238771 Track A: IRB - Planning for the unpredictable

Sunday, October 30, 2011: 2:30 PM

Elizabeth O'Connell, BS, RN , Public Health Research, Social & Scientific Systems, Inc., Durham, NC
Track A 2:30-3:00PM

The purpose of the presentation is to illustrate the overriding importance of understanding IRB regulations at your institution in order to move approval of your protocol forward to keep study development progressing; handling issues for special populations; how to consider incentives; and tips on the development of effective and communicative consent forms.

Learning Areas:

Learning Objectives:
Identify 3 methods to pre-emptively and effectively work with IRBs to keep study development progressing

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am a Senior Study Manager and Regulatory Specialist at Social & Scientific Systems with over 15 years of experience in operationalizing research protocols and implementing epidemiologic studies, including surveys, field studies, and clinical studies. As the Regulatory specialist at SSS, I am responsible for coordinating and disseminating regulatory information from NIH to study staff. I consult with study managers across NIEHS studies and act as a liaison with the NIEHS IRB and ethics staff. I designed a multi-functional regulatory database to address our need for a systematic approach to tracking the regulatory process for multiple projects and multiple institutions conducted for the Epidemiology Branch at the National Institute of Environmental Health Sciences.
Any relevant financial relationships? Yes

Name of Organization Clinical/Research Area Type of relationship
Social & Scientific Systems Epidemiology Employment (includes retainer) and SSS is an employee owned company

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.