Webinars
SEPTEMBER 2018
“Successful Strategies for Adjusting to the New Rule ”
Date: Friday, September 21, 2018
Time: 7:30 a.m. -9:00 a.m.
Location: CI SM Room 1017 (Strauss McCaskill Center Room 10017)
Description: In light of extensions of the effective date for the revised “Common Rule” or “New Rule”, organizations are facing a moving target for adherence. At the time of this writing, it is unclear whether July 19 will become the next effective date, however some burden-reducing provisions may be permitted…or not. This webinar will discuss strategies and guidance tools that can help organizations structure degrees of readiness in order to be as prepared as possible for the unknown.
Objectives:
- Understand the status of the “New Rule and any permitted burden-reducing provisions or informed consent enhancements
- Learn to structure AAHRPP expectations regarding the moving effective date of the “New Rule”
- Acquire tools to strategize responses to the release of the “New Rule”
1.5 CRS Elective Credits
MyCompass Course ID: 1963-0166
“When SBER Involves Drugs and Devices: Cases to Clarify FDA Oversight”
(Recorded September 20, 2018)
Date: Wednesday, September 26, 2018
Time: 11:00 a.m. -12:30 P.m.
Location: ED II G104A/B
Description: Increasingly, social, behavioral, and educational research (SBER) incorporates techniques and devices that are more traditionally found in biomedical research, creating challenges for IRBs in determining whether a study falls under US Food and Drug Administration (FDA) oversight. The FDA’s authority includes drugs, biologics, and medical devices. FDA oversight may also extend to mobile medical applications and other innovations, which can create challenging regulatory questions as to whether a study falls under FDA jurisdiction.
Objectives:
• Define some key FDA regulatory concepts and recognize their potential application to SBER
• Determine whether an SBER protocol involves FDA-regulated drugs or devices
• Apply appropriate IRB review levels to studies with FDA-regulated drugs or devices
1.5 CRS Elective Credits
OCTOBER 2018
“Clinical Trials and Assessment of Suicidal Ideation and Behavior”
Date: Friday, October 5, 2018
Time: 7:30 a.m. -8:30 a.m.
Location: CI SM Room 1017 (Strauss McCaskill Center Room 10017)
Recorded on: May 15, 2018
Description: Suicide treatment experts Larry Alphs, Jennifer Giddens and David Sheehan present latest trends and developments in measuring suicidal ideation and behavior.
Topics:
- Drug development targeting suicidality
- What’s new in design and execution of studies of suicidal ideation and behavior
- Phenotypes in suicidality
- Assessments in clinical trials for anti-suicidality treatments
1.0 CRS Elective Credits
MyCompass Course ID: 1963-0167
“Health Literacy and Informed Consent for Research” (Recorded July 31, 2018)
Presenter: Christopher Trudeau, JD
Associate Professor
UAMS Center for Health Literacy
Associate Professor of LAW UALR Bowen School of Law
Date: Friday, October 19, 2018
Time: 7:30 a.m. -8:30 a.m.
Location: CI SM Room 1017 (Strauss McCaskill Center Room 10017)
Recorded: July 31, 2018
Objectives:
- Why health literacy matters to consent
- Changes to the “Common Rule” that require clarity
- Clear Consent and Assent Processes
1.5 CRS Elective Credits
MyCompass Course ID: 1963-0168
PRIM&R Webinar: “Responsible Conduct of Research: What IRBs Need to Know”
Date: Thursday, October 25, 2018
Time: 12:00 p.m. – 1:00 p.m.
Location: ED 2 G137
Description: Integrity and the proper conduct of research are essential for the advancement of science and to maintain continued public trust in the research enterprise. While the US federal mandates concerning the Responsible Conduct of Research (RCR) primarily require institutions to provide training in specific topic areas, the movement to enhance integrity in research has grown worldwide. RCR principles are broad and provide scientists and scholars from every discipline with a framework of professional responsibilities. Many IRB professionals and members may not realize that “protection of human subjects” is one of the core RCR topics. What should you, as an IRB professional or IRB member, know about RCR, and how can you recognize and manage RCR issues to enhance and promote ethical research?
