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

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the institutional review board

The Institutional Review Board

Monica B. Spaulding, M.D.

Chair-Health Sciences IRB

Professor of Medicine

outline
Outline
  • What is an IRB?
    • Why does it exist
    • What do we do
  • IRB Reviews
    • Full
    • Expedited
  • HIPAA
    • Its impact on your research
what is an institutional review board
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
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
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 1999-2000
major research problems occurred between 1999 2001
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
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
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
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
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
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 representatives
    • Usually approved relatively rapidly
expedited projects
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
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
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 purposes
    • Medical record information (confidentiality important)
  • Collection of data by voice recordings, etc.
    • IRB must assure that confidentiality is assured
the phenomenon of continuing review
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
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
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 committee
  • The studies are reviewed closely by at least three committee members and are discussed by the full committee.
  • Approval takes much longer, just because of the processes involved
what do we review for both fulll and expedited projects
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 enrolled
    • Are risks minimized and reasonable in relationship to any potential benefit
  • The informed consent
  • Are HIPAA requirements met
informed consent
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 elements
  • The informed consent must be written so that a 10th grader can understand it
    • This is very hard!
how should this be reviewed
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 reviewed
How should this study be reviewed?
  • 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
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 compensation
irb decisions
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
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
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
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
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 information
  • The authorization may be included in the whole informed consent or be a separate document
waiver from an authorization
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
De-identified data
  • Data that is de-identified, according to 18 identifiers, is not subject to HIPAA rules
  • 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
conclusion
Conclusion
  • 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
questions
Questions
  • Health sciences IRB
    • 150 Parker Hall
    • Phone 829-2752
    • Contact: IRB office
    • Website:
      • www.research.buffalo.edu/humansubjects/IRB/healthsciences