| Listing of the 2015 Classes with Brief Descriptions |
Proposed date for the Twenty-First Convention, Thursday and Friday, May 21-22, 2015 Web page is updated on October 1 of each year. |
| 8:00 a.m. Thursday |
| 2015-01, General Opening Session |
This is the general opening, Top Ten IRB presentation, and recognition of faculty, other introductions and notebook binder overview. |
| 8:30 a.m. Thursday |
| 2015-02, Keynote Address |
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| 9:00 a.m. Thursday |
| 2015-03, The 17th Mock Board Meeting |
This board will execute a complete agenda, review a pediatric social science protocol, and offer a number of IRB education opportunities related to ethics, special precautions and mental health. It is open to critique. The Board seeks release from regulatory restriction. |
| 11:00 a.m. Thursday |
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2015-04, Current IRB Issues |
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The speaker will select topics that have had high discussion over the year and focus a discussion on them. |
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2015-05, Early IRB Career Workshop |
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This workshop offers a career introduction and it will give an overview of what the new IRB employer or leader may expect over the period of employment. |
| 12:00 Noon - 1:00 Friday |
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2015-05, Lunch |
| 1:00 p.m. Thursday |
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2015-07 Fundamentals of Human Subjects Protections |
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This session will explore the timeline of events that led to the current regulations for human research protections. |
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2015-08 Comprehensive Regulations: |
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This session will focus on the differences between the FDA and OHRP regulations. |
| 2:00 p.m. Thursday |
| 2015-09 Data Security-Data Monitoring: |
| This session will explore the essential elements a data monitoring who, what, where, and how's of data safety and monitoring. Then expose delegates to recent data security breaches and the requirements of a data security plan. |
| 22015-10 IDE Emergency use Research: |
| This speaker will discuss expanded access of the circumstances and how an unapproved IDE can be utilized. |
| 3:00 p.m. Thursday |
| 2015-11 Electronic System vs. Paper: |
| This session will explore the various opportunities in IRB software management systems available to assist in document processing. |
| 2015-12 Ethical Considerations in the Era of Mobile Devices: |
| This speaker will discuss human subject research in a technology-driven environment. The facilitator will analyze internet research, social media influences, and the healthcare technology as facilitated by mobile devices. The session will analyze growth in this area and its impact on the conduct of human subject research. |
| 4:00 p.m. Thursday |
| 2015-13, Q&A with the Experts: |
A panel of regulatory and civilian experts will respond to questions on informed consent and “Current Ethical and Regulatory Challenges in the IRB. |
| 5:00 p.m. Thursday |
| 2015-14, Committee Meetings |
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A. Top Ten B. 2015 Convention Planning C. Leadership Succession D. Minority College and University Research Program Dialogue Group |
| 6:00 p.m. Thursday |
| 2015-15, Networking Reception |
Sponsored by TBD |
| 8:00 a.m. Friday |
| 2015-16, Developing IRB Minutes |
| The facilitator will share a concept that allows regulatory as well as institutional officials to reconstruct an IRB meeting from its minutes. There will be examples of effective and less than effective minutes for reconstructing a meeting. |
| 2015-17 National Cancer Institute (NCI) and CIRB |
| This session will explore the pros and cons of what the NCI has to offer through its Central IRB (CIRB) services. |
| 9:00 a.m. Friday |
2015-18, IRB Audit and Monitoring: |
| This class will offer a method for IRB audit and monitoring. Audit policy will be discussed. |
2015-19 Qualitative Language |
| This session will include critical discovery analysis and quantative based approaches. |
| 10:00 a.m. Friday |
2015-20, OHRP Exit Report, Mock Board |
| OHRP will discuss the mock determination letter and the mock institution's response with reference documents before the convention delegates. |
| 11:00 a.m. Friday |
| 2015-21, Recruitment, Training IRB Staff and Board Members |
A systemic model will be set for a given level of activity where the convention delegate may skew up or down to local training needs. Work distribution per FTE will be introduced. |
| 2015-22, HIPAA Privacy Rule |
This speaker will examine the privacy rule that Congress introduced in the 1990s, and includes a discussion of the privacy update. |
| 12:00 noon Friday |
| 2015-23, Check out |
| 12:30 pm Friday |
| 2015-24, Behavioral Research |
This speaker will compare and contrast biomedical and behavioral research. The session will identify areas of socio-behavioral research which pose a unique challenge for investigators and IRBs. Case study analysis will be used to create real scenarios for IRB leaders to consider in reviewing these types of studies. |
| 2015-25 Minimal risk relative to privacy information |
This session will explore when some privacy information utilized may take the research beyond minimal risk. |
| 2015-26, Closing Comments and Wrap-up |
What worked well, what did not work well, and what should be changed for the 2016 convention. |