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					Exceptions to Written
Informed Consent in
Human Subject Research
By:Khristy Bozylinski, MS
                         Written Informed Consent

   What is the purpose of consent
    forms in human subject research?
    (45 CFR 46.116)
      Adequately inform participants/representatives about a
       study in language understandable to the
       participant/representative without using exculpatory
       language
      Minimize the possibility of coercion or undue influence



   Why does the IRB review consent
    forms?            (45 CFR 46.116(a)(b)

         Ensure the 8 basic elements of informed consent are
          adequately contained in the consent document
Foundation for Informed Consent
         Requirements
                        Belmont Report

           The Ethical Principles and Guidelines for
              Research Involving Human Subjects

              Basic Ethical Principles
                   Respect for Persons
                   Beneficence
                   Justice
              Applications
                   Informed Consent
                   Assessment of Risk and Benefits
                   Selection of Subject
            Respect for Persons
   Participants should be treated as
    autonomous individuals
     Persons   able to make own decisions

   Those with diminished autonomy
    (illness, mental disability) are provided
    additional protections
      Evaluation to sign consent
      Legal Authorized Representative sign
        consent
             Written Informed Consent
                    Regulations
   Written informed consent is required by
        both FDA and DHHS regulations

       DHHS – 45 CFR 46.116
            “General requirements for informed consent”
       FDA – 21 CFR 50.20
            “General requirements for informed consent”

   The IRB has the authority to waive the
    written informed consent requirement

       Based on federal regulations
      Exceptions To Written Informed
                 Consent
   DHHS Exceptions – (Minimal Risk Studies)
       Waiver or Alteration of Informed Consent Requirements
            45 CFR 46.116(d)
       Waiver for Written Documentation
            45 CFR 46.117(c)

   FDA Exceptions – (Greater than Minimal Risk)
       Exception from General Requirements (Emergency Use)
            21 CFR 50.23
       Exception from Informed Consent Requirements for
        Emergency Research
            21 CFR 50.24
      DHHS Exception Regulations
         Minimal Risk Studies

   45 CFR 46.116(d)          45 CFR 46.117(c)

     Waiver/Alteration
                      of        Waiver
                                      for Written
      Informed Consent           Documentation
Waiver/Alteration of Informed Consent
            Requirements
          45 CFR 46.116(d)
           (d) An IRB may approve a consent procedure
            which does not include, or which alters, some or
            all of the elements of informed consent set forth in
            this section, or waive the requirements to obtain
            informed consent provided the IRB finds and
            documents that:
                (1) the research involves no more than minimal risk
                 to the subjects;
                (2) the waiver or alteration will not adversely affect
                 the rights and welfare of the subjects;
                (3) the research could not practicably be carried out
                 without the waiver or alteration; and
                (4) whenever appropriate, the subjects will be
                 provided with additional pertinent information after
                 participation.
Application of 45 CFR 46.116(d)
   Most common application of
    the regulation:

     Retrospective    Chart Reviews
          Assessing treatment outcomes
          Examining chemistry values
Waiver of the Requirement for Written
 Documentation 45 CFR 46.117(c)
         (c) An IRB may waive the requirement for the investigator to
          obtain a signed consent form for some or all subjects if it
          finds either:

            (1) That 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. Each subject will be asked
             whether the subject wants documentation linking the
             subject with the research, and the subject's wishes will
             govern; or
            (2) That 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.
                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.
Application of 45 CFR 46.117(c)
   Most common application of
    regulation:

     Questionnaires
          Evaluating the effectiveness of
           programs


     Interviews
          Evaluate the quality of services
Example
          Which regulation best applies to the
           following proposed research study?

         Researcher wants to examine the outcomes of
          patients who received clinically indicated radiation
          treatment for breast cancer
         Collect limited data from medical records of all
          individuals who have undergone the radiation in
          past 5 years, about 7,000 performed
         Data will be coded
Example
    Which regulation best applies to the following
              proposed research study?

   Researcher wants to evaluate the effectiveness of an
    exercise intervention program
   All individuals taking the exercise class will be asked to
    fill out a questionnaire asking how they feel about the
    program and if they believe it is helping them achieve
    their fitness goal
   Questionnaire will not have any identifying information
   Individuals do not have to complete the questionnaire
    to remain in the fitness program
    FDA Exceptions to Informed Consent
        Greater Than Minimal Risk


   21 CFR 50.23                21 CFR 50.24

     Emergency   use, not        Emergency   medicine
      research                     research
     No data collection          Data collection
     No existing protocol        IRB approve protocol
                                   and consent form(s)
            21 CFR 50.23
Exception from General Requirements
          (Emergency Use)
    Investigator and a physician who is not otherwise
       participating in the clinical investigation certify:

   Individual is in a life threatening situation that necessitates the
    use of the test article
   Informed consent can’t be obtained because of an inability to
    communicate with individual
   Time is not sufficient to obtain consent from the individual’s legal
    representative
   No alternative method approved to provide equal or greater
    likelihood of saving the life of the individual
           21 CFR 50.24
  Exception from Informed Consent
Requirements for Emergency Research
   The IRB and a licensed physician who is a member of the IRB or consultant
    to the IRB find that:
      Individual is in a life threatening situation and available treatments are unproven
       or unsatisfactory
      Obtaining informed consent is not feasible as a result of their medical condition
       and intervention must be administered before consent from individual’s legal
       representative is feasible
      No reasonable way to identify prospectively individuals likely to become eligible
      Participation holds prospect of direct benefit because the individual is in a life
       threatening situation that necessitates intervention
   Consultation with community representatives
        Public disclosure to community where potential participants will be drawn
Example
          Which regulation best applies to the
           following proposed research study?
        Researcher wants to examine the clinical impact of
         an investigational drug, requiring an IND, in the
         resuscitation of patients in the emergency room
        Drug must be administered within 30 minutes of
         presenting to the emergency room to be effective
        The risks of the drug are not completely known but
         no other standard of care treatment methods are of
         known benefit to patients presenting with this
         condition
         It is not possible to prospectively identify individuals
         who would be eligible
        Data will be collected
IRB’s Responsibilities
            Always consider the principle of
             respect for persons

            Assess potential risks before
             granting waivers

            Ensure risks are minimized
                 Regulations:
    Tools to assess ethical considerations
 Ensure the protection of research participants
   Amdur, R, Bankert, E. Institutional Review Board: Management and
    Function. Massachusetts: Jones and Bartlett Publishers, 2002.

   United States Department of Health & Human Services: Office for
    Human Research Protections (OHRP)
      Website: http://www.hhs.gov/ohrp/


   United States Food & Drug Administration
      Website: http://www.fda.gov/

				
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