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

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

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

Tested and Novel Approaches to Educating your Research Community

Alyssa Speier, MS, CIPQA/QI Specialist

Harvard School of Public Health

Page 2: Tested and Novel Approaches to Educating your Research Community Alyssa Speier, MS, CIP QA/QI Specialist Harvard School of Public Health

Agenda2

Key Considerations Who? What? When? How?

Informal/Formal Opportunities Non-Traditional Ideas Virtual Options

LogisticsChallenges and RecommendationsDesign an Education SessionQuestions?

Page 3: Tested and Novel Approaches to Educating your Research Community Alyssa Speier, MS, CIP QA/QI Specialist Harvard School of Public Health

Who to Educate?3

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

Page 4: Tested and Novel Approaches to Educating your Research Community Alyssa Speier, MS, CIP QA/QI Specialist Harvard School of Public Health

What to Teach?4

Initial vs. Refresher/Continuing TrainingBasic

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

Page 5: Tested and Novel Approaches to Educating your Research Community Alyssa Speier, MS, CIP QA/QI Specialist Harvard School of Public Health

What to Teach? (cont.)

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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

Page 6: Tested and Novel Approaches to Educating your Research Community Alyssa Speier, MS, CIP QA/QI Specialist Harvard School of Public Health

When?6

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

Page 7: Tested and Novel Approaches to Educating your Research Community Alyssa Speier, MS, CIP QA/QI Specialist Harvard School of Public Health

How?7

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

Page 8: Tested and Novel Approaches to Educating your Research Community Alyssa Speier, MS, CIP QA/QI Specialist Harvard School of Public Health

How? Non-Traditional Ideas8

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

Page 9: Tested and Novel Approaches to Educating your Research Community Alyssa Speier, MS, CIP QA/QI Specialist Harvard School of Public Health

How? Non-Traditional Ideas (continued)

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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

Page 10: Tested and Novel Approaches to Educating your Research Community Alyssa Speier, MS, CIP QA/QI Specialist Harvard School of Public Health

How? Virtual Options10

WebinarE.g., Webex, GoTo Meeting, etc.

E-NewsletterYoutube

Public or privateSkype

InteractivityLive Question/AnswerAudit Exit Interview

Page 11: Tested and Novel Approaches to Educating your Research Community Alyssa Speier, MS, CIP QA/QI Specialist Harvard School of Public Health

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Social NetworksE.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)

Page 12: Tested and Novel Approaches to Educating your Research Community Alyssa Speier, MS, CIP QA/QI Specialist Harvard School of Public Health

Quick Notes Example12

Page 13: Tested and Novel Approaches to Educating your Research Community Alyssa Speier, MS, CIP QA/QI Specialist Harvard School of Public Health

Example Monthly Education Session Schedule

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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

Page 14: Tested and Novel Approaches to Educating your Research Community Alyssa Speier, MS, CIP QA/QI Specialist Harvard School of Public Health

Logistics14

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

Page 15: Tested and Novel Approaches to Educating your Research Community Alyssa Speier, MS, CIP QA/QI Specialist Harvard School of Public Health

Challenges and Recommendations

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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.

Page 16: Tested and Novel Approaches to Educating your Research Community Alyssa Speier, MS, CIP QA/QI Specialist Harvard School of Public Health

Design an Educational Opportunity #116

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?

Page 17: Tested and Novel Approaches to Educating your Research Community Alyssa Speier, MS, CIP QA/QI Specialist Harvard School of Public Health

Design an Educational Opportunity #217

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?

Page 18: Tested and Novel Approaches to Educating your Research Community Alyssa Speier, MS, CIP QA/QI Specialist Harvard School of Public Health

Questions?

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