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Office for Human Subject Protection
Office of the Vice President for Research

Educational Forum and Materials

The Office for Human Subject Protection (OHSP) hosts a monthly seminar series called the ‘University of Rochester Human Research Protection Program (UR-HRPP) Educational Forum’. The aim of the series is to broadly educate study team members on the:

  • Conduct of research that complies with federal regulation and institutional policy
  • Implementation of best practices to ensure the protection of the rights, welfare and safety of human subjects

Sessions are open to all faculty, staff and students and are announced via the OHSP mailing list and OHSP News and Updates. Continuing Medical Education (CME) credit and Certificates of Attendance are routinely available for those in attendance.

Miss a session? When available, session slides and recordings are posted in the ‘UR-HRPP Educational Materials’ course in Blackboard. See details below.

 

UR-HRPP Educational Materials

The ‘UR-HRPP Educational Materials’ course is a repository of slides and recordings from UR-HRPP Educational Forum sessions as well as other recorded OHSP content. The course is available to all faculty, staff and students via Blackboard. Materials available in the course (listed below) may be viewed for personal or professional development, as well as for the purposes of training, onboarding, and/or as preventative action measures. Staff/students must self-enroll in the course to access materials.

Learn how to self-enroll in the Blackboard course to access materials

Learn about additional OHSP training available in Blackboard

Content available

The ‘UR-HRPP Educational Materials’ course includes:

Note:

  • Closed captioning is available for recordings, as indicated.
  • Corresponding Joint Task Force (JTF) Core Competencies are identified when the content of a given recording supports the knowledge, skills, and attitudes needed to meet the identified competency.

Access these recordings by self-enrolling in the Blackboard course

Recent UR-HRPP Educational Forum materials

Recent forums materials are organized by date in the ‘Recent UR-HRPP Educational Materials’ folder, available on the ‘UR-HRPP Educational Materials’ course homepage. Recordings and slides are available for the following sessions:

  • Principal Investigator (PI) Oversight Panel Discussion (11/4/2024) – Bridget Young, PhD, Associate Professor; Jin Xiao, DDS, PhD, Associate Professor; Patrick Davies, PhD, Professor; Paul Barr, MD, Professor
  • Assessment of ‘Soft Skills’ in the Search for Clinical Research Professionals (10/10/2024) – Kylie Sands, MBA, CCRP, Clinical Trials Operation Manager, St. Lawrence Health
  • IDS: Your friendly institutional research pharmacy (9/12/2024) – Kyle Richards, PharmD, BCPPS, Manager, Investigational Drug Service

Archived UR-HRPP Educational Forum materials

Archived forum materials are categorized by content area within the Blackboard course. To access the materials listed below:

