All Access Webinar Package (Organizations Only)

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)

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)

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)

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

Learning Objectives:

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

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

Learning Objectives:

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

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

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)

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)

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)

Recommended Use: Required
ID (Language): 20165 (English)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

Presented by: Cansu Canca, PhD – AI Ethics Lab; Tamiko Eto, MS, CIP – Stanford Research Institute (SRI) International, Office of Research Integrity

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)

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)

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)

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)

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

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)

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)

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)

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)

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

Learning Objectives:

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

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)

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)

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)

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)

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)