stanley estime, msci, cip senior qa/qi specialist lisa gabel, cip qa/qi specialist irb...
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Stanley Estime, MSCI, CIPSenior QA/QI Specialist
Lisa Gabel, CIPQA/QI Specialist
IRB Determinations: What type of Review will your study receive?
122AgendaIs Your Project Human Subjects Research?Is Your Project Exempt?Does it Qualify for Expedited Review?Does it Require Full Board Review?Mode of Review Decision TreeHelpful ToolsCase Studies
33Is Your Project Human Subjects Research?Research:A systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Human Subjects:A living individual about whom an investigator (whether professional or student) conducting research obtains:(1) Data through intervention or interaction with the individual, or(2) Identifiable private information-IRB review/determination not required for NHSR, but highly recommended-To obtain a formal written determination, complete Not Human Subjects Research Request Form-If investigators have questions about whether an activity is Human Research, contact the OHRA-Any HSPH affiliate (including students) can submit a request and serve as PI
4Is the Data Identifiable?Coded data is identifiable unless:Codes can be stripped prior to analysisThe PI gets an attestation from the data provider
De-identified/Anonymized dataCannot contain participant codes/IDs if there is a link to identifiable information in existence unless the PI gets an attestation
Coded: Data are separated from personal identifiers through use of a code. As long as a link exists, data are considered indirectly identifiable and not anonymous or anonymized. De-identifiable: Data do not include any identifiers, direct or indirect.Anonymized: Previously identifiable data that have been de-identified and for which a code or other link no longer exists. An investigator would not be able to link anonymized information back to a specific individual. Anonymous: Data that were collected without identifiers and that were never linked to an individual. Coded data are not anonymous.
5Is Your Project Exempt?Study procedures must fit within Exemption category(ies)Research conducted with children cannot be exempt under b(2) unless activities are limited to observation without investigator interactionResearch conducted with prisoners is not eligible Research regulated by FDA is not eligible
Investigators MUST obtain an IRB exemption determination prior to conducting Human Research
No long-form consent document required; however, process to obtain consent must be in place:That the project is researchThat participation is voluntaryA brief description of the study proceduresInvestigator name and contact information5-Investigators MUST obtain an IRB exemption determination prior to conducting Human ResearchComplete the Exemption Request Form -Any HSPH affiliate (including students) can act as PI on exempt research
66Exemption Categories, examplesResearch conduced in commonly accepted educational settings, involving normal educational practicesSurveys, interviews, observation of public behavior Surveys, interviews, observation of public behavior if participants are public officialsCollection of existing data, documents, specimensEvaluation of public benefit or service programs, etc. subject to approval of Department or Agency headsTaste and food quality evaluation and consumer acceptance7Common Exemption CategoriesCategory #2Use of educational tests, survey procedures, interview procedures (e.g. focus groups) or observation of public behavior If information is recorded in a manner that human subjects cannot be identified, directly or through identifiers linked to the subjects; ORIf human subjects can be identified, any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation
*No Minors unless limited to observation of public behavior.88Common Exemption CategoriesCategory #4Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources arePublicly available or Recorded with no identifiers (no links)Examples of links to identifiers that make a study not exempt:Hospital patient IDStudent IDPhone number
99Does it Qualify for Expedited Review?Expeditable research activities must:Present no more than minimal risk to human subjects, ANDInvolve only study procedures published in the Federal Register (see handout)
If research is deemed greater than minimal risk and/or does not fit under the expeditable categories, Full Board review is required.10Minimal RiskThe 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.1111Expedited categories, examplesSome clinical studies of drugs and medical devices Routine collection of blood samples in healthy participants (