Human Research at Virginia Tech: Policies and Procedures

To Err is Human: Top 10 Common Research Pitfalls

What is Post Approval Monitoring?

# 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”

# 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 . . .

# 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

# 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

# 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

# 6 Technology Errors - Data at Transit

But I am just a researcher . . .

#7 De-Identification of the Data

- Case Study: Townsfolk in Mass. Plays “Clue”

- What does “identifiable” mean in research?

- Exempt (aka low risk research)

# 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?

# 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!

# 10 Changing Euthanasia Procedures (Animal)

Thank You For Listening!

Questions?

Contact Information:

Andrea NashIRB-PAM Officer231-0014anash@vt.edu

Louisa GayIACUC-PAM Officer231-7678lgay@vt.edu