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IRB Triage:. What Path Do I Follow? IRB Administrators 2012 PRIDE/ Theresa M. Straut, CIP, RAC. May 30, 2012. Incoming. Or. One key to managing workload: Triage. Recognizing the correct review path can save time and potentially reduce regulatory burden. - PowerPoint PPT Presentation

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IRB Triage: What path do I follow?

IRB Triage:What Path Do I Follow?

IRB Administrators 2012PRIDE/ Theresa M. Straut, CIP, RACMay 30, 20121Incoming

#Or

#One key to managing workload: TriageRecognizing the correct review path can save time and potentially reduce regulatory burden. Standardized forms can guide submitters, however, forms can be answered incorrectly.

Recognize if you have enough information to make a determination.

#With help text4Review submissions to determine:Is it Research?Is it Human Subjects Research?Is it exempt?Is the study expeditable?

#Recognizing the correct pathway early can aid in faster turn around times and less burden for the IRB. Answer the questions in this orde5Where to begin:Is this project Research?Common Rule Definition of Research:Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge [38 CFR 16.102(d)]

#A systematic investigation is a project that is planned in advance and that uses data collection and analysis to answer a questionGeneralizable knowledge is information that expands the knowledge base of a scientific discipline or other scholarly field of study. [VHA handbook 1058.05 par 4]#Although research must include systematic investigation, non-research operations activities also include systematic investigation to ensure reliable outcomes. Systematic investigation does not, in and of itself, define research. NOTE: Examples of systematic investigations that may or may not constitute research, include (but are not limited to) activities involving questionnaires or surveys; observations; focus groups; interviews; analyses of existing data; analyses of biological specimens; medical chart reviews; epidemiologic reviews or analyses; program evaluations; and quality assessment, quality improvement, and quality management.

7Project is Not Research if: Designed and implemented for VA purposes, andIs not designed to produce information that expands the knowledge base of a scientific discipline or other scholarly field. [VHA handbook 1058.05 par 5]

#Routine data collection and analyses associated with VA activities do not typically constitute research, in and of themselves.HRPP 101 VA PRIDE/COACHWashington, DC

Research, Human Subjects Research, Exemptions, Expedited Review, and Engagement8Examples of Not ResearchQuality ImprovementCompetence or qualification reviews of VA employees and health care professionalsBusiness planning and development, such as cost-management and planning analysesCase studies

Additional examples are in VHA handbook 1058.05

#9Project is Always Research if: Funded or supported as research

Clinical investigations as defined under Food and Drug Administration (FDA) regulations.

[VHA Handbook 1058.05, par. 5d]

#HRPP 101 VA PRIDE/COACHWashington, DC

Research, Human Subjects Research, Exemptions, Expedited Review, and Engagement10Probable Research Design CharacteristicsStratification, Matched pairs, Double blinding, PlaceboAssessment of an intervention that is not yet standard or accepted practiceComparison of two or more interventionsCollection of clinical information that is not medically necessaryInterventions not designed for direct patient benefit[[VHA Handbook 1058.05, par. 5e]

#HRPP 101 VA PRIDE/COACHWashington, DC

Research, Human Subjects Research, Exemptions, Expedited Review, and Engagement11If Research, does it involve Human Subjects? Common Rule Definition of Human Subject: Human subject means a living individual about whom an investigator conducting research obtains(1) data through intervention or interaction, or(2) identifiable private information

[38 CFR 16.102(f)]

#HRPP 101 VA PRIDE/COACHWashington, DC

Research, Human Subjects Research, Exemptions, Expedited Review, and Engagement12If Research, does it involve Human Subjects?Common Rule Definition of Human Subject (continued):

An intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subjects environment that are performed for research purposes

Interaction includes communication or interpersonal contact between investigator and subject [38 CFR 16.102(f)]

#HRPP 101 VA PRIDE/COACHWashington, DC

Research, Human Subjects Research, Exemptions, Expedited Review, and Engagement13If Research, does it involve Human Subjects?Common Rule Definition of Human Subject (continued):Private information includes information about:Behavior in which an individual can reasonably expect that no observation or recording is taking place, and Information provided for specific purposes which the individual can reasonably expect will not be made public (e.g., medical record)

[38 CFR 16.102(f)]

