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Informed Consent

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Title: Informed Consent


1
Informed Consent
  • Vicki Hammen, Vice Chair, IRB
  • IRB Brown Bag
  • February 9, 2009

2
Regulations
  • The Code of Federal Regulations (CFR) addresses
    the process separately from documentation
  • 45 CFR 46.116 and 21 CFR 50.20, 50.23, 50.24
    50.25 covers the process
  • 45 CFR 46.117 and 21 CFR 50.27 deals with
    documentation

3
45 CFR 46.116
  • Except as provided elsewhere in this policy, no
    investigator may involve a human being as a
    subject in research covered by this policy unless
    the investigator has obtained the legally
    effective informed consent of the subject or the
    subjects legally authorized representative.

4
Why conduct a consent process?
  • According to the Belmont Report, informed consent
    falls under the principle of Respect for
    Persons
  • requires that individuals, to the degree that
    they are capable, be given the opportunity to
    choose what shall or shall not happen to them.
  • It has been stated that a signed document without
    an effective informed consent process is not
    worth the paper it is written on (Cohen, J. ,
    personal communication, 2008)

5
Key Components
  • The three important elements that must be address
    in the informed consent process are
  • Information about the research study
  • Full disclosure of the nature of the research and
    the subjects participation
  • Comprehension
  • Does the potential participant fully understand
    the information presented to him/her?
  • Voluntariness
  • Process must be free from any form of coercion or
    undue influence

6
The cost of an inadequate process
  • Tampa Tribune article, March 2000
  • A lawsuit accusing USF doctors of experimenting
    on pregnant women without their consent is
    settled for 3.8 million dollars
  • The experiment was not considered risky and no
    adverse events were recorded
  • The failure of the physicians to obtain informed
    consent from the pregnant women cost their
    hospital

7
What went wrong?
  • Women were given a 3 page, densely written
    document to read
  • Document was given while women were in active
    labor
  • None of the women thought they were participating
    in a research study
  • There were no benefits to participation for the
    mothers or their babies
  • A law firm specializing in clinical research
    problems filed suit on behalf of the unwitting
    participants

8
Effective Informed Consent
  • Information about the Research Project
  • Purpose Why are you conducting this research?
  • Duration How long will you need the subject?
  • Experimental If the procedure is experimental
    are there any other approved methods of choice?
  • Usually only necessary in biomedical or
    pharmaceutical clinical studies

9
  • Information, cont
  • Procedures Method to convey the information may
    vary depending on the type of research, the
    complexity, and prospective participant
  • Must be thorough but avoid MEGO (My Eyes Glaze
    Over)
  • Sometimes too much information is worse than too
    little
  • Consider using pictures, demonstrations, or videos

10
  • Risks
  • Are there any risks to participating?
  • What are the reasonably foreseeable risksnot all
    possible
  • How likely are the risks?
  • Benefits
  • Do not feel that you have to provide substantial
    benefits for the subjects
  • Payment for participation is not a benefit

11
  • Alternatives to participating
  • Typically included in biomedical studies
  • Confidentiality
  • Very rare to be able to guarantee complete
    confidentiality, even with anonymous Internet
    surveys
  • Address how you will protect the confidentiality
    of the subjects data
  • during the project, if they wish to withdraw, and
    following

12
  • Compensation for Injury
  • Not typically required, only for studies with
    greater than minimal risk
  • May need to address how any reactions will be
    handled
  • Contact information
  • Who to contact with addition questions or concerns

13
  • Right to refuse or withdraw
  • Need to explain what will happen to the
    individual if they decide to withdraw
    participation during the experimental session or
    afterwards
  • Will there be any consequences?

14
Comprehension
  • Informed consent is not valid unless the
    prospective subject understands the information
    that has been presented
  • It is the investigators responsibility to insure
    comprehension
  • Simply stating that the subject is to ask
    questions if they do not understand is not
    sufficient

15
  • Most subjects will not ask questions so as not to
    appear unintelligent or that they were not
    listening
  • The researcher needs to insure the potential
    subject has the answers to who, what when, where,
    and how as they pertain to the research study

16
ICE FT (Bankert Amdur, 2006)
  • Informed Consent Evaluation Feedback Tool
  • A list of 10 questions posed to the subject
  • Provides information about subjects level of
    understanding
  • Subject is given the questions to review at the
    start of the informed consent interview
  • Question address Purpose, benefits, risks, other
    options, costs, alternatives, withdrawal,
    voluntariness, record review, questions for the
    researcher

17
Voluntariness
  • The provision of consent must be free from any
    form of coercion or undue influence
  • Particular concern when seeking students as
    research participants
  • A faculty member cannot recruit subjects from
    students in their classes or advisees
  • Implied authority
  • Individual obtaining consent in a medical setting
    wearing a lab coat

18
Voluntariness, cont
  • Only legally competent adults can give consent
  • Minors can give assent, not consent
  • Incompetent adults cannot give consent, but their
    legally authorized representative can
  • Must be sensitive to more subtle forms of
    coercion
  • Social pressure
  • Especially from vulnerable populations children,
    prisoners
  • Request from authority figures
  • Undue incentives for participation

19
Assent
  • The subject gives their knowledable agreement
    to participate
  • Must have sufficient capacity to understand what
    is happening and feels free to express his/her
    wishes
  • Children above age 7 must provide assent
  • Can be a very simplified description
  • If they object this can veto parental or guardian
    consent

20
Informed Consent--Conclusion
  • Informed consent is a process in which the
    outcome is an informed choice regarding the
    voluntary participation in a research project.

21
Questions?
  • IRB website
  • Forms and Checklists
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