human research at virginia tech: policies and procedures
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To Err is Human: Top 10 Common Research Pitfalls. Human Research at Virginia Tech: Policies and Procedures. Presented by: Andrea Nash IRB-PAM Officer. What is Post Approval Monitoring?. # 1 Attempting to Cover Up a Mistake. Why Would Someone Try to Cover Up? - PowerPoint PPT PresentationTRANSCRIPT
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Human Research at Virginia Tech: Policies and Procedures
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
When in doubt, self report to the PAM officer
Why Would Someone Try to Cover Up?- Not realizing something was a mistake- Not realizing the potential risk- Self identity management
“Good Intentions”
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# 2 Not Seeking Approval
Source: http://www.researchcompliance.vt.edu/department/starting.php
What are the consequences?
Picture this. It is two days before graduation . . .
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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 didn’t?* Didn’t think it was a “big deal”* Saw no possible harm* Didn’t have time* Thought someone else had already done it
What is the purpose of a protocol, amendments and continuing reviews (annual reviews)?
Why does this paperwork exist?
What are the consequences?
- Lancet formally retracts 1998 paper linking vaccine and autism- Unapproved invasive procedures at his son's birthday party
England – February 2010
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# 5 Technology Errors - Data At Rest
Encryption Toolshttp://security.vt.edu/sensitiveinfo.html
Secure Delete Toolshttp://security.vt.edu/securedelete.html
Useful Informationhttp://security.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
- Case Study: Townsfolk in Mass. Plays “Clue”
- What does “identifiable” mean in research?
- Exempt (aka low risk research)
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# 8 Issues in the Consent Process
The Process StorageThe Proper Form
-Separate
-Minimum of 3 years after study is closed
-Controlled access
Why is it important?
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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 NashIRB-PAM [email protected]
Louisa GayIACUC-PAM [email protected]