MRI Informed Consent DRAFT



CONSENT TO PARTICIPATE IN A

MAGNETIC RESONANCE IMAGING

(MRI) RESEARCH

TITLE:

PROTOCOL NO.:

SPONSOR:

INVESTIGATOR:

MRI SITE(S):

STUDY-RELATED PHONE NUMBER(S):

This consent form could contain words that you do not understand. Please ask the study doctor or the study staff to explain any words or information that you do not clearly understand. You can take home an unsigned copy of this consent form to think about or discuss with family or friends before making your decision.

Please consider this information carefully before deciding whether to participate in this research.

PURPOSE OF THE STUDY

You are invited to participate in a research study. The purpose of this study is to {Clearly describe the purpose of the study and why the patient has been invited to participate.} The study will use Magnetic Resonance Imaging (MRI) to create images of your {Part of the body that will be scanned}

PROCEDURES

The study requires a total of {number of visits and frequency}. During the visits, we will ask you to answer some questionnaires and we will perform the MRI in visits # xxx and # xxx

Each MRI test will last approximately {length of the MRI test} minutes/ hours

Your participation in this study consists of laying on a table and having your body slide into a large horizontal tube. You will be asked to lay as still as possible during this time. We will use foam cushions to help keep your head from moving. The MRI machine periodically makes loud banging noises. We will provide earplugs or headphones for you to wear during the MRI exam.

During the scan (if applicable describe any procedures or activities that the participant will be asked to do during the scan i.e.: read words, see pictures, etc.

(If applicable include a paragraph with follow up information. The participant should be provided the opportunity to NOT have any follow up.) In some cases, we may want to contact you for additional information or to participate in a follow-up experiment. If we do, your participation is optional. If you would prefer that we do not contact you, please initial below to indicate this.

Do not contact me for follow-up ________ Participant Initials

RISKS AND DISCOMFORTS

MRI are machines approved by the Food and Drug Administration in the US for diagnostic and research proposes. MRI uses large magnet fields. There are no known or foreseeable risks or side effects associated with scanning procedures except for those people who have electrically, magnetically or mechanically activated implants, or metal in or on their bodies.

In order to make sure the MRI procedure will be safe, we will ask you to fill out a screening form before starting the study. It is important that you tell the researchers in this study if you have any history of the following:

• Metal fragments in your body, eyes or face.

• Implantation of any electronic devices such as (but not limited to) cardiac pacemakers, cardiac defibrillators, cochlea implants or nerve stimulators.

• Surgery on the blood vessels of your brain or the valves of the heart

• Claustrophobia (fear of enclosed places)

• Body piercing or tattoos

FOR WOMEN: Although the majority of data suggests that MRI scans are perfectly safe for embryos or fetuses, there is still much that remains unknown. For this reason, we believe that it is safer not to allow anyone who suspects they might be pregnant to participate in MRI scanning. If you are pregnant or you feel that there is any chance that you may be pregnant, YOU SHOULD NOT participate in this study at this time. You do not need to tell us why you have chosen not to participate. Not participating is your right.

An MRI scan is not uncomfortable but if you are prone to claustrophobia (fear of enclosed spaces) please notify the researcher in charge of the scan. If you do not wish to participate due to this reason, you can opt out.

You can expect to hear a loud knocking sound during the imaging. We will give you earplugs to help to reduce the sound. It is important that you remain as still as possible during the study. We will provide foam pillows that are reasonably comfortable, and are designed to keep your head still and in a relaxed position. If any of the procedures are uncomfortable, you can notify the researcher in charge of the scan. We will give you a signal button to indicate at any time that you wish to stop.

IMPORTANT: This project is for research purposes only and is not directed or designed for clinical diagnosis as part of medical treatment, and the scans performed in this study are not optimal to find abnormalities. The MRI conducted for research studies is not intended to replace the Standard of Care suggested by your physician. You should not expect that the investigators review the MRI in a way that could detect an abnormality. You should not participate in the study if you want or expect to obtain a clinical diagnosis.

