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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 video recordings and slides, as applicable, for :

Note:

  • Acknowledgement of Training Completion documentation is available to support continuing education for all UR-HRPP Educational Forum and supplemental/refresher materials.
  • 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 Forum Materials’ module, available on the ‘UR-HRPP Educational Materials’ course homepage. Recordings and slides are available for the following sessions:

  • Annual OHSP Updates (February 13, 2025) – Wendy Duncan, Director, Research Subjects Review Board, Kathleen Wessman, Director, Quality Improvement, & Kelly Unsworth, Director, Research Education & Training, Office for Human Subject Protection
      • JTF competencies: N/A

All other UR-HRPP Educational Forum Materials for the 2024-2025 academic year have been archived (see below).

Archived UR-HRPP Educational Forum materials

Archived forum materials are categorized by content area within the ‘Archived UR-HRPP Educational Forum Materials’ module in 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’ module.
  2. Select the applicable content area folder to identify archived forums related to the content area.
  3. Within each content area folder, sessions are organized in chronological order. Click on the name of session to view recordings/materials from a given session.
Compliance
  • CAPA Plans: Solutions, not Blame (February 25, 2014)
    • JTF competencies: 4.2, 4.3, 5.6
  • Continuing Non-Compliance (November 29, 2016)
    • JTF competencies: 3.2, 5.6
  • Protocol Deviations & Violations & Non-Compliance… Oh My! (September 12, 2019)
    • JTF competencies: 4.2, 4.3
  • Utilizing a CAPA Process to Ensure Clinical Trial Compliance (December 12, 2024)
    • JTF competencies: 5.3, 5.4
Conflict of Interest
  • Conflicts of Interest in Research (February 22, 2018)
    • 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 (March 8, 2016)
    • JTF competencies: 6.1, 6.2, 6.3
  • GDPR for Researchers: Implications of the European Union’s New General Data Protection Regulations (April 11, 2019)
    • JTF competencies: 4.4, 4.7
  • Data Security in Human Subject Research (September 29, 2020)
    • JTF competency: 4.7
Department/Scientific and Ancillary Reviews
  • UR Scientific Review Process – Peer Review (March 30, 2017)
    • JTF competency: 1.2
Essential/Study Documentation
  • Essential Study Documentation – Part 1 (December 9, 2021)
    • JTF competencies: 4.3, 5.6
  • Essential Study Documentation – Part 2 (January 21, 2022)
    • JTF competencies: 4.3, 5.6
Informed Consent
  • Back to Basics: Informed Consent – Translating Requirements into Practice (November 12, 2020)
    • JTF competencies: 2.3, 2.4
  • Building from Basics: Informed Consent – Planning Your Process (January 14, 2021)
    • JTF competencies: 2.3, 2.4
  • Health Literacy and the Informed Consent Process (May 13, 2021)
    • JTF competency: 2.5
  • Informed Consent Discussions: A Little Bit Regulation, A Little Bit Meliora (April 14, 2022)
    • JTF competency: 2.4
  • The Virtue Ethics of the Informed Consent Process in Research (March 31, 2023)
    • JTF competencies: 2.4, 7.3
  • Remote Consent Refresher and REDCap eConsent Update (October 31, 2023)
    • JTF competencies: 2.3
IRB Submissions and Review Process
  • RSRB Mock Board Meeting (January 29, 2013)
    • JTF competency: 2.3
  • Put on Your IRB Hat: Let’s Review a Protocol! (March 14, 2019)
    • JTF competency: 1.3, 2.3, 2.5
  • RSRB Determinations: Human Subjects Research & Exemptions (February 11, 2021)
    • JTF competency: 2.3
  • Preparing IRB Submissions (April 27, 2023)
    • JTF competency: 4.3
  • Top 10 Ways to Facilitate IRB Modifications (September 14, 2023)
    • JTF competency: 2.3
Investigational Products
  • What’s New with Expanded Access? (December 10, 2020)
    • JTF competencies: 3.2, 3.3
  • FDA vs. non-FDA Regulated Research: What’s the difference and why does it matter (March 14, 2024)
