Informed Consent Process and Federal Regulations That Must Be Met to Waive Informed Consent

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Informed Consent Process and Federal Regulations
That Must Be Met to Waive Informed Consent
Open Library June 4, 2004
Tracey Craddock Regulatory Compliance
Manager Office of the IRB University of Alabama
at Birmingham
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Informed Consent Process

• Code of Federal Regulations
• 45 CFR 46.116 General Requirements for
  Informed Consent
• 45 CFR 46.117 Documentation of Informed
  Consent
• 21 CFR 50.20 Consent Requirements of the FDA
  Regulations

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Informed Consent Process

• Consent Form Process Question on the Human
  Subjects Protocol
•  a. If the time period between informing the
  subject and soliciting a decision is less than 24
  hours, describe the time sequence considered and
  the reasons why the 24-hour minimum is neither
  feasible nor practical.
•  b. Describe how participants will be
  "recruited."
•  c. Please explain how consent will be obtained.
•  d. Will more project-specific instruments be
  used in the consenting process?

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Informed Consent Process

• If the time period between informing the subject
  and soliciting a decision is less than 24 hours,
  describe the time sequence considered and the
  reasons why the 24-hour minimum is neither
  feasible nor practical.

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Informed Consent Process

• How will participants be "recruited? Recruitment
  materials such as brochures, advertisements, etc.
  should be submitted

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Informed Consent Process

• How will consent be obtained?
• WHO?
• PI, SC
• WHERE?
• At UAB, Off campus
• WHEN?
• Timeframe

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Informed Consent Process

• Will more project-specific instruments be used in
  the consenting process?
• Patient information sheets
• Video

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Persons Obtaining Informed Consent

• List on the Human Subjects Protocol all personnel
  who will be conducting the consent discussion and
  obtaining consent from participants
• Include a Signature Line on the consent form for
  Person Obtaining Informed Consent (if other than
  investigator)

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Persons Obtaining Informed Consent

• All individuals who will be obtaining informed
  consent must complete an initial, approved
  training course on human subjects protection and
  must update their training annually
• Check the IRB website at www.uab.edu/irb/training
  for information regarding training requirements

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Persons Obtaining Informed Consent

• To add or delete individuals from the list of
  persons obtaining informed consent
• amendment to the IRB
• Investigators Progress Report at the time of
  renewal
• Keep the IRB promptly notified of any changes to
  the persons obtaining informed consent

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Waiving Informed Consent

• To request a waiver of informed consent, you must
  address the federal regulations found in 45 CFR
  46.116 (d) (1-4) and provide this information in
  the Human Subjects Protocol

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Waiving Informed Consent

• 45 CFR 46.116 (d)
• An IRB may approve a consent procedure which
  does not include, or which alters, some or all of
  the elements of informed consent set forth in
  this section, or waive the requirements to obtain
  informed consent provided the IRB finds and
  documents that

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Waiving Informed Consent

1. The research involves no more than minimal risk
   to the subjects
2. The waiver or alteration will not adversely
   affect the rights and welfare of the subjects
3. The research could not practicably be carried out
   without the waiver or alteration and
4. Whenever appropriate, the subjects will be
   provided with additional pertinent information
   after participation.

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Waiving Informed Consent

• 45 CFR 46.117 (c)
• An IRB may waive the requirement for the
  investigator to obtain a signed consent form for
  some or all subjects if it finds either

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Waiving Informed Consent

• That the only record linking the subject and the
  research would be the consent document and the
  principal risk would be potential harm resulting
  from a breach of confidentiality. Each subject
  will be asked whether the subject wants
  documentation linking the subject with the
  research, and the subjects wishes will govern
  or

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Waiving Informed Consent

• That the research presents no more than minimal
  risk of harm to subjects and involves no
  procedures for which written consent is not
  normally required outside of the research
  context.
• In cases in which the documentation requirement
  is waived, the IRB may require the investigator
  to provide subjects with a written statement
  regarding the research.

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Waiving Informed Consent

• Other requirements may apply for research
  involving children referred to in 45 CFR 46.408

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Waiving Patient Authorization

• Human Subjects Protocol HIPAA Questions
• A waiver must be approved by the IRB if Protected
  Health Information from a covered entity is to be
  used in research without the patients'
  authorization

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Waiving Patient Authorization

• If you are requesting a partial waiver of patient
  authorization (required if personal health
  information is to be used in recruitment
  processes), you must submit a Partial Waiver of
  Authorization to Use PHI in Recruiting
• If you are requesting a waiver of patient
  authorization, you must submit a Request for
  Waiver of Patient Authorization to use PHI in
  Research.
• These forms can be found on the IRB website at
  www.uab.edu/irb/hipaa.