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?

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