VERY IMPORTANT - BEFORE PRINTING YOUR DOCUMENT: Be …



VERY IMPORTANT - BEFORE PRINTING YOUR DOCUMENT: Be sure to delete the informational text, such as this, which has been italicized and underlined. Please include a version date and page numbers in the footer to assist with tracking future amendments. Make sure your font size is no smaller than 12-point, that your formatting is consistent, and that you have removed any unnecessary spaces.

Informed Consent to Participate in Research

and Authorization for Collection, Use, and

Disclosure of Protected Health Information

You [or “your child is” or “your adolescent is”, if applicable] are being asked to take part in a research study. [Insert one of the following sentences, if applicable: “You, as used in this consent form, refers to you and/or your adolescent (if he/she is a minor requiring consent).” OR “You, as used in this consent form, refers to you and/or your child (if he/she is a minor requiring consent).”] This form provides you with information about the study and seeks your authorization for the collection, use and disclosure of your protected health information necessary for the study. The Principal Investigator (the person in charge of this research) or a representative of the Principal Investigator will also describe this study to you and answer all of your questions. Before you decide whether or not to take part, read the information below and ask questions about anything you do not understand. Your participation is entirely voluntary. If you choose not to take part in this study, you will not be penalized or lose any benefits to which you would otherwise be entitled.

1. Name of Study Participant

________________________________________________________________________

2. Title of Research Study [Grants and IRB projects must have EXACT same title]

3. Principal Investigator Name, Address, and Telephone Number(s) [The names of sub-investigators and/or study coordinators and/or other contact information must be included here as well])

4. Source of Funding or Other Material Support [i.e. study sponsor(s) information]

5. What is the purpose of this research study?

The purpose of this study is

6. What will be done if you take part in this research study?

Provide detail on all study interventions including when and where study interventions will take place.

Does the protocol include the use of any drugs or devices that are being used in a manner not previously approved by the FDA? This includes not only IND drugs or experimental devices, but also using approved drugs or devices in unapproved manners or for unapproved conditions. If so, you must include a statement that specifically indicates these items. Examples include:

is , is not approved by the Food and Drug Administration (FDA).

The manner in which is being used in this research has not been approved by the Food and Drug Administration (FDA).

has not been approved by the Food and Drug Administration (FDA) for treating people with .

Does the protocol include/involve clinical treatment or procedures that would normally be required during normal clinical care for people with the condition being studied? If so, you must include the following questions and provide the appropriate answers in this consent:

6a.What procedures would be done as part of your normal clinical care (even if you did not take part in this research)?

6b.What procedures will be done only because you are taking part in this research study? If you have any questions now or at any time during the study, you may contact the Principal Investigator or contact person listed on the front page of this form.

7. If you choose to take part in this study, how long will you be expected to take part in the

Research?

[Please provide enough information so that the potential participant will have a good idea of his/her time commitment, how long they will be expected to actively participate in the research project].

8. How many people are expected to take part in this research?

[Cite the maximum number of research subjects that are expected to participate at this site and all locations, if applicable.]

9. What are the possible discomforts and risks?

[Please consider all possible risks and discomforts to the participant, and include that information here.]

If your study involves genetic testing you must include the following:

“A new Federal law, called the Genetic Information Nondiscrimination Act (GINA) makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law protects you in the following ways:

• Health insurance companies and group health plans may not ask for your genetic information obtained during this research study.

• Health insurance companies and group health plans may not use your genetic information when making decisions about your eligibility for insurance or your premiums.

• Employers with 15 or more employees may not use your genetic information obtained during this research study when making a decision to hire, promote, or fire you, or when setting the terms of your employment.

Be aware that GINA does not protect you against discrimination by companies that sell life, disability, or long-term care insurance. If you think that these laws have been violated, it will be up to you to pursue any compensation from the offending insurance and/or employer.”

NOTIFICATION FOR FLORIDA RESIDENTS:

By Florida law, the results of any DNA analysis, which includes DNA typing and genetic testing, are the exclusive property of the person tested, and may not be disclosed without your permission (as provided in this form). Nemours is notifying you that the DNA analysis described in this document will be performed as described, and results will be provided to those individuals and / or groups noted in the section on ‘use and disclosure of PHI’. At your request, Nemours will provide the results of DNA analysis that it receives to your child’s primary care physician. The DNA analysis is performed strictly for research purposes and will not be used in any decision regarding insurability, employment, mortgage, loan, credit or education opportunity.

This study may include risks that are unknown at this time.

Taking part in more than one research study or project may further increase the risks to you. If you are currently enrolled or have recently taken part in another research study, you must tell the person reviewing this consent form with you.

