IRB Assessment and Management of QI Projects

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IRB Assessment and Management of QI Projects

• H. Edward Davidson, PharmD, MPH
• Assistant Professor, Clinical Internal Medicine
• Glennan Center for Geriatrics and Gerontology
• Eastern Virginia Medical School
• Partner, Insight Therapeutics, LLC

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Objectives

• Review relevant terminology regarding quality
  improvement (QI) project review
• Describe how to categorize a QI project for IRB
  submission
• Present a case study
• Explore current controversies surrounding this
  topic

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Definitions

• Research A systematic investigation including
  research development, testing and evaluation
  designed to develop or contribute to
  generalizable knowledge (45 CFR 46.102)
• Quality improvement A systematic, data-guided
  activity designed to bring about immediate
  improvement in health care delivery in a local
  setting. Lynn J et al. Ann Intern Med
  2007146666-73.

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Definition of Human Subject

• A living individual about whom an investigator
  conducting research obtains (1) data through
  intervention or interaction with the individual,
  or (2) identifiable private information.
• 45 CFR 46.102(f)

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Institutional Review Board

• Administrative bodies established to protect the
  rights and welfare of human research participants
• Have the authority for all research activities
  to
• Approve or disapprove
• Require modifications
• Assess violations
• Investigate subject complaints
• Conduct continuing reviews

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Research QI
Part of the continuum of change in healthcare

• Quality Improvement
• Systematic experiential
• learning
• Operational context
• Rapid feedback of trends
• that shape changes

• Clinical Research
• Distinct from clinical care
• Designed to contribute to
• scientific knowledge

• Clinical Practice
• Adaptation, innovation
• At the individual patient
• level

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There is a Grey Area
Quality Improvement
Research
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Research Vs. Quality Improvement
Component Research QI
Purpose - Generates new knowledge - Tests hypotheses - Examines internal processes and guides actions toward improvement
Scope - May be generalizable to other patients, situations, settings - Examines internal institution/process-specific issues
Informed consent - Must be obtained if human subjects are involved (or justified to waive) - Generally not required
Beyea SC. AORN J 1998.
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Research Vs. Quality Improvement (cont.)
Component Research QI
Design Scientific framework Well controlled - Focuses on processes
Subject selection - Based on research purpose, study design, power analysis, and statistical models - Available patients or subpopulation of patients
Results - Presented and available to others - Used by the specific institution or organization
Beyea SC. AORN J 1998.
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The Basics of IRB Review for a QI Project
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Level of Risk Determines Level of IRB Review
More than Minimal Risk
Full IRB Committee Review
Expedited Review
Minimal Risk
Exempt from Review
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Definition of Minimal Risk in Subpart A of Code
of Federal Regulations

• Minimal risk means that the probability and
  magnitude of harm or discomfort anticipated in
  the research are not greater in and of themselves
  than those ordinarily encountered in daily life
  or during the performance of routine physical or
  psychological examinations or tests

Daily lives of the subjects of the research, not
healthy individuals
45 CFR 46.1029(i)
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Which is greater?

• Risk of harm or discomfort anticipated in the
  research

OR

• Risk of harm or discomfort ordinarily encountered
  in daily life

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Scope of IRB Review

• All research that uses
• Human subjects
• Tissues/specimens from humans
• Data/records from human subjects
• Quality assurance, quality improvement, and
  program evaluations have the potential to involve
  human subjects and therefore are subject to IRB
  oversight

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Four Levels of IRB Evaluation

1. Evaluation for involvement of human subjects
2. Exempt from regulations addressing IRB review
3. Expedited IRB review
4. Full board (convened) review

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Evaluation for Involvement of Human Subjects

• IRB has oversight authority to determine if a
  study can be classified as Not Human Subjects
  Research
• These projects may be
• research by definition, however they do not
  involve human subjects, or
• Other projects such as quality assurance or
  program evaluation that do not meet the
  definition of research

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Human Subject Regulations Decision Charts
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Research that Qualifies for Exempt Status

• Research in educational settings involving normal
  education practices
• Educational tests, survey procedures, interview
  procedures, or observing public behavior unless
  subjects can be identified and disclosure places
  subjects at risk of criminal and civil liability
• Educational tests, survey procedures, interview
  procedures, or observing public behavior unless
  subjects are elected/appointed or candidates for
  public office and federal statue requires
  maintenance of confidentiality

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Exempt Status (cont.)

• Collection/study of existing data, documents,
  records, pathological/diagnostic specimens if
  these sources are publically available or if the
  information is recorded in such a way that
  subjects cannot be identified
• Federal department/agency research and
  demonstration projects evaluating public benefit
  programs
• Taste and food quality evaluation and consumer
  acceptance studies

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Research that Qualifies for Expedited Status

• Clinical studies of drug or devices when an IND
  or IDE are not required
• Collection of blood samples
• Prospective collection of biological specimens
  for research purposes by non-invasive means
• Collection of data through noninvasive procedures
  routinely employed in clinical practice
  (excluding x-rays or microwaves)

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Expedited Status (cont.)

