Basic Track: Nuts and Bolts of Informed Consent

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Basic Track Nuts and Bolts of Informed Consent

• Freda E. Yoder,
• Division of Education and Development
• Office for Human Subject Protections (OHRP)
• Department of Health and Human Services (HHS)
• Research Community Forum - Richmond, VA
• September 16, 2008

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Informed Consent Requirements

• Background
• Basic Informed Consent Requirements
• Seeking informed consent
• Documenting informed consent
• Resources

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Regulation for Protection of Human Subjects

• HHS Regulations Title 45 CFR part 46
• Subpart A basic HHS Policy
• Other federal departments agencies have adopted
  
• The Common Rule - Federal Policy
• - Departments of Agriculture, Energy, Commerce,
  HUD, Justice, Defense, Education, Veterans
  Affairs, Transportation, HHS Home land
  Security. NSF, NASA, EPA, AID, Social Security
  Administration, CIA, and the Consumer Product
  Safety Commission
• only in part

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• The Common Rule does not mean common rules

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Regulations for Protection of Human Subjects of
Research

• Basic HHS Policy
• 45 CFR part 46, subpart A
• Basic IRB informed consent requirements
• Revised June 18, 1991, June 23, 2005
• FDA Regulations
• 21 CFR part 50 - Informed Consent
• 21 CFR part 56 - Standards for Institutional
  Review Boards (IRBs)
• Revised June 18, 1991

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Additional HHS Protections in 45 CFR part 46

• Subpart B - Pregnant Women, Human Fetuses and
  Neonates Involved in Research
• Subpart C - Prisoners as Subjects
• Subpart D - Children as Subjects

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Which Regulations Apply?
FDA
HHS

• HHS research conducted or supported by HHS or
  covered by FWA
• FDA - research involves products regulated by FDA
• Both if HHS research involves FDA regulated
  product

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Basic HHS FDA Regulatory Protections
Informed Consent
IRB Review
Plus HHS Institutional Assurances
FDA Bioresearch Monitoring Program
(Inspections)
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• Basic Informed Consent Requirements

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• No investigator may involve a human being as a
  subject in research unless the investigator has
  obtained the legally effective informed consent
  of the subject or the subjects legally
  authorized representative
• 46.116

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Legally Effective Informed Consent

• Adults with impaired capacity to consent not
  generally able to give legally effective consent
• legally authorized representative
• In most cases, minors cannot give consent
• parental permission child assent
• Legal age of consent and who is a legally
  authorized representative
• based on applicable laws in jurisdiction where
  research is conducted.
• 46.116

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Informed Consent, contd

• Key principles of the informed consent process
• Full disclosure of information
• Adequate comprehension
• The subject's voluntary choice

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Full Disclosure

• Nature of the research and subject's
  participation
• Elements of informed consent
• 46.116(a)
• Exculpatory language regarding legal rights or
  liability is forbidden
• 46.116

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Basic Elements of Informed Consent

• Alternatives
• Confidentiality
• Compensation for injury
• Whom to contact
• Right to refuse or withdraw
• 46.116(a)

• Research
• - Purpose
• - Duration
• - Procedures
• Risks/discomforts
• Benefits

Additional elements at 46.116(b), when
appropriate
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Adequate Comprehension

• Subject or legally authorized representative must
  have capacity to understand information
• Information in language understandable to subject
  or representative
• 46.116

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Voluntary Participation

• Informed Consent may be sought only under
  circumstances that
• provide sufficient opportunity to consider
  whether or not to participate, and
• minimize the possibility of coercion or undue
  influence
• 46.116

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When can Informed Consent be Altered or
Waived?

• HHS
• Consistent with 46.116(c) or (d)
• Waiver of child assent parental permission -
  46.408 (subpart D)
• Secretarial waiver 46.101(i) e.g., research
  conducted in emergency setting

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Informed Consent Waiver or Alteration at
46.116(d)

• IF IRB finds and documents that
• no greater than minimal risk,
• will not adversely affect rights welfare of
  subjects,
• research could not practicably be carried out
  without the waive or alteration, AND
• when appropriate, subjects will be debriefed
  after participation

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Parental or Guardian Permission and Child
Assent - Waiver or Alteration

• Under 46.116
• Parental/guardian permission when not a
  reasonable requirement to protect subjects -
  46.408(c)
• Child assent when
• capacity of some or all children is so limited
  that they cannot reasonably be consulted, or
• if research holds out prospect of direct benefit
  - not available outside research context

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• When informed consent is required, informed
  consent must be documented by the use of a
  written consent form approved by the IRB and
  signed by the subject or their legally authorized
  representative unless waived under 46.117(c)
• A copy shall be given to the person signing the
  form
• 46.111(a)(5)

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Documentation of Informed Consent -
46.117(b)

• Long form document, embodying all elements
• Short form, oral presentation of all elements

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Documentation Research with Children

• Documentation of parental permission shall be in
  accord with 46.117
• 46.408(d)
• The IRB shall determine whether and how assent
  must be documented.
• 46.408(e)

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Waiver Written Documentation Informed Consent
- 46.117(c)

• IRB may waive documentation if it finds
• either
• 1. consent form only record linking subject and
  research AND
• principal risk from breach of confidentiality.
• OR
• 2 minimal risk research AND research
  procedures do not require written IC if done
  outside research context

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The Informed Consent Process

• Informed consent is not a single event or just
  a form to be signed -- rather, it is an
  educational process that takes place between the
  investigator and the prospective subject.

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Key Points

• Understand the key principles of the informed
  consent process
• Know the HHS regulatory requirements for seeking
  and documenting informed consent
• Understand conditions for altering or waiving
  informed consent requirements
• Remember - Goal is to protect the rights and
• welfare of human subjects of research

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Questions for OHRP?

• OHRP Web page http//www.hhs.gov/ohrp
• Links to FAQs, guidance by topics, compliance
  oversight procedures, educational other
  resources
• Join Listserv http//www.hhs.gov/ohrp/news/index.
  html
• Contact OHRP
• Phone [phone]
• E-mail ohrp_at_hhs.gov