Informed Consent

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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

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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)

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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

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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

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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

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• 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

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• 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

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• 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

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• 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

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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

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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

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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

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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

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Informed Consent--Conclusion

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

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Questions?

• IRB website
• Forms and Checklists