Obtaining Medical Records Research Retrospective Budget

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					The Institutional Review Board

    Monica B. Spaulding, M.D.
    Chair-Health Sciences IRB
      Professor of Medicine
   What is an IRB?
       Why does it exist
       What do we do
   IRB Reviews
       Full
       Expedited
       Its impact on your research
     What is an
     Institutional Review Board?

   An administrative body established to protect
    the rights of welfare of human research subjects
    recruited to participate in research activities
   Independent of other committees and
    independent of the needs of the institution
   All research involving human subjects (or their
    records) must be reviewed by an IRB
Why do IRBs exist?
   Historical context
       Nuremburg trials
            Atrocious trials done in the name of science
       Tuskegee syphilis trial
            1932 -1972 study designed to look at the natural history
             of untreated syphilis
       Willowbrook Hepatitis study
            Retarded children were deliberately fed a solution
             including the feces of children with hepatitis
Rules governing IRB activity

   After the Tuskegee studies were reported in The NY
    Times and The Washington Post, Congress acted
   National Research Act of 1974
      Established IRBs

   Code of Federal regulations contains broad outlines of
    what an IRB should do
       New rules can be written or rules can be modified generally
        in response to bad events, such as those occurring in 1999-
Major research problems
occurred between 1999-2001
   Death of a research participant in a gene
    therapy trial at the University of Pennsylvania
       First suit against a University for clinical research
   Death of a normal volunteer At JHH
       Closed research activities at Johns Hopkins, the
        medical school with the largest federal research
        budget at the time
   Investigations of research conduct closed
    research at 10 major research universities
    because of misconduct
Death of a normal subject at
Johns Hopkins (1)
   An investigator was studying the physiology of
    asthma and reactive airways

   He recruited normal volunteers to inhale a drug
    formerly used for ↑BP
       The drug had been taken off the market when better drugs
        were available

   Since it could no longer be purchased, he made the
    drug in his lab
Death of a normal subject at
Johns Hopkins (2)
   The subject, a regular volunteer in research studies, developed
    respiratory distress about 24 hours post participation and
    subsequently died
   Massive literature searches turned out rare reports of pulmonary
    problems from the drug when it was being used clinically
   The FDA investigated, denied all responsibility, although they
    had reviewed the project
   The Office for Human Research Protection investigated, found
    fault with the IRB and shut down all research
   OHRP then reviewed the IRB activities at other institutions and
    faulted the system
Problems discovered with IRB
activities across the country
   Insufficient project review by the IRBs
       Casual review of research projects
       Lack of attention to regulations
   Lack of knowledge about research
    regulations by those doing research
   Financial conflicts of interest by those
    doing research
IRB changes since 2001

   Requirement for each researcher to
    complete an educational program
       We use CITI, a web-based program
   Potential for audits by the Office of
    Human Research Protection
   HIPAA rules
Types of IRB Review
   Full review
       More than minimal risk
       Requires review and approval (by vote) of a full
        IRB committee
   Expedited
       < minimal risk
       Approved by IRB chair and designated
       Usually approved relatively rapidly
Expedited projects
       Most residents will be doing expedited projects
       Non invasive studies include:
             Review of charts, old x-rays or other imaging studies,
              lab values
             Or invasive studies which use simple blood draws
         Approval is generally rapid
         If changes are needed, we usually communicate
          them by e-mail
         Nevertheless, give your self enough time to deal
          with the IRB minutiae
Categories of expedited review
   Clinical studies on drugs and devices as long
    as the study does not increase risk
   Blood tests, within limits
       From healthy adults >110 pounds
       The amount drawn may not exceed 550 mls over
        an 8 week period and less than 2Xs/week
       Different rules for children
   Biologic specimens collected by non-invasive
    means (scaling of teeth, nail
    clippings, sputum etc.)
         Categories of Expedited
         Review (2)

   Collection of data through non-invasive
    procedures routinely employed in clinical
    practice (excludes x-ray and microwaves)
   Study of materials collected for non-research
       Medical record information (confidentiality important)
   Collection of data by voice recordings, etc.
       IRB must assure that confidentiality is assured
The phenomenon of
continuing review
   All studies must be re-reviewed at least yearly
   The IRB sends a reminder
   Information desired
          Number enrolled
          Problems encountered
          Is the study still appropriate (literature review)
   If the investigator does not respond to our
    reminder, the study will be suspended and
    will be closed
      Some studies are exempt from
      IRB continuing review

