, the last sentence should be modified to disclose the nature of any potential
conflicts of interest relating to this study, financial or otherwise.
WHOM TO CONTACT
If at any time you have any questions about the research repository, you may contact <insert
Principal Investigator name here> at <insert principal investigator telephone>and
<address>.
In case of study-related injury, please contact <insert Principal Investigator name here> at
<insert principal investigator telephone>.
If you have any questions relating to your (your child’s) rights as a research subject, please
contact the University of Miami’s HUMAN SUBJECTS RESEARCH OFFICE (HSRO), at
305-243-3195.
AGREEMENT TO PARTICIPATE
You will receive a copy of this signed informed consent form.
I have read this consent form, which is printed in English (a language which I read and
understand). This study has been explained to my satisfaction and all of my questions relating to
procedures, risks and discomforts, and side effects have been answered. If I have any further
questions regarding this study, or in the event of a study-related injury, I should contact the
appropriate person named above. Based on this information, I voluntarily give permission
(consent) (for my child) to take part in this study.
________________
Signature of Participant
________________
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Date
University of Miami - Repository Informed Consent Form
EPROST # ___________________
Version Date _____________
Printed Name of Participant
________________
Signature of Parent/Legally Acceptable Representative
__________________
Date
________________
Printed Name of Parent/Legally Acceptable Representative
________________
Printed Name of Child (if applicable)
_______________
Signature of Person Obtaining Consent
____________
Date
________________
Printed Name of Person Obtaining Consent
Assent is required for participants age 7 to 18 years. A separate assent form has been
provided.
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