• Research involving material that have been
  collected, or will be collected solely for
  non-research purposes
• Collection of data from voice, video, digital, or
  image recording made for research purposes
• Research on individual or group characteristics
  or behavior or research employing survey,
  interview, oral history, focus group, program
  evaluation human factors evaluation, or quality
  assurance methodologies

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Waivers

• Waiver of consent
• Waiver for authorization for the use of Protected
  Health Information (PHI)

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Exception from Requirement for Informed Consent

• An IRB may waive consent requirement or alter
  consent element if it finds and documents that
• Research involves no more than minimal risk
• Rights and welfare of subjects will not be
  adversely affected
• Research could not be practicably carried out
  without waiver or alteration and
• When appropriate, the subjects will be provided
  pertinent information after participation.

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Waiver of Authorization for the Use of PHI
Justification

• Provide a brief description of the specific PHI
  to which you are requesting access
• The research could not practically be conducted
  without access to and use of the PHI
• The research could not practicably be conducted
  without the alteration or waiver

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Waiver of Authorization for the Use of PHI
Justification (cont.)

• The use or disclosure of PHI involves no more
  than minimal risk to the individuals, based on,
  at least, the presence of the following elements
• An adequate plan to protect the identifiers from
  improper use/disclosure
• An adequate plan to destroy the identifiers at
  the earliest opportunity consistent with the
  conduct of the research
• Adequate written assurance that PHI will not be
  reused/disclosed to any other person or entity,
  except as required by law, for authorized
  oversight of the research project

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Items to Exclude for De-identification

• ? Names ? E-mail address
• ? Addresses ? SS
• ? Zip codes ? Medical Record
• ? Dates except years ? Health plan beneficiary
  s
• ? Telephone s ? Account s
• ? Fax s ? Certificate/license s
• ? VIN s ? Device ID serial s
• ? URLs ?Full face photo images
• ? biometric identifiers ? internet protocol
  address s
• ? any other unique identifying , characteristic
  or code

45 CFR 64.514(b)(2)
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Institutional Assurance

• Institutional Assurances of Protection for Human
  Subjects
• Institutions contract with the Department of
  Health and Human Services
• Institution stipulates it will abide by 21CFR56
• Federal Wide Assurance (FWA)

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Case Study in QI Research
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Study Design

• A prospective cohort study of 5 evidence-based
  procedures recommended by the CDC and identified
  as having the greatest effect on the rate of
  catheter-related blood stream infections and the
  lowest barriers to implementation.

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Ethical Review

• The study was approved by the institutional
  review board of Johns Hopkins University School
  of Medicine. Informed consent was waived because
  the study was considered exempt from review.

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OHRP Actions/Findings

• An anonymous complaint was made to OHRP after the
  publication of the article
• Project was suspended (only the submission of
  data from Michigan hospitals to JHU)
• OHRP ruled project not exempt
• Participating hospitals in Michigan did not have
  FWA
• JHU and MHA revised procedures/policies and
  project re-reviewed by JHU was approved as
  expedited with waiver of consent
• Data transmission allowed to be re-instated

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Disagreement on IRB Role

• I think it is very maddening. The OHRP has
  created an impossible situation. Why in heavens
  name would the OHRP want to tie QI researchers up
  in knots?
• It comes down to evaluating the level of risk to
  patientsAnd there needs to be someone, somewhere
  in the process evaluating the risk to patients of
  each intervention.

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Controversies
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Publication ICMJE Requirements
http//www.icmje.org/index.htmlpublish
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Rigor in QI Methods

• Eccles M, Grimshaw J, Campbell M, Ramsay C.
  Research designs for studies evaluating the
  effectiveness of change and improvement
  strategies Qual Saf Health Care 20031247-52
• The methods of evaluating change and
  improvement strategies are not well described.
  The general principle under-lying the choice of
  evaluative design is, however, simplethose
  conducting such evaluations should use the most
  robust design possible to minimize bias and
  maximize generalizability.
• Speroff T, OConnor GT. Study designs for PDSA
  quality improvement research. Qual Manag Health
  Care 20041317-32.
• Improving the rigor of the quality improvement
  literature will build a stronger foundation and
  more convincing justification for the study and
  practice of quality improvement in health care.

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Policy Options

• Establish separate committee to review QI
  projects
• Usually a subcommittee of the IRB
• Follow usual IRB guidelines and submission
  process for all projects

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Suggested Reading

• Lynn J et al. The ethics of using quality
  improvement methods in health care. Ann Intern
  Med 2007146666-73.
• Klepser ME et al. Ethical issues related to
  clinical, translational, and health system
  research. Pharmacotherapy 200828229-43.
• Neff MJ. Institutional review board consideration
  of chart reviews, case reports, and observational
  studies. Respir Care 2008531350-53.