Webinars Coming in 2015
Single IRB Review for Multisite Studies: Promoting Quality Review and Oversight
During the past several years, the human research enterprise has witnessed an increase in the use of a single IRB for review of multi-site studies. “Single IRB review” refers to a multitude of models, including, institution-based, independent, central, collaborative, or lead-IRB review. With the issuance by the National Institutes of Health (NIH) of a draft policy to promote the use of a single IRB for multi-site studies funded by the NIH, as well as the ANPRM emphasis on promoting efficiency through the use of single IRB review, it is an opportune time to examine guidance available for relying on a single IRB in multi-site studies. This webinar will discuss the SACRHRP recommendations on the topic, including consideration of local context, applicable law and local standards, participant safety and post-approval monitoring, and other essential issues for HRPP consideration. Participants will learn what to consider in Authorization Agreements, how to develop processes to oversee ongoing research and what information to obtain from the investigative site when your IRB is the IRB of record. In addition, examples of how to best utilize staff, as well as ways to reduce time-consuming activities that do not contribute to research review or oversight, will be discussed.
David A. Borasky, M.P.H.,
Vice President, Quality Management, Copernicus Group
Sabune J. Winkler, J.D.,
Director, Regulatory Affairs Operations, Harvard Catalyst
May 5, 2015: 10:00 - 11:30 a.m. ET Register Here
May 7, 2015: 3:30 - 5:00 p.m. ET Register Here
Patient Centered Outcomes Research
The rapidly growing funding for patient-centered outcomes research is affecting many organizations and IRBs. Research projects comparing outcomes of various clinical practices, including both observational and randomized studies yield valuable evidence in a learning health care system. This type of research also poses some new considerations for IRBs as they proceed to efficiently review comparative effectiveness research without compromising protections. This webinar will address the ethical issues that have been raised to date in this type of research, and offer guidelines for training IRB members to review outcomes research. Also, some attention will be given to all activities conducted along the boundary between research and practice.
The ethical conduct of human research involving vulnerable populations continues to be an appropriate focus of HRPPs everywhere. Sponsors of research continue to commit substantial resources to assessing, managing, and treating the challenges (both physical/medical and mental/behavioral) with which these communities grapple. This webinar will explore cutting edge issues in how an HRPP should address the issues of research in vulnerable populations in areas ranging from recruitment and informed consent to retention and compensation.
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 firstname.lastname@example.org.
The cost for each connection is:
$ 90.00 for AAHRPP clients
$130.00 for non-clients