All Access Webinar Package (Organizations Only)

Provide your organization's learners with access to currently available and future webinar recordings.

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About this Subscription Package

The All Access Webinar Package includes all of CITI Program’s currently available webinar recordings as well as future recordings released during your subscription period*. Webinars reflect current topics important to our subscribing organizations and their learners. These topics come from the range of CITI Program’s catalog of courses and are presented by experts.

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*This product includes most CITI Program generated webinars. Some webinars offered through special / partner programs may not be offered as part of this package.

Release Date: November 1, 2019

Language Availability: English

Suggested Audiences: Billing/Coding Staff, Bioethicists, Clinical Research Coordinators (CRCs), Clinical Researchers, Compliance Professionals, Department Administrators, Faculty, Institutional Review Boards (IRB) members, Institutional/Signatory Officials, IRB Chairs, IRB/HRPP Administrators and Staff, Principal Investigators, Privacy Officers, Registration Staff, Research Administrators, Research Team Members, Researchers, Sponsors, Students

Organizational Subscription Price: $1,000 per year/per site for government and non-profit organizations; $1,200 per year/per site for for-profit organizations
Independent Learner Price: Not available for individual learners

Webinar Content

Handling of Hazards in Research Animal Facilities

Presented by: Bhupinder Singh, BVSc & AH, MVSc, DACLAM – Rutgers University

Learning Objectives:

  • Identify the types of hazards in research animal facilities.
  • Examine the risk assessment of hazards.
  • Explain the hierarchy of controls for hazard mitigation.
  • Describe the role of oversight committees.
  • Describe the role of professionals.

Recommended Use: Required
ID (Language): 20865 (English)

Conducting a Literature Search for Animal Use Alternatives

Presented by: Jessie Carder, MS and Erika Edwards, MS – USDA Animal Welfare Information Center

Learning Objectives:

  • Define the 3Rs (replacement, reduction, and refinement of animal use). ​
  • Know which databases and web resources to use to find 3Rs alternatives. ​
  • Be able to use search syntax tools to build search strings and find relevant results.
  • Build your own alternatives literature search using the step-by-step process taught. ​
  • Understand who AWIC is, what they do, and their products and services.

Recommended Use: Required
ID (Language): 20864 (English)

Noncompliance and the IACUC: Basic Approaches for Success

Presented by: Mark Suckow, DVM, DACLAM - University of Kentucky

Learning Objectives:

  • Identify the goals of compliance
  • Understand the impact of non-compliance
  • Discuss the general types of non-compliance
  • Describe the reasons for non-compliance
  • Identify key elements related to identification and reporting of non-compliance
  • Discuss possible approaches to non-compliance
  • Understanding ways to prevent non-compliance

Recommended Use: Required
ID (Language): 20570 (English)

Research and Clinical Ethics Considerations for Xenotransplantation

Elisa J. Gordon, PhD, MPH – Vanderbilt University Medical Center;  Michael K. Gusmano, PhD – Lehigh University; Karen J. Maschke, PhD – The Hastings Center

Learning Objectives:

  • Recognize at least three ethical and policy issues about xenotransplantation.
  • Explain ethical concerns regarding eligibility criteria for participating in a first-in-human pig kidney xenotransplant trial.
  • Identify at least two ethical concerns about participant informed consent.
  • Recognize potential ethical and policy issues regarding access to pig kidneys (and other animal organs) if the FDA approves xenotransplantation for routine clinical care.

Recommended Use: Required
ID (Language): 21254 (English)

Human Enhancement and its Ethical Implications

Presented by: Misti Ault Anderson, MS, MA – The Greenwall Foundation

Learning Objectives:

  • Discuss and differentiate between different definitions of human enhancement
  • Understand differing viewpoints on ethical implications of human enhancement
  • Understand transhumanism and potential downstream ethical considerations

Recommended Use: Required
ID (Language): 20577 (English)

Ethics & Policy Issues in CRISPR Gene Editing

Presented by: Josephine Johnston – The Hastings Center

In this webinar, we explore the ethical and policy issues associated with CRISPR gene editing. The webinar begins with an introduction to CRISPR, including comparing it to existing gene editing and gene transfer technologies. It continues with a discussion on the laws, regulations, and recommendations affecting use of gene editing technologies in humans (and the commensurate ethical objections to use of these technologies to make heritable changes to human babies). In looking toward the future, the webinar concludes with a discussion on the ethics and policy questions that are likely to receive attention from international and national policymakers.

Recommended Use: Required
ID (Language): 19647 (English)

COVID-19: Supporting Ethical Care and Responding to Workforce Concerns in a Public Health Emergency

Presented by: Nancy Berlinger, PhD - The Hastings Center

Learning Objectives:

  • Clarify public health duties in relation to the duty of care during a public health emergency.
  • Identify ethical challenges in resource allocation (staff, stuff, space) and managing changing work conditions.
  • Respond to workforce stress and concerns related to COVID-19.
  • Collaborate effectively with other hospitals regionally.

Recommended Use: Required
ID (Language): 20076 (English)

Race in Clinical Research: Ethics and IRB Decision Making

Presented by: Nicolle Strand, JD, MBE, MPH - Lewis Katz School of Medicine, Temple University

Learning Objectives:

  • Explain why race should not be used as a proxy for biology in clinical research.
  • Apply the lessons of BiDil to studies that come to IRBs.
  • Trace the root causes of stark health disparities along racial lines, such as, sociocultural forces, structural issues, and trauma.

Recommended Use: Required
ID (Language): 20431 (English)

The Role of Data Managers in Clinical Trials

Iris Rigor, MPH, CCRP - National Cancer Institute, NIH

Learning Objectives:

  • Explain the importance of data management in clinical trials.
  • Describe the roles and responsibilities of clinical data managers (CDMs) in clinical trials.
  • Discuss the ways in which data managers interact with other clinical trial stakeholders such as clinical research coordinators (CRCs) and clinical research associates (CRAs).

Recommended Use: Required
ID (Language): 21250 (English)

Sponsor-Patient Engagement: How Patients Shape Clinical Development

Mary Stober Murray, MS-PopH - Murray Advisors, LLC

Learning Objectives:

  • Explain the reasons sponsors of clinical trials integrate patient perspectives in medicines development.
  • Describe patient engagement frameworks, approaches, and metrics.
  • Identify barriers to patient engagement.
  • Detail the co-creation process among clinical trial stakeholders in developing patient engagement mechanisms.
  • Outline future implications of patient engagement for emerging trends in the conduct of clinical trials.

Recommended Use: Required
ID (Language): 21376 (English)

Study Start-Up: Challenges and Strategies

Presented by: Jenifer Prather, MPH, RN – Integrative Measures LLC

Learning Objectives:

  • Explain the challenges related to the efficiency and effectiveness of study start-up.
  • Identify potential strategies to improve study start-up.
  • Discuss real-world examples of challenges and solutions in study start-ups.
  • Describe concrete steps toward improving study start-up.

Recommended Use: Required
ID (Language): 20967 (English)

Infection Control/Prevention and Pandemics: What have we learned? What do we need to learn?

Presented by: Scott C. Roberts, MD, MS - Yale University

Learning Objectives:

  • Learn the core concepts of infection prevention in healthcare settings.
  • Understand the variability in pathogen transmission.
  • Recognize prevention tools and techniques to better prepare for future pandemic threats in healthcare.

Recommended Use: Required
ID (Language): 20879 (English)

Managing Risk by Contract – Sponsor Perspectives on Clinical Trial Agreements

Presented by: Katherine Leibowitz, JD - Leibowitz Law

Learning Objectives:

  • Describe sponsor goals and concerns regarding study data, source records, and specimens in the clinical trial agreement (CTA).
  • Explain how digital health technologies (DHTs), decentralized clinical trials (DCTs), and cybersecurity concerns impact CTA negotiations.
  • Describe sponsor goals and concerns regarding risk allocation, including subject injury, indemnification, and insurance in the CTA.
  • Identify ways to expedite CTA negotiations.

Recommended Use: Required
ID (Language): 21143 (English)

CRA Relationships with CRCs

Presented by: Elizabeth Waddell, CCRA - The CRA Helper

Learning Objectives:

  • Distinguish the roles of the clinical research associate (CRA) and clinical research coordinator (CRC)
  • Discuss strategies for CRAs to build rapport with CRCs
  • Describe how CRAs can maintain effective relationships with study sites

Recommended Use: Required
ID (Language): 20966 (English)

CRAs and Interim Monitoring Visits

Presented by: Divyesh Kukadiya, MS, CCRP - Children’s National Hospital

Learning Objectives:

  • Describe the primary functions of a CRA.
  • Detail the role that CRAs play in conducting interim monitoring visits.
  • Discuss the range of possible findings from an interim monitoring visit.
  • Explain the core traits of an effective CRA.

Recommended Use: Required
ID (Language): 20965 (English)

From Protocol to Manual of Procedures (MOP)

Presented by: Michelle Mack, PhD - Duke University School of Medicine

Learning Objectives:

  • Define the distinction between a research protocol and a manual of procedures (MOP).
  • Identify key information to include within the MOP.
  • Explain the regulatory status of a MOP.
  • Describe the use of a MOP in small and large trials.

Recommended Use: Required
ID (Language): 20566 (English)

Discrete Choice Experiments (DCEs) in Neurologic Health

Presented by: Judy Illes, CM, PhD - University of British Columbia; Mark Harrison, PhD - University of British Columbia

Learning Objectives:

  • Recognize the design of DCEs.
  • Describe the analysis of DCE data.
  • Understand how results can predict the use of interventions.
  • Discuss the ethical considerations for recruitment and participation.

