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OHSP Training Framework

The Office for Human Subject Protection (OHSP) Division of Research Education & Training has developed online training courses, collectively referred to as the OHSP Training Framework, to aid in the professional development of faculty and staff conducting human subject research. These courses:

OHSP has not set forth broad course completion requirements related to these courses. Rather, faculty and staff should self-assess their competence and complete training accordingly. Department/Division leadership and/or Principal Investigators (PI) may also use these courses to support their training/onboarding needs.

A description of training framework components is provided below. Courses included in the framework are available, free-of-charge, to all University of Rochester faculty, staff and students via Blackboard.

Learn how to sign up for the OHSP Training Framework Courses

 

General recommendations based on role or experience

Although it is not required, OHSP generally recommends the following minimum training:

  • For Incoming Investigators (new to the University), regardless of experience:
    • Orientation to Conducting Human Subject Research
  • For Junior Faculty Investigators:
    • Orientation to Conducting Human Subject Research
    • Research Boot Camp
    • Core Training: PI Oversight
  • For less experienced/inexperienced study staff (e.g., Coordinators, Research Nurses, Project Managers, Research Assistants):
    • All Training Framework courses
    • Completion Process Recommendation: Complete courses in order, following completion of Human Subject Protection and Good Clinical Practice training. I.e., the Orientation course should be completed prior to Research Boot Camp; Research Boot Camp should be completed prior to any applicable Core Training modules, etc.
    • Completion Process Recommendation: Balance course completion efforts with time spent doing ‘on the job’ observation and application: This is critical in order for training content to be effective.
      • Trainees that are overloaded with didactic training are more likely to have difficulty focusing on the content, retaining information, and appropriately apply content.
      • Online training should be spaced out and complement ‘real world’ opportunities to apply the content.
      • ‘Real word’ opportunities should occur as quickly as possible following course completion. E.g., via observation, discussion, and hands-on practice. Similarly, allowing staff to gain ‘real world’ experience prior to completing Core Training modules will be of benefit.

OHSP training framework components

Orientation to Conducting Human Subject Research
  • Course Overview: The aim of this course is to provide a general overview of review processes and requirements concerning the conduct of human subject research at the UR.
  • Approximate Length: 1 hour
  • Learning Objectives:
    • Summarize the purpose of the University’s Human Research Protection Program (HRPP).
    • Describe key components of the University’s Human Research Protection Program (HRPP).
    • Recognize factors that impact the process for initiating research.
    • Identify research-related resources and services available within the University.
  • Content Outline:
    1. The HRPP at the UR (6 minutes):
      1. Purpose of the HRPP
      2. HRPP Oversight
      3. HRPP Components
    2. Institutional Review Board (IRB) Review (12 minutes)
      1. Office for Human Subject Protection
      2. IRB Scope & Review Process
      3. IRB Reliance Model
    3. Contracts, Grants & Agreements (7 minutes)
      1. Office of Research and Project Administration (ORPA)
      2. Clinical Research Billing Compliance
    4. Privacy & Data Security (10 minutes)
      1. Data Security Assessment Form
      2. HIPAA Compliance
      3. International Regulations
    5. Additional Requirements (8 minutes)
      1. HRPP Training Requirements
      2. Conflicts of Interest
      3. UR-HRPP Ancillary Committees
    6. Steps for Getting Started (13 minutes)
Research Boot Camp
  • Course Overview: This course is comprised of four learning modules aimed at understanding and applying key considerations, requirements, and best practices related to study protocol development, the informed consent process, Institutional Review Board (IRB) review, and post-IRB approval responsibilities.
  • Approximate Length: 5 hours
  • Learning Objectives:
    • Describe the purpose of a study protocol.
    • Identify the elements of a study protocol.
    • Describe the informed consent process, including components of an ethically valid consent process.
    • Describe regulatory and institutional requirements regarding the informed consent process.
    • Identify elements of consent that must be included in the informed consent process, as defined by the federal regulations.
    • Summarize alterations of informed consent.
    • Describe factors that impact the informed consent process.
    • Describe the Research Subjects Review (RSRB) role and scope.
    • Describe the RSRB review process.
    • Distinguish between a Reviewing Institutional Review Board (IRB) and a Relying IRB.
    • Summarize the responsibilities of the Principal Investigator.
    • Describe essential study documentation.
    • Determine when a modification must be submitted to the Reviewing IRB for review.
    • Describe IRB reporting requirements, including research event reporting and annual reporting
  • Content Outline:
    1. Study Protocol Basics: Elements & Development Considerations (70 minutes)
      1. Purpose of a Study Protocol
      2. Elements of a Study Protocol
      3. Lessons Learned in Protocol Development
    2. Informed Consent: Federal Regulations, Institutional Policy & Good Practice (100 minutes)
      1. Basic Informed Consent Requirements
      2. Variations of Informed Consent
      3. Special Consideration in Informed Consent
      4. Planning & Implementing the Informed Consent Process
    3. IRB Review Processes (80 minutes)
      1. University of Rochester (UR) Institutional Review Board (IRB) Overview
      2. IRB Review Processes
      3. IRB Review of Multi-Site Research
    4. Study’s Approved… What’s Next? (55 minutes)
      1. Roles & responsibilities
      2. Regulatory & protocol compliance
      3. Essential documentation
      4. Data & safety monitoring and research event reporting
      5. Progress reports/continuing reviews & study closure
  • JTF Core Competency Alignment: The content included within this course supports the knowledge, skills, and attitudes needed to meet the following Joint Task Force (JTF) Core Competencies: 1.2, 1.3, 2.3, 2.4, 2.5, 2.7, 2.8, 4.2, 4.4, 4.6, 4.7, 5.3, 5.5, 5.6, 7.3.