#HRPP 101 VA PRIDE/COACHWashington, DC

Research, Human Subjects Research, Exemptions, Expedited Review, and Engagement14If Research, does it involve Human Subjects?Common Rule Definition of Human Subject (continued):Private information must be individually identifiable to constitute research involving human subjects (identity of the subject is or may readily be ascertained by the investigator or associated with the information)

[38 CFR 16.102(f)]

#HRPP 101 VA PRIDE/COACHWashington, DC

Research, Human Subjects Research, Exemptions, Expedited Review, and Engagement15If it is human subjects research, is it exempt?Exempt: Research activities in which the only involvement of human subjects will be in one or more of the categories outlined in 38 CFR 16.101(b) may be exempt from the provisions of VHA Handbook 1200.05 and the Common Rule.The exempt status must be determined by the Institutional Review Board (IRB) Chair or an IRB voting member designated by the Chair

[VHA Handbook 1200.05 par. 16]#Exempt research includes research activities in which the only involvement of human subjects is in one or more of the categories listed in 38 CFR 16.101(b). The exempt status must be determined by the Institutional Review Board (IRB) Chair or an IRB voting member designated by the Chair (see par. 16). NOTE: Such an exemption applies only to requirements found in 38 CFR Part 16. All other relevant VA and Federal requirements apply.

Early recognition of a potentially exempt study will aid in reducing timelines and regulatory burden.HRPP 101 VA PRIDE/COACHWashington, DC

Research, Human Subjects Research, Exemptions, Expedited Review, and Engagement16Categories of Exempt Research*[See full text @ 38 CFR 16.101(b)]Research conducted in established/commonly accepted educational settings, involving normal educational practices**Research involving educational tests, surveys, interviews, or observation of public behavior unless identifiable and sensitive/riskySame as #2, but covers public officials/candidates and confidentiality maintainedExisting data, documents, records, pathologic specimens, or diagnostic specimens (if publicly available, or recorded by investigator so participants cannot be identified)Research and demonstration project (if approved by VA Secretary)Taste and food evaluation/consumer acceptance with conditions* None apply to research with prisoners**Exception with children as subject (e.g., no surveys)

#HRPP 101 VA PRIDE/COACHWashington, DC

Research, Human Subjects Research, Exemptions, Expedited Review, and Engagement17Can Human Subjects Research be Reviewed by an Expedited process?1.Must fit one or more of the expedited review categories, and be no more than minimal risk-OR-2.Minor changes in previously approved research during the period for which the approval is authorized [38 CFR 16.110]18#HRPP 101 VA PRIDE/COACHWashington, DC

Research, Human Subjects Research, Exemptions, Expedited Review, and Engagement18What is Minimal Risk?

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 tests38 CFR 16.102(i)

SACHRP : Understanding Minimal Risk (case examples)www.hhs.gov/ohrp/sachrp/sachrpminrisk20080131.html #HRPP 101 VA PRIDE/COACHWashington, DC

Research, Human Subjects Research, Exemptions, Expedited Review, and Engagement19Expedited Categories(See VHA Handbook 1200.05 for Full Text) Some clinical studies of drugs and medical devices Collection of blood (limited by volume and frequency) Prospective collection of specimens by noninvasive means Noninvasive collection of data (excluding x-rays) Materials collected for non-research purposes Voice, video, digital, or image recordings Group Characteristics, Surveys, Interviews, and Quality Assurance8-9. Continuing review under specific conditions#HRPP 101 VA PRIDE/COACHWashington, DC

Research, Human Subjects Research, Exemptions, Expedited Review, and Engagement20The Old Glory VA Medical Center establishes a special geriatric clinicOld Glory implements a process to refer patients for special services (e.g., vision care, physical therapy)For internal quality assurance, Nurse Nicols audits patient charts to evaluate whether the referral process is working He surveys patients to evaluate their satisfaction

Case Study # 1#HRPP 101 VA PRIDE/COACHWashington, DC

Research, Human Subjects Research, Exemptions, Expedited Review, and Engagement21Is the nurse conducting a systematic investigation? Yes Activity planned in advanceActivity uses data collection and analysis to answer a questionIs this activity designed to develop or contribute to generalizable knowledge? NoActivity is for internal operationsWill not expand the sc

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