Throughout the study, the researchers will notify you of new information that may become available and might affect your decision to remain in the study.

If you wish to discuss the information above or any discomforts you may experience, you may ask questions now or call the Principal Investigator or contact person listed on the front page of this form.

10. What are the possible benefits to you?

You may or may not personally benefit from taking part in this study.

[Please consider all possible benefits to the participant, and include that information here. If there is no potential for direct benefit, please state that here as well.]

11. What are the possible benefits to others?

12. If you choose to take part in this research study, will it cost you anything?

13. Will you receive compensation for taking part in this research study?

14. What if you are injured because of the study?

15. What other options or treatments are available if you do not want to be in this study?

[Please list other available standard-of-care treatments, if applicable. For non-therapeutic studies, please state that they have the option to not take part in the study.]

16. Can you withdraw from this research study?

You are free to stop taking part in this research study at any time without penalty and without losing any benefits to which you are entitled.

If you decide to stop taking part in this research study for any reason, you should contact ____________________ [Principal Investigator or study coordinator's name] at (904) XXX-XXXX.

If you have any questions regarding your rights as a research participant, you may call the Baptist Health Institutional Review Board (IRB) office at (904) 202-2127.

17. If you withdraw from this study, can information about you still be used and/or collected?

If you stop taking part in this study, no new information will be collected about you. However, information that was already collected may still be used and shared with others if the researchers have relied on it to complete and protect the validity of the research.

[If applicable to your project, consider including the following information: “If you decide to stop taking part in the research, you may be asked to (return for a final visit and/or return study medication and/or answer some final questions over the phone and/or whatever “final visit” type procedures are appropriate for your protocol).”]

18. Can the Principal Investigator withdraw you from this research study?

You may be withdrawn from the study without your consent for the following reasons:

[The following are examples of reasons why research subjects may be withdrawn from the study. Please include as many are relevant to your project and any others deemed appropriate]

• You do not qualify to be in the study, because you do not meet the study requirements.

• You need a medical treatment not allowed in this study.

• The investigator decides that continuing in the study would be harmful to you.

• Study treatments have a bad effect on you.

• You are unable to keep appointments or take the study treatment as directed.

• Other protocol-specific reasons, for example, the dose of study treatment you are taking has been found to be unsafe.

• The study is cancelled by the Sponsor, and/or other administrative reasons.

19. If you agree to take part in this research study, the Principal Investigator will create, collect, and use private information about you and your health. Once this information is collected, how will it be kept secret (confidential) in order to protect your privacy?

Only certain people have the legal right to review these research records, and they will protect the secrecy (confidentiality) of these records as much as the law allows. These people include researchers for this study, certain Baptist Health System officials, the hospital or clinic [delete references to hospital and/or clinic if not applicable – if applicable, specifically name the hospital and or clinic(s)] involved in this research, and the Institutional Review Board(s)/Institutional Review Committee(s) (IRB(s) and IRC(s); an IRB or IRC is a group of people who are responsible for looking after the rights and welfare of people taking part in research). Otherwise, your research records will not be released without your permission unless required by law or a court order.

[If appropriate, add the following:] The study data sent by the researchers to the study sponsor will not include your name, address, social security number, or other information that directly identifies you. Instead, the researchers assign a code number to the study data and may use your initials. Some study data sent to the sponsor may contain information that could be used (maybe in combination with other information) to identify you (for example, your date of birth). If you have questions about the specific health information that will be sent to the study sponsor, you should ask the study investigator(s).

Under new 21 CFR 50.25(c), the following statement must be reproduced word-for-word in informed consent documents for applicable clinical trials:

“A description of this clinical trial will be available on , 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.”   

If you take part in this research study, the researchers will collect, use and share your protected health information with others. Items 20 – 29 below describe how this information will be collected, used, and shared.

20. If you agree to take part in this research study, what protected health information about you may be collected, used, and shared with others?

Your protected health information may be collected, used, and shared with others to determine if you can take part in the study, and then as part of your participation in the study. This information can be gathered from you or your past, current, or future health or study records, from procedures such as physical examination, x-rays, blood or urine tests, or from other procedures or tests. More specifically, the following information may be collected, used, and shared with others:

[The investigator must list/describe the protected health information that will be created, used and/or disclosed to determine the subject’s eligibility for the study and information obtained through the course of the study. The list/description must contain sufficient specificity to identify the information in a specific and meaningful fashion. The following list provides examples and categories for investigators to consider listing here (Note, as a general rule, the more sensitive the information, the more specifically it should be described, i.e. HIV results). You should only request information that is consistent with your protocol (for example, do not request mental health records if they are not pertinent to your study objectives.) Be sure to DELETE those items from this list NOT relevant to your project.]

