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IRB Determinations 1

IRB Determinations

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IRB Determinations. AAHRPP Site Visit Results. Site visitors observed a real commitment to human subject protections Investigator and research staff opinions of the IRB and OPHS are markedly positive Identified 8 areas of concern - PowerPoint PPT Presentation

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Page 1: IRB  Determinations

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IRB Determinations

Page 2: IRB  Determinations

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AAHRPP Site Visit Results• Site visitors observed a real commitment to

human subject protections• Investigator and research staff opinions of

the IRB and OPHS are markedly positive• Identified 8 areas of concern

o All were addressed in a response sent to AAHRPP January 3, 2014

• AAHRPP Accreditation Council meets on March 17, 2014

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Areas of Concern1. Technical resources for IRBear platform2. Quality improvement activities to assess HRPP

compliance and quality, efficiency, and effectiveness 3. IRB determinations of serious and/or continuing

noncompliance; reports to regulatory agencies4. Conflicts of interest – Organizational and individual5. Control of investigational medical devices6. Clinical trials agreements (contracts) with sponsors7. Qualifications and knowledge of IRB chair, vice chairs, and

members -- Evaluations and feedback 8. Contingent approvals and deferrals of protocols

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IRB ApprovalThe IRB must determine that all of the approval criteria are satisfied in accordance with the Common Rule and FDA regulations:

1. Risks are minimized2. Risks are reasonable in relation to anticipated benefits and the

importance of the knowledge to be gained3. Selection of subjects is equitable4. Informed consent will be sought5. Informed consent will be appropriately documented6. Adequate provision for monitoring the data collected to

ensure subject safety7. Adequate provisions to protect subject privacy and maintain

confidentiality of the data8. Additional safeguards for subjects who are vulnerable to

coercion or undue influenceand relevant subparts (children, pregnant women, prisoners)

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IRB Approval of Research with Conditions“Contingent Approval”

The IRB requests that the investigator either:• Make specified changes to the research protocol or

consent documents; • Confirm specific assumptions or understandings on the

part of the IRB regarding how the research will be conducted; or

• Submit additional documents such that, based on the assumption that the conditions are satisfied, the IRB is able to make all of the determinations required for approval.

The IRB chair or her qualified designee may determine by expedited review that the investigator’s response satisfies the IRB’s conditions, i.e., further review by the convened IRB is unnecessary.

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IRB DeferralThe IRB cannot make one or more of the determinations required for approval under the regulations.• Information in the research protocol is insufficient for the

IRB to determine if one or more approval criteria have been adequately met; and

• The IRB is unable to specify changes to the research protocol that would allow the IRB to make the required determinations

The IRB requires that the investigator either:• Make changes to the protocol or consent documents; or• Submit clarifications or additional documents

The convened IRB must review and approve the revised research project.

Page 7: IRB  Determinations

Contingent Approval or Deferral?What’s your determination?

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1. The convened IRB requires the investigator to do the following:

• Re-locate in the informed consent document the statement ,“You will receive $500 for participating in this study,” from the Benefits section of the form to a separate section titled Compensation.

Should the IRB “approve with contingencies” or “defer” final review?

Page 8: IRB  Determinations

Contingent Approval or Deferral?

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2. The convened IRB requires the investigator to do the following:

• Provide a justification for using a placebo and withholding currently available treatment for a serious medical condition for subjects assigned to the control group.

Should the IRB “approve with contingencies” or “defer” final review?

Page 9: IRB  Determinations

Contingent Approval or Deferral?

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3. The convened IRB requires the investigator to do the following:

• Clarify whether individuals who have taken aspirin within 14 days prior to enrollment will be excluded from the study because of concerns about the risks of bleeding.

Should the IRB “approve with contingencies” or “defer” final review?

Page 10: IRB  Determinations

Contingent Approval or Deferral?

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4. The convened IRB requires the investigator to do the following:

• Add “a history of aspirin use in the past 14 days” to the exclusion criteria for subject enrollment in the research protocol.

Should the IRB “approve with contingencies” or “defer” final review?

Page 11: IRB  Determinations

Serious and Continuing Noncompliance

Noncompliance – Failure to abide by the regulations, institutional policies and procedures, or IRB requirements or determinations. Serious noncompliance – Noncompliance that may impact subject safety, increase risks to subjects, affect integrity of the data, violate a subject’s rights or welfare, or affect subjects’ willingness to participate in the study. Continuing noncompliance – Series of noncompliant actions or omissions taken by an investigator or study staff, in reasonably close proximity, which indicates the need for evaluation of the methods and systems used to protect human subjects.

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Examples of Serious Noncompliance

• Failure to notify the IRB of changes in approved procedures

• Continuation of research activities following protocol expiration

• Failure to adequately protect participant privacy and confidentiality of data

• Failure to conduct research according to the IRB approved protocol

• Failure to follow proper accountability procedures for an investigational drug

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IRB Review of Investigator Noncompliance

• The fully convened IRB must make a formal determination whether an event constitutes serious and/or continuing noncompliance

• A motion should be made and a vote taken on the determination

• The meeting minutes should include the motion and outcome of the vote.

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Mandatory Reporting to External Agencies

• Serious or continuing noncompliance must be reported to the appropriate Federal Department or Agency head if the research is federally funded or involves FDA-regulated products.

• Other events that must be reported are: o Unanticipated problems that involve risks

to subjects or otherso Suspension or termination of IRB approval

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Guidance for IRB Motions:Noncompliance Determinations• Acknowledge or Defer (see handout)• If a final determination of serious and/or

continuing noncompliance is made, the IRB must specify whether the noncompliance requires reporting to an external agency such as the study sponsor, OHRP, or the FDA

• The IRB also may defer its final determination and require an additional response or action on the part of the investigator to resolve the issue