  1. From the ‘UR-HRPP Educational Materials’ course homepage, select the ‘Archived UR-HRPP Educational Forum Materials’ folder.
  2. Select the applicable content area folder. Within the content area folder, sessions are organized alphabetically.
Compliance
  • CAPA Plans: Solutions, not Blame (2/25/2014)
    • Resources available: Slides and video
    • JTF competencies: 4.2, 4.3, 5.6
  • Continuing Non-Compliance (11/29/2016)
    • Resources available: Slides and video
    • JTF competencies: 3.2, 5.6
  • Protocol Deviations & Violations & Non-Compliance… Oh My! (11/29/2016)
    • Resources available: Slides and video
    • JTF competencies: 4.2, 4.3
Conflict of Interest
  • Conflicts of Interest in Research (2/22/2018)
    • Resources available: Slides and video
    • JTF competencies: 5.5, 7.2
Data Security and Data Management
  • A Database is Worth a Thousand Words (or More!): The Role of Data Management (3/8/2016)
    • Resources available: Slides and video
    • JTF competencies: 6.1, 6.2, 6.3
  • Data Security in Human Subject Research (9/29/2020)
    • Resources available: Slides and video (closed captioning available)
    • JTF competency: 4.7
  • GDPR for Researchers: Implications of the European Union’s New General Data Protection Regulations (4/11/2019)
    • Resources available: Slides and video
    • JTF competencies: 4.4, 4.7
Department/Scientific and Ancillary Reviews
  • UR Scientific Review Process – Peer Review (3/30/2017)
    • Resources available: Slides and video
    • JTF competency: 1.2
Essential/Study Documentation
  • Essential Study Documentation – Part 1 (12/9/2021)
    • Resources available: Slides and video (closed captioning available)
    • JTF competencies: 4.3, 5.6
  • Essential Study Documentation – Part 2 (1/21/2022)
    • Resources available: Slides and video (closed captioning available)
    • JTF competencies: 4.3, 5.6
Informed Consent
  • Back to Basics: Informed Consent – Translating Requirements into Practice (11/12/2020)
    • Resources available: Slides and video (closed captioning available)
    • JTF competencies: 2.3, 2.4
  • Building from Basics: Informed Consent – Planning Your Process (1/14/2021)
    • Resources available: Slides and video (closed captioning available)
    • JTF competencies: 2.3, 2.4
  • Health Literacy and the Informed Consent Process (5/13/2021)
    • Resources available: Slides and video (closed captioning available)
    • JTF competency: 2.5
  • Informed Consent Discussions: A Little Bit Regulation, A Little Bit Meliora (4/14/2022)
    • Resources available: Slides and video (closed captioning available)
    • JTF competency: 2.4
  • Remote Consent Refresher and REDCap eConsent Update (10/31/2023)
    • Resources available: Slides and video (closed captioning available)
    • JTF competencies: 2.3
  • The Virtue Ethics of the Informed Consent Process in Research (3/31/2023)
    • Resources available: Slides and video (closed captioning available)
    • JTF competencies: 2.4, 7.3
IRB Submissions and Review Process
  • Preparing IRB Submissions (4/27/2023)
    • Resources available: Slides and video (closed captioning available)
    • JTF competency: 4.3
  • Put on Your IRB Hat: Let’s Review a Protocol! (3/14/2019)
    • Resources available: Slides and video
    • JTF competencies: 1.3, 2.3, 2.5
  • RSRB Determinations: Human Subjects Research & Exemptions (2/11/2021)
    • Resources available: Slides and video (closed captioning available)
    • JTF competency: 2.3
  • RSRB Mock Board Meeting (1/29/2013)
    • Resources available: Slides and video
    • JTF competency: 2.3
  • Top 10 Ways to Facilitate IRB Modifications (9/14/2023)
    • Resources available: Slides and video (closed captioning available)
    • JTF competency: 2.3
Investigational Products
  • FDA vs. non-FDA Regulated Research: What’s the difference and why does it matter (3/14/2024)
    • Resources available: Slides and video (closed captioning available)
    • JTF competency: 4.4
  • What’s New with Expanded Access? (12/10/2020)
    • Resources available: Slides and video (closed captioning available)
    • JTF competencies: 3.2, 3.3
Multi-Site Research
  • A Look Inside: The Roles & Responsibilities of a Coordinating Center (11/17/2015)
    • Resources available: Slides and video
    • JTF competencies: 3.2, 4.2
  • IRB Reliance and Collaborative Research: Requirements to Rely on an External IRB and for the RSRB as the Reviewing IRB for Non-UR Sites (10/13/2022)
    • Resources available: Slides and video (closed captioning available)
    • JTF competencies: 2.3, 3.2
  • Multi-Site Study Oversight: Investigator Responsibilities, Quality by Design, and Risk Management (4/11/2023)
    • Resources available: Slides and video (closed captioning available)
    • JTF competencies: 4.2, 5.3, 6.4
Quality Management
  • Integrating Quality into Investigator-Initiated Clinical Trials (4/8/2021)
    • Resources available: Slides and video (closed captioning available)
    • JTF competencies: 4.3, 5.3, 6.4
