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IRB Training Session: What to Expect When Youre Expecting to be Reviewed

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Title: IRB Training Session: What to Expect When Youre Expecting to be Reviewed


1
IRB Training SessionWhat to Expect When Youre
Expecting to be Reviewed
  • Pacific University
  • Faculty Pre-School Conference
  • August, 2006

2
Overview of IRB Purpose and Purview
3
Purpose of IRB
  • The goal of the Pacific University IRB is to
  • Assist Investigators at Pacific University in
    their efforts to protect the rights and welfare
    of individuals who participate in research
    conducted at or under the auspices of the
    University
  • Ensure Pacific University's compliance with
    federal regulations regarding the protection of
    human subjects

4
Origins of IRB Oversight
  • The Nuremberg Code
  • John Watson Rosalie Raynors Little Albert
    Study (1920)

5
Origins of IRB Oversight
  • Tuskegee Study of Untreated Syphilis in the Negro
    Male (1932)
  • Stanford Prison Experiment (1971)

6
Common Rule
  • Respect
  • Ensuring that individuals can make informed
    choices about their participation in research,
    and protecting those individuals with diminished
    autonomy
  • Beneficence
  • Ensuring that the potential risks of a study are
    minimal, or are justified by the potential
    benefits
  • Justice
  • Ensuring that the selection of research
    participants is fair, and not based simply on
    their easy availability, their willingness to
    participate, or other considerations not directly
    related to the problem being studied.

7
What is research?
  • Federal Definition
  • A systematic investigation, including research
    development, testing and evaluation, designed to
    develop or contribute to generalizable knowledge

8
What is NOT research?
  • Classroom evaluations
  • Data collected from students within a class for
    demonstration/learning purposes only
  • If collected from individuals NOT in the class,
    you should submit a proposal to the IRB
  • Taking various physiologic measurements from
    individuals or groups that request such tests for
    their own use are not research

9
Types of Participant Risk to Consider
  • Inconvenience
  • Physical risk
  • Psychological risk
  • Social risk
  • Economic risk
  • Legal risk

10
Cost-Benefit Analysis
High
Diagonal of Indecision
Cost of Doing
Low
High
Low
Benefit of Doing
Source Rosnow, 1997
11
Why You Should Care about Obtaining IRB Approval
  • Federal mandate
  • Failure to follow federal regulations could lead
    to severe consequences
  • If something were to go wrong with
    non-IRB-approved research, ALL federal funding at
    the University could be pulled!
  • Legal action could be taken against the
    University and/or the Investigator(s)

12
The Research Review Process at Pacific
  • Types of Review and What to Expect

13
Types of Review
  • 1. Full Board Review
  • Data collection involves a federally protected
    population
  • Children or adolescents (i.e., Pps under the age
    of 18)
  • Inmates
  • Pregnant women
  • Other socially or politically vulnerable groups
  • Participants behavior is manipulated
  • Potential for personal identification of
    participants
  • Study content is of a sensitive nature (e.g.,
    sexual behavior, mental illness) or is of
    illicit/illegal activities (e.g., drug abuse,
    binge drinking)

14
Types of Review
  • 2. Exempt from Full Board Review
  • Data that are either publicly available or wholly
    deidentified (i.e., archival data, chart reviews
    where names are removed from info)
  • Standard educational tests
  • Simple observation of public behavior on public
    property
  • Minimal risk survey or interview procedures
  • Data collection with public officials or
    political candidates regarding their office

15
Types of Review
  • 3. Expedited Review
  • Research involves minimal risk but does not
    qualify for Exempt from Full Board Review
  • "Minimal risk" the probability of harm or
    discomfort is not greater than that ordinarily
    experienced in daily life or during the
    performance of routine psychological or physical
    examinations or tests
  • E.g., Administering BDI Assessment of certain
    physical abilities for research purposes

16
If Research with Human Participants, What Next?
  • Submit a proposal to the IRB for review,
    including as relevant
  • Cover letter
  • Proposal
  • Informed consent form
  • Any survey instruments or questionnaires
  • Recruitment materials
  • Photo/Video release
  • Letter of agreement with outside agency
  • Templates on IRB website www.pacificu.edu/resear
    ch/irb

17
What to Expect After Submission
  • Submit both electronic and hard copy (signed by
    all Investigators and/or Advisors)
  • Expect the review process to last no less than 4
    weeks time lag depends on the complexity of the
    research and quality of the proposal
  • Several steps are taken in the review process

