Partners HealthCare System
Research Consent Form
Subject Identification
Research Tissue Bank
Version Date: November 2005
Protocol Title:
Principal Investigator:
Site Principal Investigator:
Description of Subject Population:
[RESEARCHERS: This is a draft consent form for specimens for a dedicated bank (i.e., a
tissue collection for research related to a specific illness or condition). Researchers may
customize this form to address issues or procedures specific to their needs. Specimens
collected under this consent form can be used by Partners researchers, and collaborators
for research related to a specific condition, for example, “breast cancer” or “asthma and
inflammation.”
This form, as written, allows sharing of specimens with industrial collaborators, and the
release of medical record numbers to other Partners investigators, if those investigators
seek independent IRB approval. It is up to the researcher to decide whether these provisos
are desirable.
This form also includes an option at the end which requests the more general use of
specimens (i.e., tissue collection for research on any and all topics). Investigators are not
required to include this option unless they wish to, and it is of course the decision of the
subject as to whether they wish to allow this.
Instructions in bold should be deleted before forwarding your form for review.
Collection of Samples and Health Information for Research
About this consent form
Please read this form carefully. It tells you important information about a research study. A
member of our research team will also talk to you about taking part in this research study.
People who agree to take part in research studies are called “subjects.” This term will be used
throughout this consent form. If you have any questions about the research or about this form,
please ask us. If you decide to take part in this research study, you must sign this form to show
that you want to take part. We will give you a copy of this form to keep.
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Partners HealthCare System
Research Consent Form
Research Tissue Bank
Version Date: November 2005
Subject Identification
Some of the people who are eligible to take part in this study may not be able to give consent
because they are less than 18 years of age (minors). Instead we will ask the parent or
guardian of the child to give consent. Throughout the consent form, “you” always refers to
the person who takes part in the study.
What is the purpose of this research tissue bank?
[RESEARCHERS: This is written for leftover materials after a clinically indicated
procedure. It could be modified to accommodate a dedicated sample obtained exclusively
for research, for example, a blood draw or a skin biopsy. Please modify as needed for your
situation.]
The purpose of this research tissue bank is to collect, process and store samples until researchers
need them to do research on [state scope of research, e.g., breast cancer, cancer, cystic
fibrosis]. Research tissue banks collect and store many types of samples, such as blood, urine or
other bodily material.
Tissue banks have rules about which researchers can get samples and what kind of research they
can do using the samples. Researchers can use samples and information from this bank to study
medical questions related to [state scope of research, e.g., breast cancer]; for example, what
causes and what helps prevent, treat, or cure this disease, and how it may be passed on in
families.
We are asking you to allow us to place your samples in a tissue bank because you are having
samples taken as part of your routine medical care. As part of your routine care, your doctor will
obtain [Specify samples to be collected, e.g., tumor, blood, urine etc, and name all that are
applicable. This section will need modification if prospective extra samples are taken, for
example, a blood sample exclusively for research.] from you for testing. After the tests for
your medical care are completed, part of your samples may be left over. Normally these leftover
samples would be thrown away. We are asking you to allow us to collect and store this leftover
[specify samples to be collected, e.g., tumor, blood, urine etc, name all that are applicable]
in a research tissue bank.
If you agree, the leftover samples will be frozen and sent to the bank. We are also asking for
your permission to store some of your health information with your samples so that your samples
will be more useful for research.
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Partners HealthCare System
Research Consent Form
Subject Identification
Research Tissue Bank
Version Date: November 2005
Our research tissue bank is located at [specify location by institution/city]. There is no set limit
to the number of individuals who provide samples to this bank. The more samples and health
information that we can collect, the more useful the tissue bank will be for research.
How are my samples collected and stored?
[RESEARCHER: Amend this section as necessary, if your bank is not collecting excess
clinical specimens. If you are obtaining samples during a clinically indicated procedure
from your own patients, add a statement that the treatment decision has been made
independent of this research tissue banking project. Clarify explicitly whether only
procedures/excisions needed for treatment are done, even though you have a research
interest in this area, or whether “extra” material is taken. If cell lines will be created, add
the sentence below.]
We will create a living tissue sample (called a “cell line”) that can be grown in the laboratory.
This allows researchers to have an unlimited supply of your cells in the future without asking for
more samples from you.
