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Legally Effective Informed Consent VA Requirements

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Legally Effective Informed Consent VA Requirements Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education (PRIDE) – PowerPoint PPT presentation

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Title: Legally Effective Informed Consent VA Requirements


1
Legally Effective Informed ConsentVA Requirements
  • Kevin L. Nellis, M.S., M.T. (A.S.C.P.)Program
    Analyst
  • Program for Research Integrity Development and
    Education (PRIDE)

2
Topics
  • General requirements
  • Required elements
  • Additional elements
  • FDA element for Clinical Trial
  • Documentation
  • Waiver of documentation
  • Waiver of informed consent

3
General Requirements
4
General Requirements
  • No investigator may involve a human being as a
    subject in research covered by VHA Handbook
    1200.05 unless the investigator has obtained the
    legally effective informed consent of the subject
    or the subject's legally authorized
    representative (LAR)

5
Circumstances Under Which Informed Consent May Be
Sought
  • Investigator seek informed consent only under
    circumstances that
  • Provide the prospective subject /LAR sufficient
    opportunity to read the informed consent document
    when applicable
  • Provide the prospective subject,/LAR, sufficient
    opportunity to consider whether or not to
    participate
  • Minimize the possibility of coercion or undue
    influence

6
Circumstances Under Which Informed Consent May Be
Sought
  • Information given to the subject/LAR must be in
    language understandable to the subject or the
    subjects LAR
  • No informed consent, whether oral or written, may
    include any exculpatory language
  • Made to waive, or appear to waive, subject's
    legal rights or
  • Releases, or appears to release investigator,
    sponsor, institution, or its agents from
    liability for negligence

7
Person Obtaining Informed Consent
  • If someone other than the investigator conducts
    the informed consent process, the investigator
    must formally and prospectively designate in
    writing in the protocol or the IRB application
  • Person so designated must have received
    appropriate training to perform this activity
  • Must be knowledgeable about the research to be
    conducted and the consenting process
  • Must be able to answer questions about the study

8
Observing the Process
  • The IRB has the authority to observe or have a
    third party observe the informed consent process

9
Informed Consent FormVA Form 10-1086
  • Use the most current IRB-approved version of VA
    Form 10-1086
  • Include all required elements, unless waived by
    IRB
  • Include any additional elements required by the
    IRB
  • Must contain a designated block for each required
    signature and date
  • Block may be a labeled line, window of a table,
    or other format

10
Required Elements
11
Required Elements
  • Statement that the study involves research
  • Explanation of the purposes of research
  • Expected duration of the subject's participation
    (e.g., length of the subjects commitment)
  • A description of the procedures to be followed
  • Identification of any procedures that are
    experimental

12
Required Elements
  • Reasonably foreseeable risks or discomforts
    (e.g., Physical, social, legal, economic,
    psychological risks, or other) from the research
  • Risks solely from treatments or services to be
    the responsibility of the health care provider,
    should not be described in the consent form
  • Include language advising subjects to review the
    risks of such clinical treatments or services
    with their health care provider(s)

13
Required Elements
  • Describe any benefits to the subject or to others
    that may reasonably be expected from the research
  • Disclose appropriate alternative procedures or
    courses of treatment, if any, that might be
    advantageous to the subject

14
Required Elements
  • Describe extent to which confidentiality of
    records identifying the subject will be
    maintained, and if appropriate, state
  • Federal agencies including, but not limited to,
    the FDA, OHRP, ORO, and the VA Office of the
    Inspector General (OIG) may have access to the
    records
  • FDA may choose to inspect research records that
    include the subjects individual medical records

15
Required Elements
  • For research involving more than minimal risk
  • An explanation as to whether any compensation is
    available if injury occurs, and
  • An explanation as to whether any medical
    treatments are available if injury occurs and, if
    so, what they consist of, or where further
    information may be obtained
  • NOTE VA provides care for all research-related
    injuries (38 CFR 17.85)

16
Required Elements
  • Explain whom to contact
  • For answers to pertinent questions about
  • The research
  • The subjects' rights
  • Research-related injury to the subject
  • At least one contact must be someone other than
    the investigator or study personnel

17
Required Elements
  • Provide a statement(s) that
  • Participation is voluntary
  • Refusal to participate involves no penalty or
    loss of benefits to which the subject is
    otherwise entitled
  • Subject may discontinue participation at any time
    without penalty or loss of benefits to which the
    subject is otherwise entitled

18
Required Elements
  • VA requires the following elements of informed
    consent
  • Name of the study
  • Name of the PI or Local Site Investigator (LSI)
    in multi-site studies
  • Sponsor of the study

19
Additional Elements
20
Additional Elements Required by Common Rule,
When Appropriate
  • Unforeseeable risks to subject, fetus, or embryo
  • Anticipated circumstances when subjects can be
    terminated from the research
  • Consequences of withdrawal from the study
  • Additional Costs
  • Subjects in VA research cannot be charged, nor
    their insurance be billed, for research
  • Veterans may pay co-payments for medical care and
    services but not for research

21
Additional Elements Required by Common Rule,
When Appropriate
  • Statement that any significant new findings which
    may relate to the subjects willingness to
    continue participation, developed during the
    course of the research, will be provided to the
    subject
  • Approximate number of subjects involved in the
    study

22
Additional Elements Required by VA, When
Appropriate
  • That the investigator believes that the human
    biologic specimens obtained could be part of, or
    lead to the development of, a commercially
    valuable product
  • If the specimens are to be retained after the end
    of the study for future research
  • Where the specimens will be retained
  • Who will have access to them
  • How long they will be retained

23
Additional Elements Required by VA, When
Appropriate
  • If any of the data will be retained after the
    study for future research
  • Where the data will be stored
  • Who will have access to the data
  • If the subject will be re-contacted for future
    research whether within VA or outside VA