   Exempt studies are reviewed by the IRB
    chair, designated as exempt and a letter is sent
    indicating that and the applicable federal Regulation
   Exempt studies do not require continuing review
   Six exempt categories
      Surveys, publicly available tissues or samples, food

       evaluations, educational tests
   Note that any study done in minors, prisoners or other
    special populations cannot be exempt
    Full review projects

   These are generally invasive studies or utilize a new
    drug or drugs.
   In most cases, residents are not involved as a PI in such
    a study
   Such studies are reviewed monthly, but by the
   The studies are reviewed closely by at least three
    committee members and are discussed by the full
   Approval takes much longer, just because of the
    processes involved
What do we review for both
fulll and expedited projects?
   Research design
       Are the objectives clear with sufficient background
        information to justify the study?
       Is there a reasonable statistical plan?
            Does it require more subjects than can reasonably be
       Are risks minimized and reasonable in relationship
        to any potential benefit
   The informed consent
   Are HIPAA requirements met
Informed consent
   If a consent is required, there are a
    number of required elements
   The IRB provides a template at their
    web site which includes the required
   The informed consent must be written
    so that a 10th grader can understand it
       This is very hard!
How should this be reviewed?
   The PI is a physical therapist who wants to
    investigate the effect of a controlled exercise
    program on osteoarthritis of the knee
   Eligible subjects have osteoarthritis and will be
    randomized to their usual activities or a program
    which requires supervised exercise 3 Xs/ week
   All subjects have permission from their MD to
    participate. All will have an x-ray of their knee as
    part of the study and will answer weekly
    questionnaires about quality of life
   Can this be expedited?
        How should this study be
   A dentist is interested in why students chose to
    have oral piercings
   He develops a survey in which high school
    students will be asked a variety of questions incl.
       Do you have any oral piercings?
       Have you ever considered having one?
       Did you have any hesitation about a piercing. If so, what were
        your concerns?
   The survey is anonymous, without an IC
   What kind of review should this be?
What should be in the IC?
   Clear indication that this is research
   Description of what will be done
   Description of risks and benefits
   Indicate that participation is ‘voluntary’
   alternatives to participation and what these are?
   A statement about compensation for potential injury
    is needed.
      Usually the statement says that there is no

    IRB decisions
   Approval without any changes
   Approval pending minor changes
       Most common
       For expedited projects those revisions are usually
        handled by e-mail
   Tabled
       Major questions have been raised about the study
        design, but the study is believed to be worthwhile
   Disapproved (rare)
Other IRB communication
   Once approved, the study must be done
    as described
       Changes to the study or to the informed
        consent need to be approved by the IRB
   Ads must be approved
   Deviations from the proposal need to be
    sent to the IRB
IRB Committees at UB
   Social and Behavioral
       Studies which are not invasive
       Usually cover studies done on the Amherst campus
   Womens and Childrens Hospital
       For those <18 unless emancipated adults
       All studies on pregnancy come to HS-IRB
   Health Sciences IRB
       Invasive studies
       Medical records
       Studies which may have HIPAA issues
HIPAA – Health Insurance
Portability and Accountability
   The law was written to protect individuals
    from losing insurance with a job change
   Congress was supposed to define and
    establish guidelines for medical privacy but
    didn’t get around to it
   Thus the law was written by the Department
    of Health and Human Services
   Clearly it has far reaching effects, particularly
    in research
HIPAA authorization
   Researchers can create PHI, access and
    receive PHI by reviewing records
   If this is being done prospectively, the
    patient must authorize the release of
   The authorization may be included in
    the whole informed consent or be a
    separate document
Waiver from an authorization
   Retrospective medical record review
       If possible, consents from the involved individuals
        are needed
       This is impossible in many cases
            Subject has died or has moved
       A waiver allows you to access that
        information, providing that
            There is a plan to protect the information
            It is coded or somehow secured
            Statement that the research cannot be done without it
            You indicate why obtaining a consent is impossible
De-identified data
   Data that is de-identified, according to
    18 identifiers, is not subject to HIPAA
   But the investigator must get the data
    when it has been de-identified
       Removing identifiers and storing data under a
        secure code doesn’t fulfill the letter of the law
   Institutional Review Boards exist to protect
    participants in research
   IRBs also protect researchers
       Second opinion about research quality
            Is the question worth asking?
            Is the study being done in the safest way?
            Can the question be answered?
            Can it be statistically justified?
       HIPAA concerns are so far manageable, although
        an added burden for many
   Health sciences IRB
       150 Parker Hall
       Phone 829-2752
       Contact: IRB office
       Website:
            www.research.buffalo.edu/humansubjects/IRB/healthsciences

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