Webinars Coming in 2014
Keeping Your Eye on the Ball: How and Why to keep the IRB focused first and foremost on the Regulatory Approval Criteria
There is increasing evidence that IRB’s do not consistently discuss or consider the regulatory approval criteria when reviewing research at convened meetings. There is also ample evidence of an absence of documentation that regulatory criteria were applied. This webinar will discuss methods and tools to assist IRBs focus the review process on the essential issues. Real world examples and innovative solutions will be presented in detail. Participants will learn techniques for educating IRB members and staff in applying the review criteria, and will learn ways to reduce time-consuming activities that do not contribute to this review.
Presenters:
Jeffrey A. Cooper, M.D., M.M.M.
Vice President Global Consulting, WIRB-Copernicus Group
Jonathan M. Green, M.D.,
Associate Dean of Human Studies, Executive Chair of the IRB, Washington University
Register Here for January 28, 2014, 10:00 a.m. ET
Register Here for January 30, 2014, 3:30 p.m. ET
Negotiating a Clinical Trial Agreement that Works (and meets the AAHRPP Accreditation Standards)
The core concept of a human research protection program is that many functions within an organization have a role in the protection of participants in human research. Clinical trial agreements between the organization and the sponsor of the research outline responsibilities that further the safety of participants, the conduct of the study, and the publication or disclosure of results. This webinar will address the topics of research-related injury, reporting of sponsor monitoring visits, organizational responsibilities regarding data and safety monitoring, and ongoing safety notifications after the study has closed. Participants will learn techniques for negotiating these provisions, designing master agreements and meeting the AAHRPP Standard I.8.
Understanding and Utilizing Metrics for HRPP Quality Improvement
Based on client feedback, AAHRPP has clarified some terminology and refined definitions to increase the consistency and value of the metrics data collected on applications and annual reports. In this webinar, changes made to the data that is requested from accredited organizations on annual reports and accreditation applications, will be reviewed by a member of the AAHRPP quality improvement committee charged with review of our Metrics data collection effort. The discussion will also include information about how to gather this data at your institution, and how to use it to improve the quality and efficiency of your human research protection program. Participants will learn how to use metrics, how to access data comparable to your organization, as well as establish benchmarks for use over time. This webinar will address the information you will need to obtain meaningful data and how to use it to drive your quality improvement program.
Reportable Events: Developing Policies and Procedures to Guide HRPPs from the Initial Evaluation to Final Reporting
This area of the regulations and guidance by the Department of Health and Human Services remains one of the most difficult areas for HRPPs to master. What do investigator’s need to report to the IRB? What procedures should IRB’s follow to evaluate these events? This webinar will describe the challenges, and offer some methods for improving outcomes including specific examples of methods employed by AAHRPP-accredited organizations. The presentation will include tools and strategies for HRPPs to follow from the first discovery of non-compliance or unanticipated problems involving risk to participants (including reports of protocol deviations), to assist them in investigating, reviewing and reporting these events.
You can enroll your organization by registering online for each computer connection you want to make from your organization. Please check the webinar system requirements to make sure you can participate.
The number of connections is limited to 96, but you can have as many colleagues participating through that connection as you wish. And if there are topics you would like to see for other webinars, please suggest them by writing to accredit@aahrpp.org.
The cost for each connection is:
$ 90.00 for AAHRPP clients
$130.00 for non-clients