IRB members and chairs, institutional officials, investigators, research compliance officers, vice presidents of research, and support research staff.
|7:30 am||Registration and Breakfast|
|8 am||Welcome and Introduction|
|8:15 am||Criteria for the Review of Research |
This module reviews regulation 45 CFR 46/21 CFR 56 §111(a) and how it relates to the Belmont principles. More specifically, this module covers risk/benefit, subject selection and recruitment, informed consent, data safety monitoring, privacy and confidentiality, and vulnerable populations.
|10:30 am||Informed Consent (process, documentation, and waivers and alterations) |
The module on informed consent will review the historical and ethical underpinnings of informed consent, the process and regulatory requirements, documentation of informed consent, waivers and alterations, and informed consent in special circumstances.
|1 pm||Conflicts of Interest|
Using several well-known examples, this module begins with a brief introduction on the definition of conflicts of interest. The module then goes into detail on the following topics: the federal agencies and regulations governing conflicts of interest and disclosures by researchers, the laws and regulations governing IRB members, the governmental and non-governmental guidance documents, and best practices relating to conflicts of interest in research.
|2 pm||HIPAA as it Pertains to IRBs and Research|
The curriculum for this module will begin with an overview of the HIPAA privacy regulations, and will continue with a discussion on HIPAA and research authorizations. In addition, the module will present information on the use of PHI without authorization, including purposes of preparatory research, decedents’ information, waiver of authorization, limited data sets, de-identified data, and transition provision. Finally, the module will cover databases and tissue banks, recruitment of research subjects, and institutional considerations.
|3:15 pm||Research with Biological Specimens (includes issues with genetic research) |
The curriculum for this module begins with a background on the topic. The module then reviews the use of a specimen in a single protocol and specimen banking, including discussion on the Bank itself, depositing into the Bank, and accessing specimens from the Bank. Finally, the module presents information on issues, including the scope of consent, tiered consent, secondary uses, ownership of specimens (withdrawal of consent), and return of results.
|4:15 pm||Questions and Answers Session|
Bruce Gordon, MD
Bruce Gordon MD is Professor of Pediatrics in the section of Pediatric Hematology/Oncology and Stem Cell Transplantation at the University of Nebraska Medical Center (UNMC), and in the Division of Health Promotion, Social and Behavioral Health Sciences, University of Nebraska College of Public Health. He received his BA (1979) and MD (1983) from Johns Hopkins University, and completed residency and fellowship at Case Western University and UNMC. He has been a faculty member at UNMC since 1989 and served as clinical director of the Pediatric Stem Cell Transplantation Program.
Dr. Gordon has been a member of the UNMC Institutional Review Board since 1992 and served as chair since 1996. He served on the Applied Research Ethics National Association (ARENA) Public Policy Committee, and on the conference planning committees for both PRIMR and ARENA. He is a founding member of the Collaborative Institutional Training Initiative (CITI), serves on its Executive Advisory Committee, and is the author of two modules for the course. He has been a site visitor for OHRP and for AAHRPP. He served on the American Society of Clinical Oncology Task Force on Oversight of Clinical Research, the NIH Regulatory Burden Advisory Group Human Research Subcommittee, and the AAMC Informed Consent Working Group. In 2004 he was appointed chairman of the National Cancer Institute Pediatric Central IRB, and in 2005 he was appointed to the Secretary's Advisory Committee on Human Research Protections (SACHRP) subpart A subcommittee.
J. Michael Oakes, PhD
J. Michael Oakes, PhD, is an Associate Professor in the Division of Epidemiology, University of Minnesota, and a fellow of the MN Population Research Center and an Adjunct Professor of Sociology. His professional interests center on quantitative methodology, social epidemiology, and research ethics. He is an active researcher and frequent principal investigator on a wide variety of studies addressing a vast array of methodological, health, and ethical topics. Dr. Oakes has authored over 41 papers exploring problems at the intersection of social and medical sciences; his first text entitled Methods In Social Epidemiology was released last year. He teaches several graduate-level courses in statistical methods and social epidemiology. Finally, Dr. Oakes is an AAHRPP site visitor and Council member, reviews grant applications for NIH (section HSOD) and RWJF obesity prevention programs, and consults with a number of not-for-profit community organizations aiming to reduce health disparities among populations.
- 6.00 CE Contact Hours