  • Quality Systems Approach to Clinical Site Management – An Overview of Standard Operating Procedures (SOPs) (4/5/2016)
    • Resources available: Slides and video
    • JTF competencies: 1.4, 5.3
  • Self-Auditing at the Research Site or Study Level (12/8/2022)
    • Resources available: Slides and video (closed captioning available)
    • JTF competencies: 4.3, 5.3
  • Tools and Tidbits to Help Ensure Quality Trials at Clinical Research Sites
    • Event date: 2/23/2017
    • JTF competency: 4.2
    • Resources available: Slides and video
Regulations and Guidance
  • ICH GCP E6 R2 – Changes? Yes. Challenges?  Not as Difficult as You May Fear (10/25/2017)
    • Resources available: Slides and video
    • JTF competencies: 4.2, 4.3
Research Ethics
  • Research Ethics Consultations (1/11/2024)
    • Resources available: Slides and video (closed captioning available)
    • JTF competencies: 2.3, 7.2
  • The Ethical Risks of Machine Learning Research (2/8/2024)
    • Resources available: Slides and video (closed captioning available)
    • JTF competencies: 2.3, 2.5, 7.2
Roles and Responsibilities
  • Coulda, Shoulda, Woulda: Lessons Learned in Conducting Research from OHSP/RSRB Staff & Board Members (10/6/2015)
    • Resources available: Slides and video
    • JTF competencies: 2.3, 4.2, 4.3
  • Leading with Purpose – How to Build and Maintain a Resilient Research Team (11/9/2023)
    • Resources available: Slides and video (closed captioning available)
    • JTF competency: 8.1
  • Meet the New AVP for Human Subject Protection: Q&A with Elizabeth Kipp Campbell (5/9/2024)
    • Resources available: Slides and video (closed captioning available)
    • JTF competency: N/A
  • OHSP Policy 901: Investigator Responsibilities (9/16/2014)
    • Resources available: Slides and video
    • JTF competencies: 3.2, 4.2, 5.6
  • WWYD: A Refresher on Study Team Responsibilities (5/11/2023)
    • Resources available: Slides and video (closed captioning available)
    • JTF competency: 4.4
Study Protocol/Design
  • Am I doing research? The journey from standard clinical care to pragmatic trials: conducting comparative effectiveness research while maintaining research subjects protections and rights (3/22/2022)
    • Resources available: Slides and video (closed captioning available)
    • JTF competencies: 1.3, 2.1, 4.1
  • Best Practices for the Development & Management of Databases, Repositories & Registries (2/13/2020)
    • Resources available: Slides and video
    • JTF competency: 2.3
  • How Coordinators Can Assist in Ensuring Practicality of Study Assessments – From the Subject’s Point of View (12/12/2019)
    • Resources available: Slides and video
    • JTF competencies: 1.1, 1.3
  • Standard Deviations from the Mean: When Does a Patient Become a Subject (11/18/2014)
    • Resources available: Slides and video
    • JTF competencies: 2.1, 2.3, 7.3
Subject Payment
  • Research Subject Payment Policy and Procedure (11/10/2022)
    • Resources available: Slides and video
    • JTF competency: N/A
Subject Safety
  • Adverse Events through the Lens of the IRB (3/12/2020)
    • Resources available: Slides and video
    • JTF competencies: 2.3, 3.4, 3.6, 4.6, 4.10
  • Planning for Your Plan: Data and Safety Monitoring Plan Development & Implementation (12/16/2014)
    • Resources available: Slides and video
    • JTF competencies: 3.2, 4.8, 4.10
Training and Onboarding
  • OHSP Education & Resource Updates (9/8/2022)
    • Resources available: Slides and video (closed captioning available)
    • JTF competency: 5.3
  • Study Team Member Onboarding: Critical Considerations for Planning for Success (1/9/2020)
    • Resources available: Slides and video
    • JTF competencies: 1.4, 4.3, 5.3
Vulnerable Populations
  • Consent in the Pediatric Population (2/10/2022)
    • Resources available: Slides and video (closed captioning available)
    • JTF competencies: 2.3, 2.4, 2.5

More training materials

Supplemental and refresher training videos

To access the materials below, select the ‘Supplemental & Refresher Training Materials‘ folder from the ‘UR-HRPP Educational Materials’ course homepage. 

  • Informed Consent: Refresher Training (3/9/2022)
    • JTF competencies: 2.3, 2.4
    • Resources available: Slides and video (closed captioning available)
Click IRB demo videos

To access the materials below, select the ‘Click IRB Demo Videos‘ folder from the ‘UR-HRPP Educational Materials’ course homepage. These videos can also be accessed directly from the Click IRB Resources webpage. 

  • Log In & Basic Navigation
  • Department Review
  • Ancillary Review
  • Create & Submit a Study
  • Create & Submit a Study for External IRB Review
  • Respond to Clarification Requests
  • Create & Submit a Modification
  • Create & Submit a Continuing Review
  • Create & Submit a Report of New Information

reach out

Get additional support

If you have questions or are interested in learning more, contact Kelly Unsworth at kelly_unsworth@urmc.rochester.edu.

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