Imagining Failures to Identify Blind Spots in Device Research with David Staley, Director, Seattle Children's Research Institute
New York State SOCRA Chapter Virtual Presentation*
Imagining Failures to Identify Blind Spots in Device Research
David Staley, MA, Director, Clinical Research Quality Assurance and Regulatory Support, Seattle Children’s Research Institute
November 15, 2023, Noon – 1:00 p.m. PST/3:00 – 4:00 p.m. EST
Both risk assessment and root-cause analyses can be useful in identifying reasons for failures in situations or events. Research also supports another approach. In 1989, a team of researchers discovered that prospective hindsight—imagining failures beforehand—increases the ability to correctly identify reasons for future outcomes by 30%. Prospective hindsight offers advantages in improving the quality of outcomes and preventing mishaps in areas of research. Participants in this session will examine the strategy of using prospective hindsight to spot potential blind spots in areas of research operations and compliance. Using prospective hindsight, participants will assess a research study scenario to identify potential blind spots that could negatively affect the quality of the outcomes. Then, participants will suggest changes to the scenario to improve their outcomes.
David Staley is the Director of Clinical Research Quality Assurance and Regulatory Support at Seattle Children's Research Institute. In the early 2000s, he became an IRB translator and reviewer while studying Spanish Translation. At first, he regarded his educational pursuits and career trajectory as two separate paths. His career path, or so he thought, had been set: a life in academia researching and teaching language and literature. Only he was wrong. The more he immersed himself in the nuances of research informed consent documents the more he realized how his studies in the humanities potentially related to everything, particularly the research ecosystem (ethics, operations, and compliance). The two worlds weren’t so distant.
Since then, David has found purpose, excitement, and intrigue in interconnecting language and literature with the research world. He is an accomplished leader, writer, and public speaker with twenty years of experience working in human research protection programs, research compliance, and regulatory affairs. In both realms of research compliance and regulatory affairs, he has led and overseen system-wide programs in dynamic research enterprises, while advising and educating on complex ethical and compliance issues. He has authored and spoken about a variety of topics from strategies to identify research compliance blind spots to principles for decision-making and practice in quality assurance and risk preparedness. He has earned both a Master’s degree in Spanish Literature and a Bachelor's degree in Spanish Translation.
The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program will provide 1 hours of continuing education hours. *When registering, note Certificate of Attendance Need (General or SOCRA).
 Deborah J. Mitchell, J. Edward Russo, and Nancy Pennington, “Back to the future: Temporal perspective in the explanation of events,” Journal of Behavioral Decision Making 2, no. 1 (January 1, 1989): 25-38, https://doi.org/10.1002/bdm.3960020103.