Recap of Changes to VHA Directives 1200.05 and 1200.01

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Recap of Changes to VHA Directives1200 05 and 1200 01I RB an d R D C ommi tte e Works h opAugust 20 21 2019Soundia Duche MA MS.
Chief Education and Training Objectives Highlight Significant New Responsibilities andRequirements outlined in VHA Directive 1200 05 Highlight Significant New Responsibilities and.
Requirements outlined in VHA Directive 1200 01 Provide a list of available ORD resources forimplementing changes in VHA Directives 1200 05and 1200 01Policy that is under consideration for revision.
VHA Directives 1200 05 and 1200 01 VHA Directive 1200 05 Requirements for the Protection ofHuman Subjects in Research published January 7 2019 All requirements are enforceable VHA Directive 1200 01 Research and Development.
Committee published January 24 2019 All requirements enforceable as of May 1 2019 except for thefollowing which will be enforceable on January 20 2020 Establishment of a Research and Development Committee Conflictof Interest Committee for review of OGE Form 450 Alternative VA .
Research Financial Conflict of Interest Statement Completion of Information System Security Officer ISSO andPrivacy Officer PO reviews of all research prior to final VA Use of a Material Transfer Agreement MTA for transfer ofbiospecimens from VA in collaborative research activities.
VHA Directive 1200 05 VHA Directive 1200 05 IRBMembership and Function IRB Membership Elimination of the requirement that VA staff from the.
facility must be appointed as voting members to an IRBother than its own that serves as an IRB of record forthe facility IRB of Record For multisite research an IRB of a non affiliated medical.
or dental school can serve as the IRB of record for a VAfacility if that IRB has specifically been designated byORD as an IRB that may serve as a multi site IRB for VAfacilities Commercial IRB cannot be an IRB of Record.
VHA Directive 1200 05 ExemptVHA Directive 1200 05 revised to be inalignment with the exempt requirements in therevised Common Rule except for certainrestrictions on broad consent.
Expansion of studies that may qualify for Increase in number of exempt categories Broadening of scope of studies that may qualify for Introduction of limited IRB review New review responsibility for IRBs reviewing exempt 6.
VHA Directive 1200 05 Broad Specific to research subject to the 2018Requirements Specific to the storage maintenance andsecondary use of identifiable data biospecimens.
Applies to two new exempt categories 7 and 8 VA specific Limitations Can only be used when data or biospecimens arecollected solely for research purposes Documentation of broad consent cannot be waived.
VHA Directive 1200 05 Continuing A number of studies subject to the 2018 Requirementsno longer require continuing review CR by the IRB Research eligible for expedited review Research that has progressed to the point that it.
involves only one or both of the following Data analysis inclusive of analysis of identifiable privateinformation or identifiable specimens and or Access to follow up clinical data obtained from proceduresthat subjects undergo as part of clinical care.
Justification is required if the IRB elects to conduct CRon research that no longer requires it VHA Directive 1200 05 Removal ofCertain VA Specific Approval Criteria IRB is no longer responsible for reviewing and.
approving the following Relevance of the research to the mission of the VA andthe Veteran population that it serves Inclusion of Non Veterans Ensuring that mechanisms are implemented to manage .
reduce or eliminate potential actual or perceivedconflicts of interest COI related to the research VA specific approval criteria for inclusion of individualswith impaired decision making capacity Please note Investigators must still inform the IRB of.
any COIs that may affect any aspect of the research 9 VHA Directive 1200 05 HealthInsurance Portability andAccountability Act HIPAA The written HIPAA authorization may either be a.
standalone document or combined with theresearch informed consent form If a standalone document is used VA Form 10 0493 Authorization for Use and Release of IndividuallyIdentifiable Health Information Collected for VHA.
Research must be used Combining the two documents is not advised byVHA Privacy in certain instances When there is optional future use of data and specimens When legally authorized representatives LARs may.
consent on behalf of the subject 10 VHA Directive 1200 5 Researchinvolving Vulnerable Populations Pregnant Women Certification by the Facility Directoris only required for interventional studies or invasive.
monitoring of pregnant women as subjects and forneonatal research In Vitro Fertilization Research involving the provisionof in vitro fertilization services can be approved as VA Fetal and Human Stem cells Research involving a.
fetus can be approved as VA research Research using human fetal tissue and human stem cellsis governed by NIH policy for recipient of NIH research Multiple NIH restrictions exist on the use of human fetal VHA Directive 1200 01.
VHA Directive 1200 01 R DCommittee Membership and Voting members of the R D Committee can now alsobe appointed to VA under the IntergovernmentalPersonnel Act IPA or a Without Compensation WOC .
appointment R D Committee meets on a regular schedule asneeded as opposed to prior monthly requirement R D Committee meeting minutes must be documented anddisseminated to the Quadrad Director Associate Director .
Chief of Staff and Associate Director for Patient Care Services R D Committee approval can occur outside of theconvened committee by designated review for certainspecified activities Requirement to establish a local R D Conflict of.
VHA Directive 1200 01 Continuing Research not under the oversight of anothersubcommittee requires continuing review by the R DCommittee e g exempt research R D continuing review elements include .
Scientific Progress Budget changes Changes in space personnel equipment supplies Summary and impact of unanticipated problems Any issues of non compliance.
VHA Directive 1200 01 VA Specific Approval Criteria R D Committee is now responsible for reviewing andapproving the following for all research exempt andnon exempt research .
Relevance of the research to the mission of the VA andthe Veteran population that it serves Inclusion of Non Veterans R D Committee responsible for ensuring thatInformation System Security Officer ISSO and Privacy.
Officer PO review is complete before final VA R D Committee can approve contingent on ISSO and PO VHA Directive 1200 01 Subcommittee Responsibilities Clarifies that a subcommittee does not include committees.
established by a Memorandum of Agreement MOU orother agreement R D Committee responsible for reviewing all research related committees and subcommittees at least annually R D Committee responsible for ensuring the adequacy of.
each subcommittee s review procedures includingreviewing and approving all subcommittee SOPs FAQ dated 6 5 19 clarifies that R D Committee must have away to ensure that each of it s subcommittees has effectiveSOPs for protocol review.
VHA Directive 1200 01 External Committee Responsibilities Multi site studies R D Committee must determinewhether the facility should participate in the multi sitestudy and ensure that the appropriate IRB agreements.
as required by VHA Directive 1200 05 and VHAHandbook 1058 03 Assurance of Protection for HumanSubjects in Research are in place prior to using theexternal IRB R D Committee must document.
Research supports the VA mission Is scientifically meritorious Ensures the security of VA data and storage of dataand specimens in accordance with all applicable 17 ORD Resources Supporting.
Implementation of VHA Directives1200 05 and 1200 01 Summary of Significant Changes to VHA Directive 1200 05 https www research va gov reso... VHADirective1200 05 pdf.
ORD Guidance Documents https www research va gov reso... ORPP E Webpage https www research va gov prog... Moon Shoot Documents Sample Documents .
https www research va gov prog... ORPP E FAQs https www research va gov prog... ORPP E Webinar Recordings https www research va gov prog... ORPP E Regulatory Mailbox vhacoordregulatory va gov.
05/15/2013 09:43:55 Title: Recap of Changes to VHA Directives 1200.05 and 1200.01 Subject: Recap of Changes to VHA Directives 1200.05 and 1200.01 Last modified by: Rivera, Portia T Company: Dept. of Veterans Affairs

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