IRB members and chairs, institutional officials, investigators, research compliance officers, vice presidents of research, and support research staff.
- Conducting Research Beyond Your Backyard
- Applying the Expedited Categories
- Internet Research
- Case Studies
- Children & Adolescents: Pediatric Research Subpart D
|8 am||Registration and Breakfast|
|8:20 am||Welcome and Introduction|
|8:30 am||Conducting Research Beyond Your Backyard|
IRBs face different challenges when reviewing protocols that are conducted outside their institution, whether the research is conducted across town, in another region of the United States, or internationally. This presentation will discuss concepts, regulatory requirements, and cross-cultural and ethical considerations that an IRB must consider when the research is conducted beyond the boundaries of its institution, particularly when conducted internationally. Finally, the session will offer tools and strategies for acquiring local knowledge of the research setting.
|9:45 am||Applying the Expedited Categories|
Similar to applying the exemption categories, this module will review the federal regulations governing expedited categories, including what types of research are expedited. In addition, the modules will review OHRP Guidance on expedited categories, as well as using expedited review.
|10:15 am||Internet Research|
The curriculum for this module will review recruiting subjects over the Internet, observation of Internet activity, and collecting data over the Internet. In addition, the module will consider IRB review issues, including risk/benefit, consent, participation by minors, and privacy and confidentiality. Finally, this module will discuss electronic data security and IRB review requirements.
|12:15 pm||Case Studies|
|3:15 pm||Children & Adolescents: Pediatric Research Subpart D|
The curriculum for this module aims to familiarize attendees with the ethical principles as they pertain to subpart D and the regulations. In addition, the module reviews what is sufficient pediatric expertise, pediatric risk/benefit assessment and definitions, parental permission and assent, wards of state, and subpart D documentation requirements.
|3:30 pm||Questions and Answers Session|
George Gasparis, CIP
George Gasparis, is the president of The PEER Consulting Group, LLC. Mr. Gasparis has over 30 years of experience in the administration or conduct of human subjects research. Prior to starting “PEER”, he served as the Executive Director, HRPP/IRB at Columbia University (CU), CU Medical Center (CUMC) from 2003-12. He worked at OHRP for seven years and served as the Director, Division of Assurances and Quality Improvement from 2000-03, where he led the development of the OHRP QI Program. He has also served as the Director, GWUMC IRB and as a Data Manager for over 40 clinical trials at GWUMC.
Moira Keane, MA, CIP
Moira Keane is the former Executive Director of the University of Minnesota, Human Research Protection Program which includes the Institutional Review Board (IRB), and the Institutional Biosafety Committee (IBC). The HRPP oversees the research of all University of Minnesota campuses which encompasses review of basic science, clinical research, and social and behavioral sciences projects conducted by faculty, staff, and students. She is actively involved in subjects protections and served as Chair of the AAHRPP Council on Accreditation, as Vice Chair of the Council on Certified IRB Professionals (CCIP), and as a member of the Secretary’s Advisory Committee on Human Subjects Protection (SACHRP) Sub Part A Sub Committee.
Continuing Education Credit
- DPM: Des Moines University (DMU) is approved by the Council of Podiatric Medical Education as a provider of continuing education in podiatric medicine. DMU has approved this live activity for a maximum of 6.0 continuing education contact hour(s).
- MD: This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Iowa Medical Society (IMS). Des Moines University (DMU) is accredited by the IMS to provide continuing medical education for physicians. DMU designates this live activity for 6.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
- DO: Des Moines University (DMU) is accredited by the American Osteopathic Association (AOA) and approves this live activity for 6.0 AOA Category 1-A CME credit(s).
- Other Professionals: This live activity is designated for 6.0 AMA PRA Category 1 Credit(s)™.
- 6.00 AMA PRA Category 1 Credits™
- 6.00 AOA Category 2A
- 6.00 CE Contact Hour(s)
- 6.00 CPME