- Complete past medical history

- Information about HIV/AIDS

- Information about hepatitis infection

- Information about sexually transmitted diseases

- Information about other infectious diseases that must be reported to Public Health authorities

- Records of physical exams

- Laboratory, x-ray, MRI, and other test results

- Diaries and questionnaires

- Records about study medications or drugs

- Records about study devices

- Information related to diagnosis and treatment of a mental health condition

- Autopsy report or death certificate, if available

- Your social security number for compensation purposes

Information collected about you and your health (called protected health information), will be stored in locked filing cabinets or in computers with security passwords.

If you agree to be in this research study, it is possible that some of the information collected might be copied into a "limited data set" to be used for other research purposes. If so, the limited data set may only include information that does not directly identify you. For example, the limited data set cannot include your name, address, telephone number, social security number, or any other photographs, numbers, codes, or so forth that link you to the information in the limited data set. If used, limited data sets have legal agreements to protect your identity and confidentiality and privacy.

21. For what study-related purposes will your protected health information be collected, used, and shared with others?

Your protected health information may be collected, used, and shared with others to make sure you are eligible to take part, to carry out, and to evaluate the results of the research study. More specifically, your protected health information may be collected, used, and shared with others for the following study-related purpose(s):

[The investigator must list each purpose for the collection, use and disclosure of the protected health information. The investigator must list as one purpose the information contained in the response to question #5 of this consent. Additionally, the investigator may list all additional purposes. The following, non-exhaustive list of possible purposes provides examples and categories for investigators to consider listing here:]

- to determine the effectiveness of the study drug (or device, or procedure) in treating ___

- to evaluate a possible new use for the study drug (or device, or procedure)

- to determine the causes or effects of the study condition ____

Once this information is collected, it becomes part of the research record for this study.

22. Who will be allowed to collect, use, and share with others your protected health

information?

Your protected health information may be collected, used, and shared with others by:

[The Investigator must provide an exhaustive list of the names or other specific identification of any other persons or classes of persons that may collect, use or disclose the information, for example, named independent Data Safety Monitoring Board, named outside collaborators involved in the study, or any other persons or specific classes of persons who will be in any way collecting, using, or disclosing the subjects protected health information. Be cautious here, since it is better to be over rather than under-inclusive.

- the study Principal Investigator, ________________ [insert P.I. name here] and the research staff associated with this study

- other professionals in the Baptist Health System that provide study-related treatment or procedures

- the Baptist Health Institutional Review Board (IRB); an IRB is a group of people who are responsible for looking after the rights and welfare of people taking part in research)

23. Once collected or used, with whom may your protected health information be shared?

Your protected health information may be shared with:

[Investigator must provide an exhaustive list of any additional names or other specific identification of the persons or classes of persons to whom the protected health information will be disclosed, for example, an external Review Board or consultant. Persons or classes of persons listed here should only be those outside the University or Shands.]

- the study sponsor, _________________________ [insert sponsor name here]

- United States and foreign governmental agencies who are responsible for overseeing research, such as the Food and Drug Administration, the Department of Health and Human Services, and the Office of Human Research Protections

- Government agencies who are responsible for overseeing public health concerns such as the Centers for Disease Control and Federal, State and local health departments

- Your insurance company, for purposes of obtaining payment.

24. If you agree to participate in this research, how long will your protected health information be collected, used, and shared with others?

[The investigator may input (1) a specific date or event, (2) “until the end of the study”, (3) ‘for “X” number of years after signing the consent form’, (4) ‘for “X” number of years after the study closes’; or (5) “Your protected health information will be collected until the end of the study. This information will be used and shared with others forever, since it will be stored for an indefinite period of time in a secure database.” (If you allow subjects to withdraw, you may wish to add the following sentence: “If you withdraw your permission for the use and sharing of your protected health information, then your information will e removed from the database.”)]

25. Why are you being asked to authorize the collection, use and sharing of your protected health information?

Under a new Federal Law, researchers cannot collect, use, or share any of your protected health information for research unless you allow them to by signing this consent and authorization.

26. Are you required to sign this consent and authorization and allow the researchers to collect, use and disclose (give) to others of your protected health information?

No, and your refusal to sign will not affect your treatment, payment, enrollment, or eligibility for any benefits outside this research study. However, you cannot participate in this research unless you allow the collection, use, and sharing of your protected health information by signing this consent/authorization.

27. Can you review or copy your protected health information collected, used, or shared with others under this authorization?

You have the right to review and copy your protected health information. However, you may not be allowed to do so until after the study is finished.