Recommended Use: Required
ID (Language): 20867 (English)

Clinical Trial Staff Diversity and Cultural Humility

Presented by: Bashar Shihabuddin, MD, MS – Nationwide Children’s Hospital and The Ohio State University; Jessica Fritter, MACRP, ACRP-CP – The Ohio State University

Learning Objectives:

  • Explain how the presence or absence of diversity among clinical trial staff impacts the generalizability of results.
  • Discuss the significance of clinical staff diversity on study success.
  • Apply cultural humility and reflection to study design, research team structure, and subject recruitment.

Recommended Use: Required
ID (Language): 20651 (English)

Understanding ISO 14155:2020 Revisions

Presented by: Liza Gordillo, MS – KLS Martin Group

Learning Objectives:

  • Describe the scope and purpose of ISO 14155:2020.
  • Detail the changes from ISO 14155:2011 to ISO 14155:2020.
  • Consider how the ISO 14155:2020 standard impacts sponsor and investigator responsibilities.

Recommended Use: Required
ID (Language): 20563 (English)

Working with the FDA: Medical Devices and Regulatory Touchpoints

Presented by: Robert Michalik, JD, RAC - RegulatoryPro Consulting

Learning Objectives:

  • Examine the legal and regulatory requirements for executing a successful clinical investigation of a medical device.
  • Explore the practical aspects of clinical development and FDA compliance for medical devices, including FDA touchpoints.
  • Discuss Breakthrough Device designation criteria as a regulatory strategy.

Recommended Use: Required
ID (Language): 20673 (English)

FDA Inspections of GMP Facilities: How to Be Inspection Ready

Presented by: Susan Leister, MBA, PhD, CQA, CSSBB – Technical Resources International, Inc.

Learning Objectives:

  • Describe the process of U.S. Food and Drug Administration (FDA) inspections of Good Manufacturing Practices (GMP) facilities.
  • Discuss how a site can be “inspection ready” at all times.
  • Discuss possible FDA inspection outcomes.

Recommended Use: Required
ID (Language): 20580 (English)

CRA Soft Skills, Time Management, and Effective Site Relationships

Presented by: Elizabeth Waddell, BS, CCRA - The CRA Helper

Learning Objectives:

  • Identify the different soft skills used by clinical research associates (CRAs).
  • Discuss strategies for CRAs to build rapport with their sites.
  • Describe how CRAs can maintain effective relationships with their sites and study teams.
  • Identify different CRA deliverables and tips to meeting timelines.

Recommended Use: Required
ID (Language): 20564 (English)

Understanding 483s and Surviving Them

Presented by: Theresa A. O’Lonergan, PhD, MA - Velocity Clinical Research

Learning Objectives:

  • Explain the FDA inspection process and purpose of FDA Form 483.
  • Identify the most common FDA citations for clinical sites and investigators.
  • Discuss structure of an FDA Form 483 and methods for assessing findings (including observations and violations).
  • Consider appropriate responses to an FDA Form 483.
  • Review actions to correct and prevent inspection findings.

Recommended Use: Required
ID (Language): 20582 (English)

Research Equity and the Part We Play

Presented by: Nicole Fisher, BS - AbbVie

Learning Objectives:

  • Describe how diversity in clinical trials ensures research equity.​
  • Identify the best strategies for building trust and transparency in clinical research.​
  • Explain how ethics plays a part in recruitment practices.

Recommended Use: Required
ID (Language): 20561 (English)

Improving the Clinical Trial Participant’s Experience: From Recruitment through Study Closure

Presented by: Deena Bernstein, MHS - Datacubed Health; Claudia Gomes, MS, ACRP-CP - JEM Headlands LLC

Learning Objectives:

  • Identify strategies sponsors and CROs can integrate into study design to enhance the overall clinical trial participant experience.
  • Discuss best practices for engagement that sites can implement to improve participant experience.
  • Describe tools that can be used to improve retention of clinical trial participants.
  • Explain the importance of listening to the voice of the clinical trial participants to improve their satisfaction with all patient-facing aspects of the clinical trial process.

Recommended Use: Required
ID (Language): 20433 (English)

ClinicalTrials.gov Enforcement: An Update

Presented by: Anthony Keyes, MBA, PMP - Johns Hopkins University

Learning Objectives:

  • Review recent FDA notices of noncompliance.
  • Identify and mitigate potential noncompliance pitfalls.
  • Discuss modernization of the Protocol Registration and Results System (PRS) and database by the National Library of Medicine (NLM).

Recommended Use: Required
ID (Language): 20560 (English)

Building a ClinicalTrials.gov Compliance Program – Tips for Investigators and Institutions

Presented by: Anthony Keyes, MBA, PMP - Johns Hopkins University

This webinar reviews the main regulations and policies that govern clinical trial registration and results reporting. It also describes the risks and liabilities involved with noncompliance and discusses how organizations can build compliance monitoring programs.

Recommended Use: Required
ID (Language): 19747 (English)

Informed Consent and Clinical Investigations: A Focus on the Process

Presented by: Linda Reuter, MS, CIP - Biomedical Research Alliance of New York (BRANY)

Learning Objectives:

  • Identify and understand current challenges related to the effectiveness and validity of informed consent.
  • Discuss potential strategies to improve the overall consent process.
  • Identify potential next steps toward improving the informed consent process.

Recommended Use: Required
ID (Language): 20204 (English)

Remote Informed Consent: The Same, but Different, but Still the Same

Presented by: Belinda Smith, MS, RD, CCRC – University of Kentucky

Learning Objectives:

  • Consider requirements that apply to remote consent processes and documentation including HHS, HIPAA, and FDA regulated research.
  • Adapt informed consent components for a remote process including areas of regulatory flexibility afforded by agencies due to the pandemic.
  • Explore electronic consent solutions and challenges.
  • Review remote consent process examples in various research scenarios.

Recommended Use: Required
ID (Language): 20397 (English)

Informed Consent and Research with Wearable Tech

Presented by: Megan Doerr, MS, LGC – Sage Bionetworks

Learning Objectives:

  • Define wearables, list examples and the data types they collect.
  • Explain one model of how to conceptualize and describe the risk from wearable sensors/technologies in research.
  • Describe the sources of this risk to research participants.
  • Identify key concepts to support disclosure of risks to participants.

Recommended Use: Required
ID (Language): 20206 (English)

Understanding Decentralized Clinical Trials (DCTs) and Virtual Study Visits

Presented by: Amanda Rangel, MS, CCRC - VirTrial, a Signant Health Company

Learning Objectives:

  • Identify differences between traditional trials and decentralized clinical trials.
  • Review brief history of development of DCTs.
  • Learn about the terminology, regulations, and best practices of DCTs.
  • Learn appropriate preparation for, interactions during, and overall conduct for virtual visits.

Recommended Use: Required
ID (Language): 20398 (English)

Decentralized Clinical Trials (DCTs) and Your Workforce

Presented by: Kimberly Ray, BS - Clinical Reseach Consultant

Learning Objectives:

  • Describe some technology solutions typically used in decentralized clinical trials (DCTs).
  • Explore how traditional clinical research jobs at investigational sites are changing when conducting DCTs or trials that use many types of technology.
  • Identify any new skills that are necessary to conduct clinical research in this new environment.
  • Explore new positions and roles that may be needed for DCTs.

Recommended Use: Required
ID (Language): 20432 (English)

A Beginner’s Guide to Being a Sponsor-Investigator

Presented by: Melissa A. Scotti, PhD, CIP - Northwell Health

Learning Objectives:

  • Define the sponsor-investigator role.
  • Identify sponsor-investigator regulatory responsibilities.
  • Discuss considerations for study planning including: study design, leveraging resources, and working with research/institutional support services.

Recommended Use: Required
ID (Language): 20520 (English)

U.S. Department of Energy Interim Policy on Conflicts of Interest

Presented by: Lory Hayes, PhD, CHRC - University of Miami

Learning Objectives:

  • Understand the U.S. Department of Energy’s Interim COI policy
  • Recognize individual and institutional responsibilities
  • Delineate management and reporting requirements associated with the Interim policy
  • Identify non-compliances and different corrective action options based on the Interim policy

Recommended Use: Required
ID (Language): 20803 (English)

Emergency Preparedness and Response: Collaborative Approaches to Ensure Sustainability of Research Oversight

Nichelle Cobb, PhD, CIP –  Association for the Accreditation of Human Research Protection Programs; Robert Hood, PhD –  Association for the Accreditation of Human Research Protection Programs

Learning Objectives:

  • Discuss why an emergency preparedness plan for an HRPP is critical to the protection of research participants.
  • Identify the factors to consider when developing an emergency preparedness plan.
  • Consider who should be involved in the development of an emergency preparedness plan and its dissemination.
  • Understand the importance of evaluating and modifying the emergency preparedness plan as needed.

Recommended Use: Required
ID (Language): 21498 (English)

Disaster Response and Research Reactivation Efforts

Presented by: Myra Luna-Lucero, EdD – Teachers College, Columbia University

Learning Objectives:

  • Describe the importance of using experiences to improve disaster response and research reactivation. ​
  • Examine ways to improve future disaster response and research reactivation approaches.​
  • Identify time and task tracking initiatives and knowledge repository development to build from institutional and professional experiences. ​
  • Explore a sample continuity plan for disaster response and research reactivation.