core training modules

Study Design
  • Approximate Length: 2 hours
  • Learning Objectives:
    • Describe basic elements of observational and experimental study designs.
    • Summarize key elements of ethical study design.
    • Evaluate study protocols against feasibility standards.
  • Content Outline
    1. Study Design Basics
      1. Types of Research
      2. Other Types of Reviews
      3. Phases of Clinical Research
      4. General Classes of Research
    2. Ethical Study Design
      1. Relevant Question
      2. Scientific Validity
      3. Appropriate Selection of Subjects
      4. Favorable Risk-Benefit Ratio
      5. Respect for Subjects
    3. Evaluating Study Protocols (aka Study Feasibility)
      1. Operational ‘Do-Ability’
      2. Scientific Merit
  • JTF Alignment*: 1.2, 1.3, 2.3, 2.8, 3.3, 4.1, 5.2, 6.1, 7.3
PI Oversight
  • Approximate Length: 2 hours
  • Learning Objectives:
    • Identify sources that define the responsibilities of a Principal Investigator.
    • Describe general responsibilities of a Principal Investigator.
    • Summarize common errors in conducting human subject research.
  • Content Outline
    1. The Principal Investigator (PI) Role
      1. Definition of a PI
      2. PI Oversight
    2. PI Responsibilities
      1. Levels of Compliance
      2. OHSP Policy 901 Investigator Responsibilities
    3. Common Problem Area
    4. Best Practices in PI Oversight
  • JTF Alignment*: 4.2, 5.1, 5.3, 7.3, 8.1
Study Operations
  • Approximate Length: 2 hours
  • Learning Objectives:
    • Describe how organizational structure affects day-to-day study activities.
    • Summarize study activities occurring prior to the initiation of a study, during protocol implementation and at study close-out.
    • Identify study management strategies and tools that aid in running compliant studies.
    • Summarize roles and activities in multi-site research.
  • Content Outline
    1. Organizational Structure of a Study
    2. Study Start-Up
      1. Planning for Study Procedures/Tasks
      2. Planning for Data Management
      3. Study Team Establishment & Training
      4. Compliance Strategies
    3. Study Conduct
      1. Subject Enrollment
      2. Study Visit Management
      3. Subject Completion
      4. Non-Compliance
    4. Study Close-Out
      1. Types of Study Closures
      2. Storage & Retention
    5. Multi-Center Research
      1. Roles & Responsibilities
      2. Study Monitoring
  • JTF Alignment*: 3.2, 4.2, 5.2, 5.4
Recruitment & Retention
  • Approximate Length: 1 hour
  • Learning Objectives:
    • Summarize various recruitment methods and factors that affect recruitment.
    • Describe how to assess study feasibility as it relates to subject recruitment and retention.
    • Apply best practices for subject recruitment and retention throughout the course of a study
  • Content Outline:
    1. Recruitment & Retention Factors
      1. Recruitment Funnel
      2. Barriers to Recruitment & Factors of Study Participation
      3. Determining Study Feasibility (as it relates to Recruitment & Retention)
    2. Recruitment Strategies
    3. Retention Strategies
    4. Planning for Recruitment & Retention
  • JTF Alignment*: 5.2, 5.4
Informed Consent
  • Approximate Length: 2.5 hours
  • Learning Objectives:
    • Analyze factors that influence the quality and effectiveness of the informed consent process.
    • Respond to situations where the informed consent process has been or potentially will be compromised.
    • Use techniques to improve the informed consent process.
  • Content Outline:
    1. Introduction & Overview
      1. Principle of Respect for Persons
      2. Quality & Effectiveness of Informed Consent
    2. Context, Communication & Context
      1. Drafting Consent Forms & Improving Readability
      2. Communication Basics
      3. Strategies for Successful Consent Discussions
      4. Context-Related Considerations
    3. Challenges, Errors & Troubleshooting
      1. Strategies for Managing Consent-Related Challenges
      2. Corrective & Preventative Actions
  • JTF Alignment*: 2.4, 4.2

Note: The following modules are currently unavailable: Investigational Products; Subject Safety; Essential Documentation; and Quality Management & Non-Compliance. These courses are in the process of being transitioned to an online format.

In the interim, consider using the following as supplemental training material:

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