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					Institutional Review Board
            February 16, 2011
         Prepared by: Akane Zusho
Goals
 Brief history of human subjects protection
 What is the role of the IRB?
 What is the IRB process?
 Tips and tricks for a smooth IRB application
     History of Human Subjects Protection
  1949
Nuremberg
  code                                                                              Nuremberg code
                                                                                    advocated for:

                                                                                    Voluntary participation
                                                                                    Informed consent




            Nazi physicians were charged with conducting experiments that were
            carried out during the war on unconsenting concentration camp victims
      History of Human Subjects Protection
1932-1972
 Tuskegee
  Syphilis
Experiment




   399 impoverished African American men infected with
   syphilis were studied by the US Public Health Service for
   40 years. They were never told that they had syphilis, nor
   were they treated for it when a cure became available
History of Human Subjects Protection
    Belmont Report (1979)
          Principle            Description                      Application

Respect for persons   Everyone has the right to choose   Informed consent process
                      whether or not to participate in   must include three elements:
                      research; Extra protection         • information
                      should be afforded to those with   • comprehension
                      diminished autonomy                • voluntariness

Beneficence           Human subjects should not be       Assessments of risks and
                      harmed; Research should            benefits
                      maximize benefits and minimize
                      risks

Justice               The benefits and risks of          Fair procedures and
                      research must be distributed       outcomes in the selection of
                      fairly                             research subjects
The IRB Process
                        Submit IRB
                         protocol



                                         IRB review
    Study Completion
                                         (local/full)




          Continuing Review
                                    Report of
            (amendments,
                                action/Approval
              multi-year)
When should I submit an IRB protocol?
                                          Submit when you are
                                           planning on conducting
             Submit IRB
              protocol
                                           research that involves
                                           human subjects that you
  Study                   IRB review       plan on presenting and/or
Completion                (local/full)
                                           publishing at some point in
                                           time
                                            Residency/Dissertation
     Continuing       Report of
      Review           action                research
                                          Download forms at:
                                            http://www.fordham.edu/irb
Who will review my proposal?
                                          Three types of proposals:
                                            Exempt (Local): Extant datasets
             Submit IRB                      with no identifiers; “Normal
              protocol                       educational practices”
                                            Expedited (Local): Surveys,
  Study                   IRB review         interviews, oral histories, focus
Completion                (local/full)
                                             groups, program evaluation with
                                             identifiers
                                            Full Board: More than minimal
                                             risk (vulnerable populations);
     Continuing       Report of
      Review           action                funded research
How can I ensure that my proposal will
be approved?
                                          Informed consent form – see
                                           samples at:
                                           http://www.fordham.edu/academics/office_of_resea
             Submit IRB                    rch/institutional_review/sample_consent_forms_259
              protocol                     51.asp