Recommended Use: Required
ID (Language): 20876 (English)

The Challenge of Medicare Advantage Plans and Local Coverage Determinations

Presented by: Kelly Willenberg, DBA, RN, CCRP, CHRC, CHC - Kelly Willenberg, LLC

This webinar reviews how to identify Medicare Advantage Plan challenges for both drug and IDE studies, describes the variance of local coverage determinations nationally, and identifies areas that cause frustration within the process and ways to handle denials correctly.

Recommended Use: Required
ID (Language): 19565 (English)

Service Dogs in Science: Barriers to Inclusion

Joey Ramp-Adams - Assistance Dog International (ADI)

Learning Objectives:

  • Recognize people with disabilities are in the sciences.
  • Identify the barriers for service dog handlers in science.
  • Identify biosafety levels and risks.
  • Understand policies, procedures and risk assessment.
  • Discuss the solutions from barriers to inclusion.

Recommended Use: Required
ID (Language): 21245 (English)

Service Dog 101: Everything You Need to Know

Joey Ramp-Adams - Assistance Dog International (ADI)

Learning Objectives:

  • Understand the legal foundation
  • Identify the different categories of working and support animals
  • Identify a service dog
  • Discuss the training and use of service dogs.

Recommended Use: Required
ID (Language): 21243 (English)

Field Research Safety: Assessing and Managing Risk

Presented by: Alex Derr, MPA - The Next Summit

Learning Objectives:

  • Develop the ability to conduct a comprehensive risk assessment for wilderness research.
  • Identify hazards present in wilderness research environments, including natural elements (terrain, weather), wildlife, social/psychological (harassment, crime), and logistical (transportation and equipment failure)
  • Learn to continually assess the likelihood and the severity of the risk posed by the hazard to impact the field research experience.
  • Identify ways to create and adjust wilderness field research risk management plans to lower risk effectively.

Recommended Use: Required
ID (Language): 21242 (English)

What Researchers Need to Know about Infection Prevention

Presented by: Philip Chan, MD, MS - Brown University

Learning Objectives:

  • Identify how infectious diseases are transmitted​
  • Identify the components of standard precautions​
  • Discuss the prevention of bloodborne infectious diseases

Recommended Use: Required
ID (Language): 20878 (English)

Sustainable Science: How to Make Research Labs Greener

Presented by: Nicholas Ciancio, BS, MPA/MPH – University of Alabama at Birmingham

Learning Objectives:

  • Identify the environmental impact of research in the United States.
  • Assess how to mitigate the environmental impact of research operations.
  • Determine ways to enroll key stakeholders in mitigating the environmental impact.

Recommended Use: Required
ID (Language): 20875 (English)

Building a Laser Safety Program

Presented by: Zachariah Tribbett, CHP, CLSO, MA - Yale University

Learning Objectives:

  • Identify when a laser safety program is needed.
  • Identify the primary regulations that outline program requirements.
  • Describe required program elements.
  • Discuss laser control measures and implementation.
  • Discuss how to work through the ongoing challenges of running a laser safety program

Recommended Use: Required
ID (Language): 20874 (English)

Export Compliance: An Overview for Staff, Students, and Faculty

Presented by: Wendy M. Epley, MSc-RTC, ECoP® - EAR & ITAR  - Epley Consulting, LLC

Learning Objectives:

  • Discuss what export controls are.
  • Recognize how export controls can affect various activities within institutions of higher education.
  • Identify potential export control risks in higher education activities.

Recommended Use: Required
ID (Language): 20166 (English)

I’ve Been Funded, Now What?

Presented by: Elizabeth Lyons, PhD, MPH - The University of Texas Medical Branch

Learning Objectives:

  • Describe strategies for:
    • Promoting eudaimonia at work
    • Planning project progress
    • Tracking and celebrating progress
  • List potential trainings and methods that could assist with planning

Recommended Use: Required
ID (Language): 20882 (English)

Writing Your First R01

Presented by: Christy Chang, PhD – University of Maryland, Baltimore

Learning Objectives:

  • Learn how to assess if an investigator is ready to write their first R01.​
  • Understand the required elements of an R01 application.​
  • Understand what characteristics are considered major weaknesses and how to fix them.

Recommended Use: Required
ID (Language): 20857 (English)

NIH Career Development (“K”) Awards- Matching Needs to Opportunities

Presented by: Nancy L. Devino, PhD - University of Texas

Learning Objectives:

  • Summarize the overall purpose of K awards
  • Identify the most appropriate K mechanism for a given investigator
  • Describe the common components of K awards
  • Identify some of the challenges in writing a K proposal

Recommended Use: Required
ID (Language): 20856 (English)

New Data Sharing Requirements for NIH-Funded Research

Presented by: Ibraheem Ali, PhD – University of California, Los Angeles

Learning Objectives:

  • Identify key requirements in the NIH Data Management and Sharing (DMS) Policy.
  • Summarize the components of an NIH data management and sharing plan (DMSP).
  • Recognize key considerations when working with human subjects research data.
  • Identify steps to prepare your research group and institution for the policy.

Recommended Use: Required
ID (Language): 20862 (English)

Successfully Navigating Subrecipient Monitoring

Presented by: Beth Kingsley, CRA - Yale University; Robert Prentiss, BA - Yale University

Learning Objectives:

  • Identify the regulations governing subrecipient monitoring
  • Discuss the risk assessment requirements and potential applications
  • Identify ongoing subrecipient monitoring as it applies to invoices

Recommended Use: Required
ID (Language): 20568 (English)

Managing Your Grants as Systems: A Guide for Grant Management Success

Presented by: L. Eric James II, MS JD – Minnesota State University, Mankato

Learning Objectives:

  • Identify key management stakeholders for your grant’s success
  • Compare multi-faceted strategies for approaching grant management
  • Define a strategic, operational, and tactical plan for grant management

Recommended Use: Required
ID (Language): 20555 (English)

Getting Started in Grant Writing: An Introduction for Graduate Students, Postdocs, and New Faculty

Presented by: Nancy L. Devino, PhD - University of Texas

Learning Objectives:

  • Identify major phases in grant proposal development.
  • Locate relevant sources of information on funding opportunities.
  • Summarize information found in a Request for Proposals.
  • Outline the steps to go from proposal concept to proposal submission.

Recommended Use: Required
ID (Language): 20395 (English)

Cost Allowability on Federally Sponsored Awards

Presented by: Kathryn Watkins, MEd, CRA, CFRA - University of Akron; Jeffrey Ritchie, MA, CRA, CFRA - Hamilton College

Learning Objectives:

  • Determine allowability of costs to federally sponsored projects
  • Recognize the importance of context when determining cost allowability
  • Identify typically unallowable costs
  • Distinguish areas of risk associated with unallowable costs

Recommended Use: Required
ID (Language): 20420 (English)

Controlled Unclassified Information – What it is, Isn’t, and University Obligations

Mary Duarte Millsaps, CRA, ECoP® (ITAR & EAR) - North Carolina State University

Learning Objectives:

  • Gain an understanding of the Federal Controlled Unclassified Information (CUI) Program
  • Understand the key elements of the CUI program and universities’ responsibilities
  • Provide key resources

Recommended Use: Required
ID (Language): 21258 (English)

FMLA Essentials: Guidance for Employers in Grant-Funded Research Settings

Tanya Brown, MSHR, PHR, SHRM-CP - Vanderbilt University

Learning Objectives:

  • Overview of the Family Medical Leave Act (FMLA) Regulations
  • Review the process for administering FMLA
  • Understand the leave entitlements afforded by the FMLA
  • Review the considerations for administering FMLA in a research setting

Recommended Use: Required
ID (Language): 21235 (English)

Exploring the Global Campus: Navigating the Mental Health of International Students

Sitara Rambarran, MS - Nova Southeastern University

Learning Objectives:

  • Understand the unique challenges faced by international students in adapting to a new academic and cultural environment.
  • Explore cultural factors influencing mental health perceptions and help-seeking behaviors among international students.
  • Highlight effective strategies for promoting mental health awareness and resilience among international students.

Recommended Use: Required
ID (Language): 21234 (English)

Expanding Our Concept of Access: Universal Design in Online Course Design

Presented by: Amanda Kraus, PhD - University of Arizona; Angela Bruch, PhD - Capella University

Learning Objectives:

  • Understand the concepts and principles of Universal Design and Universal Design for Learning.
  • Apply Universal Design strategies to online course development.
  • Grow Universal Design strategies for teaching.

Recommended Use: Required
ID (Language): 20858 (English)

Design With the End in Mind

Presented by: Michele Poulos, MEd - ECPI University

Learning Objectives:

  • Describe the Understanding by Design framework
  • Identify the three stages of the backward design process
  • Recount the significance of starting with desired outcomes
  • Explain why assessment is an integral part of the backward design process

Recommended Use: Required
ID (Language): 20861 (English)

Artificial Intelligence: The Impact on Academic and Research Integrity

Presented by: Lisa Blackman-Siddall, PhD – Capella University

Learning Objectives:

  • Learn basic terminology and definitions. What is “Generative AI” (GenAI)?
  • Learn some of the pros and cons of using GenAI and how these may impact your decision-making regarding integrity.
  • Begin to think about policy, procedures, and practice in teaching and learning at your institution, to support integrity.
  • Consider - how can we ensure academic and research integrity? How can we grow ethical thinkers?

