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How to Conduct Research in AIAN Communities THE VALIDITY OF INFORMED CONSENT IS DEPENDENT UPON THE P

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Title: How to Conduct Research in AIAN Communities THE VALIDITY OF INFORMED CONSENT IS DEPENDENT UPON THE P


1
How to Conduct Research in AI/AN CommunitiesTHE
VALIDITY OF INFORMED CONSENT IS DEPENDENT UPON
THE PROCESS, NOT THE DOCUMENT
Ernest D. Prentice, Ph.D. University of Nebraska
Medical Center
June 17, 2005Fort Yates, ND
2
OBJECTIVES
  • Present historical perspectives of informed
    consent to participate in research.
  • Discuss the criteria for obtainment of valid
    consent.
  • Discuss how to structure the process of informed
    consent to make it legally and ethically valid.
  • Discuss ethical dilemmas related to informed
    consent using a case study approach.
  • Describe the required element of consent on the
    ICF.

3
THE GENESIS OF INFORMED CONSENT TO PARTICIPATE
IN RESEARCH
4
William Beaumont
William Beaumont conducted Gastric Physiology
experiments on Alexis St. Martin, 1832
5
Walter Reed
Walter Reed conducts Yellow Fever experiments in
Cuba in 1900
6
1939-1945
The Nazi Doctors conduct experiments using
concentration camp prisoners
7
NAZI MEDICAL EXPERIMENTS 1939-1945
  • Experimental Surgery Ravensbrook
  • Osteology Auschwitz
  • Sterilization Research Auschwitz
  • Typhus Experiments Buchenwald
  • Poison Experiments Buchenwald
  • Sea Water Experiments Dachau
  • High Altitude Experiments Dachau
  • Freezing Experiments Dachau
  • ..

8
THE NUREMBERG CODE10 POINTS
  • Voluntary Consent
  • Yield fruitful results otherwise unobtainable
  • Based on animal experiments
  • Avoid physical and mental suffering
  • Not done if injury expected

9
THE NUREMBERG CODE10 POINTS (contd)
  • Risk less than importance of problem
  • Protect subject from injury
  • Conducted by qualified people
  • Termination by subject
  • Termination by investigator

10
PRINCIPLE 1
The voluntary consent of the human subject is
absolutely essential. This means that the person
involved should have legal capacity to give
consent should be so situated as to be able to
exercise free power of choice without the
intervention of any element of force, fraud,
deceit, duress, over-reaching or other ulterior
form of constraint or coercion and should have
sufficient knowledge and comprehension of the
elements of the subject matter involved as to
enable him to make an understanding and
enlightened decision.

11
VALID INFORMED CONSENT
  • The subject has legal capacity and competency to
    consent .
  • The subject is in a position to exercise free
    power of choice.
  • The subject has sufficient knowledge and
    comprehension.

12
LEGAL CAPACITY TO CONSENT
  • Legal capacity to consent to participate in
    research means the subject is competent to
    consent and has reached the age of majority.

13
FACTORS WHICH DETERMINE COMPETENCY
  • Educational level
  • Complexity of the study
  • Cognitive impairment
  • Court determination

14
CASE STUDY
  • A study involves the administration of an
    investigational enhancing agent combined with an
    FDA approved thrombolytic agent to ER patients
    with an acute MI. The PI states enrollment with
    be restricted to only competent subjects and does
    not want to apply for an FDA 50.24 waiver. What
    are the issues?

15
FREE POWER OF CHOICE
  • Free power of choice means the person is in a
    position to thoughtfully consider whether to
    participate in research without undue influence,
    coercion or constraint.

16
FACTORS WHICH INFLUENCE DECISIONS
  • Patient Doctor trust relationship
  • Therapeutic misconception
  • Between a rock and the hard place

17
CASE STUDY
  • Dr. Christiaan Barnard performed the worlds
    first human to human heart transplant on December
    3, 1967 which raised the issue of whether a dying
    patient can truly exercise free power of choice.

18
COMPREHENSION
  • Comprehension means the subject has sufficient
    knowledge and understanding of the research.

19
CASE STUDY
  • A patient with advanced lung cancer has only a
    7th grade education and is barely literate. She
    is unable to fully comprehend the research (a
    late phase II study) which offers the best
    prospect of health benefit. She has no one to act
    as a legally authorized representative (LAR).
    Can/should this patient be enrolled?

20
CASE STUDY
  • A patient strongly objects to discussing the
    research in detail since her husband has already
    granted his approval for participation. She is
    fully prepared to sign the consent document.
    Indeed, she insists on signing the consent form
    without further delay. Should the investigator
    respect the patients wishes?

21
CASE STUDY
  • During the course of a clinical trial for Type
    II Diabetes, the physician investigator
    develops a treatment preference even though the
    data are not yet scientifically valid (pIs there a legal, regulatory or ethical
    obligation to inform the prospective subject of
    this preference?

22
ONE POINT OF VIEW
  • To the extent that important preliminary
    evidence indicates efficacy of the active agent,
    there should be an increasing presumption of a
    requirement to inform prospective subjects of the
    preliminary evidence and its implications.

