To Err is Human:

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To Err is Human Top 10 Common Research Pitfalls
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What is Post Approval Monitoring?
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1 Attempting to Cover Up a Mistake

• Why Would Someone Try to Cover Up?
• Not realizing something was a mistake
• Not realizing the potential risk
• Self identity management

Good Intentions
When in doubt, self report to the PAM officer
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2 Not Seeking Approval
Picture this. It is two days before graduation .
. .
Source http//www.researchcompliance.vt.edu/depar
tment/starting.php
What are the consequences?
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3 Failure to Provide and/or Receive Proper
Oversight on the Research Team

• Roles/Responsibilities
• Principle Investigator (PI) Vs Co-PI
• who
• forms
• implementing protocol
• questions

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4 Protocol Drift
Obligation To seek and receive approval before
implementing any changes
The reasons stated why they didnt? Didnt
think it was a big deal Saw no possible
harm Didnt have time Thought someone else
had already done it
What is the purpose of a protocol, amendments and
continuing reviews (annual reviews)?
England February 2010
Why does this paperwork exist?

• - Lancet formally retracts 1998 paper linking
  vaccine and autism
• Unapproved invasive procedures at his son's
  birthday party

What are the consequences?
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5 Technology Errors - Data At Rest
Encryption Tools http//security.vt.edu/sensitivei
nfo.html Secure Delete Tools http//security.vt.e
du/securedelete.html Useful Information http//se
curity.vt.edu/students.html
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6 Technology Errors - Data at Transit
But I am just a researcher . . .
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7 De-Identification of the Data
- What does identifiable mean in research?
- Case Study Townsfolk in Mass. Plays Clue
- Exempt (aka low risk research)
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8 Issues in the Consent Process
Why is it important?
The Process
Storage

• Separate
• Minimum of 3 years after study is closed
• Controlled access

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9 Failure to Properly Monitor Animals
Post-Procedurally
Resource http//www.researchcompliance.vt.edu/pam
/pages/iacuc_notebook.html
If you did not write it down, it did not happen!
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10 Changing Euthanasia Procedures (Animal)
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Thank You For Listening!
Questions? Contact Information Andrea
Nash IRB-PAM Officer 231-0014 anash_at_vt.edu Louis
a Gay IACUC-PAM Officer 231-7678 lgay_at_vt.edu