Recommended Use: Required
ID (Language): 21233 (English)

Burnout and Wellbeing in U.S. Higher Education

Presented by: Sarah Lipson, PhD, EdM - Boston University School of Public Health

Learning Objectives:

  • Understand the importance of reducing burnout among higher education faculty and staff​
  • Identify common sources of burnout and actions to address these sources​
  • Understand the prevalence of burnout among higher education employees and variations across individual characteristics

Recommended Use: Required
ID (Language): 20860 (English)

Mentoring Learners and New Faculty Engaged in the Doctoral Quest

Presented by: Phillip M. Randall, PhD, CGP - Capella University

Learning Objectives:

  • Identify the key factors of effective mentoring and learner success
  • Define the components of effective mentoring
  • Identify the tools of effective mentoring
  • Define mentorship, sponsorship, and their relationship as dimensions of effective mentoring and learner success
  • Identify mentor and learner advocacy scotomas (blind spots)

Recommended Use: Required
ID (Language): 20870 (English)

AI in Higher Education: An Overview

Presented by: Iris Palmer, MPP -  New America

Learning Objectives:

  • Define predictive analytics.
  • Describe how colleges are using predictive analytics.
  • Identify possible ethical and implementation challenges with predictive analytics.
  • Identify the possible pitfalls in implementing predictive analytics and strategies for addressing these pitfalls.

Recommended Use: Required
ID (Language): 20805 (English)

Addressing and Understanding Mental Health Challenges for Faculty and Staff

Presented by: Negar Shekarabi, PsyD – University of California, Irvine 

Learning Objectives:

  • Understand and explore the role of faculty in mental health on campus.
  • Describe what is and is not mental health allyship.
  • Review what other institutions are doing to address faculty and staff mental health.
  • Identify how leadership can support their faculty.

Recommended Use: Required
ID (Language): 20559 (English)

How to Implement Trauma-Informed Care: An Introduction

Presented by: Elise Suna, MSEd, LMFT

Learning Objectives:

  • Recognize the impact of trauma and the principles of trauma-informed care
  • Learn strategies to implement trauma-informed care practices with clients, patients, and/or students
  • Apply methods of how to mitigate secondary-traumatization and promote resilience in their organization

Recommended Use: Required
ID (Language): 20739 (English)

A 21st Century Approach to ADA Compliance: Equity and Access

Presented by: Amanda Kraus, PhD – The University of Arizona

Learning Objectives:

  • Define the purpose and implications of Section 504 and the Americans with Disabilities Act (ADA).
  • Compare and contrast concepts of accessibility and inclusion within higher education.
  • Recognize universal design strategies that promote both compliance and inclusion in a learning environment.

Recommended Use: Required
ID (Language): 20558 (English)

Best Practices for Global Research Partnerships: Benefits and Challenges

Presented by: Lisa V. Adams, MD – Geisel School of Medicine at Dartmouth

Learning Objectives:

  • Describe the inherent challenges and paradigm shift required to develop equitable international research partnerships.
  • Apply three practical steps to ensure balance exists in global health partnerships.
  • Discuss the importance of modern global health education and practices.
  • Review specific approaches to adopt and promote equitable global health programs.

Recommended Use: Required
ID (Language): 20557 (English)

Open Access Publishing: An Introduction

Presented by: Sarah Melton, PhD – Educational Consultant

Learning Objectives:

  • Demonstrate an understanding of open access publishing history.
  • Recognize current practices in open access publishing.
  • Identify how open access publishing has affected the scholarly landscape.

Recommended Use: Required
ID (Language): 20578 (English)

Preparing to Publish in Traditional and Hybrid Journals

Presented by: Paige Morgan, PhD – University of Delaware Library, Museums and Press

Learning Objectives:

  • Identify the scholarly publication process for traditional and hybrid journals from start to finish.
  • Recognize techniques for finding and assessing potential publication venues.
  • Determine strategies for sharing and promoting scholarship and increasing its discoverability that are compatible with your career/research agenda.
  • Compare equity of different levels of access to scholarly research.

Recommended Use: Required
ID (Language): 20638 (English)

Understanding and Addressing Mental Health on Campus: Opportunities and Challenges in Higher Education

Presented by: Sarah Lipson, PhD, EdM – Boston University School of Public Health and Healthy Minds Network

Learning Objectives:

  • Identify the state of campus mental health in terms of mental health prevalence and help-seeking, trends over time, and inequities.
  • Recognize the opportunities for investing in student mental health and the connection between wellbeing and academic performance.

Recommended Use: Required
ID (Language): 20556 (English)

Remote Contact Tracing Basics for COVID-19

Presented by: Terry Adirim, MD, MPH, MBA – Florida Atlantic University

Learning Objectives:

  • Describe the fundamentals of contact tracing and its public health role in preventing the spread of infectious diseases.
  • Describe the clinical course of COVID-19 infection.
  • Identify COVID-19 transmission and methods to prevent spread.
  • Discuss the three types of COVID-19 testing.
  • Describe the types of treatments for COVID-19.
  • Review contact tracing steps.

Recommended Use: Required
ID (Language): 20199 (English)

Investigating and Tracing a Case’s Contacts

Presented by: Joanna Drowos, DO, MPH, MBA - Florida Atlantic University

Learning objectives

  • Describe the steps in the remote contact tracing process, including initial notification, interviews, locating and notifying exposed contacts, and monitoring contacts.
  • Outline evidence-based practices for remote communication and interviewing when investigating cases or following up with contacts.

Recommended Use: Required
ID (Language): 20200 (English)

Contact Tracing Ethics and Responsibilities

Presented by: Lisa Martinez, MD, FACP - Florida Atlantic University

Learning Objectives:

  • Contrast the public health need for contact tracing with the individual’s need for privacy and autonomy.
  • Define confidential information, and outline strategies for ensuring data privacy and protection.
  • Review the legal basis and limits for social distancing, quarantine, and isolation.

Recommended Use: Required
ID (Language): 20201 (English)

Managing Conflict with Your Dissertation Chair

Presented by: LaVena Wilkin, PhD – Sullivan University

Learning Objectives:

  • Identify the roles, responsibilities, and expectations from the dissertation committee members and chair for the candidate
  • Communicate respectfully, even when emotions are high
  • Be assertive without being aggressive

Recommended Use: Required
ID (Language): 20384 (English)

Effectively Communicating Research Results to Non-Scientific Audiences

Presented by: Erin Heath, MSc - American Association for the Advancement of Science (AAAS); Mary Catherine Longshore, MA - American Association for the Advancement of Science (AAAS)

Learning Objectives:

  • Identify the public engagement with science model.
  • Identify ways to leverage your identity to connect authentically with others.
  • Define ways to create actionable goals and consider whom to engage with and what you will discuss.
  • Identify ways to engage in science and technology policy.
  • Identify resources available to assist in understanding and engaging in policy.

Recommended Use: Required
ID (Language): 20735 (English)

Title IX: 50 Years and Modern Challenges

Presented by: Amber Grove, Esq. – University of North Carolina Wilmington

Learning Objectives:

  • Identify foundational legal and policy components of Title IX and their relation to higher education practice.
  • Critically analyze the development of Title IX over time to understand trend areas and ongoing potential impact/change.
  • Apply understanding of Title IX and related equity issues to create supportive and inclusive environments.

Recommended Use: Required
ID (Language): 20759 (English)

Title IX and the New Regulations

Presented by: Jules C. Irvin-Rooney, JD, MA - Title IX and Clery Act Consulting, LLC

Learning Objectives:

  • Identify key changes in the 2020 Title IX federal regulations from the U.S. Department of Education
  • Discuss implications for campuses, apparent ambiguities, and current challenges
  • Share examples of how campuses can shape policy and implementation in this area that may keep evolving under different political administrations
  • Discuss how new policies will affect administrators, students, and faculty

Recommended Use: Required
ID (Language): 20202 (English)

Accreditation 101 for New and Adjunct Faculty

Presented by: John Osborne, MA - Everglades University Online Campus

Learning Objectives:

  1. Identify the purpose, importance, and benefits of accreditation
  2. Review the different types of accrediting bodies
  3. Explain the role and responsibilities of faculty members in accreditation at their institutions

Recommended Use: Required
ID (Language): 20203 (English)

Principles and Practices for Managing Undue Foreign Influence in an Academic Environment

Presented by: Allen A. DiPalma, MBA - University of Pittsburgh

Learning Objectives:

  • Understand the reasons behind current undue foreign influence concerns.
  • Identify some frequent disclosure practices used to manage foreign influence risk.
  • Recognize industry best practice suggestions to more effectively manage foreign influence risk.
  • Be familiar with recent government released directives that will impact future guidance.

Recommended Use: Required
ID (Language): 20416 (English)

Blockchain and Higher Education

Presented by: Kerri Lemoie, MA - Concentric Sky

Learning Objectives:

  • Summarize the history of blockchain
  • Explain blockchain characteristics that have led to its usefulness beyond cryptocurrency
  • Identify use cases in higher education
  • Review initiatives fostering the use of blockchain in higher education

Recommended Use: Required
ID (Language): 20418 (English)

FCPA and University Research: What Faculty and Administrators Need to Know

Presented by: Alyssa B. Greenwald, JD, LLM, MA - Yale University

Learning Objectives:

  • Describe the FCPA, including the statute’s key terms and provisions.
  • Recognize high-risk activities, particularly research and other Higher Ed activities.
  • Identify strategies for monitoring and mitigating risk associated with international research.

