Download
1 / 12

compliance process - PowerPoint PPT Presentation


  • 203 Views
  • Updated On :

OHRP Compliance Oversight Procedures. Compliance Process . OHRP discovers or receives an allegation or indication of non-compliance COMPLAINT(S) PI, IRB MEMBER, SUBJECT, PRIVATE CITIZEN, ETC. SELF REPORTING INSTITUTION, PI MEDIA OTHER INCIDENT REPORT FDA INSPECTION NIH PSV REPORT

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'compliance process ' - Sophia


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript

Compliance process
Compliance Process

  • OHRP discovers or receives an allegation or indication of non-compliance

    • COMPLAINT(S)

      • PI, IRB MEMBER, SUBJECT, PRIVATE CITIZEN, ETC.

    • SELF REPORTING

      • INSTITUTION, PI

    • MEDIA

    • OTHER INCIDENT REPORT

      • FDA INSPECTION

      • NIH PSV REPORT

      • COOPERATIVE GROUP AUDIT


Compliance process1
Compliance Process

  • OHRP determines if it has jurisdiction

  • OHRP notifies institution and requests institutional response (may include additional documentation, institutional investigation and report, etc.)

  • OHRP may take immediate action if protection of human subjects warrants


Compliance process2
Compliance Process

  • OHRP evaluates institutional response

  • OHRP requests additional information

    OR

  • OHRP issues a report of findings

    OR

  • OHRP performs site visit


Compliance process3
Compliance Process

Most compliance oversight evaluations can be resolved through correspondence with the institution and do not require an on-site review or a formal report of findings.


Compliance investigation outcomes
Compliance Investigation Outcomes

  • Institution is in compliance

  • Institution is in compliance, but improvements suggested

  • Assurance restricted

  • Assurance suspended

  • Funding removed (temporarily or permanently) from specific projects*

  • Debarment (institution or individual)*

    *OHRP Recommendation



Compliance concerns

Initial & Continuing Review

Expedited Review Procedures

Reporting of Problems

IRB Review of Changes

Application of Exemptions

Informed Consent

IRB Membership, Support & Workload

Documentation

Compliance Concerns

OHRP Compliance Activities: Common Findings and Guidance

http://ohrp.osophs.dhhs.gov/references/findings.pdf


Ohrp compliance oversight data 10 98 12 01
OHRP Compliance Oversight Data 10/98-12/01

A-Initial Review

B-Continuing Review

C-Expedited Review

D-Reporting

E-Protocol Changes

F-Exemptions

G-Informed Consent

H-IRB

I-Documents

J-Written Procedures

%

Institutions with Deficient IRB Procedures (N=125)


Overarching Concerns

Does the institution support and respect the IRB and its mission?

Is there a “culture of compliance”?

Are IRB members and investigators knowledgeable about regulatory requirements?

Is there adequate documentation of IRB findings and actions?


Current climate
Current Climate

Reactive Hyper-Protectionism

Not the appropriate response!


ad