                                          Child assent form (if applicable)
  Study                   IRB review      Clear recruitment procedures
Completion                (local/full)
                                           including scripts/copies of
                                           flyers
                                          Study materials attached
     Continuing       Report of
      Review           action             Safeguarding of confidentiality
                                          Demonstrate benefits; minimize
                                           risk (including coercion)
How long will my approval last?
                                          Your approval will only last
                                           for 1 year; if data collection
             Submit IRB                    will last longer than 1 year,
              protocol
                                           you must resubmit a
                                           continuing review protocol
  Study                   IRB review
Completion                (local/full)    Study amendments must be
                                           approved by IRB chair (send
                                           email to irb@fordham.edu)
     Continuing       Report of
      Review           action
Protocol Page 1
 If this is your dissertation
  study, make sure that you
  list the date of your
  proposal defense
 You cannot submit an IRB
  protocol for your
  dissertation study unless
  you have defended your
  proposal
Protocol Page 2 - Purpose
 Provide a jargon free
  description of the proposed
  research that will be
  comprehensible to
  individuals who do not
  have expertise in your
  field. Include specific
  study objectives and
  rationale. A maximum
  of 100 words may be
  used. The IRB will
  include this description in
  the monthly agenda
Protocol Page 2 - Methods
   NUMBER OF SUBJECTS: Provide the number of subjects
    that you propose to recruit. If minors are involved in this
    research, include the number of subjects who are expected
    to be age 0 – 7 and age 8 – 17.
   ELIGIBILITY CRITERIA
       Inclusion Criteria: Describe criteria for inclusion in the
        study (e.g., age, health status, language). List criteria for
        each study site (if different), and for each phase of data
        collection (if applicable).
       Exclusion Criteria: Describe criteria for exclusion from
        the study (e.g., age, health status, language). List criteria
        for each study site (if different), and for each phase of data
        collection (if applicable).
       Determination of Eligibility Criteria: Indicate how,
        when, and by whom prospective subjects will be identified
        and eligibility determined. Include this information for each
        study site (if different), and for each phase of data
        collection (if applicable).
   VULNERABLE SUBJECT GROUPS
        minors (under 18)
       involuntarily institutionalized (including prisoners)
       cognitively impaired
       mentally or emotionally disabled
       students enrolled in a class in which the instructor is the
        investigator
Protocol Page 2 - Methods
 SUBJECT RECRUITMENT
   Explain how, where, when, and by
    whom prospective subjects will be
    identified, selected and invited to
    participate in the study.
   NOTE: If researcher is subject’s
    instructor, physician, or job
    supervisor, or if vulnerable subject
    groups will be recruited, explain what
    precautions will be taken to minimize
    potential coercion or undue influence
    to participate.
   If other individuals who are not part
    of the research team will assist in
    identifying or recruiting study
    subjects, describe their role in detail.
    Describe how you will request their
    assistance with subject recruitment
   Include any materials used to do so
    (e.g., phone script, email, etc.)
Protocol Page 2 - Methods
STUDY PROCEDURES
   Describe how the research will be conducted, providing
    information about all study procedures (e.g., methods of
    data collection (e.g., interview by phone or in person, self-
    administered questionnaire, focus group, online survey,
    mail survey, etc.). If data collection will include
    photographing, audio- and/or videotaping, please describe
    this. Be sure to clearly describe the chronological sequence
    of study procedures. Explain who will conduct the
    procedures, where and when they will take place. Indicate
    frequency and duration of subject involvement in data
    collection, tests, visits, sessions, as well as total time
    commitment for the study.
   Identify any procedures that are experimental/
    investigational and explain how they differ from standard
    procedures (medical, psychological, educational). If
    applicable, distinguish between procedures that the subject
    would undergo regardless of enrollment in the study and
    procedures done specifically for study purposes.
    If any type of deception will be used, explain what it will
    entail and why it is justified. This includes both “active
    deception” (deliberately giving false information about study
    purpose and/or procedures to subjects) and “lack of full
    disclosure” (withholding complete information about the
    study from subjects). Will subjects be debriefed, and if so
    when, by whom, and what explanation will be given to
    them? Include debriefing forms(s)/materials in the
    attachments.
Protocol Page 2 - Methods
DATA COLLECTION INSTRUMENTS
 If any interviews, questionnaires, surveys,
   or focus groups will be conducted for the
   study, describe each and include in the
   attachments.
Protocol Page 3 - Methods
INCENTIVES
 If subjects are compensated for their participation (in
   cash, gift card, or voucher), explain in detail the
   amount and methods/ terms of payment. Include any
   provisions for partial payment if the subject withdraws
   before the study is complete. When subjects are
   required to provide Social Security number in order to
   be paid, this data must be collected separately from
   consent documentation. When applicable, describe
   security measures that will be used to protect subject
   confidentiality.
   If a raffle will be used, please explain the number and
   value of prizes and how subjects will enter the raffle.
   Describe how identifying information required for the
   raffle is kept separate from study data.
   If non-monetary compensation (e.g., course credit,
   services) will be offered, explain how it will be
   provided.
   State the rationale for the amount and method of
   compensation, including appropriateness of amount
   and type of compensation for the study population and
   avoiding undue influence to participate.
  Protocol Page 3 - Risks
     Describe all known risks, discomforts,
      and/or side effects of study procedures,
      whether physical, psychological, social,
      economic, political, or legal (e.g., pain,
      stress, discomfort, embarrassment, invasion
      of privacy), noting probability and
      magnitude of potential harm. Include risks
      of randomization and placebo if applicable.
     Discuss measures that will be taken to
      minimize risks or discomforts to subjects. If
      subjects belong to a vulnerable population,
      or if risks are more than minimal, describe
      additional safeguards that will be taken.




For most protocols: No foreseeable risks for participating in the study
Protocol Page 3 - Benefits
 Describe any potential direct benefits
   to the individual subject and how
   they will be optimized. If subjects
   will not benefit directly from study
   procedures, state “There is no direct
   benefit to subjects.” NOTE: Do not
   include compensation/payment to
   subjects in this section, as
   remuneration is not considered a
   “benefit” of participation in research.
 Describe any other potential benefits
   to, including to the community, the
   profession, future clients, etc., and
   how they will be optimized.
Informed Consent Form
 Make sure you consult the sample consent forms provided on
  the IRB
  websitehttp://www.fordham.edu/academics/office_of_rese
  arch/institutional_review/sample_consent_forms_25951.as
  p
 This is one way to expedite your review process
 Keep in mind that if you are recruiting minors, you will need
  to obtain parental consent
Exempt Protocol
 If secondary data are used in this study, please complete
  the following:
   Source of the data
   Are the data de-identified, i.e., has all information that could be
    used to identify individual subjects been removed from the data
    file? If not, state whether the identifiers can be removed before
    the researcher(s) receive the data file and who would do this.
 Are the data publically available?

				
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