28. Is there a risk that your protected health information could be given to others beyond your authorization?

Yes. There is a risk that information received by authorized persons could be shared with others beyond your authorization and not covered by the law.

29. Can you revoke (cancel) your authorization for collection, use, and sharing of your protected health information?

Yes. You can revoke your authorization at any time before, during, or after your participation in the research. If you revoke, no new information will be collected about you. However, information that was already collected may still be used and shared with others if the researchers have relied on it to complete and protect the validity of the research. You can revoke this authorization by giving a written request with your signature on it to the Principal Investigator.

30. How will the researcher(s) benefit from your being in this study?

In general, presenting research results helps the career of a scientist. Therefore, the Principal Investigator or other researchers may benefit if the results of this study are presented at scientific meetings or published in scientific journals.

31. How are the financial interests of the investigator(s) and the other participants in this study associated with this research?

[Specific Disclosure(s) if the investigator(s) or any of their family might benefit from this study:

The person(s) leading this medical research study might benefit financially from this study. Specifically, (insert all that apply from below):

1. (Sponsor name) is paying some or all of the salary for the doctors and staff who are working on this research study).

2. This research study is supported by money from (Sponsor name). In addition, the person(s) leading this research study receive(s) extra money from (Sponsor name) for work that is not a part of this study. These activities may include consulting, advisory boards, giving speeches, or writing reports. The person running this research might receive hundreds or thousands of dollars for this work.

3. (Sponsor name) pays (investigator’s name) running this research study enough money for study supplies, staff salaries, and for each person who agrees to participate in the study. This amount of money is just enough to cover the cost of the study.

4. (Sponsor name) pays (investigator’s name) who runs this research study extra money which may be used for other work-related costs such as travel to meetings, paying support staff, purchasing new office equipment, or funding other research.

5. Your doctor might benefit financially from this medical research study. (Sponsor name) paid your doctor $_________ for referring you to this research study. Your doctor may use this money however s/he wishes.

6. The person(s) leading this medical research study own(s) (or has applied for) a patent on the new (test, drug, treatment) being studied. Research studies like the one you are thinking about joining are done to determine whether the new (test, drug, treatment) is safe and effective. If research shows the new (test, drug, treatment) is safe and effective, the person(s) leading this study would receive a part of the profits from any sales of this (test, drug, treatment).

7. This research study is designed to test a product made by (Sponsor name). The person(s) running this study has/have an investment in (Sponsor name) such as stock. The amount of money the investment is worth might be affected by the results of this study. This means that the person(s) running this study could gain or lose money depending on the results of this study.

8. One or more of the investigators have a family member (spouse, dependent, sibling, parent or in-law) who has a financial or employment relationship with the sponsor.

CONSENT DOCUMENT SUGGESTED VERBAGE FOR FINANCIAL DISCLOSURE, IF NONE OF THE ABOVE ARE APPLICABLE:

The investigator(s), their family(spouse, dependent, sibling, parent or in-law) and their staff will not profit financially from this study.

32. Signatures

There are different versions of signature lines and information to use depending on the type of subjects being enrolled. The different versions are shown below and are labeled PLEASE INCLUDE ONLY ONE VERSION AND DELETE THE OTHERS.

Version 1: Only Impaired Adults and/or Children who cannot read or understand

Version 2: Competent Adults and Impaired Adults/Children who can read/understand

Children and Consent of Both Parents: For studies involving children that are greater than minimal risk and no direct benefit to the child, regulations require the signature of both parents. Note the following:

( Include a signature line for Parent 1 and Parent 2.

( This requirement applies unless the second parent is deceased, unknown, incompetent, or not reasonably available or unless only one parent has legal responsibility.

Consent for Incompetent Persons

Under Florida law, several classes of persons can consent for incapacitated/incompetent adults. They are listed below in order of who has the greatest legal authority to consent for an incompetent adult. Consent must be sought first from the person at the top of the list. Only if that option is not reasonably available, does the next option apply, and so on down the list. If the first reasonably available person refuses consent, however, that refusal is final. Indicate in both the Introductory Questionnaire and the ICF whom consent will be sought from, again, starting at the top of the list. If the list is partial, it must still reflect the order required by State law. For example, a health care surrogate and attorney in fact may be listed but a proxy cannot be listed unless all the options before a proxy are also listed.

(a) Health care surrogate: Any competent adult expressly designated to make health care decisions for a particular incapacitated individual. The designation should be in writing.

(b) Attorney in fact ("power of attorney"): A competent adult to whom the subject has delegated authority to make health care decisions by means of a validly executed durable power of attorney.

