Research Consent Form

Marshfield Clinic Research Foundation

A Division of Marshfield Clinic

1000 N Oak Avenue, Marshfield, WI 54449

SP Code:	PI:

Title:

Introduction and Purpose of Study

You are invited to take part in a research study conducted by [List sponsor and any participating sites.]

You have been asked to participate in this research because

[Explain succinctly and simply why the potential subject is eligible to participate.]

[State what the purpose of the study is, and what is it designed to discover or establish.]

[Describe how long the entire study is expected to last and how long the subject will be involved in each aspect of it].

[State the approximate number of subjects to take part in the study nationally and locally, as available.]

Being in this study is voluntary. Whether or not you decide to take part in this research is completely up to you. You should read the following information carefully before you make a decision. In writing this consent form, some technical words were necessary. Please ask for an explanation of any you do not understand. Ask the study doctor or staff as many questions as you wish about this consent form and what will happen to you as part of this research.

Study Plan

If you volunteer for this study, you will be asked to do the following things:

[Describe the procedures, chronologically, using lay language. Indicate which procedures, drugs or devices are investigational (untested, unapproved or innovative) or are standard or approved but being done/used solely for the purpose of this study.]

[Attach a schema when appropriate.]

[Specify the subjects' assignment to study groups, length of participation for each procedure, frequency of procedures and where they will be done.]

[If randomization is to be done on different arms of the study, explain the process Include randomization probabilities.]

[For research involving placebo, explain the use of the placebo.]

If you begin taking any new medication, please remember it is very important to let your study doctor know right away. He or she will determine if the new medication could cause problems with the medication you are taking on this research study.

Potential Risks and Discomforts

[Identify each intervention with a subheading and then describe any foreseeable risks, discomforts, inconveniences and how they will be managed. Include the frequency when possible (e.g. Likely, Less Likely, Rare).]

[If applicable, discuss possible risks of drug combinations.]

[Attach a schema when appropriate.]

[For studies involving several drugs with common side effects, it is preferable to list them under a shared heading versus repeating the same side effects several times.]

[If the research has a genetic component, include the following paragraph:]

Although remote, there is a risk that information about your genetic make-up may be accidentally released to you or others. Researchers will take the steps outlined in this consent form to protect your genetic information.

This research may also involve risks or discomforts that are presently not known.

Pregnancy, Birth Control and Breast Feeding

[Note: If this does not apply to your study, please omit this entry and delete the heading.]

[Address any issues with birth control, pregnancy or breastfeeding in terms of participation on the study. Discuss any possible risks to the embryo or fetus. Address birth control requirements for the subject and/or subject's partner.]

It is important that you not become pregnant or breastfeed while on this study since the effect of these drugs on pregnancy and the fetus is unknown. Talk to your study doctor about acceptable birth control while on this study. If you should become pregnant during the course of the study, you should notify study staff immediately. It is also important to not breastfeed a child while you are on this study.

Potential Benefits to Subjects

It is not possible to know if you will benefit medically by taking part in this research. Based upon experience with this [drug, procedure, device, etc.] in [animals, patients with similar conditions], researchers believe it may be of benefit to people with your condition. However, it may not be helpful to you. It is hoped that information learned from this study will benefit you and others with a condition like yours in the future.

Alternatives to this Study

[Describe any appropriate alternative therapeutic diagnostic or preventive options that should be considered before the subject decides whether or not to participate in the study. Include intervention(s) being studied if they are available off protocol. If there are no efficacious alternatives, state that an alternative is not to participate in the study.]

[If not a treatment study, don’t describe alternatives.]

You do not have to be in this study to get medical care at any of the participating sites. If you choose to not take part, your doctor will talk with you about other care available at this facility.

Bio-Banking for Future Research

As part of this study, the researcher and staff will obtain [specify and name all samples to be collected] for research testing. After those tests are completed, there may be samples left over. We are asking you to allow us to store this leftover material for use in future research. Also, we are asking to access your medical record information along with the sample for future research. Samples and medical information are most useful for research when they are studied together. Researchers at Marshfield Clinic Research Foundation will be allowed to use your sample and information for research, if their research project has been approved by the Institutional Review Board.

The only risk to you for taking part in this bio-bank is the slight risk that your identifiable information could be accessed by someone not authorized by the research study. However, standard Marshfield Clinic security and confidentiality practices will govern the use of your sample and information in order to decrease the chance of this happening.

If you change your mind about taking part in the bio-bank, you may request that your sample and information be removed. Any samples that are not currently in use as part of an approved project will be destroyed.

Cost for Participation

[In an effort to clearly convey costs that may be incurred by subjects enrolling in studies, the IRB has approved the following language options. Language variations are acceptable, as long as the appropriate message is conveyed. Please select the most appropriate language, based on the type of study and how costs will be billed:]

Standard Cost Intro Statement

A. [Use this statement when the patient or their insurance carrier is responsible for “Some” of the costs for participation in the study.]

Some of the visits, tests and procedures required as part of this research study would be required for the treatment of your condition whether or not you participate in this research. These are considered “standard of care” and you /your insurance company will be billed for these costs. You will also be responsible for any associated co-payments and deductibles.

[Then add EITHER]:

The study sponsor is providing funds to cover study visits, tests and procedures that are not considered ‘standard of care.’ You will not be billed for these items.

[OR]:

The following visits, tests or procedures are not considered ‘standard of care’ and will result in additional costs to you: (LIST VISITS, TESTS, PROCEDURES, DRUG/DEVICE)

B. [Use this statement when all visits, tests & procedures are considered ‘standard of care’ and the patient or their insurance carrier is responsible for all costs.]

