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Basics of Informed Consent (Part 1)

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Basics of Informed Consent (Part 1) Paula Bistak, DMH, RN, MS, CIP, CHRC Executive Director, HSPP Donna Hoagland, LPN, BS, CIP, CCRC, CHRC IRB Director, New Brunswick ... – PowerPoint PPT presentation

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Title: Basics of Informed Consent (Part 1)


1
Basics of Informed Consent (Part 1)
  • Paula Bistak, DMH, RN, MS, CIP, CHRC
  • Executive Director, HSPP
  • Donna Hoagland, LPN, BS, CIP, CCRC, CHRC
  • IRB Director, New Brunswick/Piscataway and
    Stratford/Camden
  • Carlotta Rodriguez, BS, CIP, CHRC
  • IRB Director, Newark Campus IRB
  • Cheryl Forst, RN, BSN, CCRP
  • HSPP Analyst Director
  • Christine Asmann-Finch, DMH, MS
  • Program Development Specialist/Medical Humanist

2
Session Overview
  • Introduction
  • Ethical Principles
  • Regulations
  • Consent as a Process
  • Specifics
  • Required Elements
  • Documentation
  • Waivers
  • Common Findings
  • Subject Perspectives

3
Informed Consent
  • Basic Ethical Principles for the Protection of
    Human Subjects in Research
  • Belmont Report
  • Established in 1979 by the National Commission
    for the Protection of Human Subjects of
    Biomedical and Behavioral Research
  • Ethical Principles and Guidelines for the
    Protection of Human Subjects in Research
  • Respect for Persons
  • Beneficence
  • Justice

4
Informed Consent
  • Respect for Persons
  • Informed consent for persons requires that
    subjects, to the degree that they are capable, be
    given the opportunity to choose what shall or
    shall not happen to them. This opportunity is
    provided when adequate standards for informed
    consent are satisfied.
  • Ethical and Regulatory Aspects of Clinical
    Research

5
Respect for Persons
  • Application through Informed Consent
  • Information
  • Comprehension
  • Voluntariness

6
Informed Consent
  • Informed consent results
  • when a full disclosure of the role, benefits,
    risks, choices, and outcomes are explained in
    understandable ways.
  • Voluntary informed consent cannot be realized
    until
  • differentials of power, class, economics,
    desperation, and other possible sources of
    coercion are considered and addressed.

7
Legally Effective Informed Consent
  • Consent by
  • Research Subject
  • or
  • Research Subjects Legally Authorized
    Representative for Research (LAR) under State Law
  • State of New Jersey
  • Access to Medical Research Act

8
Legally Effective Informed Consent
  • No coercion or undue influence (recruitment)
  • Obtained by Investigator/Staff trained and
    authorized by IRB
  • Language understandable to the subject
  • Use lowest level vocabulary and syntax
  • Avoid jargon
  • No exculpatory language
  • Contains required elements
  • If applicable - Six additional elements

9
General Requirements for informed consent
  • 45 CFR 46.116 Common Rule
  • 21 CFR 50. 25 FDA
  • ICH E-6 Section 4.8.10 (GCP)

10
Informed Consent
  • Informed consent is a process, not just a signed
    document.

11
Informed Consent Process
  • The process should
  • Provide adequate information
  • generally, what a reasonable person would want to
    know before making a decision
  • Confirm the participants comprehend the
    information
  • Assure consent is given voluntarily

12
Elements
  • Statement that the activity is research
  • Purpose of the study
  • Description of the study procedures (identifying
    those that are experimental)
  • Duration of subject involvement

13
Elements (continued)
  • Potential risks and discomforts of participation
  • Potential benefits of participation (to the
    subject and others)
  • Alternatives (if any)
  • Confidentiality of records description
  • Number of subjects (if it may have an impact on
    the decision)

14
Elements (continued)
  • Compensation for injury statement (for greater
    than minimal risk studies)
  • Statement of voluntary participation
  • Contact person for questions
  • About research
  • About rights
  • About injury

15
Required Elements
  • If the study is a clinical trial, the following
    must be included
  • "A description of this clinical trial will be
    available on ClinicalTrials.gov, as required by
    U.S. Law. This Web site will not include
    information that can identify you. At most, the
    Web site will include a summary of the results.
    You can search this website at any time."

16
Additional Elements
  • Statement that there may be risks which are
    unforeseeable
  • Under what circumstances investigator could
    terminate subjects participation (include plan
    to exit subjects)
  • Additional costs to subject

17
Additional Elements (cont.)
  • Consequences of subjects withdrawal from
    research (include plan to exit subjects)
  • Statement that will be told of new findings
  • Approx. number of subjects in study

18
Documentation of informed consent (46.117)
  • informed consent shall be documented by the use
    of a written consent form approved by the IRB and
    signed by the subject or the subjects legally
    authorized representative. A copy shall be given
    to the person signing the form

19
Waivers
  • Waiver of Informed Consent
  • Waiver of the Requirement to Obtain Documentation
    of Consent
  • no signature

20
Waiver or Alteration of Informed Consent
  • The research involves no more than minimal risk
    to the subjects
  • The waiver or alteration will not adversely
    affect the rights and welfare of the subjects
  • The research could not practicably be carried out
    without the waiver or alteration and

21
Waiver or Alteration (continued)
  • Whenever appropriate, the subjects will be
    provided with additional pertinent information
    after participation

22
Waiver of Documentation
  • 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.
  • The research presents no more than minimal risk
    of harm to subjects and involves no procedure for
    which written consent is normally required
    outside of the research context.

23
Waiver of Documentation (continued)
  • 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.

24
Passive Consent
  • Federal regulations do not support the concept of
    passive consent. There is no such thing as
    passive consent from the regulatory standpoint.

