Informed Consent to Research Participation

1
Informed Consent to Research Participation

• June 19, 2006

2
Ethical Basis for IC

• Autonomous authorization
• Kant treats participants as more than mere
  means, but as ends in themselves
• Right to choose treatment (placebos)
• Protection of welfare
• Possibly better participation, compliance, more
  successful research (partnership?)

3
What is Informed Consent?

• A process
• Ongoing conversation throughout study and before
  each intervention
• Bilateral questions and answers
• Evolving decision making not just single
  permission
• A document
• Written documentation at beginning of study
• Adequacy of content
• Clarity (reading level, length, format)

4
Legal (Regulatory) Basis for IC

• Developed parallel to IC to treatment
• Nuremberg Code
• Declaration of Helsinki
• Belmont Report
• History of abuses
• Willowbrook, Tuskeegee, Radiation

5
Federal Common Rule IC

• 2 prongs of protections
• IRB Review
• Is this a study for which it is ethical to ask
  any subject to consent?
• Evaluate proposed disclosures, consent forms, and
  need for additional safeguards
• Individual Informed Consent
• Specific disclosure requirements
• Safeguards for special populations

6
Minimum you must have

• Statement research, purpose, duration,
  procedures
• Reasonably foreseeable risks
• Reasonably expected benefits
• Alternatives
• Confidentiality
• More than MR compensation or treatment
  available?
• Who to contact for questions or injury
• Participation voluntary/ no penalty for
  withdrawal
• Additional elements where necessary

7
What you should not have

• Statement that this is treatment or
  aspirational benefit language
• Exculpatory language waiving subjects legal
  rights, or releasing investigator/sponsor/institut
  ion from liability
• Misleading language, false promises

8
IC Exceptions

• Regulations dont always apply
• IRB may waive some or all requirements if
• Minimal risk research
• Waiver does not adversely affect rights and
  welfare of subjects
• Waiver necessary to carry out research
• When appropriate, subject informed after
  participation

9
Exceptions

• FDA regulations authorize emergency use of test
  article
• Life threatening condition necessitating use
• Subject lacks capacity
• No time to obtain surrogate consent
• No alternative that provides lt likelihood of
  helping
• Uninvolved physician reviews and evaluates use

10
Exceptions

• Both FDA and HHS allow waiver of consent for
  emergency research
• Life threatening situation, and available therapy
  unproven or unsatisfactory controlled
  investigation necessary
• IC not feasible
• Direct therapeutic benefit
• Could not practicably be carried out w/out
• Additional protections provided (community)

11
Special Populations

• Vulnerable research subjects are persons who are
  relatively or absolutely incapable of protecting
  their own interests. They have insufficient
  power, prowess, intelligence, resources, strength
  or other needed attributes to protect their own
  interests through negotiations for informed
  consent." (Robert J. Levine, Ethics and
  Regulation of Clinical Research, Yale University
  Press, 1988, P.72)
• When some or all of the subjects are likely to
  be vulnerable to coercion or undue influence,
  such as children, prisoners, pregnant women,
  mentally disabled persons, or economically or
  educationally disadvantaged persons, additional
  safeguards have been included in the study to
  protect the rights and welfare of these
  subjects." (45 CFR 46.111(d))

12
Safeguards for Vulnerable

• Consider different vulnerabilities and adapt
  safeguards to match (NBAC). Can have more than
  one vulnerability
• Institutional
• Subject to formal authority Prisoners,
  military, college students
• No inappropriate incentives/pressures
• Dont inform institutional authority (but can be
  difficult)
• No institutional authority present during IC

13
Vulnerable

• Deferential
• Informal hierarchies (gender, race, class,
  professionals, personal relationships)
• Research staff sensitive to deference
• IC discussions separate from party to which
  defers?
• Medical (seriously ill)
• Therapeutic misconception
• Neutral 3rd pty Timing of request

14
Vulnerable

• Economic
• IRB evaluate payment, access to health care or
  other social services
• Social (undervalued social groups)
• IRBs, investigators sensitive to social
  perceptions
• Involve community in study planning
• Include more than just socially vulnerable

15
Vulnerable

• Communicative (language)
• Translators, Translate consent documents
• Cognitively Impaired
• Children, Developmentally Disabled, Mental
  Illness, Elderly, Brain Damage, Substance Abuse
• Temporary, Cycles Timing of IC

16
Cognitively Impaired

• Capacity
• For what?
• Who decides?
• Under what standard?
• Surrogate Decision making

17
Capacity

• Choose components
• Choice
• Understanding
• Appreciation
• Reasoning
• Decide how to apply the standard
• Quantitative Aspects
• Qualitative Aspects

18
Capacity Screening

• Routine vs. Targeted
• Cost of screening
• Base rate of impairment
• Extent of harm avoided
• Develop a protocol
• Easily administered Adaptable
• Set expectations, Educate staff, guides

19
Applying the Standard

• Levels of capacity
• Consent facilitators
• Assent vs. Consent
• Anticipated changes in capacity
• Advance Decision making
• Surrogates

20
Surrogate Decision Making

• Who?
• How?
• Was the person ever competent?
• Does the person have an AD?
• Does the AD apply in this situation?
• Is there other evidence of preferences?

21
Surrogate Decision Making

• Explicit advance directive
• Effectuate decision
• Evaluate circumstances and monitor
• Some evidence of preferences
• Substituted Judgment
• Establish applicability and degree of certainty
• Override refusal under extremely limited
  circumstances

22
Surrogate Decision Making

• No evidence of preferences
• Best interests
• Limited participation
• Conclusion remaining issues
• Person neither consenting nor objecting
• Incompetent revocation of AD

23
IRB Role in assuring IC

• Require information from investigators on Form
  and Process
• Scrutinize Form
• Clarity (reading level, format, length)
• Evaluate Process
• Random review of interactions
• Who is getting consent (skill level)
• Specify standard of competence and determine when
  to use capacity screening Develop educational
  tools for LARs
• Require safeguards for vulnerable populations

24
Investigator Role is assuring IC

• Draw from example forms
• Develop process skills
• Openly acknowledge vulnerability in certain
  populations and state how will address
• Recognize conflicts of interest
• Employ creative disclosure methods

25
Disclosure Methods

• Timing of disclosures and consent
• Repeat disclosures
• Short readable consent forms
• Continuing assessment
• Facilitators
• Family
• Videos
• 3rd Party Educators

26
Conclusion

• Understand reasons for IC and view as process,
  not single point in time event
• Understand limits of IC
• Therapeutic Misconception
• Framing power and authority
• Range of acceptable research