| A Listing of the 2009 Classes with Brief Descriptions |
| May 7-8, 2009 |
| 8:00 a.m. Thursday |
| 2009-01, Orientation |
This is the general opening, recognition of Top Ten IRBs for Human Subject Protection Education, faculty and other introduction, along with notebook overview. This is not a class, but an hour to get acquainted. Thomas E. Ball, Executive Director, NAIM, Atlanta, GA, will facilitate this session. |
| 9:00 a.m. Thursday |
| 2009-02, Getting Started in an IRB Office |
This is an introduction to IRB work. First, there will be the community hospital’s approach followed by the academic medical center’s approach, then a combined view of starting to work in a busy IRB office. |
| 2009-03, Investigational Device Exemption (IDE) Regulation (21 CFR 812) |
This session will include a discussion about the differences between Significant Risk Device Studies vs. Non-significant Risk Devices vs. Exempt Devices. Fabienne Santel, MD, FDA, Center for Devices and Radiological Health, Rockville, MD, will facilitate this session. |
| 2009-04, Effectively Managing an IRB |
| This session will focus on compliance checks and balances in an IRB program where work flows with minimal disruption. |
| 10:00 a.m. Thursday |
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2009-05, Basic Protocol Review |
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This session will look at review elements of a biomedical and a social science protocol. The advantage/disadvantage of both primary and a full board review will be explored. This session will be facilitated by Richard D’Augusta, R.Ph., MPA, ORO, VA Regional Director, Bedford, MA. |
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2009-06, Mock Board |
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This 10 year-old Mock Board offers a number of IRB education methods. It is a practice that is open to critique. It executes a full agenda with long-term Mock Board members. It seeks to be released from mock regulatory restrictions. This session will be facilitated by Ray R. Maddox, Pharm.D., Director, Research, St. Joseph’s/Candler Hospital, Savannah, GA. |
| 11:00 Thursday |
| 2009-07, Conflict on the Panel |
| The working lunch session will first identify the cause for the IRB to do an exploratory audit of an investigator to determine the level of compliance. |
| 12:05 p.m. Thursday |
2009-09, Investigator Audit |
| The working lunch session will first identify the cause for the IRB to do an exploratory audit of an investigator to determine the level of compliance. |
| 1:00 p.m. Thursday |
| 2009-10, Sponsored Research Applications |
| How does the research committee and IRB assure that federally funded research follows guidelines listed in a grant approval letter? The class will look at DHHS grants and civilian grant awards. This session will be facilitated by Jere Boyer, Ph.D., CIM, CIP, CCRC, IRB Consultant, Canton, OH. |
| 2009-11, SAE vs. AE Reports |
What AE responsibility does the investigator have to the local IRB? There will be examples of local AE’s that may cause the IRB to have concern. The data safety monitoring board will be introduced. FDA’s Center for Drug Evaluation and Research has been invited to lead this session.
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| 2:00 p.m. Thursday |
| 2009-12, Research Abroad: Considerations for Collaborating Institutions |
| This session will include U.S. regulation application to international research, cooperative IRB review arrangements, and dual regulations when American institutions are conducting joint research with a foreign government or co-investigating with institutions in a foreign country where DHHS funds are used. This session will be facilitated by OHRP. |
| 2009-13, Protecting Human Subjects Data in Genetics Research |
| The facilitator will assure that subject data will be protected at the agreed level. |
| 2009-14, Assuring Investigator Compliance |
| After an example of broken IRB trust, the facilitator will develop an investigator action plan to protect the IRB and institution, to protect the investigator, and to protect the subject. Marjorie Speers, Ph.D. Director, AAHRPP Washington, DC, will facilitate this session. |
| 3:00 p.m. Thursday |
| 2009-15, Step-by-Step Emergency, Compassionate, and Humanitarian Devices |
In this session, the speaker will review FDA’s guidance on the use of unapproved devices and HUDs. Marian Serge, RN, CIM, Nurse Consultant, CDRH, FDA, Rockville, MD, will lead this session. |
| 2009-16, Writing Policies and Procedures |
This is an open dialogue session. The writing (or rewriting) of policies and procedures will be considered, with focus on a methodological approach to satisfy regulatory requirements and institutional needs. Sara S. Plaspohl, MHS, CIM, CIP, Research Ethics Officer, Memorial Health University Medical Center, Savannah, GA, will facilitate this session.
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| 4:00 p.m. Thursday |
| 2009-17, Developing Minutes |
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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. This session will be lead by a staff member from OHRP, Rockville, MD.
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| 2009-18, HIPAA with Children Research |
| This speaker will review the regulation that applies to pediatric cases/assent and compare it with the regulation for the adult population. |
| 2009-19, Consent Form Elements |
| In this session, the facilitator will take a consent form through the process of element inclusion and satisfy the regulatory requirement for each. Marian Serge, RN, CIM, FDA Center for Device, Rockville, MD, will facilitate this session. |
| 7:00 a.m. Friday |
2009-20, Repeat Thursday’s Most Demanding Class Conflict |
2009-21, Committee Meeting |
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| 8:00 a.m. Friday |
| 2009-22, Dual IRB Project, Investigator and Sponsor |
| After this class has ended, the delegate will be able to develop an effective policy that will oversee both sponsor and investigator activity when it is dual presented to the IRB. This session will be led by George Gasparis, CIP, Executive Director, IRB, Columbia University, NY, NY. |
| 2009-23, Students Research |
| Pitfalls when educating the student research population will be shared. The session will focus on both mentor and student IRB education. |
| 9:00 a.m. Friday |
| 2009-24, Advanced IRB Concepts |
This session will focus on human subject protection in a large academic research institution. Internal structure, staff, and reporting that meet the expectation of regulatory agencies will be shared.
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| 2009-25, Statistics Analysis in Protocol Review |
This class will examine the safety pre-test of the sponsor’s hypotheses as part of the review. The pre-test finding will be weighed against the sponsor’s stated belief in the hypotheses. Thomas E. Wasser, Ph.D., CIM, HealthCore, Inc., Wilmington, DE, will facilitate this session. |
| 10:00 a.m. Friday |
| 2009-26, Pros & Cons of Transitioning IRB Files/Records from Traditional Paper to Electronic Format |
Andrew Olmsted, IRBNet, Cambridge, MA, will lead this session.
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| 2009-27, Mock Board Exit Report |
This will be continuous education from the previous day’s Mock Board meeting. There will be a review of violations from earlier years. The mock review and regulatory finding along with lifting or announcing continued mock restrictions is the third part of this class.
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| 2009-28, Technology and Electronic Files |
Delegates will share three systems of IRB software and state future needs for consideration. Two different IRB software design teams will review the information and give probability of future need. |
| 11:00 a.m. Friday |
| 2009-29, Effective Recruitment |
The facilitator will bring a discussion approach that leads to successful recruiting and maintaining IRB staff and Board members. |
| 2009-30, Sponsored Research Challenge |
The IRB finds challenge with a given sponsor who is also the only investigator for the activity. The potential conflict is the investigator/sponsor in question sits in a well-represented seat at the IRB table. |
2009-31, Mental Health Research |
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| 12:00 p.m. Friday |
2009-32, Committee Meeting |
| 12:30 p.m. Friday |
2009-33, Open Meeting for Planning the 2010 Convention in New Orleans, LA. |