Recommended Use: Required
ID (Language): 20422 (English)

Data Management and Security for Student Researchers: An Overview

Presented by: Mariette Marsh, MPA, CIP, CHPC, CHRC - University of Arizona

Learning Objectives:

  • Define the basic principles governing protection and confidentiality of research data
  • Identify best practices to use in storing and securing research data
  • Assess situations in which research data may need extra security protections

Recommended Use: Required
ID (Language): 20423 (English)

Studying Up, Studying Down, and Studying Sideways: Ethical Considerations in Research

Diana Riviera, PhD - Capella University

Learning Objectives:

  • Define and differentiate between studying up, studying down, and studying sideways.​
  • Recognize the ethical challenges associated with each type of research positionality.​
  • Consider ethical principles to real-world research scenarios.​
  • Identify ways to develop ethical research strategies to conduct ethical research across different social strata.​
  • Reflect on power dynamics to understand how power dynamics influence research and how to address them ethically.

Recommended Use: Required
ID (Language): 21259 (English)

Space Exploration, the Outer Space Treaty, and the Future of Human Subjects Research Ethics

Presented by: Tom Salazar, JD, MS, CIP - Travis Air Force Base

Learning Objectives:

  • Learn why human subjects research in space (HSRS) is fundamentally different than human subjects research on earth.​
  • Understand the limitations of current principles governing human subjects research ethics when applied to HSRS.​
  • Explore short-term and long-term considerations for ensuring progress in space exploration and science is not made at the expense of research participants in space.

Recommended Use: Required
ID (Language): 21230 (English)

Participating in Vaccine Research

Presented by: Margaret Rankovic, MEd, CIP - CITI Program

Learning Objectives:

  • Describe what research is.
  • Identify what a vaccine is.
  • Discuss different efforts to create a COVID-19 vaccine.
  • Review the role, rights, and responsibilities of a subject in a research study.
  • Consider reasons to participate or not in research.
  • Identify some ways to find a vaccine trial to join.

Recommended Use: Required
ID (Language): 20319 (English)

Utilizing Outside Experts on the IRB

Presented by: Kimberley Serpico, EdD, CIP - Harvard Chan School of Public Health

Learning Objectives:

  • Review regulatory provisions for utilizing outside experts on the IRB.
  • Discuss project findings related to using outside expertise.
  • Consider any unmet needs, barriers, challenges, and/or concerns related to external consultation.
  • Describe how outside expert review impacts IRB decision-making and the quality of IRB review.

Recommended Use: Required
ID (Language): 20863 (English)

Advance Research Directives: Tools for Supporting People Who Lack Decision-Making Capacity

Presented by: Nola Ries, PhD, MPA, LLM, JD, BA (Hons) - University of Technology Sydney

Learning Objectives:

  • Define the concept of advance research planning, which may include making an advance research directive (ARD).
  • Discuss ARDs as a strategy to support research inclusion for adults who lack capacity to give their own consent.
  • Appraise ethical and legal considerations for research that includes adults with cognitive impairment.
  • Identify ways to adapt an ARD form and guidance booklet for your organization’s own use.

Recommended Use: Required
ID (Language): 20576 (English)

Why Sex Matters from Research to Patient Care

Presented by: Chyren Hunter, PhD - National Institutes of Health and American Medical Women’s Association; Caroline Paul, MD - NYU Grossman School of Medicine, NYU Langone Health, and American Medical Women’s Association; Kimberly J. Templeton, MD - University of Kansas and American Medical Women’s Association; Janice Werbinski, MD, FACOG - Western Michigan University Homer Stryker MD School of Medicine and American Medical Women’s Association

Learning Objectives:

  • Understand the concepts of sex and gender and how they differ.
  • Explain how the exclusion of sex disaggregation of data in research impacts patient care, healthcare education, and the development of the next generations of researchers.
  • Describe the intent and impact of the NIH Sex as a Biologic Variable (SABV) policy.
  • Consider how Institutional Review Boards at medical institutions can prospectively impact the inclusion of sex and gender in research proposals, including disaggregation and reporting of results by these variables.

Recommended Use: Required
ID (Language): 20866 (English)

NIH Data Management and Sharing Policy for SBER: Implications for Researchers and IRBs

Presented by: Dessi Kirilova, MA - Qualitative Data Repository; Diana Kapiszewski, PhD - Georgetown University and Qualitative Data Repository

Learning Objectives:

  • Identify the reasons for and goals of the NIH’s 2023 Data Management and Sharing Policy (DMSP) and how the policy complements other efforts related to research transparency/access to data.
  • Review the most salient points of the new DMSP for SBER researchers and IRBs.
  • Understand how data repositories and their resources can facilitate meeting the policy’s objective.

Recommended Use: Required
ID (Language): 20571 (English)

Paying Participants in Research: Regulations, Ethics, and Practical Considerations

Presented by: Brandon Brown, MPH, PhD – University of California - Riverside

Learning Objectives:

  • Identify the regulations around payment in research.
  • Describe limitations in payment data in the peer-reviewed literature.
  • Discuss some of the factors which may determine payment decisions.
  • Propose one potential solution to determine appropriate payment amounts.

Recommended Use: Required
ID (Language): 20575 (English)

How to Conduct an Audit of a Ceded Study

Presented by: Leslie Howes, MPH, CIP - Harvard T.H. Chan School of Public Health

Learning Objectives:

  • Identify ways to assess your ceded portfolio and when auditing is appropriate and/or necessary.
  • Discuss unique considerations for auditing from the perspective of the sIRB and participating site.
  • Outline available resources and tools to support auditing of ceded studies.

Recommended Use: Required
ID (Language): 20574 (English)

Quality Improvement Activities and the Common Rule

Presented by: Linda Reuter, MS, CIP - Biomedical Research Alliance of New York (BRANY)

Learning Objectives:

  • Determine if a quality improvement (QI) activity is regulated research per the revised Common Rule.
  • Summarize characteristics of QI activities.
  • Consider potential overlap of regulated research and QI.
  • Review key differences between QI and research.

Recommended Use: Required
ID (Language): 20572 (English)

IRB Protocol Noncompliance: When Research Goes Rogue, What Next?

Presented by: Lisa R. Blackman-Siddall, PhD – Capella University

Learning Objectives:

  • Define IRB protocol noncompliance and consider nuances that apply to your institution.
  • Determine the potential importance and content of policy, SOPs, and other practice documents at your institution.
  • Explore scenarios and different potential corrective actions.
  • Clarify institutional goals for improvement.

Recommended Use: Required
ID (Language): 20428 (English)

Research with Native American Communities: Important Considerations When Applying Federal Regulations

Presented by: Cynthia Pearson, PhD – University of Washington

This webinar discusses how to apply the federal regulations when planning, conducting, and reviewing research with tribes. Explores the three principles from the Belmont Report from an indigenous perspective. Includes essential tools to help facilitate the conduct of ethical research with AIAN communities.

Recommended Use: Required
ID (Language): 19639 (English)

Preparing for Single IRB (sIRB) under the Common Rule

Presented by: Nichelle Cobb, PhD – University of Wisconsin-Madison

This webinar will provide an overview of the sIRB requirement under the revised Common Rule, including comparing it to the NIH Policy. Dr. Cobb, Director of SMART IRB Operations and one of the Ambassadors for SMART IRB, addresses issues for researchers, relying institutions, and reviewing IRBs. She discusses setting up reliance agreements, considerations for local context, key responsibilities, and strategies for communication when using an sIRB.

Recommended Use: Required
ID (Language): 19660 (English)

Running a Virtual IRB Meeting

Presented by: Angela L. Bruch, PhD - Capella University

This webinar identifies the elements, challenges, and regulatory requirements for running a virtual IRB meeting as well as the process for consulting with principal investigators and others to support IRB review. It also describes communication best practices for IRB reviewers and researchers while discussing how to support important key relationships between the IRB, the organization, and researchers.

Recommended Use: Required
ID (Language): 19827 (English)

Nuts & Bolts of Running a Virtual IRB Meeting

Presented by: Angela L. Bruch, PhD - Capella University

Learning Objectives:

  • Understand virtual IRB meetings and their benefits, especially in times of emergencies.
  • Discuss how to develop a format/script for running a virtual IRB meeting.
  • Describe how to document a virtual meeting in the IRB meeting minutes.
  • Identify additional considerations for meeting regulatory requirements in a virtual convened meeting.
  • Identify key players in running virtual meetings and ways to best engage them.
  • Identify how virtual meetings may fit with emergency disaster plans and when those plans are implemented.

Recommended Use: Required
ID (Language): 20060 (English)

Medical Marijuana: A Budding Field of Research

Presented by: Jane Z. Dumsha, PhD, CHES – Philadelphia College of Osteopathic Medicine

This webinar identifies federal regulations and unique issues relevant medical marijuana research. It also discusses how to apply the federal regulations and the Belmont Report’s ethical framework to this research. It concludes with considerations for IRB Review and covers steps for getting started in medical marijuana research.

Recommended Use: Required
ID (Language): 19969 (English)

Understanding Consent Requirements and “Key Information” Under the Revised Rule

Presented by: Misti Ault Anderson, MS, MA – HHS Office for Human Research Protections

This webinar provides learners with a review of the new regulatory requirements for understandability in informed consent documents. During the webinar, learners will explore ways to develop consent materials that reflect what potential participants need to know and understand in order to make autonomous decisions about whether to participate in research, with particular emphasis on the new “key information” requirements of the revised Common Rule. This webinar is ideal for individuals preparing consent materials for new research, as well as IRB members and staff who review consent forms or provide support to researchers at their organizations.

