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Deception in Human Research

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Deception in Human Research – PowerPoint PPT presentation

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Title: Deception in Human Research


1
Deception in Human Research
2
Learning Objectives
  • Define Deception and Incomplete Disclosure
  • Understand when Deception or Incomplete
    Disclosure are allowable in human research
  • Review APA recommendations

3
Deception/Incomplete Disclosure
  • Deception is intentionally misleading prospective
    participants about the research.
  • Incomplete Disclosure is not giving participants
    accurate or adequate information about some
    aspect of the research.
  • Both Deception and Incomplete Disclosure
    interfere with a participants ability to provide
    legally effective informed consent.

4
Use of Deception in Research
  • Often necessary to study human behavior.
  • In general, the IRB must consider
  • Is the use of deception scientifically and
    ethically justified?
  • Would the information being withheld from the
    subjects influence their decision to participate
    in the research?
  • Is it permissible to alter and/or the exclude a
    required element of informed consent?
  • Is it appropriate to debrief participants?

5
Required Elements of Informed Consent
  • A statement that the study involves research.
  • An explanation of the purposes of the research.
  • A description of the procedures to be followed.
  • A description of any reasonably foreseeable risks
    or discomforts to the subject.
  • A description of any benefits to the subject or
    to others which may reasonably be expected from
    the research.

6
Required Elements of Informed Consent
  • A description of appropriate alternative
    procedures.
  • A statement describing the extent, if any, to
    which confidentiality of records will be
    maintained.
  • An explanation of whom to contact for answers to
    pertinent questions about the research and
    research subjects' rights.
  • A statement that participation is voluntary.

7
Example
  • An investigator wants to understand which
    background music is more distracting in a
    learning environment - Country versus Hip-Hop.
    The investigator intends to recruit college
    students and explain to participants that she is
    interested in examining learning and memory.
  • Participants will be required to learn sets of
    words and then be tested on recall and
    recognition of the words immediately after and 24
    hours later.
  • The participants are not told about the true
    purpose of the research or certain elements of
    the study design. Therefore if the research is to
    be conducted, some of the required elements of
    consent must be altered.

8
Alteration of the Elements of Informed Consent
DHHS 45 CFR 46.116(d)
  • An IRB may approve a consent procedure which does
    not include,
  • or which alters, some or all of the elements of
    informed consent,
  • or waive the requirements to obtain informed
    consent provided the
  • IRB finds and documents that
  • 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
  • whenever appropriate, the subjects will be
    provided with additional pertinent
    information after participation.

9
APA Guidelines on Use of Deception in Research
  • Do not conduct a study involving deception unless
    it has been determined that the use of deceptive
    techniques is justified by the study's
    significant prospective scientific, educational,
    or applied value and that effective nondeceptive
    alternative procedures are not feasible.
  • Do not deceive prospective participants about
    research that is reasonably expected to cause
    physical pain or severe emotional distress.
  • Explain any deception that is an integral feature
    of the design and conduct of an experiment to
    participants as early as is feasible, preferably
    at the conclusion of their participation, but no
    later than at the conclusion of the data
    collection, and permit participants to withdraw
    their data.

10
APA Guidelines on Use of Deception in Research
  • Debriefing Participants
  • Provide a prompt opportunity for participants to
    obtain appropriate information about the nature,
    results, and conclusions of the research, and
    take reasonable steps to correct any
    misconceptions that participants may have.
  • If scientific or humane values justify delaying
    or withholding this information, take reasonable
    measures to reduce the risk of harm.
  • If investigators become aware that research
    procedures have harmed a participant, take
    reasonable steps to minimize the harm.

11
e-IRB Application and IRB Reviewer Checklist
  • When Deception is proposed
  • Investigators are required to complete Appendix G
  • IRB Reviewers must complete Supplementary IRB
    Checklist Waiver/Alteration of Informed Consent

12
Any questions?
13
Thanks for listening!
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