Topics
• An overview of RCR, including the core topic areas (scientists as responsible citizens, mentor/mentee relationships, authorship, conflicts of interest, collaborative research issues, data management, use of vertebrate animals and human subjects, peer review, and misconduct); and emerging research integrity issues, such as reproducibility and the effects of institutional culture
• The importance of RCR on a global and local level, including key principles from various international and institutional research codes of conduct, the difference between compliance and integrity, and the relationship between ethics and high-quality research
• An examination of cases in human subjects research that have RCR implications
• Tips for IRBs on how to spot RCR issues during review of noncompliance, the research record, and amendments; and tips on coordination and collaboration with other institutional bodies and staff around issues of ethics and integrity
MyCompass Course ID: 1963-0183
NOVEMBER 2018
“Paying Clinical Trial Subjects ”
Date: Friday, November 9, 2018
Time: 7:30 a.m. -9:00 a.m.
Location: CI SM Room 1017 (Strauss McCaskill Center Room 10017)
Recorded on: March 20, 2018
Description: Research ethics specialist Luke Gelinas discusses the ethical and regulatory issues involved with paying research subjects and proposes a practical framework that can guide the design and evaluation of payment offers.
Topics:
- Reasons to pay research participants and the role that payment plays in facilitating recruitment
- Risk of undue influence and the possibility that payment might motivate deception about eligibility
- Current practices regarding payment of research participants, such as payment rates and frequency of payment in various types of clinical research
- Methods of calculating payment amounts, including distinguishing different reasons for offering payment, such as reimbursement, compensation for time, or recruitment incentive
1.5 CRS Elective Credits
MyCompass Course ID: 1963-0169
**Updates Coming Soon**
“What is GDPR & How Does It Impact Your Research”
Presenter: Christopher Trudeau, JD
Associate Professor
UAMS Center for Health Literacy
Associate Professor of LAW UALR Bowen School of Law
Date: TBA
Time: TBA
Location: CI SM Room 1017 (Strauss McCaskill Center Room 10017)
Objectives:
- Explanation of the legal requirements of the EU’s new “General Data Protection Regulations”
- Understanding of when and whether these GDPR regulations relate to your research
- Articulatation of 3 strategies for complying with these new GDPR requirements
1.0 CRS Elective Credits
DECEMBER 2018
“Time Management in Clinical Trials”
Date: Friday, December 7 , 2018
Time: 7:30 a.m. -8:30 a.m.
Location: CI SM Room 1017 (Strauss McCaskill Center Room 10017)
Description: Clinical Trial specialists Kari Lotsberg and Fabian Sandoval discuss the value of having staff dedicated solely to patient recruitment.
Topics:
- The five stages of recruitment
- Recruitment problems that can stem from lack of time
- Benefits of a community recruitment strategy
1.0 CRS Elective Credits
MyCompass Course ID: 1963-0172
“Addressing Acceptable Recruitment Methods for Sponsors and Sites”
Date: Friday, December 14, 2018
Time: 8:00 a.m. -9:00 a.m.
Location: CI SM Room 1017 (Strauss McCaskill Center Room 10017)
Recorded on: Feb. 20, 2018
Description: Patient recruitment experts David Borasky and Amanda Plucinak present strategies for expediting study recruitment.
Topics:
- How to develop data to understand why studies are behind schedule and over-budget
- How to use proven strategies and tactics to improve your patient recruitment numbers
- How to foster awareness of the importance of implementing appropriate effort into creating a recruitment plan for a study
- How to comply with new GDPR requirements
1.0 CRS Elective Credits
MyCompass Course ID: 1963-0180
JANUARY 2019
“Sensors and Wearables in Clinical Trials”
Date: Friday, January 18, 2019
Time: 7:30 a.m. -9:00 a.m.
Location: CI SM Room 1017 (Strauss McCaskill Center Room 10017)
Description: Device expert Thomas Shook discusses how the use of wearable devices and sensors can impact the world of clinical trials.
Topics:
- Best practices in use of sensors and wearables, including subject protection and data privacy
- How mHealth is changing data collection in clinical trials
- New types of health information now collectible with sensors
- The regulatory impact of sensors and wearables
1.50 CRS Elective Credits
MyCompass Course ID: 1963-0173