On May 3-6, 2010, we offered five highly acclaimed educational programs: IRB 101sm, IRB 201, IRB Administrator 101, Building Trust Between Minorities and Researchers: A National Bioethics Research Infrastructure Initiative, and Tissue Banking in 2010 and Beyond. These courses were geared specifically to meet the educational needs of IRB/HRPP members, administrators, and staff.
Monday, May 3, 8:30 AM–4:00 PM
IRB 101sm wa a full-day program that will feature a series of lectures, interactive discussions, and case studies. The two experienced PRIM&R faculty members leading this course reviewed:
- The development of the federally mandated IRB system within the United States;
- The underlying ethical principles and procedures for reviewing research involving the protection of human subjects; and
- The key components of the regulations that govern IRB operations.
Faculty for IRB 101:
Tuesday, May 4, 8:30 AM–4:00 PM
IRB 201 was designed for IRB/HRPP members and staff who understand the fundamentals of IRB/HRPP operations and who are now interested in obtaining the next level of training. Participants gained the knowledge and skills required both to serve as effective reviewers and to teach others to become effective reviewers.
The highly regarded faculty highlighted key criteria for the review of research, including:
- Risks to participants are minimized;
- Risks are reasonable in relation to anticipated benefits;
- Selection is equitable;
- Informed consent will be sought and waivers of informed consent;
- Informed consent will be documented including waivers of documentation;
- Research plan makes adequate provisions for monitoring safety;
- Adequate provisions to protect privacy and maintain confidentiality; and
- Additional safeguards for participants likely to be vulnerable to coercion or undue influence.
Faculty for IRB 201:
- Jeffrey Cooper, MD, MMM
- Moira Keane, MA, CIP
Building Trust Between Minorities and Researchers: A National Bioethics Research Infrastructure Initiative
Tuesday, May 4, 8:30 AM–12:30 PM
According to the NIH, the recruitment and retention of racial and ethnic minorities into clinical trials is a leading challenge confronting clinical researchers, and undoubtedly contributes to the persistence of health disparities. Most of the published literature is focused on religious, spiritual, and cultural beliefs among minorities as the primary barriers to increased participation. Far less has been published on the knowledge, attitudes, beliefs and cultural competence of researchers as potential barriers to increased participation of minorities in research.
Our nation lacks scientific consensus about the methods and procedures needed to effectively and respectfully increase participation of minority populations in biomedical and public health research. Through targeted efforts with minority communities and especially with researchers working to include minorities in medical research, the goal of the “Building Trust” Bioethics Research Infrastructure Initiative at the University of Pittsburgh is to develop, implement and evaluate strategies aimed at increasing minority participation in biomedical and public health research.
This educational program focused on the confluence of both minority participants and researchers in the context of recruitment and retention processes and informed consent for clinical trials research using innovative methods. The program included the following discussions:
- Introduction to the Bioethics Research Infrastructure Initiative
- The Recruitment-Retention Continuum: Challenges and Barriers on the Road to Informed Consent
- The Informed Consent Conversation: Using Patient Simulators to Improve Communication with Minority Participants in Research
- Discussion on strategies for improving the informed consent process
Faculty for Building Trust Between Minorities and Researchers:
- David Barnard, MA, MTS, PhD, JD
- Jonas Chaney
- Sandra Quinn, PhD
- Stephen B. Thomas, PhD
Tissue Banking in 2010 and Beyond!
Wednesday, May 5, 8:30 AM–4:30 PM
Research in genetics and personalized medicine has increased the demand for tissue banks and/or repositories that can provide researchers with access to large numbers of well-curated, quality specimens. When asked to review tissue banks, IRBs find the specifics of regulatory and ethical oversight complex and at times confusing.
During this course, two highly experienced faculty:
- Initiated discussions surrounding the importance of tissue banking, standard models of tissue banking, and the basic regulatory approaches that inform the role of the IRB;
- Reviewed the ‘gnarly’ issues surrounding tissue banking, such as consent forms and process, return of research results, identifiability of specimens, and centralized banks; and
- Engaged participants in interactive case-based discussions on the challenges IRB members encounter when reviewing protocols that include tissue banking.
Faculty for Tissue Banking in 2010 and Beyond:
IRB Administrator 101
- P. Pearl O'Rourke
- Judith M. Scheer, SM, RN
Wednesday, May 5, 8:30 AM–4:00 PM
Thursday, May 6, 8:30 AM–12:15 PM
IRB Administrator 101 is a one and a half-day program, specifically geared toward both new administrators and those in need of a refresher course.
Two highly experienced faculty will:
- Identify the key components of HRPPs;
- Examine the primary responsibilities of administrators; and
- Develop strategies and policies that will strengthen an institution’s HRPP.
The faculty for IRB Administrator 101 will also highlight key administrator tasks such as:
- Advising principal investigators, research staff, IRB chair and members, and institutional officials;
- Managing protocol review;
- Recordkeeping and reporting;
- Handling allegations and complaints;
- Developing policies and procedures;
- Managing staff and infrastructural needs;
- Serving liaison functions;
- Providing/overseeing education;
- Conducting quality improvement or assurance reviews; and
- Coordinating off-site administrative agreements.
Faculty for IRB Administrator 101:
- Elizabeth Bankert, MA
- Ada Sue Selwitz, MA
Please contact PRIM&R via email or telephone at 617.423.4112, ext. 0.