24
Additional Elements Required by VA, When
Appropriate
  • Statement regarding any payment the subject is to
    receive for participating in the study and how
    the payment is to be made
  • If the subject will receive a report of the
    aggregate results or any results specific to the
    subject

25
FDA Element for Clinical Trials
26
FDA Amended Informed Consent Requirements on
January 4, 2011
  • Effective date is March 7, 2011
  • Must be compliant for clinical trials that are
    initiated on or after March 7, 2012
  • Statement is required on all informed consent
    documents (e.g., including short form and written
    summary)
  • Required by FDA Amendments Act of 2007 (FDAAA)
  • Designed to promote transparency

27
Applicable Clinical Trials
  • Required only for applicable clinical trials
  • Defined in FDAAA, 42 U.S.C. 282(j)(1)(A), section
    402(j) (1)(A) of PHS Act
  • NIH/NLM has elaborated on the meaning of
    applicable clinical trial
  • http//prsinfo.clinicaltrials.gov/fdaaa.html
  • http//prsinfo.clinicaltrials.gov/ElaborationsOnDe
    finitions.pdf

28
The Statement is
  • A description of this clinical trial will be
    available on http//www.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 Web site at any
    time.
  • 21 CFR part 50.25(c)

29
Documentation
30
Documentation of Informed Consent
  • Informed consent must be documented prospectively
    by the use of a written consent form approved by
    the IRB, unless documentation of informed consent
    has been explicitly waived by the IRB
  • Email communications do not constitute
    documentation of informed consent

31
Consent Form
  • VA Form 10-1086, Research Consent Form, must be
    used
  • One exception a DoD informed consent form may be
    employed for active duty military personnel
    participating in VA research at DoD sites when
    VA-specific language is not necessary (e.g., when
    language for treatment of research related-injury
    is not needed because active duty military
    personnel are covered by DoD)

32
Consent Form for VA Research
  • Must use the most recent IRB-approved informed
    consent form (VA Form 10-1086)
  • Requirement to utilize VA Form 10-1086 to
    document informed consent applies to all
    VA-approved research including, but not limited
    to, studies in which VA investigators working on
    VA Research enroll subjects at the affiliate
    hospital or other sites outside VA (e.g.,
    community centers or shopping malls)

33
Consent Form for VA Research
  • Must contain version date (e.g., in a header or
    footer) on each page
  • IRB approval date must be documented by the use
    of a stamp or preprinted box on each page of the
    informed consent form
  • Must be signed and dated by
  • Subject or LAR
  • Person obtaining informed consent
  • Witness, if required by IRB

34
Consent Form for VA Research
  • Original filed in the investigators research
    file
  • Copy must be provided to the subject or LAR
  • Where applicable, a copy must be placed in the
    medical record (see VHA Handbook 1907.01)
  • NOTE If using facsimile, the person who obtains
    informed consent must sign and date the facsimile
    and measures must be employed to ensure the
    confidentiality and privacy

35
Consent Form for VA Research
  • Informed consent form may be either
  • Written informed consent (long form)
  • Short form written consent document stating that
    the elements of informed consent required by 38
    CFR 16.116 have been presented orally to the
    subject or the subjects LAR
  • See VHA Handbook 1200.05 for additional
    requirements

36
Waiver of Documentation
37
Waiver of Documentation of Informed Consent
  • IRB may waive documentation of informed consent,
    if
  • The only record linking subject and 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

38
Waiver of Documentation of Informed Consent
  • IRB may waive documentation of informed consent,
    if
  • The research presents no more than minimal risk
    of harm to subjects and involves no procedures
    for which written consent is normally required
    outside of the research context

39
Waiver of Documentation of Informed Consent
  • Unless IRB has granted a waiver of informed
    consent the investigator, or designee, must still
    perform an adequate informed consent process
  • IRB must document its determinations regarding a
    waiver of documentation of informed consent in
    the IRB minutes or in the protocol file
  • IRB may require the investigator to provide
    subjects with a written statement regarding the
    research (e.g., information sheet, FAQs, letter,
    etc)

40
Waiver of Informed Consent
41
IRB May Alter Element(s) Or Waive Informed
Consent, If It Finds And Documents
  • The research or demonstration project is to be
    conducted by or subject to the approval of state
    or local government officials and is designed to
    study, evaluate, or otherwise examine (i) public
    benefit or service programs (ii) procedures for
    obtaining benefits or services under those
    programs (iii) possible changes in or
    alternatives to those programs or procedures or
    (iv) possible changes in methods or levels of
    payment for benefits or services under those
    programs and
  • The research could not practicably be carried out
    without the waiver or alteration

42
IRB May Alter Element(s) Or Waive Informed
Consent, If It Finds And Documents
  • Research involves no more than minimal risk to
    the subjects
  • Waiver or alteration will not adversely affect
    the rights and welfare of the subjects
  • Research could not practicably be carried out
    without the waiver or alteration and
  • Whenever appropriate, the subjects are provided
    with additional pertinent information after
    participation

43
Waiver of Informed Consent
  • Other applicable Federal, State, or Local Laws.
    The informed consent requirements in this VHA
    Handbook 1200.05 are not intended to preempt any
    applicable Federal, state, or local laws which
    require additional information to be disclosed in
    order for informed consent to be legally
    effective
  • The IRB must document its determinations
    regarding a waiver of informed consent in the IRB
    minutes or in the protocol file

44
Key Points
  • Legally effective informed consent encompasses
    both the process and the form
  • Incorporate all VA and Common Rule requirements
    into the process
  • IRB may waive documentation of informed consent
    or may alter elements or waive informed consent
  • IRB must document findings

45
QUESTIONS
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