Best Practices for Submitting Implementation and Improvement Protocols for IRB Review John F. Ennever, MD, PhD, CIP Director Human Research Protection Program Office of Human Research Affairs Boston Medical Center and Boston University Medical Campus M EDICAL C AMPUS

Goals of this talk Understand common IRB terms: NHSR, Exempt, Non-exempt Distinguish between Quality Improvement activities that require IRB submission and activities that don’t Lose your fear of the IRB 2

Definition Human subjects research : two parts 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 Research: A systematic investigation designed to develop or contribute to generalizable knowledge 3

“Not human subjects research - NHSR” Studies that meet the previous definitions are human subjects research Studies that do not meet the previous definitions are NHSR NHSR does not require submission to the IRB 4

When is Quality Improvement NHSR? QI always involves “human subjects” but not always “research” Distinction is based on the purpose of the activity. If your project is designed in order to add to the body of generalizable knowledge, then the QI activity IS human subjects research and requires submission to the IRB. 5

If it is submitted to the IRB …. Exempt vs. Non-exempt Research Exempt means it does not require IRB “approval” Fits one of 6 categories (expanded to 10) However, the IRB staff, not you, make this determination (requires submission to the IRB) Non-exempt means it must be approved by the IRB Can be by full board or by chair or designee 6

When is Quality Improvement NHSR? NOT EASY 7

Scenario 1: QI Implementation – NHSR or not? Problem: Significant proportion of patients > 60 not getting recommended pneumococcal vaccine. Activity: Measure for 6 months proportion of outpatient visits of unvaccinated patients > 60 Add Epic alert flagging every encounter with unvaccinated patient > 60 After 6 months of alert use, remeasure 8

NHSR? 9

Why? QI implementation that IS NHSR All “subjects” who get the intervention are expected to benefit The measurements collected are to determine the effect of the process change All “subjects” involved in the intervention receive standard of care at a minimum The intervention meets evidence-based or consensus-based quality standards 10

Why (continued)? QI Implementation that is NOT NHSR The intent of the project is to test a novel hypothesis, answer a research question or replicate another study. The project involves suppressing part of standard of care The intent is to design or develop a new standard of care 11

Scenario 2: QI Implementation – NHSR or not? Problem: Same as Scenario 1 (unvaccinated patients > 60) Activity: Measure for 6 months proportion of outpatient visits of unvaccinated patients > 60 Add Epic alert flagging every encounter with unvaccinated patient > 60 Randomize by MR number alert to Provider or to Medical Assistant After 6 months of alert use, remeasure, compare Provider vs MA 12

NHSR? 13

Scenario 3: QI Development – NHSR or not? Background: Human Papilloma Virus (HPV) sexually-transmitted disease causing cervical and other cancers effective vaccine available HPV vaccine must be administered prior to sexual activity Problem: Providers may have difficulty discussing HPV vaccination with pre-adolescent children and their parents Activity: Develop program to train providers to discuss this sensitive issue, based on published literature 14

NHSR? 15

Scenario 4: QI Development – NHSR or not? Problem: Same as Scenario 3 (hard to discuss HPV vaccination) Activity: Develop program to train providers to discuss this sensitive issue, based on interviews and focus groups with providers, parents and children to obtain qualitative data on communication barriers and common misperceptions surrounding HPV vaccination. 16

NHSR? 17

Summary Quality Improvement activities can be NHSR (no submission to IRB is required) or not (must be submitted to IRB) Characteristics of QI activities that are not NHSR (require IRB submission): o Developing the intervention involves interviews or focus groups o Implementing the intervention involves  Testing a research hypothesis  Altering standard of care 18

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Thank you! 21