After the tests for your medical care are completed, your leftover [specify samples and method
of collection] will be frozen and sent to the bank. Staff at the bank will assign your sample a
code number and store it in a freezer. They will not keep your name or other information that
could identify you with your sample. They will use the code number to connect your sample to
health information stored in a computer database. The computer database is protected with a
password. Only staff at the bank will know the password.
For what type of research will my samples be used?
Your samples and information will be used to [fill in purpose of this collection and type of
research which will be performed.] The long-term goals of the research are to learn how to
better understand, prevent, diagnose or treat [condition]. It is not possible to list every research
project. Also, we cannot predict all of the research questions that will be important over the next
years. As we learn more, new types of research and new research questions related to
[condition] may be worked upon.
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Partners HealthCare System
Research Consent Form
Subject Identification
Research Tissue Bank
Version Date: November 2005
Could my samples be used for other unrelated research?
[RESEARCHERS: This is an optional section which allows unrelated uses only if materials
are fully de-identified and cannot be linked by anyone to the person from whom the
materials came, any longer. You may not wish to include this. Balance the value with the
unease your patients may have with this.]
Yes, but only if they are stripped of all information that could link the sample to you. In the
future, someone might want to do research on a different unrelated topic. Bank staff would only
allow this if your samples were stripped of all information linking the samples to you. It would
not be possible for this unrelated research to be linked back to you by anyone. Bank staff would
destroy all numbers and codes connecting the sample to you before giving the sample to a
researcher for unrelated research.
Which researchers can use my samples and what information about me
can they have?
[RESEARCHERS: Specify who will have access. Only your research group? Others at
Partners? Outside academic and commercial collaborators? The norm would be to allow
all of these possibilities, and that is described below. You are welcome to be more focused
or restrictive here, but then you must adhere to those restrictions. If your distribution of
samples is more limited, delete this section and rewrite your own to be consistent with your
protocol submission. You may wish to limit identifiable use to your research group and
only allow others in the institution the use of coded samples, without access to the key to the
code. Or, you may not wish to include commercial collaborators. Researchers outside
Partners should never receive directly identifiable information, or contact information and
should never contact subjects. The IRB will consider your protocol and wording and
modify, if needed.]
Your samples will be made available for researchers at MGH (Massachusetts General Hospital),
BWH (Brigham and Women’s Hospital) and other Partners institutions. The bank will usually
provide samples with very limited information that does not identify you (for example, your age
and diagnosis). The bank will only provide identifiable information (such as your medical
record number) to researchers whose study has been approved by the ethics board. In the future,
these researchers or bank staff may review your medical records to collect additional health
information about you. Our research group may contact you in the future at your medical visits
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Partners HealthCare System
Research Consent Form
Subject Identification
Research Tissue Bank
Version Date: November 2005
or by phone to follow your medical condition. [RESEARCHERS: clarify whether re-contact
and ongoing review of patients medical records is intended. We recommend planning and
describing proposed research uses of tissues carefully “up front” and not proposing recontacting subjects to inquire about new uses or “re-consenting.” Re-contact is not
prohibited, but if this is expected it should be mentioned in the consent form.]
Occasionally, we will make samples available to researchers at other academic institutions,
which are not a part of Partners. Often these are other scientists, affiliated with Harvard
University, who are working with researchers at MGH and BWH. However, we will never give
researchers at other academic institutions your name or other information that could likely
identify you.
Occasionally, your samples, without your name or other information that could likely identify
you, may be shared with for profit companies that are working with MGH, BWH or other
Partners researchers on a specific research project. Researchers at for profit companies will
never be given your name or other information that could likely identify you. Your samples will
not be sold to anyone for profit.
How long will my samples and information be kept?
There is no scheduled date on which your samples and information in the bank will be destroyed.
Your samples may be stored for research until they are “used up.” [RESEARCHERS: If you
requested establishment of cell lines, delete the second sentence and insert the following:
Your sample will be used to create a living tissue sample, which may be stored and used for
research indefinitely.] The code linking your samples to your medical record may be kept
indefinitely so that your samples and updated health information may be used for research in the
future. [RESEARCHERS: If you did not request ongoing medical record review, the
second sentence could be eliminated, but most of you will wish to review medical records
going forward.]
Can I stop allowing my samples and information to be stored and used
for research?