Recommended Use: Required
ID (Language): 19970 (English)

Health Disparities: Promoting Equity and Diversity in Clinical Research

Presented by: Nancy Wintering, LCSW, CCRP – Thomas Jefferson University

This webinar provides an overview of health disparities, raising awareness of this issue in research design and conduct. We will discuss how implicit bias and ways of communicating perpetuate disparities and discrimination in clinical research and healthcare. The webinar also provides information about resources for researchers available from the National Institutes of Health (NIH) and the National Institute on Minority Health and Health Disparities (NIMHD) to understand and address health disparities. Finally, the webinar concludes with strategies and tools to facilitate more diverse research teams and inclusive research practices.

Recommended Use: Required
ID (Language): 20079 (English)

Artificial Intelligence (AI) and Human Subject Protections

Presented by: Cansu Canca, PhD – AI Ethics Lab; Tamiko Eto, MS, CIP – The Mayo Clinic

This webinar reviews the current regulatory framework for human subject protections and its applicability to research involving AI. It then identifies existing protections and limitations in those protections for subjects in AI research. The webinar concludes by describing approaches to shape policy and provide training on AI research that involves human subjects.

Recommended Use: Required
ID (Language): 20114 (English)

Social Media and Research Recruiting

Presented by: Elizabeth A. Buchanan, PhD – Marshfield Clinic Research Institute

Provides an overview of the development of social media recruitment for research and an in-depth review of the most current and common types of social media research recruitment practices. During this review, learners will explore the opportunities as well as the challenges that using social media for research recruitment present. The webinar concludes with a discussion of what IRBs review with respect to recruitment and how these elements relate to using social media to recruit, which researchers may find helpful as they develop their own studies that include recruiting using social media.

Recommended Use: Required
ID (Language): 20151 (English)

COVID-19 and Human Research Protection Programs

Presented by: Brenda L. Ruotolo, BA - Columbia University; Challace D. Pahlevan-Ibrekic, MS - Northwell Health

Learning Objectives:

  • Explore how a human research protection program (HRPP) responded to and has dealt with the COVID-19 pandemic.
  • Discuss the timeline and the other points that were considered as the crisis has evolved.
  • Review key considerations and communication strategies that institutions may employ during a disaster period.
  • Identify key strategies institutions may employ during the COVID-19 pandemic with researchers, subjects, and IRB staff.
  • Describe and discuss considerations for on-going research during the COVID-19 pandemic.

Recommended Use: Required
ID (Language): 20072 (English)

Working with Your IRB

Presented by: Angela L. Bruch, PhD - Capella University

Learning Objectives:

  • Discuss effective communication strategies for students and faculty to work with their IRB
  • Describe how to respond to an IRB request
  • Identify important deadlines and dates in the IRB review process
  • Review what needs to be reported to the IRB and when

Recommended Use: Required
ID (Language): 20205 (English)

IRB Administrator Professional Development and Self-Advocacy

Presented by: Margaret Rankovic, MEd, CIP – CITI Program

Learning Objectives:

  • Develop a professional development plan to advance your career.
  • Discuss key areas where you can develop yourself as an IRB professional based on your strengths and weaknesses.
  • Use self-advocacy to advance your career.
  • Identify ways you can show leadership in your current position.
  • Discuss the importance of networking as it relates to professional development in this field.

Recommended Use: Required
ID (Language): 20347 (English)

Leveraging IT Insight in IRB Review: Why Technology-Based Expertise is Critical to Human Subjects Protections

Presented by: Kimberley Serpico, MEd, CIP - Harvard T.H. Chan School of Public Health; Joseph Zurba, CISSP, CISA - Harvard Medical School; Tonya Ferraro, MEd - Boston Children's Hospital; Aaron Kirby, MSc - The Harvard Clinical & Translational Science Center

Learning Objectives:

  • Identify the regulatory basis for including IT expertise on the IRB.
  • Discuss considerations for risk assessment of emerging technologies.
  • Describe how to encourage collaboration between existing IRB and IT offices/personnel and how to build institutional partnerships.
  • Recognize what to consider when reviewing consent forms that include technology.
  • Examine strategies for including IT expertise on the IRB.

Recommended Use: Required
ID (Language): 20424 (English)

IRB Review of Observational Research

Presented by: Ilene Wilets, PhD, CIP - Icahn School of Medicine at Mount Sinai

Learning Objectives:

  • Identify the key characteristics of the three main types of observational research studies (cohort, cross-sectional, and case-control).
  • Recognize the risks to subjects related to each observational research design.
  • Understand the types of bias associated with each study design.
  • Apply IRB review criteria to observational studies for effective protocol review and constructive feedback for the investigator.
  • Discuss the level of IRB review typically employed for the various types of observational studies.
  • Explain when a waiver of consent and a waiver of HIPAA authorization would be appropriate.

Recommended Use: Required
ID (Language): 20425 (English)

Research with Audio-Visual Mobile Data Collection Tools: Ethics and Regulations

Presented by: Ethan Larsen, PhD - Children’s Hospital of Philadelphia; Jacob Kolman, MA - Houston Methodist and Texas A&M University; Faisal Masud, MD, FCCP, FCCM - Houston Methodist and Weill Cornell Medical College; Farzan Sasangohar, PhD - Texas A&M University and Houston Methodist

Learning Objectives:

  • Identify ethical, regulatory, and liability issues associated with research using audio-visual (AV) data collection.
  • Describe the role of organizational readiness in implementing video recordings in a hospital (highly confidential) setting.
  • Explain the role of participant engagement in informing study design and facilitating study conduct.
  • Understand the roles of technological limitations and environmental contexts when collecting data with mobile devices.

Recommended Use: Required
ID (Language): 20426 (English)

U.S. Department of Defense (DoD) Regulations & Requirements for Human Subject Research

Presented by: Ann Johnson, PhD, MPH - University of Utah

Learning Objectives:

  • Determine when research is subject to DoD regulations.
  • Identify the specific DoD requirements for research including addressing 45 CFR 46 Subparts B-D, inclusion of military personnel as subjects, independent research monitor, and additional investigator responsibilities.
  • Discuss research limitations for DoD research, including waivers of consent and inclusion of certain populations.

Recommended Use: Required
ID (Language): 20481 (English)

Bring Your Own Device (BYOD) Studies

Presented by: Jeremy N. Block, PhD, MPP – Baruch College, The City University of New York (CUNY)

Learning Objectives:

  • Identify threshold questions and explore areas of BYOD studies focusing on the researcher and sponsor.
  • Explain strategies for informing and protecting participants in BYOD studies.
  • Discuss implementing IRB operations approaches for the review of BYOD studies.

Recommended Use: Required
ID (Language): 20539 (English)

Partnering with Technology Companies

Presented by: Jeremy N. Block, PhD, MPP – Baruch College, The City University of New York (CUNY)

Learning Objectives:

  • Review the goals of digital health, the interdisciplinary struggles of working with technology companies, and an overall approach to the problems.
  • Identify best practices for researchers, technology companies, institutions, and Institutional Review Boards (IRBs) for creating partnerships.
  • Explore some of the common challenges faced by the research community and technology companies in the design and conduct of research.

Recommended Use: Required
ID (Language): 20540 (English)

GDPR & Human Subject Research in the U.S.

Presented by: Cynthia Gates, JD, RN, CIP, CCRP - University of Miami

This webinar reviews the European Union’s (EU) General Data Protection Regulation (GDPR) and how the regulation affects research in the U.S. It discusses the effective date, noncompliance penalties, and applicability of the regulation. Additionally, the webinar identifies when GDPR may apply to human subjects research, what researchers and organizations should do to be compliant, and where to go for further information. This webinar was presented on 5 December 2018.

Recommended Use: Required
ID (Language): 19374 (English)

GDPR: Top Noncompliance Risks and Mitigation Strategies

Presented by: Ann Kristin Glenster, LLM, LLM, MEGA, MFA, BFA - University of Cambridge

Learning Objectives:

  • Review how the GDPR relates to higher ed and research.
  • Identify higher ed and research activities that may pose a risk to GDPR compliance.
  • Identify and devise strategies to mitigate those risks.

Recommended Use: Required
ID (Language): 20430 (English)

FERPA: A Quick Review of the Law for Researchers and IRBs

Presented by: Thomas Gold, PhD - Acceleration Group, Inc.

This webinar explores the Family Educational Rights and Privacy Act (FERPA) (20 U.S.C. § 1232g; 34 CFR 99) as it relates to and impacts research that uses student educational records. This webinar discusses strategies for researchers, Institutional Review Board (IRB) members and administrators, and educators to comply with FERPA.

Recommended Use: Required
ID (Language): 19603 (English)

FERPA and Online Learning in the Time of COVID-19

Presented by:  Thomas Gold, PhD – Acceleration Group, Inc

Learning Objectives:

  • Recall the core requirements of FERPA and other student data privacy regulations.
  • Identify key student data privacy issues related to online learning.
  • Demonstrate different approaches to digital teaching and learning in a safe and secure way.
  • Assess student learning outcomes in a way that ensures student privacy.

