1. grgrgr Human Research at Virginia Tech: A Living Process

2. IRB Approval – What Institutional Review Board (IRB) - on behalf on the government and the university, ensures the protection of human subjects’ rights - reviews and approves/requires modification of protocols - regulations/ types of methods - living process A subject always has the right to refuse at any time and not be pressured!

3. IRB Approval – What What may fall under IRB review? Any activity that obtains either data through intervention or interaction with the individual, or information about that individual Observation InterviewSurvey and Questionnaire Existing data set are just a few examples Experiment

4. IRB Approval –When When is IRB approval required? (please see flow chart) - Approval required if any of the below elements found - About living humans may or will be used in publications, thesis or dissertation. If there is remote possibility, get approval. - Funding may or may not be involved - Source of information is not publically available (magazines, newspaper) Exceptions: - Quality assessment (QA) with results only going to the entity that the QA is being performed on. - Student class projects where the results are staying in the classroom If you are unsure, please contact IRB office and ask Brandi Evans Carmen Green IRB Administrative Assistant OR IRB Administrator (540) 231-4606 (540) 231-4358 bmdilday@vt.edu ctgreen@vt.edu

5. IRB Approval – Life Cycle IRB Protocol Management System - Handles all protocol activities - https://secure.research.vt.edu/irb/ https://secure.research.vt.edu/irb/ Begin Research once approval has been granted Apply for IRB Approval Human Protection’s Training (1 st time) Upload CV (1 st time) Principle Investigator must be a VT faculty or staff member Online Application Amend ALL Prospect Changes personnel, flyers, procedures etc. Multiple amendments allowed Wait for approval before implementing Continuing Annual Review Close out protocol Ask for extension of approval period Not required for exempt research Post Approval Monitoring (PAM) Unanticipated or adverse event, contact ASAP Randomly Selected Full board - annually When finished, close the protocol by emailing Brandi Evans bmdilday@vt.edu

6. IRB Approval – Life Cycle Screenshot of a new IRB application

7. IRB Approval – Life Cycle Protocol Management’s main page By clicking on the protocol number listed on the main page, you then can access the various protocol materials you might need.

8. Surveys

9. Surveys - Hard Copy IRB date stamped consent form - When applicable, comes back with approval letter as a pdf - A watermark - lets the subjects know this was IRB approved - lets the researchers know when approval period is about to expire. An example of a study code An example of de-identified data An example of the IRB date stamp watermark at the bottom of a consent form Study Codes - Helps protect the data by de-identifying it Study Code # 3 Group # 2 Question 1: Do you work at Tech? Yes No N/A An example of de-identified survey How the researcher receives the IRB date stamp consent form

10. Surveys - Hard Copy Physical storage (consents, study code, data) - locked - kept separately - separate computers when it comes to data and study code A locked filing cabinetA password protected computer

11. Surveys - Hard Copy and Online Role of technology in research and storage - Password - !@CWkk23 8 – 16 characters long - Unique password - No words from a dictionary -Please don’t store the password on the ceiling, under the keyboard etc - Virus protection and firewall - Encryption http://www.security.vt.edu/lockitdown.html#vendortools http://www.security.vt.edu/lockitdown.html#vendortools - Laptops - easily stolen - USA customs and international travel A laptop security cable properly being used

12. Surveys - Hard Copy and Online Flash drives - Easily lost - contact PAM - Viruses - Onion like Cds - Easily scratched - use backups Recommendation: Multiple Storage Areas! Role of technology in research and storage continue

13. Surveys - Online Data Security (an addition... data in transit) - Online does NOT mean anonymous - Subjects at risk of identity thief, viruses - SSL (https://) vs Public (http://)

14. Surveys – Online cont. Survey link will be requested during IRB application When selecting a survey software, please do NOT assume. - If purchasing for a department, see VT IT Security first. - Read your acceptance and privacy statements carefully - Does it automatically reroute you? - Does the system force subjects to answer all questions? = Not Allowed

15. Resources IRB Website: www.irb.vt.eduwww.irb.vt.edu Wealth of information and resources about doing human research IRB Protocol Management System: https://secure.research.vt.edu/irb/https://secure.research.vt.edu/irb/ Interactive website that handles all protocol activity (training, initial approval, continuing review, amendments, unanticipated or adverse event report) Post Approval Monitoring: http://www.researchcompliance.vt.edu/pam/pages/irb.phphttp://www.researchcompliance.vt.edu/pam/pages/irb.php Educational videos about various elements dealing with the research and audit process Starting Point: http://www.researchcompliance.vt.edu/department/starting.phphttp://www.researchcompliance.vt.edu/department/starting.php To serve as a central reference source to assist new faculty, graduate students, and seasoned employees in identifying what information/forms must be submitted to the specific compliance committee or safety office and where additional resource information can be found VT IT Security: www.security.vt.eduwww.security.vt.edu Encryption software and other useful information about protecting your computer

16. Thank You For Listening! Questions? Contact Information: Andrea Boynton IRB-Post Approval Monitoring 231-0014 anash@vt.edu IRB-Post Approval Monitoring Office of Research Compliance 2000 Kraft Drive Blacksburg, VA 24060