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The “Informative” Informed Consent Form. Ken Kepler, MSESS Institutional Review Boards University of Florida. “Informative” Informed Consent. Overview What you need to know about informed consent. What you need to do to create an “informative” Informed Consent Form. Need to know.

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The “Informative” Informed Consent Form

Ken Kepler, MSESS

Institutional Review Boards

University of Florida


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“Informative” Informed Consent

Overview

  • What you need to know about informed consent.

  • What you need to do to create an “informative” Informed Consent Form.



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Need to know!

  • Informed Consent is a process - not just a form.

  • Informed Consent is necessary to conduct ethical research.

  • Informed Consent is the fundamental mechanism to ensure respect for persons through provision of thoughtful consent for a voluntary act.


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Need to know!

  • Informed Consent is government regulated

    • 45 CFR 46 §116, 117

    • 21 CFR 50 and 56

  • The IRB is responsible for ensuring Federal policies are being followed.

    • Reviewing of the Informed Consent form, is it…?

      • Clear, easy-to-read, accurately reflects the project

    • Reviewing the process of obtaining Informed Consent

      • Who, what, where, when, and how…….



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Need to do!

  • Meet the requirements as set forth by the Federal regulations.

    • 8 Mandatory elements of informed consent

    • Additional elements when appropriate

  • Apply the local (UF) requirements

    • Follow the Instructions!

      • http://irb.ufl.edu/docs/icf-instruct.doc


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The 8 Mandatory Elements of Informed ConsentSource: 45 CFR 46.116

#1

A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental.


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The 8 Mandatory Elements of Informed ConsentSource: 45 CFR 46.116

#2

A description of any reasonably foreseeable risks or discomforts to the subject.


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The 8 Mandatory Elements of Informed ConsentSource: 45 CFR 46.116

#3

A description of any benefits to the subject or to others which may reasonably be expected from the research.


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The 8 Mandatory Elements of Informed ConsentSource: 45 CFR 46.116

A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.

#4


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The 8 Mandatory Elements of Informed ConsentSource: 45 CFR 46.116

A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.

#5


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The 8 Mandatory Elements of Informed ConsentSource: 45 CFR 46.116

#6

For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.


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The 8 Mandatory Elements of Informed ConsentSource: 45 CFR 46.116

#7

An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights and whom to contact in the event of a research-related injury to the subject.


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The 8 Mandatory Elements of Informed ConsentSource: 45 CFR 46.116

A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

#8


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Additional Elements

When Appropriate


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Additional Elements, When AppropriateSource: 45 CFR 46.116

A statement that the particular treatment or procedure may involve risks to the subject (or embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.

#1


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Additional Elements, When AppropriateSource: 45 CFR 46.116

Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent.

#2


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Additional Elements, When AppropriateSource: 45 CFR 46.116

Any additional costs to the subject that may result from participation in the research.

#3


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Additional Elements, When AppropriateSource: 45 CFR 46.116

The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject.

#4


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Additional Elements, When AppropriateSource: 45 CFR 46.116

A statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject.

#5


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Additional Elements, When AppropriateSource: 45 CFR 46.116

The approximate number of subjects involved in the study.

#6



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Do’s

Write simply

Use small words

Include details

Describe timeframes

Use standardized language

Define risks

Define acronyms

Don'ts

Use complicated terms

Write above an 8th grade level

Put or leave unnecessary information in the form

Forget “Respect” for subjects

Authoring Informed Consent Forms


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Instead of This

Use This

Empty words

Along the lines of

Like

For the purpose of

For

For the reason that

Since

Because

On the basis of

By

Difficult words

Currently

Now

Demonstrate

Show

Effectiveness

Success

Following

After

Indicate

Show

Prior to

Before

Terminate

End

More Do’s

  • See the examples

  • Use the glossary

    • http://irb.ufl.edu/glossary.htm

  • Use the standardized text

    • http://irb.ufl.edu/irb01/forms.htm#standard


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Things to look out for when writing the informed consent form.

  • Do you have multiple ICF’s?

    • Make sure the different versions are clearly labeled in the footer.

      • Include : Subject group/population, study #, date created or revised, page x of y.

        • E.g.- Healthy subjects / 555-2006 / 1-1-06 / Page 1 of 8

        • E.g.- Stroke subjects / 555-2006 / Rev 1-1-06 / Page 1 of 8


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Things to look out for when writing the informed consent form.