Yes. You have a right to withdraw your permission, at any time, for your samples and
information to be stored in the bank and used in research. If you do, your samples and your
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Partners HealthCare System
Research Consent Form
Subject Identification
Research Tissue Bank
Version Date: November 2005
information will be destroyed. However, it will not be possible to destroy samples and
information that have already been given to researchers. If you decide to take away your
permission, you should contact the bank’s representatives in writing [provide name and contact
information].
Will I get results of research done using my samples?
No. The research we are doing is only a stepping stone in understanding [condition]. Therefore,
information from this research will not be returned to you or your doctor. Tests done for
research using your samples will not be useful in directing your medical treatment. This
information will not be placed in your medical records. [RESEARCHERS: If clinically useful
information is expected, the answer to this question may be “yes” and different discussion
will be needed. Return of patient-specific research information to subjects must be
extensively discussed in a protocol and consent form. If your group has a newsletter or
other way of generally notifying subjects of research results, that could be mentioned here.
For example, you may add the following sentence.] However, you can choose to get a
newsletter that will tell you in general about the research studies we are doing. This newsletter
will not announce your results or anyone else’s, but it will tell you what we are learning about
[insert condition]. We will also publish what we learn in medical journals.
What are the risks to me?
The main risk of allowing us to store and use your samples and certain limited health information
for research is a potential loss of privacy. However, we will take the following steps to protect
your privacy:

We will store your samples only with a code.

The tissue bank database will use the code to connect your sample to certain limited
health information about you. The information stored in the database may include your
medical record number, but will not include your name.

The tissue bank database will be password protected. Only the tissue bank staff will
know the password.

Information that could be used to identify you will only be shared with researchers within
Partners who have approval of the Partners ethics board. The ethics board is a group that
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Partners HealthCare System
Research Consent Form
Subject Identification
Research Tissue Bank
Version Date: November 2005
independently reviews and watches over all research studies involving people at BWH,
MGH and other Partners institutions. The board follows state and federal laws and codes
of ethics to make sure that the rights and welfare of people taking part in research studies
are protected.

Information that likely could be used to identify you will never be shared with
researchers outside Partners.
Your doctor, in a separate conversation, will explain the risks of the medical procedure you are
having. Allowing your samples to be placed in the bank will not change the risks of the medical
procedure itself.
[RESEARCHERS: If you will be taking or doing anything extra, e.g., blood draw, extra
biopsy samples, the risks should be specified here.]
What identifiable information about me may be used or shared with
others?
Identifiable information is information that links a sample to you as an individual, and that has
something to do with your physical and mental health. This includes information about your
past, your present, and your future health and conditions.
Researchers at Partners institutions who have received ethics board approval may use identifiable
health information from the bank and from your medical records. This means that if a researcher
gets approval from the ethics board for a research study next year that researcher will be able to
look at your medical record next year. This record will include today’s information as well as
any new information that has been added to your record.
Who will use or share my identifiable information and why?
BWH, MGH and researchers within Partners may use identifiable information about you for
research. They will use all reasonable efforts to protect the confidentiality of the health
information about you. BWH/MGH will not release your identity or other information that
likely could identify you to academic or commercial researchers outside Partners. Information
learned from any of this research will not be traced back to you or placed in your medical record.
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Partners HealthCare System
Research Consent Form
Subject Identification
Research Tissue Bank
Version Date: November 2005
The health information (including identifiable information) about you that is stored in the bank
or your medical records and used in research may need to be reviewed and disclosed for certain
other reasons. Examples include review by the hospital ethics board and quality improvement
program, or review by federal or state government agencies (such as the federal Food and Drug
Administration) or hospital accrediting agencies, in the course of carrying out their duties to
oversee the research or to meet legal, institutional, or accreditation requirements.
It is possible that outside entities that receive or see your information may not have to meet the
same privacy requirements that BWH/MGH and Partners do and may disclose identifiable
information to others. BWH/MGH will use all reasonable efforts to request recipients of
identifiable information to protect your privacy but it cannot control these recipients’ disclosures
of your information to others.
For more information about how BWH/MGH and Partners protect the confidentiality of medical
information, please see the Partners Notice for Use and Sharing of Protected Health Information
provided to you in connection with your clinical care. (See:
http://www.partners.org/privacy_notice_engl.pdf)
What are the benefits to me?
