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Human Research at Virginia Tech: Policies and Procedures

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?

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Human Research at Virginia Tech: Policies and Procedures

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  1. To Err is Human: Top 10 Common Research Pitfalls Human Research at Virginia Tech: Policies and Procedures Presented by: Andrea Nash IRB-PAM Officer

  2. What is Post Approval Monitoring?

  3. # 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

  4. # 2 Not Seeking Approval Picture this. It is two days before graduation . . . Source: http://www.researchcompliance.vt.edu/department/starting.php What are the consequences?

  5. # 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

  6. # 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)? 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?

  7. # 5 Technology Errors - Data At Rest Encryption Tools http://security.vt.edu/sensitiveinfo.html Secure Delete Tools http://security.vt.edu/securedelete.html Useful Information http://security.vt.edu/students.html

  8. # 6 Technology Errors - Data at Transit But I am just a researcher . . .

  9. #7 De-Identification of the Data - What does “identifiable” mean in research? - Case Study: Townsfolk in Mass. Plays “Clue” - Exempt (aka low risk research)

  10. # 8 Issues in the Consent Process Why is it important? The Proper Form The Process Storage • Separate • Minimum of 3 years after study is closed • Controlled access

  11. # 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!

  12. # 10 Changing Euthanasia Procedures (Animal)

  13. Thank You For Listening! • Questions? • Contact Information: • Andrea Nash • IRB-PAM Officer • 231-0014 • anash@vt.edu • Louisa Gay • IACUC-PAM Officer • 231-7678 • lgay@vt.edu

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