Friday, November 8 B12
The Basics and Beyond: Research with Prisoners, Pregnant Women and Fetuses, and Children (IRB Bootcamp Track)
Faculty: Paul Christopher, Julia Gorey, Josiah D. Rich In this session, faculty will: • Review the DHHS regulations governing research with prisoners, children, pregnant women, fetuses, i.e., 45 CFR 46 subparts B, C, and D. • Outline best practices for research with these populations and discuss other relevant guidance. • Discuss challenges and ethical considerations for research involving prisoners.
Room 107 Advanced
Faculty: Melissa Abraham, Elizabeth Hohmann In this session, faculty will: • Review common problems with protocols submitted for IRB review. • Share strategies for working with difficult investigators. • Explore best practices for managing the challenges and stressors that come with being an IRB chair.
An Update on the Clinical Trials Transformation Initiative (CTTI) Central IRB Project (Issues for Pharma/Biotech Track)
Faculty: Sara Calvert, Cynthia Hahn The CTTI Use of Central IRBs for Multicenter Clinical Trials project published results and recommendations in January 2013. Implementation of these recommendations may increase the quality and efficiency of clinical trials. In this session, faculty will: • Review the results and recommendations of the CTTI Use of Central IRBs for Multicenter Clinical Trials project. • Describe the purpose and utility of the Considerations Document, a CTTI developed guide to support communication and contractual relationships between institutions and a central IRB. • Share case examples of the successful adoption of the recommendations and use of the Considerations Document.
“State” it Like it Is: The Impact of State Laws on Informed Consent and Other Aspects of Research (Legal Track)
Faculty: Valerie Gutmann Koch, Susie A. Han, Laura Odwazny – OHRP Resource Person State laws can complicate the requirements imposed on researchers and institutions in many ways. While specific state laws may be utilized as examples and case studies, the focus of this session will be on the categories of state laws that IRBs and investigators often have to consider when engaged in certain types of research. In this session, faculty will: • Explore state law issues that should be analyzed in connection with any federal Common Rule and FDA requirements, including requirements that impact the content of informed consent, research on fetuses and fetal remains, the use of decedents’ information and tissue in research, the scope of insurance coverage for research-related services, and more. • Review the interaction between overlapping state and federal requirements, for example: Certificate of Confidentiality requirements versus state law public health reporting requirements. • Discuss the challenges of conducting multijurisdictional research across varying state requirements, such as: how to define who is a “child” under state law for purposes of consent/ assent; when electronic signatures may be used in the consent process; issues raised by the increase of social media and internet research; and issues around what constitutes the “practice of medicine” in multi-jurisdictional clinical research.
Beyond the Genome: Data Security and Privacy Advanced Concerns Surrounding Genomic Research (Out of Body Experiences: Research Involving Tissue and Data Track) Faculty: Stacey Donnelly, Laura Lyman Rodriguez, Julie Kaneshiro – OHRP Resource Person Increasing amounts of detailed genomic data often linked with healthcare and other information are being released in both research and non-research settings. Access to more data by more diverse entities for more varied purposes will inevitably increase the risks to
n ove m b e r 7- 9 , b os t on , m as s ac hu s e t t s
Protocol Rage and Meeting Fatigue: Therapeutic Options for IRB Chairs (IRB Operations and Toolkit Track)
Digital version fo the Conference Guide for the 2013 Advancing Ethical Research Conference