All of the visits, tests and procedures required as part of this research study would be required for the treatment of your condition whether or not you participate in this research. These are considered “standard of care” and you /your insurance company will be billed for these costs. You will also be responsible for any associated co-payments and deductibles.

C. [If sponsor pays for All costs for participation in the study, then include a statement to that effect. An optional example:]

There will be no additional costs to you for participating in this study. The drug (NAME), tests, procedures and visits that are a part of the study are provided at no cost to you.

Standard Cost Closing Statement:

[Use this statement to close if you selected option I.A. or I.B above.]

You may want to meet with a representative from our patient assistance center to discuss potential costs or check with your insurance company to find out what they will pay for if you participate in research.

Payment for Participation

[State whether the subject will be paid or offered other incentives for participating in the research. If subjects will be compensated, provide a specific payment schedule.]

[If a company is providing funds to conduct the study, insert the following:] X is providing funds to conduct this study. Your study doctor may receive some payment for this study, but s/he is only allowed to use the funds for education or research.

Data or Sample Sharing

[If it is possible that you may share data from this study with colleagues for research purposes, state that here. Indicate if data or samples might be provided to for-profit companies. In all cases, detail what level of identifier will accompany the data or samples.]

Possible Commercial Products

(Note: If this does not apply to your study, please omit this entry and delete the heading.)

It is possible that a commercial product will be developed as a result of this research. In the event this happens, there are no plans to share profit from such a product (if any).

Emergency Care and Compensation for Injury

(Note: This can be deleted for studies of less than minimal risk. Otherwise state:)

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

(Note: The paragraph below only applies to externally sponsored drug and device studies.)

If you suffer an adverse reaction as a result of being in this study, treatment will be available. The costs of such treatment may be covered by the study sponsor, (identify by name). Neither you nor your insurance company will be billed by Marshfield Clinic for any costs for treatment of adverse reactions (defined as illness, injury or health-related complications) resulting from this study. Marshfield Clinic does not provide any other form of compensation for a research adverse reaction. If your care and treatment due to an adverse reaction resulting from your participation in this study was provided by other than Marshfield Clinic, you should contact (Name) at (Sponsor) to arrange for payment or reimbursement of your health care costs.

Confidentiality

[Describe study specific measures that will be taken to protect subjects’ confidential information.]

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, the consent form you signed, and any other study information, 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 (or health) 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.

(If the research is an “applicable clinical trial” of a drug, device, or biological product as defined at 21 CFR 50.25(c) and is initiated on or after March 7, 2012, include the following statement.)

“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”

New Findings

You will be told of any new findings regarding this research that may affect your willingness to be in this study.

[Provide information explaining whether or not and how you plan to provide individual research results to subjects.]

It [is/isn’t] the intent of the researcher to return [aggregate/your] research results to you.

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.

It is possible that in the course of this research, information not directly related to this research, but relevant to your health may be discovered. If this happens, you will be given the information so that you may consider follow-up with your health care provider.

Withdrawal from the Study

You may change your mind about taking part in this research at any time. You may withdraw you consent for all or part of the research. If you decide to leave the study, please let your doctor know so you may do so safely. [Describe any limitations on the withdrawal of date already in use; or under FDA regulation.]

Termination from Study

Participation in the study will stop if the following occurs:

[insert as appropriate]

The sponsor, for administrative reasons, decides to take you off or terminate the study

You or your legal representative choose to change or stop your treatment

You do not follow study instructions

Your condition becomes worse

Side effects become severe

New studies indicate that this treatment is not in your best interest

Your study doctor feels this treatment is no longer helping you

(Provide information about what will happen if a subject withdraws or is withdrawn by the investigator, including what will happen to the subject’s data.)

Study Contacts

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 protect 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.

{Insert the set of signature lines most applicable to this research study}

{Use the following if the research subject will be providing consent}

Signature of Subject	Date of Signature

Printed Name of Subject

Signature of Presenter	Date Presented

Printed Name of Presenter

{Use the following if you are requesting that the IRB approve the study for enrollment of adults who may lack capacity to consent}

Signature of	Date of Signature

Subject

Subject’s Legal Guardian

Subject’s Activated Power of Attorney for Healthcare

Subject’s Next of Kin (indicate which of the following):
Spouse
Adult Child
Parent

__________________________________________

Printed Name of Signatory (If different from subject)
__________________________________________

Printed Name of Subject

Signature of Presenter	Date Presented

Printed Name of Presenter

{Use the following if you are requesting that the IRB approve enrollment of minors}

Signature of	Date of Signature

Parent of Minor Subject

Legal Guardian of Minor Subject

__________________________________________

Printed Name of Signatory
__________________________________________
Printed Name of Subject

Signature of Presenter	Date Presented

Printed Name of Presenter

{Use the following if you are requesting that the IRB approve enrollment of both adults and minors}

Signature of	Date of Signature

Subject

Parent of Minor Subject

Legal Guardian of Minor Subject

_____________________________________

Printed Name of Subject

_________________________________________

Printed Name of Signatory (if other than Subject)

Signature of Presenter	Date Presented

Printed Name of Presenter

IRB Approval Date

H:\RADMIN\ORIP\IRB\Consent Forms\CF\IRB CONSENT – Template. DOC

Revised: 01/31/14

IRB Approved -

IRB Approved - Draft #1

Consent Form -

Page 10 of 10

Research Consent Form

zirnhelj

2014-01-14

Musson, Amanda C

Marshfield Clinic