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IRB Assessment and Management of QI Projects H. Edward Davidson, PharmD, MPH Assistant Professor, Clinical Internal Medici...
Objectives <ul><li>Review relevant terminology regarding quality improvement (QI) project review </li></ul><ul><li>Describ...
Definitions <ul><li>Research:   A systematic investigation including research development, testing and evaluation designed...
What is a “Human Subject”  <ul><li>A living individual about whom an investigator … conducting research obtains </li></ul>...
Institutional Review Board <ul><li>Administrative bodies established to protect the rights and welfare of human research p...
Research & QI Part of the continuum of change in healthcare <ul><li>Clinical Practice </li></ul><ul><li>Adaptation, innova...
Research Vs. Quality Improvement Beyea SC. AORN J 1998. - Generally not required - Must be obtained if human subjects are ...
Research Vs. Quality Improvement (cont.) Beyea SC. AORN J 1998. - Used by the specific institution or organization - Prese...
The Basics of IRB Review  for a QI Project
Level of Risk Determines Level of IRB Review Minimal Risk Full IRB Committee Review Expedited Review Exempt from Review Mo...
Definition of Minimal Risk in CFR  <ul><li>…  the probability and magnitude of harm or discomfort … are not greater … than...
Scope of IRB Review <ul><li>All research that uses </li></ul><ul><ul><li>Human subjects </li></ul></ul><ul><ul><li>Tissues...
Levels of IRB Evaluation <ul><li>Evaluation for involvement of human subjects </li></ul><ul><li>Exempt from regulations ad...
Evaluation for Involvement of Human Subjects <ul><li>IRB has oversight authority to determine if a study can be classified...
Human Subject Regulations Decision Charts
Research that Qualifies for Exempt Status <ul><li>Research in educational settings involving normal education practices </...
Exempt Status (cont.) <ul><li>Collection/study of existing data, documents, records, pathological/diagnostic specimens if ...
Exempt <ul><li>Research in educational settings involving normal education practices </li></ul><ul><li>Educational tests, ...
Research that Qualifies for Expedited Status <ul><li>Clinical studies of drug or devices when an IND or IDE are not requir...
Expedited Status (cont.) <ul><li>Research involving material that have been collected, or will be collected solely for non...
Expedited <ul><li>Clinical drug/device studies not needing IND or IDE </li></ul><ul><li>Collection of blood samples, or pr...
Waivers <ul><li>Waiver of consent </li></ul><ul><li>Waiver of authorization for the use of Protected Health Information (P...
Waivers <ul><li>Can waive consent </li></ul><ul><ul><li>If no more than minimal risk, AND not adversely affecting rights/w...
Exception from Requirement for Informed Consent <ul><li>An IRB may waive consent requirement or alter consent element if i...
Waiver of Authorization for the Use of PHI Justification <ul><li>Provide a brief description of the specific PHI to which ...
Waiver of Authorization for the Use of PHI Justification (cont.) <ul><li>The use or disclosure of PHI involves no more tha...
PHI Identifiers <ul><li>Name </li></ul><ul><li>Addresses </li></ul><ul><li>Zip codes </li></ul><ul><li>Dates except years ...
Institutional Assurance <ul><li>Institutional Assurances of Protection for Human Subjects </li></ul><ul><li>Institution’s ...
Case Study in QI Research
Study Design and IRB <ul><li>A prospective cohort study of 5 evidence-based procedures recommended by the CDC to reduce ri...
OHRP Actions/Findings <ul><li>Anonymous complaint to OHRP after publication </li></ul><ul><li>Project suspended (only the ...
Disagreement on IRB Role <ul><li>“ I think it is very maddening. The OHRP has created an impossible situation. Why would O...
Controversies
Publication – ICMJE Requirements http://www.icmje.org/index.html#publish
ICMJE Publication Requirements <ul><li>Protection of human subjects in research </li></ul><ul><ul><li>Indicate procedures ...
Rigor in QI Methods <ul><li>Eccles M et al. Qual Saf Health Care 2003 </li></ul><ul><li>“ The methods of evaluating change...
Policy Options <ul><li>Establish separate committee to review QI projects </li></ul><ul><ul><li>Usually a subcommittee of ...
