Informed ConsentInternational

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Informed Consent/International

• Melody Lin, Ph.D.
• Deputy Director, OHRP
• Director, OIA
• Beijing, China
• March 2003

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Objectives (1)

• Why?
• Who?
• Elements

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Objectives (2)

• Process and Form
• Documentation and Waiver
• Research with Records and Specimens

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Why Have Informed Consent?

• Show respect to human subjects (HS)
• Mandated by regulations
• Protect HS
• Insure that HS understand risk-benefit associated
  with participation
• Provide HS all information needed for decision
  making about participation

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Is It Just Signing the Form?

• No
• Involves
• Provide information
• Ensure understanding via question and
  answer
• Obtain voluntary agreement

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Who Ensures Compliance With Regulations?

• FDA 21CFR 50
• OHRP 45 CFR 26
• Study Centers IRB

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Basic Elements (1)

• Research, why, what, how long
• Risks or discomforts
• Potential benefits
• Aware of other alternatives
• Confidentiality protection

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Basic Elements (2)

• If subjects at risk of physical harm
• Care if injured, whom to contact
• Contact for questions, problems
• Can withdraw without penalty

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Additional Elements

• Additional where appropriate
• Possible unknown risks
• Involuntary termination
• Additional costs
• Consequences of withdrawal
• Inform of new findings
• Number of subjects

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Consent Must Be

• Individual
• Voluntary
• Informed
• Effective
• Continuous

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Subject Recruitment

• Recruitment ads, telephone scripts
• Often the first step in informed consent
• Must be reviewed by the IRB

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Consent Process and Form

• Consent is a PROCESS in which
• investigator discloses all relevant information
• potential subject has opportunity to ask
  questions
• investigator answers questions
• repeat the above..
• The consent form is a permanent record of
• information conveyed
• subjects willingness to participate

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Consent Process Must

• Give subject enough time to consider the decision
• Minimize possibility of coercion or undue
  influence

45 CFR 46.116, 21 CFR 50.20
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Consent Form Must

• Be understandable to subject or representative
• NOT
• waive subjects rights
• release investigator, sponsor, institution from
  liability

45 CFR 46.116, 21 CFR 50.20
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Documentation

• Use written form approved by IRB
• Form must be signed and dated by subject or
  legally authorized representative
• Give copy to subject/ representative
• Two types of forms permissible

45 CFR 46.117, 21 CFR 50.27
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Criteria for Waiving or Altering Informed Consent

• No more than minimal risk to subjects
• Waiver will not adversely affect the rights and
  welfare of subjects
• Research could not practicably be done without
  the waiver or alteration
• When appropriate, subjects will be given
  additional pertinent information after
  participation

45 CFR 46.116(d), but not FDA
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Criteria for Waiving Written Documentation of
Consent (45 CFR 46.117, 21 CFR 56.109)

• If consent form would be the only record linking
  subjects to research, and the principal risk is
  breach of confidentiality (HHS only)
• If research has no more than minimal risk and
  involves only procedures for which written
  consent is not normally required outside research
  (HHS and FDA)

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Do Retrospective Medical Record Reviews Require

• ...IRB APPROVAL?
• Yes, if they are done for research
• ...INFORMED CONSENT of research subject?
• Not always, if the IRB agrees that waiver is
  appropriate

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Storage of Specimens for Future Research

• Why?
• Where?
• For how long?
• Who has access?
• With or without identifiers?
• Re-contact?
• What if clinically relevant information is found?

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OHRP Website

• http//ohrp.osophs.dhhs.gov/