Post on 07-Feb-2016
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HRPP Policies & Forms HRPP Policies & Forms
Created/Revised for AAHRPPCreated/Revised for AAHRPP
OutlineOutlineNewly-Created PoliciesNewly-Created PoliciesRevised PoliciesRevised Policies
Newly-Created FormsNewly-Created FormsRevised FormsRevised Forms
New ProceduresNew Procedures
NEWLY-CREATED POLICIESNEWLY-CREATED POLICIES
Presidential PoliciesPresidential PoliciesEstablishment of an Institutional Establishment of an Institutional
Conflict of Interest CommitteeConflict of Interest CommitteeOrganizational Official for Human Organizational Official for Human
Research Protection ProgramResearch Protection Program Independent Authority of the Independent Authority of the
Institutional Review BoardsInstitutional Review Boards
Newly-created PolicyNewly-created PolicySOP 308 SOP 308 Reporting to Regulatory Agencies & Reporting to Regulatory Agencies &
Institutional OfficialsInstitutional Officials
Within 30 business daysWithin 30 business daysList of individuals to notifyList of individuals to notifyContents of the letterContents of the letter
Newly-created PolicyNewly-created PolicySOP 406SOP 406Determination of Human ResearchDetermination of Human Research
The investigator has the option of completing The investigator has the option of completing the Research Determination Worksheet or the Research Determination Worksheet or contacting the IRB.contacting the IRB.
IRB Chair determines if activity is research and IRB Chair determines if activity is research and if the research involves human participants.if the research involves human participants.
If research, requires full submission.If research, requires full submission.
Newly-created PolicyNewly-created PolicySOP 411 SOP 411 Suspension or Termination of IRB Suspension or Termination of IRB
ApprovalApproval
Suspension is defined as a temporary or Suspension is defined as a temporary or permanent halt to all research activities.permanent halt to all research activities.
Terminated research is no longer Terminated research is no longer subject to CR.subject to CR.
SOP 411SOP 411The IRB can suspend or terminate The IRB can suspend or terminate
approval ofapproval ofresearch that:research that:Is not being conducted in accordance Is not being conducted in accordance
with the IRB’s requirementswith the IRB’s requirementsIs associated with unexpected serious Is associated with unexpected serious
harm to participants.harm to participants.
REVISED POLICIESREVISED POLICIES
Revised PolicyRevised PolicySOP 104A SOP 104A Conflict of Interest – InvestigatorsConflict of Interest – Investigators
Conflict of Interest is an economic Conflict of Interest is an economic interest that could affect or appear to interest that could affect or appear to affect the design, conduct, or affect the design, conduct, or reporting of the research.reporting of the research.
Revised PolicyRevised PolicySOP 104B SOP 104B Conflict of Interest - IRB MembersConflict of Interest - IRB Members
A conflict of interest arises when an A conflict of interest arises when an IRB member or consultant holds an IRB member or consultant holds an economic interest that could affect or economic interest that could affect or appear to affect the design, conduct, appear to affect the design, conduct, oversight or reporting of the researchoversight or reporting of the research
Revised PolicyRevised PolicySOP 407SOP 407Unanticipated Problems Involving Risks toUnanticipated Problems Involving Risks toParticipants or Others & Protocol Participants or Others & Protocol
DeviationsDeviations
SAE’s rolled into this policySAE’s rolled into this policy Outside SAE’s reported at the time of CROutside SAE’s reported at the time of CR Reported within 5 business daysReported within 5 business days Provides a list of examplesProvides a list of examples IRB Chair determines if UPIRB Chair determines if UP If UP-refer to convened Board for reviewIf UP-refer to convened Board for review Range of possible actionsRange of possible actions
Revised PolicyRevised PolicySOP 903SOP 903Non-compliance/Scholarly MisconductNon-compliance/Scholarly Misconduct
Non-compliance is a proven failure to Non-compliance is a proven failure to follow the regulationsfollow the regulations
Allegation of non-compliance is defined Allegation of non-compliance is defined as an unproven assertion of non-as an unproven assertion of non-compliancecompliance
SOP 903 SOP 903 Evaluation of Non-complianceEvaluation of Non-compliance
Technical non-complianceTechnical non-complianceSerious non-complianceSerious non-complianceContinuing non-complianceContinuing non-compliance
IRB Corrective actionsIRB Corrective actions
Revised GlossaryRevised GlossaryHuman Participants: DHHS and FDA Human Participants: DHHS and FDA
definitiondefinitionGuardian definitionGuardian definitionAdverse Events-refers to Adverse Events-refers to
Unanticipated Problems Involving Unanticipated Problems Involving Risks to Participants or OthersRisks to Participants or Others
NEWLY-CREATED FORMSNEWLY-CREATED FORMS
New FormsNew Forms
Determination of Human Research Determination of Human Research Worksheet Worksheet
Conflict of Interest Disclosure Form Conflict of Interest Disclosure Form Unanticipated Problem Report FormUnanticipated Problem Report Form
IRB Reviewer ChecklistsIRB Reviewer Checklists
Required by AAHRPPRequired by AAHRPPDocumentationDocumentationProvides structured, thorough reviewProvides structured, thorough reviewValuable tool for primary/secondary Valuable tool for primary/secondary
reviewer presentationsreviewer presentations
IRB Reviewer ChecklistsIRB Reviewer ChecklistsNew Study Reviewer ChecklistNew Study Reviewer Checklist
Full Board ReviewFull Board ReviewExpedited ReviewExpedited ReviewExemptExempt
Continuing Review ChecklistContinuing Review ChecklistModification ChecklistModification ChecklistVA CriteriaVA CriteriaWaiver of Consent Waiver of Consent Vulnerable PopulationsVulnerable Populations
REVISED FORMSREVISED FORMS
Revised FormsRevised Forms
New Research Project New Research Project Continuing ReviewContinuing ReviewCell LineCell Line Informed consent templates: Informed consent templates:
Main / VAMain / VA
New ProcedureNew ProcedureConflict of InterestConflict of Interest
IRB reviews COI Disclosure FormIRB reviews COI Disclosure Form If IRB determines a conflict is If IRB determines a conflict is
manageable, a plan will be provided to manageable, a plan will be provided to InvestigatorInvestigator
If a conflict cannot be managed, the If a conflict cannot be managed, the research project is not approvedresearch project is not approved
ImplementationImplementation
Date to implementDate to implementProcess to implement-trainingProcess to implement-training
Questions?Questions?
Read policiesRead policiesReview formsReview formsCall IRBCall IRB