  • 2. Title of Research Study

    • Should be the same for all paperwork

  • 3. Principal Investigator and Telephone #’s

    • Must be a able to reach a person

    • Must be a 24 hour # if a treatment study

    • #7


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Things to look out for when writing the informed consent form.

4. Sponsor of the Study

  • Must be the University of Florida if no other funding agency

    5. What is the purpose of the study? #1

  • Clearly state…“The purpose of this study is…”

  • Background information may follow


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Things to look out for when writing the informed consent form.

6.What will be done if you take part in… #1

  • Be specific, give lots of details

  • Clearly state what is research and what is standard care

  • Provide time frames - when, where, how long, how often

  • Placebo and randomization- explain

  • FDA approved or not

  • Use tables or other visuals

    This section is designed to inform potential subjects about what their participation will involve


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Things to look out for when writing the informed consent form.

  • 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 & 6b


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Things to look out for when writing the informed consent form.

7. If you choose to participate in this study, how long will you be expected to participate in the research?

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

  • Up to X, match the IQ.


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Things to look out for when writing the informed consent form.

9. What are the possible discomforts and risks? #2

  • Describe each risk

  • Order risks from greatest/most frequent to least

  • Use the standardized text

    • http://irb.ufl.edu/irb01/forms.htm#standard


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Things to look out for when writing the informed consent form.

10a and b. What are the possible benefits to you and others? #3

  • Health and other NON financial benefits.

  • Don’t overstate- use “may” instead of “will”

    11. If you choose to take part in this study will it cost you anything? #6

  • Do not use the word “free”

  • If not a VA study, remove the VA language


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Things to look out for when writing the informed consent form.

  • 12. Will you receive compensation for taking part in this study? #6

    • Compensation must be pro-rated

  • 13. What if you are injured because of this study? #6

    • Use one: consultative, dental, or medical


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Things to look out for when writing the informed consent form.

  • 14. If you do not want to take part in this study, what other options or treatments are available to you? #4

    • For Treatment studies

      • List the standard of care

      • Is there treatment outside the study?

      • Are there other treatments or medications?


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Things to look out for when writing the informed consent form.

  • 14. If you do not want to take part in this study… continued

    • For Non treatment studies

      • Your options are to not participate

      • Don’t sign the consent form

    • For student subjects

      • Use the standardized text

        • http://irb.ufl.edu/irb01/forms.htm#standard


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Things to look out for when writing the informed consent form.

15 (#7, 8) and 16. Follow the instructions


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Things to look out for when writing the informed consent form.

HIPAA Language #5

16. Use the standardized text

  • Text may be modified

  • Use minimal necessary

  • Request only info consistent with your protocol

    17. If you agree to participate in this research study, what PHI about you may be collected, used and shared with others?

  • Minimum necessary


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Things to look out for when writing the informed consent form.

HIPAA Language

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

    • Pick from the box

    • Basically, why are you collecting the PHI


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Things to look out for when writing the informed consent form.

HIPAA Language

  • 19. Who will be allowed to collect, use, and share your protected health information?

    • The sponsor

    • The government or government agencies

    • List any and everybody else


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Things to look out for when writing the informed consent form.

HIPAA Language

20. Once collected or used, who may your protected health information be shared with?

  • If not the VA remove the VA

  • Who would you be giving PHI to?


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Things to look out for when writing the informed consent form.

HIPAA Language

21. “…how long will your PHI be used or disclosed ”?

  • Address each part of the question

    • Used?

    • shared?

    • Use specific dates/events/end of study/X # of years/forever

      22-25. May not be modified from standard


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Things to look out for when writing the informed consent form.

  • 27. How will the researcher benefit from your being in this study?

    • You must disclose

      • Any patents/stocks/or direct remuneration

      • Is the PI a consultant for the sponsor?


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Things to look out for when writing the informed consent form.

  • 28. Signatures

    • Different versions of signature lines and information to use depending on the subject population enrolled.

      • Follow instructions closely

      • VA requires a witness

      • 3 versions

        • Adults

        • Adults and children, or impaired adults

        • Assent- (age 7 and up at UF)


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Informed Consent Form form.Standardized text

  • Children involved?

  • Storage of tissue or data?

  • Students/Employees?

  • Risks of MRI, Blood draws

  • Videotaping

  • Placebo/Randomization

  • Reproductive risks


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Questions? form.

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