Research Tissue Bank

Consent Form

Marshfield Clinic Research Foundation

A Division of Marshfield Clinic

1000 N Oak Avenue, Marshfield, WI 54449

SP Code:	PI:

Introduction

Please read this information carefully. It gives you important information about the collection and storage of tissue samples for research. People who agree to take part in research by giving tissue samples are called “research subjects.” “Subjects” will be used in this form. If you have any questions about the content of this form, please ask us. In writing this consent form, some technical words were necessary. Please ask us to explain any that you don’t understand. Participation in this research tissue bank is completely voluntary.

Purpose of Study

The purpose of this research tissue bank is to collect process and store samples until researchers need them for research. Tissue samples in this bank will be used mainly for research on [state scope of research, e.g. arthritis, multiple sclerosis, genetics of prostate cancer]. Research tissue banks collect and store many types of samples such as blood, urine or other bodily material. For this bank, researchers will collect [state types of tissue].

Along with tissue, researchers need to collect some health information about you for this bank. Combining information from the tissue with information from your health records is most useful for research. For this research tissue bank, the following types of information could be included from your health records [state specific examples e.g. diagnoses, treatment, prescriptions].

Our research tissue bank is located at [specify location by institution and city]. There is no set limit to the number of people who will provide samples to this bank. The more samples that can be collected, the more useful the tissue bank will be for research.

Tissue Sample and Information Collection

[Include all sections that apply and make them specific to your bank.]

[As part of your routine clinical care, your doctor will obtain [specify and name all samples to be collected, e.g. tumor, blood, list all that are applicable] for testing. After the tests for your medical care are completed, there may be samples left over. Normally, these would be thrown away. We are asking you to allow us to collect and store this leftover material in a research tissue bank].

[You will be asked to come to [state place] to have blood drawn for the research tissue bank. You will have [state amount] of blood drawn. At this visit you will also be asked to [state other requirements such as questionnaires or urine collection].

[We are also asking for your permission to store some of your health information with your samples so your samples will be more useful for research. We plan to continue to review your medical records to update your health information in the research tissue bank computer database. This information will be updated regularly. Researchers at Marshfield Clinic will be allowed to review your medical record to collect more health information about you, if their research has been approved the Institutional Review Board (IRB), the research ethics board. The IRB follows state and federal laws that are intended to protect the rights and welfare of research subjects. ]

How will my samples be stored?

[Include the sections that apply or include other information specific to your study]

[After they are collected, tissue samples will be frozen and sent to the bank.]

[Staff at the tissue bank will assign your sample a code number and store it in a freezer. They will not have access to your name or other information that could connect your information with your sample. They will use the code number to connect your sample to your health information stored in the computer database. The computer database is protected with a password.]

[All of the samples stored in the bank are labeled with a code number that connects it to medical information related to the sample. The key to the code that links the sample and information will only be available to the tissue bank staff, and will be securely stored.]

Who will have access to my samples and information?

Your samples will be made available to researchers at Marshfield Clinic, [as well as researchers, at other institutions, who work with Marshfield Clinic researchers. Your samples will not be sold to anyone for profit.] [Explain whether researchers using tissue will also receive identifying information or whether data will be de-identified before being shared.]

Use of Samples for Research

Your samples and information will be used mainly to [describe the type(s) of research to be conducted]. The long-term goals of research with this tissue bank 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, there are new questions and new types of research related to [condition] may be done.

[Include all that apply]

[Your tissue may also be used for research on other conditions, for example, as comparisons to other diseases. This could include a wide variety of conditions such as cancer, diabetes, Alzheimer’s disease.]

[We plan to do genetic research on the DNA in your tissue sample. DNA is the material that makes up your genes. All living things are made of cells. Genes are the part of cells that contain characteristics such as hair and eye color. They are passed from parent to child. Problems in genes can lead to diseases.]

[We may also perform a whole genome analysis on your DNA sample. Usually researchers study just a few areas of your genetic code that are thought to be linked to a disease or condition. In whole genome studies, all or most of your genes are analyzed and used by researchers to study links to [specify whether the GWAS data will be limited to the disease under study and related disorders or many diseases or conditions].

[As part of this research, your genotype and phenotype data will be shared with the National Institutes of Health (NIH) GWAS data repository. From this repository it will be available to other researchers conducting research with NIH funds. The information that is shared will not include direct identifiers.]

Results

You will not receive any research results from your tissue samples. The research we are doing is only one step toward understanding [insert medical condition as appropriate]. Also, the Clinical Laboratory Improvement Act (CLIA) of 1998 prohibits laboratories from providing research results to subjects or their doctors. Information from this research will not be placed in your medical records.

Risks

The main risk of allowing us to store and use your samples and health information for research is a potential loss of privacy. Marshfield Clinic will protect your privacy by labeling your samples and information with a code, and keeping the key to the code in a password protected database. [Indicate whether identifiable information will be used or shared and consider the risk of this use.]

[Insert as Appropriate]

[Your doctor will explain the risks of the medical procedure you are having. Providing leftover tissue to the research tissue bank does not change the risks of the medical procedure itself. ]

[The risks of having blood taken from your vein may include bruising, minor pain, infection at the site where the blood was taken or fainting. There will be the usual discomfort of a needle stick.]