Suggested Reading <ul><li>Lynn J et al. The ethics of using quality improvement methods in health care. Ann Intern Med 200...
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Qi Irb Presentation

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This is a presentation that describes the IRB requirements for quality imprevement projects

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Qi Irb Presentation

  1. 1. 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
  2. 2. Objectives <ul><li>Review relevant terminology regarding quality improvement (QI) project review </li></ul><ul><li>Describe how to categorize a QI project for IRB submission </li></ul><ul><li>Present a case study </li></ul><ul><li>Explore current controversies surrounding this topic </li></ul>
  3. 3. Definitions <ul><li>Research: A systematic investigation including research development, testing and evaluation designed to develop or contribute to generalizable knowledge (45 CFR 46.102) </li></ul><ul><li>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 2007;146:666-73. </li></ul>
  4. 4. What is a “Human Subject” <ul><li>A living individual about whom an investigator … conducting research obtains </li></ul><ul><ul><li>data through intervention or interaction with the individual, or </li></ul></ul><ul><ul><li>identifiable private information. </li></ul></ul><ul><li>45 CFR 46.102(f) </li></ul>
  5. 5. Institutional Review Board <ul><li>Administrative bodies established to protect the rights and welfare of human research participants </li></ul><ul><li>Have the authority for all research activities to: </li></ul><ul><ul><li>Approve or disapprove </li></ul></ul><ul><ul><li>Require modifications </li></ul></ul><ul><ul><li>Assess violations </li></ul></ul><ul><ul><li>Investigate subject complaints </li></ul></ul><ul><ul><li>Conduct continuing reviews </li></ul></ul>
  6. 6. Research & QI Part of the continuum of change in healthcare <ul><li>Clinical Practice </li></ul><ul><li>Adaptation, innovation </li></ul><ul><li>At the individual patient </li></ul><ul><li>level </li></ul><ul><li>Quality Improvement </li></ul><ul><li>Systematic experiential </li></ul><ul><li>learning </li></ul><ul><li>Operational context </li></ul><ul><li>Rapid feedback of trends </li></ul><ul><li>that shape changes </li></ul><ul><li>Clinical Research </li></ul><ul><li>Distinct from clinical care </li></ul><ul><li>Designed to contribute to </li></ul><ul><li>scientific knowledge </li></ul>
  7. 7. Research Vs. Quality Improvement Beyea SC. AORN J 1998. - Generally not required - Must be obtained if human subjects are involved (or justified to waive) Informed consent - Examines internal institution/process-specific issues - May be generalizable to other patients, situations, settings Scope - Examines internal processes and guides actions toward improvement - Generates new knowledge - Tests hypotheses Purpose QI Research Component
  8. 8. Research Vs. Quality Improvement (cont.) Beyea SC. AORN J 1998. - Used by the specific institution or organization - Presented and available to others Results - Available patients or subpopulation of patients - Based on research purpose, study design, power analysis, and statistical models Subject selection - Focuses on processes <ul><li>Scientific framework </li></ul><ul><li>Well-controlled </li></ul>Design QI Research Component
  9. 9. The Basics of IRB Review for a QI Project
  10. 10. Level of Risk Determines Level of IRB Review Minimal Risk Full IRB Committee Review Expedited Review Exempt from Review More than Minimal Risk
  11. 11. Definition of Minimal Risk in CFR <ul><li>… the probability and magnitude of harm or discomfort … are not greater … than those ordinarily encountered in daily life* or during the performance of routine physical or psychological examinations or tests </li></ul>45 CFR 46.1029(i) *Daily lives of the subjects of the research, not healthy individuals
  12. 12. Scope of IRB Review <ul><li>All research that uses </li></ul><ul><ul><li>Human subjects </li></ul></ul><ul><ul><li>Tissues/specimens from humans </li></ul></ul><ul><ul><li>Data/records from humans </li></ul></ul><ul><li>Quality assurance, quality improvement, and program evaluations that involve human subjects </li></ul>
  13. 13. Levels of IRB Evaluation <ul><li>Evaluation for involvement of human subjects </li></ul><ul><li>Exempt from regulations addressing IRB review </li></ul><ul><li>Expedited IRB review </li></ul><ul><li>Full board (convened) review </li></ul>