(c) Judicially appointed guardian: All persons who have been adjudged incompetent should have a judicially appointed guardian.

(d) Proxy: If none of the above are reasonably available, then a competent adult who has not been expressly designated to make health care decisions for a particular incapacitated individual but who is available, willing, and able to act is the next option for consent. The following possible proxies should be sought, again in order of priority, working down the list when an option is not reasonably available:

1) The subject's spouse;

2) An adult child of the subject. If the subject has more than one adult child then obtain consent from a majority of the adult children who are reasonably available;

3) A parent of the subject;

4) The adult sibling of the subject. If the subject has more than one adult sibling then obtain consent from a majority of the adult siblings who are reasonably available;

5) An adult relative of the subject who has exhibited special care and concern for the subject and who has maintained regular contact with the subject and who is familiar with the subject's activities, health, and religious or moral beliefs;

6) A close friend of the subject

Version 1, Only Impaired Adults/Children Who Cannot Read/Understand:

As a representative of this study, I have explained to the participant's legally authorized representative the purpose, the procedures, the possible benefits, and the risks of this research study; the alternatives to being in the study; and how the participant’s protected health information will be collected, used, and shared with others:

______________________________________________ _____________________

Signature of Person Obtaining Consent and Authorization Date

You have been informed about this study’s purpose, procedures, possible benefits, and risks; the alternatives to being in the study; and how the participant’s protected health information will be collected, used, and shared with others. You will receive a copy of this Form. You have been given the opportunity to ask questions before you sign, and you have been told that you can ask other questions at any time.

By signing this form, you voluntarily give your permission for the person named below to take part in this study. You are hereby authorizing the collection, use, and sharing of the protected health information as described in sections 19-29 for the person named below. You are not waiving any legal rights for yourself or for the person you are legally representing.

_________________________________________________________________________

Print: Name of Participant

_________________________________________________________________________

Print: Name of Participant's Legal Representative and Relationship to Participant: [List options that will be used for the study in order shown; see instructions for explanation: health care surrogate, attorney in fact ("power of attorney"), judicially appointed guardian, proxy, participant's spouse, adult child of participant, parent of participant; adult sibling, adult relative, close friend of the participant]

If you are not the subject, please indicate one of the following:

_____ the participant’s parent

_____ the participant’s guardian

_____ a surrogate

_____ a durable power of attorney

_____ a proxy

_____ other, please explain: __________________________________________________

_________________________________________________ __________________

Consent and Authorization Signature Date

of Parent (1) / Legal Representative

[If the consent of both parents is required, include this additional signature line.]

_________________________________________________ __________________

Consent and Authorization Signature Date

of Parent (2) / Legal Representative

Version 2: Competent Adults and Impaired Adults/Children Who Can Read/Understand:

As a representative of this study, I have explained to the participant or the participant's legally authorized representative the purpose, the procedures, the possible benefits, and the risks of this research study; the alternatives to being in the study; and how the participant’s protected health information will be collected, used, and shared with others.

______________________________________________ _____________________

Signature of Person Obtaining Consent and Authorization Date

You have been informed about this study’s purpose, procedures, possible benefits, and risks; the alternatives to being in the study; and how your protected health information will be collected, used, and shared with others. You will receive a copy of this Form. You have been given the opportunity to ask questions before you sign, and you have been told that you can ask other questions at any time.

You voluntarily agree to participate in this study. You hereby authorize the collection, use, and sharing of your protected health information as described in sections 19 – 29 above. By signing this form, you are not waiving any of your legal rights.

______________________________________________ _____________________

Signature of Person Consenting and Authorizing Date

Assent of the Child (to include, if applicable):

ADOLESCENT’S ASSENT FOR AGES 12-17 TO PARTICIPATE IN A CLINICAL RESEARCH STUDY

Title of Protocol:

You are being asked to be in a research study. Before you decide to be in it, we want to tell you about it so you can ask questions you have about it.

The doctor in charge of this study is Dr. . The main purpose of this study is to:

You don’t have to be in the study if you don’t want to, but if you do, this study may help other kids with conditions like yours. You can stop at any time. Stopping or not being in the study will not upset anyone. The doctor and assistant will take care of you as they have in the past. If you have any questions or don’t like what is happening, please tell the doctor or assistant.

Your parent/guardian knows about this study. You have had this study explained to you, and you agree to participate.

______________________________ ____________________ ____________

Patient’s Name Typed/Printed Patient’s Signature Date

______________________________ ____________________ ____________

Witness Typed/Printed Witness Signature Date

______________________________ ____________________ ____________

Member of Research Team Member of Research Team Date

(Printed) (Printed)

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