[Taking part in a genetic study could influence some insurance companies or others regarding your health. However, Federal and state laws exist which provide individuals with a variety of protections against genetic-based discrimination either by employers or by health insurers. Although remote, there is a potential risk that information about you or your genetic make-up could be accidentally released. Researchers will take all steps possible to prevent this from happening. ]

Benefits

You will not benefit directly from research samples stored in the tissue bank and used for research because you will not be given any personal results. We hope that the research using the samples and information will help us to understand more about the diseases and conditions being studied.

Costs

There will be no cost to you to have your tissue stored in the bank and used for research. Any medical care you receive that results in the leftover samples will be billed as usual to you and your health insurance company.

Payment

We will not pay you to allow us to store your tissue samples and 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 of any product or technology.

Confidentiality

Your medical, hospital, or other billing records and research material that would identify you will be held confidential and protected by Marshfield Clinic confidential policies. Medical records that identify you and the consent form signed by you, may be inspected by the following agencies:

[List as appropriate]

•	U. S. Food and Drug Administration (FDA)

•	National Cancer Institute (NCI)

•	(the sponsor and supplier of the drug) or their designees

•	Other governmental regulatory agencies

•	Marshfield Clinic Research Foundation's Institutional Review Board

•	Medical professionals who need to access your medical record for your continuing care

Because of the need to release pertinent sections of information to these parties, all efforts will be made to maintain confidentiality. These people must also keep the information confidential. Your name will not be given to anyone not associated with the study unless required by law.

The results of this study may be presented at scientific meetings or in scientific publications; however, your identity will not be disclosed.

[If the research has a genetic component, include the following: Note that while this language is not required verbatim, the communication of federal and state protections and limitations is, so some variation of this language is necessary.)

Federal and state laws exist which provide individuals with a variety of protections against genetic-based discrimination either by employers or by health insurers.

Wisconsin state law was enacted in 1991 and applies to employers, labor unions, employment agencies, licensing agencies, health insurers and self-funded insurance plans sponsored by local government. These groups may not:

Require or even request that you obtain a genetic test; or

If a genetic test is obtained, disclose the fact that a test was taken or ask for test results

The Genetic Information Non-discrimination Act (GINA) applies to health insurance companies and group health plans, and employers with 15 or more employees. Under the terms of the act, these groups may NOT:

Request genetic information collected as part of research; or

Use your genetic information when making decisions regarding your insurance eligibility or premiums; or

Use genetic information that is obtained from research when making a decision to hire, promote, or fire an individual, or when setting the terms of employment.

Be aware that neither GINA nor the comparable Wisconsin State laws protect against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. These laws also do not stop employers or health insurers from discriminating against someone on the basis of a pre-existing or apparent genetic disease or disorder.

(If the research is a Genome-Wide Association Study [GWAS], include the following statement.)

As part of this research, your genotype and phenotype data will be shared with the National Institutes of Health (NIH) GWAS data repository. From this repository it will be available to other researchers conducting research with NIH funds. The information that is shared will not include direct identifiers.

Research Related Injuries

If you become ill or injured from this study, medical care is available at Marshfield Clinic or the health care provider of your choice. You or your health insurer would be responsible for this cost. This organization has no plans to compensate you for such illness or injury, financially or otherwise.

Withdrawal from the Research Tissue Bank

Taking part in this research is voluntary and you do have the right to stop taking part. You will be able to have any samples and information that have not been, nor are currently in use as part of a research project removed from the tissue bank.

Study Contacts

You may ask more questions about the tissue bank at any time. For more information about this research or to report injuries or side effects, you may contact [PI name]	, Marshfield Clinic at 1‑800-782-8581 ext.	. For 24-hour emergency contact ,

call ____________________.

Rights of Research Subjects

Being in this study is voluntary. Refusing to participate or discontinuing participation at any time will involve no penalty or loss of benefits to which you are otherwise entitled. If you choose not to sign this consent form, your relationship with your doctor and this institution will not change.

You are not giving up any legal rights by signing this consent document and taking part in this research study.

If you have any questions about your rights as a research subject, you may contact Marshfield Clinic Research Foundation's Institutional Review Board (IRB) at 1‑800‑782‑8581 ext. 9-3022. The IRB is responsible for helping to protect the rights and welfare of human research subjects. You may also call this number to discuss problems and concerns, to request information or ask questions, and to offer input.

Signing the Consent

A signature indicates that:

You have read the above.

You have freely decided to take part in the research study described above.

The study's general purposes, details of involvement and possible risks and discomforts have been explained to you.

You will receive a signed copy of this consent form.

Signature of	Date of Signature

Subject

Subject’s Activated Power of Attorney for Healthcare

Parent of Minor Subject

Subject’s Legal Guardian

(Check appropriate title)

Printed Name of Subject

Printed Name of Signatory (if other than subject)

(if applicable)

Signature of Presenter	Date Presented

Printed Name of Presenter

IRB Approval Date

H:\RADMIN\ORIP\IRB\Consent Documents\Consent Forms\CF\Research Tissue Bank Consent Form.DOC

Version: 10/01/13

Research Tissue Bank Consent Form -

Page 6 of 6

IRB Approved -

Jaros, Linda M.

2013-09-30

Ostrowski, Melissa M

Marshfield Clinic