  14. 14. Evaluation for Involvement of Human Subjects <ul><li>IRB has oversight authority to determine if a study can be classified as “Not Human Subjects Research” </li></ul><ul><li>These projects may be: </li></ul><ul><ul><li>“research” by definition, however they do not involve human subjects, or </li></ul></ul><ul><ul><li>Other projects such as quality assurance or program evaluation that do not meet the definition of “research” </li></ul></ul>
  15. 15. Human Subject Regulations Decision Charts
  16. 16. Research that Qualifies for Exempt Status <ul><li>Research in educational settings involving normal education practices </li></ul><ul><li>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 </li></ul><ul><li>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 </li></ul>
  17. 17. Exempt Status (cont.) <ul><li>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 </li></ul><ul><li>Federal department/agency research and demonstration projects evaluating public benefit programs </li></ul><ul><li>Taste and food quality evaluation and consumer acceptance studies </li></ul>
  18. 18. Exempt <ul><li>Research in educational settings involving normal education practices </li></ul><ul><li>Educational tests, survey procedures, interview procedures, or observing public behavior unless subjects can be identified and disclosure places subjects at risk or criminal and civil liability </li></ul><ul><li>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 </li></ul>
  19. 19. Research that Qualifies for Expedited Status <ul><li>Clinical studies of drug or devices when an IND or IDE are not required </li></ul><ul><li>Collection of blood samples </li></ul><ul><li>Prospective collection of biological specimens for research purposes by non-invasive means </li></ul><ul><li>Collection of data through noninvasive procedures routinely employed in clinical practice (excluding x-rays or microwaves) </li></ul>
  20. 20. Expedited Status (cont.) <ul><li>Research involving material that have been collected, or will be collected solely for non-research purposes </li></ul><ul><li>Collection of data from voice, video, digital, or image recording made for research purposes </li></ul><ul><li>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 </li></ul>
  21. 21. Expedited <ul><li>Clinical drug/device studies not needing IND or IDE </li></ul><ul><li>Collection of blood samples, or prospective non-invasive collection of biological specimens for research </li></ul><ul><li>Non-invasive data collection using procedures routine to clinical practice (except XR or microwaves) </li></ul><ul><li>Collection of data from voice, video, digital, or image recording made for research purposes </li></ul><ul><li>Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation human factors evaluation, or QA methodologies </li></ul>
  22. 22. Waivers <ul><li>Waiver of consent </li></ul><ul><li>Waiver of authorization for the use of Protected Health Information (PHI) </li></ul>
  23. 23. Waivers <ul><li>Can waive consent </li></ul><ul><ul><li>If no more than minimal risk, AND not adversely affecting rights/welfare, AND cannot practicably carry out the research without waiver/alteration </li></ul></ul><ul><ul><li>May need to provide info to subjects later </li></ul></ul><ul><li>Can justify waiving authorization for the use of Protected Health Information (PHI) </li></ul><ul><ul><li>Must provide description of PHI to be accessed AND cannot practicably carry out research without to and use of PHI NOR waiver AND <= minimal risk </li></ul></ul><ul><ul><ul><li>Plan to protect, ASAP destroy PHI, and not re-use it </li></ul></ul></ul>
  24. 24. Exception from Requirement for Informed Consent <ul><li>An IRB may waive consent requirement or alter consent element if it finds and documents that: </li></ul><ul><li>Research involves no more than minimal risk; </li></ul><ul><li>Rights and welfare of subjects will not be adversely affected; </li></ul><ul><li>Research could not be practicably carried out without waiver or alteration; and </li></ul><ul><li>When appropriate, the subjects will be provided pertinent information after participation. </li></ul>
  25. 25. Waiver of Authorization for the Use of PHI Justification <ul><li>Provide a brief description of the specific PHI to which you are requesting access </li></ul><ul><li>The research could not practically be conducted without access to and use of the PHI </li></ul><ul><li>The research could not practicably be conducted without the alteration or waiver </li></ul>
