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Issues for Pharma/Biotech



This track will cover legal, legislative, and compliance issues. Methods for effective communication and collaboration among legal counsel, sponsors, HRPP professionals, and other stakeholders will also be discussed.


Out-of-Body Experiences: Research Involving Tissue and Data

This track will explore the complex evolving ethical and regulatory issues for the collection and banking of biological specimens for both clinical and genetic research.


Populations Requiring Additional Protections

This track will explore issues related to vulnerable populations, including: regulations; guidance; best practices; ethical principles; and community engagement. This track will include both basic and advanced sessions, and will redefine vulnerability by looking beyond populations recognized in the federal regulations.



This track includes a variety of sessions that are current, complex, or late breaking.


QA/QI and Post-Approval Monitoring

This track will address current topics and issues faced by QA/QI programs, post-IRB approval monitoring programs, or other institutional entities charged with activities such as: not-for-cause study reviews; follow-up after monitoring; review visits; reports; corrective action plans; and education.


Regulatory Balance

This track will explore potential models for streamlining IRB processes through an examination of existing regulatory flexibility, alternative review models, and best practices.


Research Involving the Internet and Social Networking

This track will explore the risks, benefits, and challenges of using the internet and social media as research tools.

22 & 23


These tracks will cover issues related to the conduct and review of social, behavioral, and educational research (SBER).


Small Research Programs

This track will address the special challenges faced by small research programs at entities such as community hospitals, colleges, and research institutions. The sessions in this track recognize that the designation “small� is typically self-imposed, and may be given on one or more of the following bases: protocol workload, number of FTE IRB staff, research budget, number of IRB members, and the character of the institution/researcher community. As a general guideline, a small research program is one that has fewer than 250 active protocols, or fewer than three FTE IRB staff.


Unaffiliated and Non-Scientist IRB Members

This track will introduce unaffiliated and non-scientist IRB members and staff to essential, basic scientific topics and foundational strategies for IRB review.

n ove m b e r 7- 9 , b os t on , m as s ac hu s e t t s



This track will provide representatives from HRPPs and drug, device, and biotechnology industries with an opportunity to discuss topics of mutual interest, including: the role of pharmaceutical companies, biotechnology companies, and CROs in conducting research abroad; adaptive clinical trial design; unanticipated problems; adverse events; and more.

2013 AER Conference Guide  

Digital version fo the Conference Guide for the 2013 Advancing Ethical Research Conference

2013 AER Conference Guide  

Digital version fo the Conference Guide for the 2013 Advancing Ethical Research Conference