Download - Overview of Accreditation Changes
Sara Brand
Associate Director
Research Compliance Administration
Communicate recent changes in policies and procedures from recent AAHRPP re-accreditationDetailed Self-AssessmentAccreditation Site Visit in December 2007Report from Self-Assessment and Site Visit
Necessitated ChangesAccreditation Council meets in March 2008 to
decide outcome
NOTE: This is not a detailed explanation of how the changes will be implemented
New policies and procedures and forms posted on website March 2008
Standard Operating ProceduresMeeting Deadlines
Fridays @ 5:00pmNew Forms
Request Forms for Vulnerable PopulationsContinuing Review FormsNoncompliance Reporting FormIND/IDE Checklists
Human Subjects Research EngagementExamples and Requirements
Section III: Performance Sites III.B – List other facilities where research-related
procedures will be performed (pharmacy, nursing, pathology, etc.) and ensure these entities are adequately informed
Section IV: Subject PopulationQuestions specific to each subject population
removed and included on new request forms“Reasonable expectation of enrollment”
Section VIII: Protection ProceduresClarification re: information the IRB wants to see if
IUPUI is the lead site of a multi-site studySection IX: Data Safety Monitoring Plan
Checkbox for repository/database protocols
Section X: Confidentiality & SafeguardsStudy Manager (data recording/collection method
and measure for safeguarding information)Section XIV: Informed Consent Process
Questions added re: who and how informed consent will be obtained (training, consent interview and consent document language)
Checkboxes for describing steps to minimize possible coercion or undue influence
Clarification re: waivers of informed consent and modifications to consent document
Financial Conflict of Interest section removedSection XX: Investigational Drugs/Devices
Clarification re: when IND or IDE is required
New Request FormsPrisoners, Children, Pregnant Women, Cognitively
ImpairedVA Requirements
No research involving prisoners, pregnant women, or children unless waiver granted by the Chief R&D Officer
Additional questions/requirements re: surrogate consent for incompetent individuals and individuals with impaired decision-making capacity
Research Involving ChildrenAssent/Waiver of Assent: some, all, or no childrenParental Permission/Waiver of Parental PermissionPolicy when a child reaches the legal age of consent
Guidance re: when IND or IDE is requiredIND and IDE Checklists
Guidance when investigator is the holder of the IND or IDE (i.e. sponsor)Formal face-to-face presentationEventual on-line presentation
Validation of IND or IDE NumberSponsor protocol; orCommunication from FDA
RegulationsUnanticipated Problems (45 CFR 46.103(b)(5)
& 21 CFR 56.106(b))Adverse Events (21 CFR 312.32 & 21 CFR
812.3)Guidance
OHRP (Jan 15 2007)FDA (Apr 2007) – Draft
For more info…
OHRP Guidance: http://www.hhs.gov/ohrp/policy/AdvEvntGuid.pdf
FDA Guidance: http://www.fda.gov/cber/gdlns/advreport.pdf
IUPUI/Clarian Policy for Prompt Reporting of UPsAdverse Events: Unexpected, related, greater
risk of harm, revision to protocol/ICOther UPs: Major Protocol Deviations,
Suspensions or HoldsReport on Prompt Reporting FormReport within (5) business days (both internal
and external)If IRB determines internal event represents
UP, report to federal agencies (OHRP, FDA) and other entities, as applicable
IUPUI/Clarian Policy on Prompt Reporting of NoncomplianceReport all noncomplianceReport on Noncompliance Reporting FormReport with (5) business daysIf IRB determines noncompliance to be serious
or continuing, report to federal agencies (OHRP, FDA) and other entities, as applicable
Continuing ReviewStudy not reviewed by expiration date….automatically
suspendedList of subjects given to IRB and COS at VA to
determine if research can continue on current subjectsDetermine Level of Risk
Based on level of risk, IRB determines when patient medical records should be flagged re: participation in research
Minutes will reflect this decisionEnrollment of Non-Veterans
JustificationRegulations pertaining to veterans in research also
pertain to non-veterans enrolled in VA research
Waiver of Consent for Planned Emergency Research is prohibited at the VA
Waiver of Authorization/Informed Consent for RecruitmentOffice of Research Oversight (ORO) Guidance
(10/09/2007)Accessing patient records for recruitment into
research requires the IRB to approve waivers of authorization and informed consent for recruitment (even when accessing own patients’ records
Questions?Questions?