18
The Review Process
  • 1. Preliminary Review completed by Chair
    usually within one week of submission
  • a. Quality check
  • Is proposal complete? Are all relevant documents
    included?
  • Are there several grammatical or spelling errors?
  • Is the proposal understandable to reviewers? Is
    jargon used to explain the proposal purpose and
    procedure?
  • b. Assignment to level of review

19
The Review Process
  • 2. Detailed Risk Assessment and Evaluation
  • Procedure depends on level of review
  • Full Board Review All members read at next
    convened meeting
  • Additional readers may be necessary if protected
    populations are involved
  • Expedited Review Two additional members read
    within 2 weeks of proposal receipt
  • Exempt from Full Board Review One additional
    member reads within 2 weeks of proposal receipt

20
The Review Process
  • 3. Feedback given to PI(s)/FA
  • PI(s)/FA will receive one of the following
    responses in the latter two, detailed
    explanations are included
  • Approved Research may begin
  • Approved with Modifications Modifications must
    be received and approved before research may
    begin
  • Not approved If PI(s) want to conduct research,
    a new proposal addressing concerns must be
    submitted

21
The Review Process
  • When feedback is given, Investigators have 30
    calendar days from receipt of contact to address
    any modifications
  • If modifications are not addressed within 30
    days, the proposal is considered to be withdrawn
    and will be closed
  • A resubmission will be treated as a new proposal

22
Important Information for IRB Users
23
Communication with the IRB
  • We expect Faculty, not students, to interact with
    the IRB
  • Each College and School has at least one board
    representative if, after reading our website,
    you have questions, please direct your questions
    to your representative first
  • Terese Rice, working with Maggie Olivos, is our
    administrative assistant
  • Terese may be contacted at irb_at_pacificu.edu or in
    the Office of Academic Affairs, x2215

24
Submission Details
  • Download templates for all aspects of your
    proposal from http//www.pacificu.edu/research/ir
    b/
  • Send an electronic copy of all materials to
    irb_at_pacificu.edu, attention Terese Rice
  • Send a hard paper copy, with all relevant
    signatures, to the IRB, c/o Office of Academic
    Affairs, attention Terese Rice

25
Tips for IRB Submissions
  • Check for completeness
  • If information is missing, the proposal will be
    returned
  • Write at an 8th-grade reading level
  • This is particularly important for the consent
    forms
  • Proofread carefully and avoid discipline specific
    jargon
  • If we cant easily read your proposal, we cannot
    assess risk

26
Faculty Responsibilities
  • Faculty supervisors must act as the liaison
    between IRB and student
  • Before submitting, faculty must ensure and
    approve
  • The quality of writing
  • Completeness of the proposal
  • Student-researchers understanding of relevant
    ethical issues in research with human
    participants
  • Ensure that faculty and students alike are
    familiar with IRB Procedures and guidelines

27
Faculty Responsibilities
  • New this year for Instructors
  • Research conducted in Research Methods Courses
    must be submitted and reviewed
  • We are no longer accepting blanket proposals for
    courses
  • Research conducted on educational curriculum and
    assessment must be submitted
  • Please plan accordingly when preparing your
    courses

28
IRB User Training Certification
  • To ensure IRB familiarity, we ask that all IRB
    users (including faculty, student PIs and
    research assistants) complete an online tutorial
  • http//cme.cancer.gov/clinicaltrials/learning/huma
    nparticipant-protections.asp
  • Once completed, please submit your assessment
    results to the IRB office
  • Beginning January 1st, 2007, all IRB users will
    be required to submit evidence of training
    completion before proposals will be processed

29
IRB General Info
  • IRB Members
  • College of Arts and Sciences Erica Kleinknecht,
    IRB Vice-Chairperson, Phil Schot, third member
    TBA
  • College of Optometry Karl Citek
  • College of Education Alfonso Lopez-Vasquez
  • College of Health Professions
  • School of Professional Psych Krista Brockwood,
    IRB Chairperson
  • Physician Assistants Mark Pedemonte
  • Occupational Therapy Linda Hunt and Sandra
    Rogers
  • Physical Therapy TBA
  • Pharmacy TBA
  • Dental Science TBA

30
IRB General Info
  • Website http//www.pacificu.edu/research/irb/
  • Email irb_at_pacificu.edu
  • Administrative support Terese Rice, Office of
    Academic Affairs

31
Thank you for coming!
  • Questions?
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