Tested and Novel Approaches to Educating your Research Community

1. Tested and Novel Approaches to Educating your Research Community Alyssa Speier, MS, CIP QA/QI Specialist Harvard School of Public Health

2. Agenda • Key Considerations • Who? • What? • When? • How? • Informal/Formal Opportunities • Non-Traditional Ideas • Virtual Options • Logistics • Challenges and Recommendations • Design an Education Session • Questions?

3. Who to Educate? • Investigators • PI, Co-Is, Residents, Student Investigators • Support Staff • Project Directors/Managers • Study Coordinators • Research Assistants • Other • Department Administrators • Grants & Contracts • IT • Financial Services • Students (undergrad./graduate) • Participants

4. What to Teach? • Initial vs. Refresher/Continuing Training • Basic • IRB Review & Approval Process • Informed Consent • Regulatory Documentation & Study Management • Specified/Advanced topics • Vulnerable Populations • Genetic Research • Etc. • Focused (by request) • Common Findings/Deficiencies • Specific Types of Research

5. What to Teach? (cont.) • Evaluate and analyze sessions • Audience demographics • Logistics • Content • Speaker effective • Format, e.g., didactic, workshop, case study, etc… • Suggestions for future • Our evaluation results • Most Popular: Tips and Tools for Keeping your Study Organized and Regulatory Compliant; Panel: Becoming a Successful Project Manager, Study Coordinator, or Research Staff; Session on Electronic IRB Submission System • Most Requested: IRB Policies, Informed Consent Process/Documentation, Exempt/Expedited/Full Board Studies, Federal Regulations • Least Popular/Poorly Attended: Virtual Tour of OHRA Website; FDA: IND/IDE Studies; IRB Jeopardy

6. When? • Regular intervals • Monthly • Education series • New Employee Orientations • Annually • New Faculty Orientation • Semester • Student Education Session • In real-time • Changes in policy • Deficiencies Discovered • Audit Exit Interview • By request • Department/Lab meetings • Ongoing • Website

7. How? • Informal • One-on-one • Small Group In-service • Department/Chair meetings • IRB Meetings • Orientation Events • New Hire • New Student • Mailings (e.g., newsletter) • Formal • Didactic • Workshop • Classroom guest lecturer

8. How? Non-Traditional Ideas • Case studies • Hands-on workshops • Consent and recruitment material editing • Computer lab trainings on electronic IRB systems • Exit Interviews and Reports from On-site Reviews • Include Best Practices along with the Corrective Actions • Fun Twists • Jeopardy • Role Play • Educational response system (i.e., hand held clickers) • Expert Panels (PIs, Study Coordinators, IRB professionals, etc.) • Invited Speakers

9. How? Non-Traditional Ideas (continued) • Go to them • Cafeteria lunch time open “clinic” hours • Offer to walk through forms on their computer • Tap into the offerings of other departments (e.g., non-traditional collaborators/partners) • Postdoc orientations/events • HR employee orientation • Administrator/Research forums • Lab Biosafety groups • Grants Managers

10. How? Virtual Options • Webinar • E.g., Webex, GoTo Meeting, etc. • E-Newsletter • Youtube • Public or private • Skype • Interactivity • Live Question/Answer • Audit Exit Interview

11. Social Networks • E.g., Facebook, LinkedIn, etc. • Twitter • Daily question or tip • Live Tweet • Session Reminders • Room/Time changes/Cancellations • Screen Shots • Within Emails • On Website • One-Note, etc. • “Quick Notes” (Screenshots with instructions)

12. Quick Notes Example

13. Example Monthly Education Session Schedule September - What’s new with ESTR (Electronic, Submission, Tracking & Reporting System)? September Student Education Session October Hot Topic! Ceding Review: Multiple institutions, one IRB review November - Panel: Becoming a Successful Project Manager, Study Coordinator, or Research Staff December - ResearchMatch 101: A Tool to Effectively and Efficiently Recruit Participants January - IRB Cheat Sheet: Tips and Tools for keeping your study organized and regulatory compliant February – IRB Implications for International Research Webinar March - Looking at the Man in the Mirror: What to do when you find Non-Compliance April - Unique Challenges in Conducting Community-Based Research April Hot Topic! So you’ve received IRB approval…what now? May -Jeopardy

14. Logistics • Location • Speaker • Advertising • RSVP Method • Electronic Form • Email • Phone • Time • Lunch break • Break in classes • Refreshments • Paper Copies • Sign-in sheet • Human Research Training Credit

15. Challenges and Recommendations • Reaching new staff/faculty • Partner with HR • Getting people to sign up and come • Offer food! • Offer training credit • Getting those to come who have signed up • Send reminders • Getting PIs/Faculty to attend • Go to them (faculty meetings, their buildings) • Reaching investigators abroad • Webinars, Quicknotes, etc.

16. Design an Educational Opportunity #1 • You have been invited to speak at the departure orientation for Student Researchers who are going abroad for a three week period to conduct de-identified data analysis • They will not need to submit to your IRB as their projects are Not Human Subjects Research • What type of presentation would you use for this audience? What logistics would you consider?

17. Design an Educational Opportunity #2 IRB Reviewers have noticed a trend in researchers submitting exemptions rather than expedited applications when expedited review is required. They have asked you to provide some sort of education to the research community to cut back on the time it takes for them to request a different application and give an explanation as to why. What type of educational opportunity would you offer? What are the logistics to consider?

18. Questions?