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  1. grgrgr Human Research at Virginia Tech: A Living Process Presented by: Andrea Boynton IRB-PAM

  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 Interview Survey and Questionnaire are just a few examples Experiment Existing data set

  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

  5. IRB Approval – Life Cycle • Apply for IRB Approval • Human Protection’s Training (1st time) • Upload CV (1st time) • Principle Investigator must be a VT faculty or staff member • Online Application Begin Research once approval has been granted When finished, close the protocol by emailing Brandi Evans • 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 • IRB Protocol Management • System • - Handles all protocol activities • - • Post Approval Monitoring (PAM) • Unanticipated or adverse event, contact ASAP • Randomly Selected • Full board - annually

  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. • Study Codes • Helps protect the data by de-identifying it An example of a study code 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 An example of the IRB date stamp watermark at the bottom of a consent form An example of de-identified data

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

  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 • Laptops • easily stolen • USA customs and international travel A laptop security cable properly being used

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

  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: • Wealth of information and resources about doing human research • IRB Protocol Management System: • Interactive website that handles all protocol activity (training, initial approval, continuing review, amendments, unanticipated or adverse event report) • Post Approval Monitoring: • Educational videos about various elements dealing with the research and audit process • Starting Point: • 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: • 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 • • IRB-Post Approval Monitoring • Office of Research Compliance • 2000 Kraft Drive • Blacksburg, VA 24060