25
Informed Consent Process
  • Process can vary but should generally include
  • Research team member provides the informed
    consent document for the participant to read
  • A member of the study team explains the study to
    the participant
  • The participant is given an opportunity to ask
    questions
  • The participant is given the opportunity to
    review the consent document with family and
    consider participating
  • Participant is given a copy of the signed consent
    document

26
Informed Consent Process
  • Process
  • Ongoing
  • Researcher should determine the subjects
    willingness to continue throughout the trial
  • Participation is voluntary
  • Subject can refuse to continue
  • Subject can withdraw at any time

27
Informed Consent Audit
  • Privacy Confidentiality
  • Location matches IRB approved protocol
  • Confidentiality maintained
  • Limited Access Electronic enrollment
  • Original consent form locked in separate location
    from other study data

28
Validate
  • Source Documents
  • Consent forms equal number of subjects
  • Confirmed as signed prior to the start of
    activities
  • Appropriately Executed (Signatures dates)
  • Study personnel who are obtaining consent are
    named on the IRB approved protocol.
  • Content of executed consents corresponds to IRB
    approved versions(current IRB stamp).

29
Consent Process
  • Documentation
  • Mirrors the description in IRB approved protocol
  • Truly represents the consent process
  • Subject questions answered
  • Given time to voluntarily decide to participate
  • Copy of the consent form given to subject
  • Auditors may visit to observe the process

  • 45CFR 46.117
  • 45 CFR 46.116

30
Informed Consent Form
  • ICF
  • Contain all required elements
  • In language understandable to the study subject.
  • Study activity represents what the subject has
    been informed( recruitment, study visits ,
    procedures, risks, benefits, payment for
    participation ect)

31
Top 10 Consent Audit Findings
  • 10. Subject signature and person obtaining
    consent on different dates
  • 9. Subject consented with wrong version of
    consent/expired consent
  • 8. Subject consented by individual not named
    on the IRB protocol
  • 7. Check boxes within consent incomplete
    (future use of samples)
  • 6. Crossed out or white out anywhere on the
    consent document
  • 5. Unable to locate consent(s) for subject(s)
    on study
  • 4. Subjects not re-consented with revised
    consent
  • 3. Ineligible subjects enrolled
  • 2. Wrong contact telephone number listed in
    consent
  • 1. Copy of the consent document NOT provided to
    the subject

32
Strive for the BEST Informed Consent
  • It starts with you !
  • It is the first instructional piece of
    information provided to the subject
  • Should be clearly written and presented to
    promote decision making
  • Understand that each interaction is
    different(circumstances, questions, communication
    style)
  • Take it serious and fully inform document !

33
CONSENT TO PARTICIPATION IN CLINICAL TRIALS
FROM A SUBJECTS POINT OF VIEW
  • CONTENT
  • What terms and ways of writing are difficult to
    comprehend?
  • CONTEXT
  • What does participation mean in the context of a
    persons life?

34
The Obvious Problems
  • Language
  • Key Concepts, Procedures Rights
  • Literacy
  • Reading level
  • Health Research Literacy
  • Randomization
  • Placebo
  • Probabilities
  • HIPAA Authorization

35
Confusing Terms/Phrases
  • Experiment, research, new treatment,
    study, investigation
  • We are experimenting with this drug to determine
    if it will lengthen time to disease progression.
  • Some side effects of the experimental drug
    are
  • We would like to keep track of your medical
    condition for x years.
  • You can withdraw from the clinical trial at any
    time.
  • Active v Passive verbs Improving the Treatment
    of Disease X with Drug Y v Drug Y in the
    Treatment of Disease X

36
Listener Harm
  • Fortune Telling
  • Ninety-five percent of the people diagnosed with
    this cancer will not be alive 5 years later.
  • Point of View Phrases
  • Some side effects of the experimental drug
    are
  • We would like permission to store your
    left-over tissue.
  • You will be randomized to an arm of the trial,
    like a flip of a coin.
  • We are researching ways to improve our
    procedures because patients like you are usually
    not compliant with our instructions (or you are
    difficult to work with).

37
Listener Harm
  • Metaphors
  • War The experimental drug will fight the
    invasive cells and try to kill/destroy them.
  • Kitchen Think of your intestines as a bowl of
    spaghetti. Through our surgery we will strain and
    cut
  • Container You will be randomized to an arm of
    the trial
  • Other
  • Curb your enthusiasm Plastic is ubiquitous in
    our homes. Exposure to the chemicals in plastic
    may be harmful to you and your children. We would
    like to measure your newborns exposure to
    plastic while in the hospital and see if there
    are any correlations with markers in the blood.

38
What Subjects Would Like or Would Like to Know
  • Permission
  • Knowledge (about self, others, disease)
  • Research results
  • Out-of-Pocket Costs for treatments, tests,
    transportation incidentals
  • Accurate estimation of time commitment to
    participate (including office wait-time)
  • Who will pay if I am injured as a result of
    participation (please make me/my family whole)

39
Motives and Meaning of Participation in Clinical
Research
  • Motives
  • Coercion by Disease
  • Personal Benefit
  • Restore Health
  • Income Access
  • Knowledge
  • Relationships
  • Health Care Provider
  • Family Community
  • Altruism

40
Motives and Meaning
  • Meaning
  • Mistrust
  • research as a metaphor for past transgressions
  • Stigma
  • disease as a metaphor for social
    disgrace/discrimination/taboo
  • Meaning in suffering

41
Contact Information
  • http//www.umdnj.edu/hsp
  • HSPP (973) 972-1149
  • New Brunswick IRB (732) 235-9806
  • Newark IRB (973) 972-3608
  • Stratford IRB (856) 566-7196
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