Recommended Use: Required
ID (Language): 20061 (English)

Supervision for Supervisors

Presented by: Shelley Victor, EdD, CCC-SLP - Nova Southeastern University

Learning Objectives:

  • Know what to expect of the supervisor and supervisee relationship.
  • Explain the roles and responsibilities of the supervisor/manager and supervisee.
  • Describe the components of the supervisory process.
  • Identify the skill set needed to supervise/manage employees.

Recommended Use: Required
ID (Language): 20738 (English)

Process Improvement and Research Administration

Presented by: Karin Scarpinato, PhD – Kennesaw State University; Inger Garnett, MSPH, LSSBB – Emory University

Learning Objectives:

  • Define Lean Six Sigma.
  • Describe the five phases of Lean Six Sigma and their tools.
  • Recognize how to apply Lean Six Sigma principles to research administration.

Recommended Use: Required
ID (Language): 20881 (English)

Tips for Research Administrators: Working with Faculty and Research Teams

Presented by: Karin Scarpinato, PhD – Research Ingenuity, LLC; Jeanne Viviani, MPA – Research Ingenuity, LLC

Learning Objectives:

  • Recognize how to create and integrate a productive research culture within an organization.
  • Identify best practices for connecting with and supporting faculty during onboarding.
  • Explore how to strengthen programs that support faculty success through listening and engaging.
  • Examine real-world case studies of what to do with large research teams.

Recommended Use: Required
ID (Language): 20579 (English)

How to Effectively Manage a Research Administration Team

Presented by: Karin Scarpinato, PhD – Research Ingenuity, LLC; Jeanne Viviani, MPA – Research Ingenuity, LLC

Learning Objectives:

  • Discuss the importance of identifying a common goal for a research administration team.
  • Identify the core principles for a research administration team.
  • Describe strategies to enable improved hiring and employee retention.
  • Identify strategies to overcome common communication and collaboration challenges within your research administration team.

Recommended Use: Required
ID (Language): 20567 (English)

CRISPR Genome Editing: Rewriting DNA and the Future of Humanity

Presented by: Megan Hochstrasser, PhD - Innovative Genomics Institute at the University of California, Berkeley

Learning Objectives:

  • Describe how CRISPR genome editing lets scientists rewrite the genetic code.
  • Explain how editing the genomes of various organisms, including humans, can help scientists learn about nature, develop disease treatments, and make agriculture more sustainable.
  • Discuss the ethical and philosophical questions associated with CRISPR genome editing.

Recommended Use: Required
ID (Language): 20503 (English)

Gender and Sexual Minorities (GSM) in Human Subjects Research

Presented by: Moore Rhys, CIP - University of California Los Angeles

Learning Objectives:

  • Understand the historical context of research in GSM communities.
  • Understand social/cultural vulnerabilities and the relationships of GSMs to care providers who may also be researchers.
  • Understand the resiliency and advocacy of the GSM community.
  • Identify best practices for researchers and IRBs when conducting/reviewing research involving or focused on GSM.

Recommended Use: Required
ID (Language): 20504 (English)

Higher Education Accelerated Credit

Presented by: Hollie Daniels, PhD - Florida State University

Learning Objectives:

  • Identify acceleration options, including Advanced Placement, dual enrollment, and International Baccalaureate.
  • Recognize and indicate ethical considerations and challenges related to researching accelerated coursework/earning accelerated credit.
  • Demonstrate an understanding of the outcomes of students who complete accelerated coursework/earn accelerated credit.

Recommended Use: Required
ID (Language): 20505 (English)

Research in Wound Care

Presented by: Alisha Oropallo, MD, FACS, FSVS, FAPWCA - Northwell Health; Sally Kaplan, RN, CCRC - Northwell Health

Learning Objectives:

  • Describe the process of how to onboard new research.
  • Identify the challenges behind grant negotiations.
  • Determine if new protocols meet your needs

Recommended Use: Required
ID (Language): 20506 (English)

NSPM 33 Research Security Programs Standard Requirement Draft: Analysis and Practical Advice for Research Institutions

Presented by: Allen DiPalma, MBA -  University of Pittsburgh

Learning Objectives:

  • Become familiar with the federal laws and other guidance released in 2021 and 2022, driving the Research Security Programs Standard Requirement.
  • Think through a hypothetical timeline for the implementation of Research Security Programs.
  • Understand the main sections of the Draft NSPM-33 Research Security Programs Standard Requirement.
  • Identify suggestions and considerations organizations can take now in preparation for the final Research Security Programs Standard Requirements.

Recommended Use: Required
ID (Language): 20893 (English)

Promoting Healthy Authorship Dynamics in Research Teams

Elise Demeter, PhD – University of North Carolina at Charlotte; Lisa M. Rasmussen, PhD – University of North Carolina at Charlotte

Learning Objectives:

  • Identify factors that lead to authorship disagreements or misunderstandings.
  • Identify relevant authorship and authorship ethics topics where students and trainees benefit from direct education.
  • Describe key points collaborators should discuss during authorship conversations and how an authorship agreement form can facilitate that conversation.
  • Formulate recommendations for an institution to improve support for ethical authorship practices based on evidence-based tools and resources.

Recommended Use: Required
ID (Language): 21247 (English)

The Importance of Mentorship in Biomedical and Behavioral Research

Michael Malek-Ahmadi, PhD – Banner Alzheimer’s Institute

Learning Objectives:

  • Define mentorship and the traits of a good mentor.
  • Describe how mentorship is essential for career development.
  • Identify ways that mentors can be more effective and impactful to their mentees.

Recommended Use: Required
ID (Language): 21404 (English)

RCR and Grant Stewardship

Presented by: Amanda Humphrey, CRA, MA, MBA - Northeastern University

Learning Objectives:

  • Identify communication and authorization channels for faculty and administrators
  • Identify through examples where roles and responsibilities could have helped to provide better grant stewardship
  • Discuss roles and responsibilities between the investigator and the institution

Recommended Use: Required
ID (Language): 21241 (English)

The Process of Publishing a Scientific Paper

Presented by: Michael Malek-Ahmadi, PhD – Banner Alzheimer's Institute

Learning Objectives:

  • Describe the process and considerations for publishing a scientific paper, including authorship, journal selection, manuscript preparation, peer review, manuscript revision, and manuscript acceptance.
  • Explain the importance of publishing for career advancement and scientific progress.
  • Recognize key considerations for peer reviewing other scientific manuscripts.

Recommended Use: Required
ID (Language): 21177 (English)

Facilitating Synchronous RCR Training Sessions

Presented by: Jim Gould, PhD - Harvard Medical School; Ross Hickey, JD, CIP, CPIA - University of Southern Maine

Learning Objectives:

  • Examine common and unique RCR experiences across different institutions.
  • Explain the need for and importance of facilitated RCR discussions.
  • Identify features of effective facilitation techniques.
  • Recognize strategies to encourage participation.
  • Describe ways to sustain productive discussions.

Recommended Use: Required
ID (Language): 20873 (English)

The Dilemma Game App: How to Facilitate a Discussion on Research Integrity

Presented by: Nick den Hollander, PhD – Erasmus University Rotterdam, The Netherlands; Ross Hickey, JD, CIP, CPIA - University of Southern Maine

Learning Objectives:

  • Describe research integrity and how to facilitate an open discussion in your research group/institute.
  • Identify recent Responsible Conduct of Research (RCR) and Responsible and Ethical Conduct of Research (RECR) updates by the National Institutes of Health (NIH) and National Science Foundation (NSF).
  • Recognize the “Dutch” context of research integrity and why the app was developed.
  • Explain the Dilemma Game App, which was developed by the Erasmus University Rotterdam.

Recommended Use: Required
ID (Language): 20569 (English)

Peer Review Fundamentals

Presented by: Camille Thomas, MLIS – Florida State University

Learning Objectives:

  • Discuss the purpose, process, and types of peer review.​
  • Evaluate research and scholarship according to best practices and publication guidelines.​
  • Recognize how to respond with constructive ​and specific feedback to research and ​scholarship outputs.

Recommended Use: Required
ID (Language): 20872 (English)

Observations from NSF Plagiarism Investigations and Strategies to Prevent Plagiarism

Presented by: Aliza Sacknovitz, PhD - National Science Foundation, Office of Inspector General

Learning Objectives:

  • Understand the mission and operations of the National Science Foundation (NSF) Office of Inspector General (OIG) and its Division of Research Integrity and Administrative Investigations.  ​ 
  • ​Detail NSF OIG’s observations regarding the researchers against whom NSF made research misconduct findings, their acts of plagiarism, their reasons for plagiarizing, and the actions NSF and their institutions took against them because of their actions.​ 
  • ​Consider institutional strategies to help prevent plagiarism. 

Recommended Use: Required
ID (Language): 20871 (English)

Promoting Statistical Rigor in Scientific Manuscripts: Perspectives of a Statistical Reviewer

Presented by: Michael Malek-Ahmadi, PhD – Banner Alzheimer’s Institute; University of Arizona College of Medicine-Phoenix

Learning Objectives:

  • Describe common statistical problems and errors that are noted in the peer review process.
  • Identify solutions and guidance on how to avoid these errors.
  • Understand how to report statistical analyses in manuscripts.

Recommended Use: Required
ID (Language): 20901 (English)

Introduction to Meta-Analyses

Presented by: Michael Malek-Ahmadi, PhD – Banner Alzheimer’s Institute; University of Arizona College of Medicine-Phoenix

Learning Objectives:

  • Understand how literature searches, inclusion criteria, and data extraction are carried out for a meta-analysis.
  • Understand the concepts of heterogeneity and publication bias and how these impact the results of meta-analyses.
  • Describe basic analytic approaches used in meta-analyses.