  26. 26. Waiver of Authorization for the Use of PHI Justification (cont.) <ul><li>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: </li></ul><ul><ul><li>An adequate plan to protect the identifiers from improper use/disclosure </li></ul></ul><ul><ul><li>An adequate plan to destroy the identifiers at the earliest opportunity consistent with the conduct of the research </li></ul></ul><ul><ul><li>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 </li></ul></ul>
  27. 27. PHI Identifiers <ul><li>Name </li></ul><ul><li>Addresses </li></ul><ul><li>Zip codes </li></ul><ul><li>Dates except years </li></ul><ul><li>Telephone #s </li></ul><ul><li>Fax #s </li></ul><ul><li>VIN #s </li></ul><ul><li>URLs </li></ul><ul><li>Biometric identifiers </li></ul><ul><li>Email addresses </li></ul><ul><li>SS# </li></ul><ul><li>Medical record # </li></ul><ul><li>Health plan beneficiary #s </li></ul><ul><li>Account #s </li></ul><ul><li>Certificate/license #s </li></ul><ul><li>Device ID & serial #s </li></ul><ul><li>Full face photo images </li></ul><ul><li>Internet protocol #s </li></ul><ul><li>Any other unique identifying #, characteristic or code </li></ul>45 CFR 64.514(b)(2)
  28. 28. Institutional Assurance <ul><li>Institutional Assurances of Protection for Human Subjects </li></ul><ul><li>Institution’s “contract” with the Department of Health and Human Services </li></ul><ul><ul><li>Institution stipulates it will abide by 21CFR56 and 45CFR46 </li></ul></ul><ul><ul><li>Federal Wide Assurance (FWA) </li></ul></ul>
  29. 29. Case Study in QI Research
  30. 30. Study Design and IRB <ul><li>A prospective cohort study of 5 evidence-based procedures recommended by the CDC to reduce risk of catheter-related blood stream infections </li></ul><ul><li>The study was approved by the Johns Hopkins University School of Medicine IRB </li></ul><ul><ul><li>Informed consent was waived because the study was considered exempt from review </li></ul></ul>
  31. 31. OHRP Actions/Findings <ul><li>Anonymous complaint to OHRP after publication </li></ul><ul><li>Project suspended (only the submission of data from Michigan hospitals to JHU – no FWA) </li></ul><ul><li>OHRP ruled project not exempt </li></ul><ul><li>JHU and MHA revised procedures/policies and project re-reviewed by JHU – was approved as expedited with waiver of consent </li></ul><ul><li>Data transmission allowed to be re-instated </li></ul>
  32. 32. Disagreement on IRB Role <ul><li>“ I think it is very maddening. The OHRP has created an impossible situation. Why would OHRP want to tie QI researchers up in knots?” </li></ul><ul><li>“ It comes down to evaluating the level of risk to patients…And there needs to be someone, somewhere in the process evaluating the risk to patients of each intervention.” </li></ul>
  33. 33. Controversies
  34. 34. Publication – ICMJE Requirements http://www.icmje.org/index.html#publish
  35. 35. ICMJE Publication Requirements <ul><li>Protection of human subjects in research </li></ul><ul><ul><li>Indicate procedures followed standards in Helsinki Declaration </li></ul></ul><ul><ul><li>Demonstrate IRB approval of any doubtful study aspects </li></ul></ul>http://www.icmje.org/index.html#publish
  36. 36. Rigor in QI Methods <ul><li>Eccles M et al. Qual Saf Health Care 2003 </li></ul><ul><li>“ The methods of evaluating change and improvement strategies are not well described. The general principle under-lying the choice of evaluative design is, however, simple—those conducting such evaluations should use the most robust design possible to minimize bias and maximize generalizability.” </li></ul><ul><li>Speroff T et al. Qual Manag Health Care 2004 </li></ul><ul><li>“ 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.” </li></ul>
  37. 37. Policy Options <ul><li>Establish separate committee to review QI projects </li></ul><ul><ul><li>Usually a subcommittee of the IRB </li></ul></ul><ul><li>Follow usual IRB guidelines and submission process for all projects </li></ul>
  38. 38. Suggested Reading <ul><li>Lynn J et al. The ethics of using quality improvement methods in health care. Ann Intern Med 2007;146:666-73. </li></ul><ul><li>Klepser ME et al. Ethical issues related to clinical, translational, and health system research. Pharmacotherapy 2008;28:229-43. </li></ul><ul><li>Neff MJ. Institutional review board consideration of chart reviews, case reports, and observational studies. Respir Care 2008;53:1350-53. </li></ul>

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