23
OPPOSING POINT OF VIEW
  • Full disclosure of treatment preferences could
    have disastrous effects on advancement of medical
    knowledge. In many cases, proper scientific
    validation of medical hypotheses might become
    unattainable.

24
ADDITIONAL CONSIDERATIONS
  • Is there a legal, regulatory or ethical
    obligation to inform currently enrolled subjects
    of the preliminary evidence?

25
FACTORS TO CONSIDER WHEN DESIGNING THE PROCESS
OF CONSENT
26
THE PROCESS OF CONSENT
  • Design the process so that it is culturally
    appropriate and sensitive.
  • Ensure the consent form is accurate, complete and
    up to date.
  • Provide information in accordance with the
    reasonable volunteer standard.
  • Use the consent form as a guide in structuring
    the dialogue.
  • Provide sufficient time for the process of
    consent.

27
THE PROCESS OF CONSENT (contd)
  • Choose the right environment and location to
    obtain consent.
  • Involve multiple health care personnel as
    necessary.
  • Include family members in the process as
    warranted.
  • Use a delayed consent procedure as necessary.
  • Ensure that the subject or proxy is competent.

28
THE PROCESS OF CONSENT (contd)
  • Ensure the subject or proxy has sufficient
    understanding.
  • Continue the process of consent throughout the
    study.
  • Remember, the process of consent is much more
    than a consent form.
  • Remember your obligation to share research
    results with the subject and community.

29
DEVELOPMENT OF THE CONSENT FORMBASED ON
REQUIREMENTS OF 45 CFR 46.116
30
CHARACTERISTICS OF A GOOD CONSENT FORM
  • Complete information
  • Accurate information
  • In compliance with 45 CFR 46
  • Logical flow of information
  • Culturally sensitive language
  • Understandable language

31
ELEMENTS OF INFORMED CONSENT
  • The title of the research study and the IRB
    tracking number
  • An invitation to the prospective subject to
    participate in the study
  • The reason the prospective subject is eligible to
    participate in the study
  • The approximate number of subjects who will be
    involved in the study (A)
  • An explanation of the scientific (S) purpose of
    the study (R)
  • An explanation of procedures including the time
    required and which procedures are experimental (R)

32
ELEMENTS OF INFORMED CONSENT (contd)
  • A description of reasonably foreseeable risks and
    discomforts (R)
  • A description of risks to the subject or fetus if
    the subject becomes pregnant (A)
  • A description of any potential benefits to the
    subject (R)
  • A description of any potential benefit to others
    or society in general (R)
  • A description of any alternatives to
    participation which may be advantageous to the
    subject (R)
  • A disclosure of costs to the subject as a result
    of participation (A)

33
ELEMENTS OF INFORMED CONSENT (contd)
  • A description of any payment for participating in
    the study
  • An explanation of available treatment if the
    subject is injured (R-MR)
  • An explanation of any available compensation if
    injured (R-MR)
  • An explanation of whom to contact with questions
    about the study or rights (R)

34
ELEMENTS OF INFORMED CONSENT (contd)
  • A statement describing the extent, if any, to
    which confidentiality will be maintained (R)
  • A statement that participation is voluntary and
    the subject can withdraw without penalty (R)
  • The consequences of a subjects decision to
    voluntarily withdraw (A)
  • The circumstances under which the investigator
    can terminate the subjects participation (A)
  • A disclosure of the investigators financial
    interest related to the research (A)

35
ELEMENTS OF INFORMED CONSENT (contd)
  • A statement that new information which may affect
    subjects participation will be provided (A)
  • A statement describing the extent, if any, to
    which confidentiality will be maintained (R)
  • Documentation of consent section for dated
    signature of the subject and investigator (R)
  • The name and phone number(s) of the
    investigator(s) and other study personnel

36
MORE TAKE HOME ON INFORMED CONSENT
37
BELMONT REPORT
  • Respect 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.

38
DECLARATION OF HELSINKI PRINCIPLE 22
  • In any research on human beings, each potential
    subject must be adequately informed of the aims,
    methods, sources of funding, any possible
    conflicts of interest, institutional affiliations
    of the researcher, the anticipated benefits and
    potential risks of the study and the discomfort
    it may entail. The subject should be informed of
    the right to abstain from participation in the
    study or to withdraw consent to participate at
    any time without reprisal.

39
CIOMS
  • Obtaining informed consent is a process that is
    begun when initial contact is made with a
    prospective subject and continues throughout the
    course of the study. By informing the
    prospective subjects, by repetition and
    explanation, by answering their questions as they
    arise, and by ensuring that each individual
    understands each procedure, investigators elicit
    their informed consent and in so doing manifest
    respect for their dignity and autonomy.

40
ICH
  • The investigator, or a person designated by the
    investigator, should fully inform the subject
    orthe subjects legally acceptable
    representative, of all pertinent aspects of the
    trial (set forth by 4.8.10). The language used
    in thewritten consent formshould be
    understandable to the subject or legally
    acceptable representative.

41
BOTTOM LINE

The ultimate responsibility for protection of the
rights and welfare of research subjects rests
with the principal investigator. Obtainment of
valid informed consent is an important part of
that protection.
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