1. INCIDENTAL FINDINGS

[The disclosure plan for informing subjects of incidental findings (IFs) must be outlined in the informed consent form (ICF). For anticipated incidental findings, the disclosure plan may also include subject preference. Some subjects may want to receive their incidental findings, and some may express (when asked) that they do not. The consent form must include:

• A description of the plan the researcher will use to report IFs (or not), and which qualified study personnel or consultants will be involved.

• A description of the timeframe that will be used to report IFs if the researchers intend to report them.

• Attestation of the research subject’s preference for whether or not he/she agrees to receive results of incidental findings.

Example 1: There is a possibility that while reviewing your MRI we may see an abnormality that we did not expect to see in this study. This is what we call an "incidental finding." If this occurs, the principal investigator or designee may tell you about the observation. When someone tells you about a finding, this may cause you anxiety and you may need to follow up with a clinician for additional tests that will result in financial costs to you independent of this research.

Example 2: (When images will not be available) The MRI pictures from this study will not be in a form readable by either you or your doctor. Therefore, a copy of the MRI pictures or the results of your individual study will not be given either to you or your doctor. Although the MRI pictures in this study are not formally reviewed by a radiologist, if in the course of processing the images we notice any abnormality that could be important to your health we would advise you to follow up with a physician.

The decision as to whether to proceed with further examination or treatment from a physician independent of this research study will be your responsibility and decision. The costs for any care that will be needed to diagnose or treat an incidental finding would not be paid for by this research study. These costs would be your responsibility.

You have the option of not being informed of the incidental findings.

Do not inform me of any incidental findings _______ Participant Initials

2. BENEFITS

[State in clear, realistic terms the benefits to the participant and/or society in general. If there are no direct benefits to the participant, then this should be stated as well.] Use whichever statement is applicable

We do not know if you will receive any direct benefits by taking part in this study. However, this research will contribute to a greater understanding of ….

[Or]

The potential benefits to you are:

3. COSTS

[If applicable in simple language state what will be billed to the subject or to their insurance. Be clear on who pays if insurance does not (do not use exculpatory language) For example: The research study will provide the MRI free of charge during this study. Procedures that are done only for the study, such as extra lab tests will not be billed to you or your insurance company. NOTE: Insurance does not pay for research procedures and this must be clear to participants.

You or your insurance company may be billed for:

• Any standard medical care provided during this research study.

• [list other costs as necessary]

You may want to talk with your insurance company about its payment policy for standard medical care given during a research study. If your insurance company does not pay, you may be billed for those charges that are related to standard medical care.

4. PAYMENT FOR PARTICIPATION

If applicable, explain the type of payment you will use. Example:, you will be paid $ xxxxx per hour for your participation in this study plus $xxxx for transportation, or free parking if you drive. We will make these payments by check through the mail.

5. ALTERNATIVE TREATMENT

This is not a treatment study. Your alternative is not to participate in this study.

6. DATA COLLECTION AND STORAGE

(To write the following section work with the IT representative in your college to develop a Data Security Plan according to the level of risk and resulting confidentiality of your data)

Example: Any information collected about you will be kept confidential and secure and only the people working with the study will see your data, unless required by law. [Note: The phrase "…unless required by law." MUST appear in this section of the consent form.] The data will be kept for ___ years in [state physical or electronic storage method]. After __ years, paper copies will be destroyed by shredding and electronic data will be deleted. We may publish what we learn from this study. If we do, we will not let anyone know your name/identity unless you give us permission.

In cases required by law, your information may be given to:

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

1. Department of Health and Human Services (DHHS) agencies,

2. Governmental agencies in other countries,

3. Governmental agencies to whom certain diseases (reportable diseases) must be reported, and

4. Western Institutional Review Board® (WIRB®)

[Add any institutional names above WIRB.]