You will not directly benefit from this bank project. We hope that research using the samples and
information gathered will help us understand, prevent, treat, or cure the illnesses and conditions
studied.
What are the costs to me to take part in the bank?
There is no cost to you to have your samples in the bank or for the research using your samples.
The medical care you received that resulted in these leftover samples will be billed as usual to
you and your health insurance company.
Will I be paid to take part?
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Partners HealthCare System
Research Consent Form
Subject Identification
Research Tissue Bank
Version Date: November 2005
We will not pay you to allow us to store your samples and to allow research to be done with your
samples. Also, there are no plans to pay you if research done with your samples and information
results in the development or sale of any product or technology.
Can I still get medical care within Partners if I don’t take part in this
research tissue bank or if I stop taking part?
Yes. Your decision won’t change the medical care you get within Partners now or in the future.
There will be no penalty, and you won’t lose any benefits you receive now, or have a right to
receive.
Taking part in the bank is up to you. You can decide not to allow your specimens and
information to be placed in the bank. If you decide to take part now, you can change your mind
and drop out later.
Whom do I call to answer questions about the bank?
You may ask more questions about the bank at any time. Bank representatives are available to
answer your questions or concerns. They can be contacted at [insert telephone number][insert
when staff are available, e.g. M-F 9-5]. The person in charge of the bank is [insert PI’s
name]. You can call [him/her] at [insert telephone number] [insert when person is
available, e.g., M-F 9-5].
Whom do I call if I have concerns about my rights as a research subject?
If you want to speak with someone not directly involved in the bank project, please contact the
ethics board office (Partners Human Research Committee). You can call them at 617-424-4100.
You can talk to them about:
 Your rights as a research subject
 Your concerns about the research tissue bank
 A complaint about the research
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Partners HealthCare System
Research Consent Form
Subject Identification
Research Tissue Bank
Version Date: November 2005
Also, if you feel pressured to take part in the research tissue bank, or to continue with it, they
want to know and can help.
[Researchers: Below is an optional section that allows unrelated uses of samples that
RETAIN A LINK to identifiable information. Unless subjects specifically agree to this use
by checking YES, their samples with a link to identifiable information cannot be given to
investigators for unrelated research.]
An OPTION to CHOOSE:
Samples in this bank will be used mainly for research on [condition]. As described above, it is
possible that unrelated research may be done on samples stripped of any link to you. Stripping
samples of links to you means that it would not be possible for anyone to know that the sample
came from you.
You have the option to let your sample AND information that could identify you be used for
other unrelated research.
In the future, someone might want to do research on an unrelated topic and might need
information that could identify you, such as your medical record number. The unrelated research
could include medical questions related to any medical condition or to how the body normally
works; for example, what causes and what helps prevent, treat, or cure any disease and how it
may be passed on in families.
Allowing your samples AND information that could identify you to be used for a different
unrelated topic is optional (not required). Allowing this might be a slightly greater risk to your
privacy. The choice is yours.
Do you agree to allow your samples and information that could identify you to be used for
medical research NOT related to [condition]?
CHECK ONE BOX, and INITIAL:
YES
NO
INITIALS _____
Consent to Collect Samples and Health Information for Research
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Partners HealthCare System
Research Consent Form
Subject Identification
Research Tissue Bank
Version Date: November 2005
I confirm that the purpose of the BWH/MGH bank and the potential risks and benefits have been
explained to me. All my questions have been answered. I have read this consent form. My
signature below indicates my willingness to have samples and health information about me
collected and stored in the bank and used and shared as described above.
Signature of Subject:
Adults or Minors, ages 14-17
Date/Time
OR
If you understand the information we have given you, and would like to give your permission for
your child/the person you are authorized to represent to take part in this research study, and also
agree to allow his/her health information to be used and shared as described above, then please
sign below:
Signature of Parent(s)/Guardian or Authorized Representative:
Parent(s)/Guardian of Minor
Date/Time
Statement of Study Doctor or Person Obtaining Consent


I have explained the research to the study subject, and
I have answered all questions about this research study to the best of my ability.
Study Doctor or Person Obtaining Consent
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Date/Time
Partners HealthCare System
Research Consent Form
Subject Identification
Research Tissue Bank
Version Date: November 2005
Consent Form Version Date:
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