    • JTF competency: 4.4
  • IDS: Your friendly institutional research pharmacy (September 12, 2024)
    • JTF competency: N/A
  • Intro to BIMO Inspections (January 16, 2025)
    • JTF competency: 3.2, 4.7
Multi-Site Research
  • A Look Inside: The Roles & Responsibilities of a Coordinating Center (November 17, 2015)
    • 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 (October 13, 2022)
    • JTF competencies: 2.3, 3.2
  • Multi-Site Study Oversight: Investigator Responsibilities, Quality by Design, and Risk Management (April 11, 2023)
    • JTF competencies: 4.2, 5.3, 6.4
Quality Management
  • Quality Systems Approach to Clinical Site Management – An Overview of Standard Operating Procedures (SOPs) (April 5, 2016)
    • JTF competencies: 1.4, 5.3
  • Tools and Tidbits to Help Ensure Quality Trials at Clinical Research Sites (February 23, 2017)
    • JTF competency: 4.2
  • Integrating Quality into Investigator-Initiated Clinical Trials (April 8, 2021)
    • JTF competencies: 4.3, 5.3, 6.4
  • Self-Auditing at the Research Site or Study Level (December 8, 2022)
    • JTF competencies: 4.3, 5.3
Regulations and Guidance
  • ICH GCP E6 R2 – Changes? Yes. Challenges?  Not as Difficult as You May Fear (October 25, 2017)
    • JTF competencies: 4.2, 4.3
Research Ethics
  • Research Ethics Consultations (January 11, 2024)
    • JTF competencies: 2.3, 7.2
  • The Ethical Risks of Machine Learning Research (February 8, 2024)
    • JTF competencies: 2.3, 2.5, 7.2
Roles and Responsibilities
  • OHSP Policy 901: Investigator Responsibilities (September 16, 2014)
    • JTF competencies: 3.2, 4.2, 5.6
  • Coulda, Shoulda, Woulda: Lessons Learned in Conducting Research from OHSP/RSRB Staff & Board Members (October 6, 2015)
    • JTF competencies: 2.3, 4.2, 4.3
  • WWYD: A Refresher on Study Team Responsibilities (May 11, 2023)
    • JTF competency: 4.4
  • Leading with Purpose – How to Build and Maintain a Resilient Research Team (November 11, 2023)
    • JTF competency: 8.1
  • Assessment of ‘Soft Skills’ in the Search for Clinical Research Professionals (October 10, 2024)
    • JTF competency: N/A
  • Principal Investigator (PI) Oversight Panel Discussion (November 4, 2024)
    • JTF competencies: 5.3, 7.1, 8.1
Study Protocol/Design
  • Standard Deviations from the Mean: When Does a Patient Become a Subject (November 18, 2014)
    • JTF competencies: 2.1, 2.3, 7.3
  • How Coordinators Can Assist in Ensuring Practicality of Study Assessments – From the Subject’s Point of View (December 12, 2019)
    • JTF competencies: 1.1, 1.3
  • Best Practices for the Development & Management of Databases, Repositories & Registries (February 13, 2020)
    • JTF competency: 2.3
  • 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)
    • JTF competencies: 1.3, 2.1, 4.1
Subject Payment
  • Research Subject Payment Policy and Procedure (November 10, 2022)
    • JTF competency: N/A
Subject Safety
  • Planning for Your Plan: Data and Safety Monitoring Plan Development & Implementation (December 16, 2014)
    • JTF competencies: 3.2, 4.8, 4.10
  • Adverse Events through the Lens of the IRB (March 12, 2020)
    • JTF competencies: 2.3, 3.4, 3.6, 4.6, 4.10
Training and Onboarding
  • Study Team Member Onboarding: Critical Considerations for Planning for Success (January 9, 2020)
    • JTF competencies: 1.4, 4.3, 5.3
  • OHSP Education & Resource Updates (September 8, 2022)
    • JTF competency: 5.3
Vulnerable Populations
  • Consent in the Pediatric Population (February 10, 2022)
    • 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‘ module from the ‘UR-HRPP Educational Materials’ course homepage. 

  • Informed Consent: Refresher Training (v.09MAR2022)
    • JTF competencies: 2.3, 2.4
Click IRB videos

To access the materials below, select the ‘Click IRB Videos‘ module 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 Committee 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 the Director Research Education and Training.

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