Recommended Use: Required
ID (Language): 20902 (English)

Changing Security Requirements from U.S. Federal Research Funding Agencies

Presented by: Shawna Sadler, MLIS - ORCID Inc.

Learning Objectives:

  • Understand why researchers should have an ORCID iD.
  • Describe how ORCID can help researchers meet the new research security expectations and the new public access and research integrity expectations.
  • Describe ORCID and author identity management.

Recommended Use: Required
ID (Language): 20734 (English)

From Cancer to COVID-19, Does Science Self-Correct?

Presented by: Ivan Oransky, MD, Retraction Watch

Learning Objectives:

  • Understand what is behind rising rates of retractions
  • Understand the role of scientific sleuths in scientific correction
  • Understand the polluting effects of scientific fraud

Recommended Use: Required
ID (Language): 20683 (English)

Importance of Peer Review and Data Validation in Research

Presented by: Adil E. Shamoo, PhD, MSc, CIP – University of Maryland School of Medicine and Shamoo Consulting

Learning Objectives:

  • Discuss the elements of peer review.
  • Describe the value of peer review.
  • Identify what is data validation.
  • Discuss the ethics of peer review versus data validation.
  • Identify the differences between peer review and data validation.

Recommended Use: Required
ID (Language): 20150 (English)

Transitioning Research to the Revised Common Rule: The What, How, and Why

Presented by: Karen Christianson, RN, BSN - HRP Consulting Group

This webinar reviews the pre-2018 and 2018 versions of the Common Rule, factors an organization may want to consider when deciding whether to transition a pre-existing study (or studies) to comply with the revised Common Rule, and strategies for the management and communication of transition decisions.

Recommended Use: Required
ID (Language): 19592 (English)

Revised Common Rule: Overview of Revisions

Presented by: Margaret Rankovic, MEd, CIP – CITI Program

This webinar provides an overview of the changes made to the pre-2018 version of the Common Rule. Discusses key revisions to each updated section of the 2018 version of the Common Rule (46.101 – 46.124), including applicability and impact of revisions. Provides examples and discusses scenarios. Run time is approximately 1 hour.

Recommended Use: Required
ID (Language): 19618 (English)

Revised Common Rule: Revisions to Definitions

Presented by: Margaret Rankovic, MEd, CIP – CITI Program

This webinar provides an in-depth review of the changes made to the definitions and terms in the 2018 version of the Common Rule. It discusses the applicability and impact of the revisions using examples and scenarios. The run time is approximately 24 minutes.

Recommended Use: Required
ID (Language): 19742 (English)

Revised Common Rule: Revisions to Informed Consent

Presented by: Margaret Rankovic, MEd, CIP – CITI Program

This webinar focuses on the revised Common Rule’s key changes to informed consent that affect research review and conduct. It identifies the new elements of informed consent, discusses the broad consent process, reviews changes for alterations and waivers of consent, and reviews the new consent posting requirement. The run time is approximately 24 minutes.

Recommended Use: Required
ID (Language): 19743 (English)

Intellectual Property and Working With Your Technology Transfer Office

Presented by: Eric Wagner, PhD, JD - Duke University

Learning Objectives:

  • Understand the different types of intellectual property and how these apply to your invention
  • Understand how to navigate the technology transfer office
  • Understand how a technology transfer office obtains value from your invention
  • Identify issues that may impact your intellectual property rights

Recommended Use: Required
ID (Language): 20419 (English)

In This Together: Meaningful Community Engagement in Research

Presented by: Rana E. Barar, MPH – University of California San Francisco

Learning Objectives:

  • Discuss the importance of engaging diverse populations in research.
  • Describe community engagement strategies.
  • Identify pitfalls to avoid when engaging community members in research.
  • Recognize some considerations for the use of technology in recruiting diverse populations.

Recommended Use: Required
ID (Language): 20868 (English)

Emerging Technologies and Homeland Security

Ryan Jenkins, PhD – Cal Poly, San Luis Obispo

Learning Objectives:

  • Explore the evolving challenges in homeland security due to emerging technologies, focusing on cyber threats, ransomware, and drone misuse.
  • Examine internet of things (IoT) vulnerabilities highlighted by incidents and their impact on security.
  • Discuss ethical and regulatory strategies to address AI threats.
  • Assess the role of disinformation and deepfakes in undermining democracy and national security.
  • Understand how homeland security can adapt to technological advances while balancing civil liberties and security needs.

Recommended Use: Required
ID (Language): 21238 (English)

Why AI Companies Should Care About Ethics

Presented by: Ryan Jenkins, PhD – Cal Poly, San Luis Obispo

Learning Objectives:

  • Analyze the concept of intrinsic and instrumental value, distinguishing between actions that are ethically good for their own sake and those that are for the sake of something else.​
  • Apply the analogies of ethics-as-engineering and ethics as bird-spotting to realistic ​use cases.​
  • Formulate strategies for operationalizing ethical principles in AI and adapting these principles to different industry contexts.​
  • Explain the role of ethicists in business, illustrating how their contributions in clarifying conceptual confusion, re-describing crucial concepts, and offering subject matter expertise can drive public trust and ethical business practices.

Recommended Use: Required
ID (Language): 21237 (English)

Healthcare Robot Ethics: Human-Robot Interaction & Human Well-Being

Presented by: Yvette Pearson, PhD – Old Dominion University

Learning Objectives:

  • Describe current and possible uses of robots in healthcare or therapeutic settings.
  • Identify and explain key ethical issues related to uses of robots in healthcare and therapeutic settings.
  • Question the potential benefits and risks of current and proposed uses of robots in healthcare or therapeutic settings.
  • Distinguish ethical concerns related to human-robot interaction (HRI) with adult humans from those specific to child-robot interaction (CRI).
  • Differentiate potential ethical issues raised by HRI for healthcare workers or clinicians from ethical concerns emerging from HRI/CRI with patients.

Recommended Use: Required
ID (Language): 20869 (English)

Drones in Academia

Presented by: Adam Grant, BA - University of Maryland

Learning Objectives:

  • Understand the basics of drone technology and nomenclature.
  • Understand the FAA airspace regulations and operator requirements.
  • Understand how export control regulations apply to drones.
  • Examine other operator and institutional considerations, such as safety, liability, and privacy concerns.

Recommended Use: Required
ID (Language): 20573 (English)

The Playbook: Successfully Developing and Deploying Digital Clinical Measures

Presented by: Andy Coravos, MBA – Elektra Labs and Harvard-MIT Center for Regulatory Science; Jennifer Goldsack, MChem, MA, MBA – Digital Medicine Society (DiMe)

Learning Objectives:

  • Identify ways to select, develop, and deploy fit-for-purpose, meaningful digital clinical measures across clinical research, patient care, and public health.
  • Identify ethical considerations associated with the introduction of digital clinical measures to clinical trials, patient care, and public health.
  • Recognize how to select the right partners for co-creating and implementing high quality, patient driven, digital measures of health.

Recommended Use: Required
ID (Language): 20380 (English)

Privacy and Ethical Considerations for Connected and Automated Vehicles (CAVs)

Presented by: Chelsey Colbert, JD, CIPP-US - Future of Privacy Forum

Learning Objectives:

  • Understand the basics of the terms “connected car” and “automated car.”
  • Understand the basics of privacy, data protection, and ethics.
  • Understand some of the privacy and ethical considerations raised by CAVs, and how the U.S. regulates CAVs.

Recommended Use: Required
ID (Language): 20429 (English)

Facial Recognition Considerations for Researchers

Presented by: Brenda K. Leong, JD, CIPP/US - Luminos.Law

Learning Objectives:

  • Explain how biometric systems work, including definitions, technology processes, and common systems such as facial recognition, fingerprints, and behavioral characterization.
  • Discuss the benefits and risks of facial recognition, including efficiencies, potential harms, and privacy considerations.
  • Describe common commercial applications of facial recognition.
  • Recognize social, ethical, and regulatory considerations for the use of facial recognition.

Recommended Use: Required
ID (Language): 20536 (English)

FAQs

What is included in the All Access Webinar Package?

The All Access Webinar Package includes all of CITI Program’s currently available webinar recordings as well as future recordings released during your subscription period*. View Webinar Catalog.

*This product includes most CITI Program generated webinars. Some webinars offered through special / partner programs may not be offered as part of this package.

What is the annual subscription fee?

The All Access Webinar Package can be added to your subscription for an annual fee of $1000 per year/per site for government and non-profit organizations; $1200 per year/per site for for-profit organizations.

How can I add the Diversity Training in Clinical Research Webinar Package to my organization's subscription?

You can add our Diversity Training in Clinical Research Webinar Package by using our course/webinar addition form or by contacting sales.

How do I add newly released webinars to my All Access Webinar Package?

Account Administrators will be notified when new webinar recordings are released. Newly released webinars can be added by submitting the webinar selection form to our Help Desk.

How will retired webinar recordings affect my organization's learners?

Account Administrators will be notified approximately 90 days prior to the retirement of a webinar recording. Learners will also see a notice posted in their gradebooks informing them of the upcoming retirement. Learners will have to complete the webinar before the retirement date to receive a Completion Report.

My organization already subscribes to specific webinars. How do I switch to the Diversity Training in Clinical Research Webinar Package?

Please contact sales for details on transitioning to the Diversity Training in Clinical Research Webinar Package.

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