Friday, November 8 C7
Room 204
Looking Beyond Responsible Conduct of Research: Ethical Research from Design to Data Collection to Dissemination of Results (Ethical Issues Track)
C8
Room 203
Emergency Research and Exception from Informed Consent (EFIC): Interesting Challenges and Lessons Learned About Community Consultation from a Multicenter Network (FDA Regulation Track)
Faculty: Michelle Biros, Neal Dickert, Sara F. Goldkind, Deneil Harney In this session, faculty and attendees will: • Discuss a combination of interesting experiences and lessons learned through the first two EFIC trials conducted through Neurological Emergencies Treatment Trials (NETT), a multicenter network of 17 hub sites funded to conduct clinical trials of interventions to address neurological emergencies. • Review data collected on investigator and study coordinator perspectives of community consultation. • Discuss network-wide data regarding community consultation, subjects’ perspectives on EFIC research and NETT studies, and network-wide experiences using different methods of community consultation.
C9
Telling it Like it Is: Challenges in Informed Consent in International Settings (Global Research Track)
Faculty: David A. Borasky, Caroline Kithinji
Room 313
C10
Regulatory Requirements and Ethical Considerations Regarding Pediatric Assent in Research (Informed Consent Track)
Room 108 Basic
Faculty: Lisa Buchanan, Robert W. Frenck, Steven Joffe In this session, faculty will: • Review the regulatory requirements for child assent and waivers of assent. • Discuss developmental issues, with an emphasis on determining when a child acquires the capacity to provide assent and consent. • Explore ethical issues, including how to proceed when there is a disagreement between children and their parents or legal guardians about research participation.
C11
Identifying, Reducing, and Managing Institutional Conflicts of Interest (Institutional Officials Track)
Room 104 Basic
Faculty: Mark Barnes, Jennifer Kulynych In this session, faculty will: • Discuss how to create and maintain an organizational culture that understands, acknowledges, and addresses potential institutional conflicts of interest. • Review how to handle institutional conflicts of interest, including those that arise when institutional officials don’t follow HRPP/IRB policies.
C12
Writing Stellar Standard Operating Procedures (SOPs) (IRB Bootcamp Track)
Room 305 Basic
Faculty: Karen Hale, Elyse Summers In this session, faculty and attendees will: • Discuss the components of comprehensive and effective HRPP/IRB SOPs. • Understand the resources, input, and/or approvals needed to develop specific SOPs.
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Faculty: Philip M. Alberti In this session, faculty will: • Describe how a clinical trial conducted entirely in accordance with Responsible Conduct of Research guidelines for review, approval, and oversight might still fall short of ethical responsibilities in the broader social contract of research. • Discuss how the conduct of research fits along a continuum from concept and funding through the dissemination of results, and what other entities bear responsibility for ensuring the results of research reach those populations that could benefit most. • Review the ethical implications of health disparities.
In this session, faculty will: • Review the international standards for informed consent and documentation of consent. • Describe challenges around obtaining meaningful informed consent, such as varying degrees of literacy, translation issues, and differences in cultural norms. • Review measures taken to adapt the Western informed consent model to international settings.