7. VOLUNTARY PARTICIPATION AND WITHDRAWAL

Your participation in this study is strictly voluntary. You may decide not to participate or you may leave the study at any time. Your decision will not result in any penalty or loss of benefits to which you are entitled.

Your participation in this study may be stopped at any time by the study doctor or the sponsor without your consent for any of the following reasons:

• if it is in your best interest;

• you do not consent to continue in the study after being told of changes in the research that may affect you;

• [CONSENT FORM PRESENTER: if the protocol lists specific reasons, insert the specific reasons for discontinuation listed in protocol]

• Or for any other reason.

If you leave the study before the planned final visit, the principal investigator may ask you to have some of the final study procedures.

8. SOURCE OF FUNDING FOR THE STUDY

[If applicable] The sponsor [name] will pay for this research study. [Or other wording, as appropriate].

9. QUESTIONS

Contact [name] at [number(s)] for any of the following reasons:

• if you have any questions about this study or your part in it,

• if you feel you have had a research-related injury or a bad reaction to the study drug, or

• if you have questions, concerns or complaints about the research

If you have questions about your rights as a research subject or if you have questions, concerns or complaints about the research, you may contact:

{Insert Name and Contact Information for FAU IRB or Western Institutional Review Board® (WIRB®), whichever is applicable}

Do not sign this consent form unless you have had a chance to ask questions and have gotten satisfactory answers.

10. CONSENT

I have read this consent form (or it has been read to me). All my questions about the study and my part in it have been answered. I freely consent to be in this research study. I have been provided a copy of this consent form for my records.

I authorize the use and disclosure of my health information to the parties listed on my HIPAA for research consent form [remove if you used a Confidentiality section rather than an Authorization section above or if you are not using PHI].

By signing this consent form, I have not given up any of my legal rights.

[Example signature block for research involving adults able to consent, minors, and adults who lack

the capacity to consent:]

Consent and Assent Instructions:

- Consent: Subjects 18 years and older must sign on the subject line below

- Consent is provided by the Legally Authorized Representative for adult subjects unable to consent

- For subjects under 18, consent is provided by the parent or guardian

- Assent: Is not required for subjects 6 years and younger

- Verbal assent is required for subjects ages 7 through 14 years using the Assent section below [and the Information Sheet for Children].

- Verbal assent is required for subjects ages 15 through 17 years using the Assent section below [and the Information Sheet for Adolescents].

__________________________________________

Subject Name (printed)

CONSENT SIGNATURE:

________________________________________ __________________

Signature of Subject (18 years and older) Date

________________________________________ __________________

Signature of Legally Authorized Representative, Date

Parent or Guardian (when applicable)

________________________________________________________________________

Authority of Subject’s Legally Authorized Representative or Relationship to Subject

________________________________________ __________________

Signature of Person Conducting Informed Date

Consent Discussion

ASSENT SECTION For Subjects Ages [7] - [17]:

Statement of person conducting assent discussion:

1. I have explained all aspects of the research to the subject to the best of his or her ability to understand.

2. I have answered all the questions of the subject relating to this research.

3. The subject agrees to be in the research.

4. I believe the subject’s decision to enroll is voluntary.

5. The study doctor and study staff agree to respect the subject’s physical or emotional dissent at any time during this research when that dissent pertains to anything being done solely for the purpose of this research.

________________________________________ __________________

Signature of Person Conducting Date

Assent Discussion

Statement of Parent or Guardian:

My child appears to understand the research to the best of his or her ability and has agreed to participate.

________________________________________ __________________

Signature of Parent or Guardian Date

ASSENT SIGNATURES, For Adult Subjects with a Legally Authorized Representative:

Assent:

For adult subjects who have a legally authorized representative, I confirm that:

□ I have explained the study to the extent compatible with the subject’s understanding, and the subject has agreed to be in the study.

OR

□ The subject is not able to assent due to lack of mental capacity.

________________________________________ __________________

Signature of Person Conducting Assent Discussion Date[pic]

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