1. Human Research at Virginia Tech: Policies and Procedures To Err is Human: Top 10 Common Research Pitfalls

2. What is Post Approval Monitoring?

3. # 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”

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

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)? 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

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 - Case Study: Townsfolk in Mass. Plays “Clue” - What does “identifiable” mean in research? - Exempt (aka low risk research)

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

11. # 9 Failure to Properly Monitor Animals Post-Procedurally Resource: http://www.researchcompliance.vt.edu/pam/pages/iacuc_notebook.htmlhttp://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