Listing of the 2014 Classes with Brief Descriptions

The Twentieth Convention, Thursday and Friday, May 8-9, 2014

Web page is updated on October 1 of each year.

8:00 a.m. Thursday
2014-01, General Opening Session

This is the general opening, Top Ten IRB presentation, recognition of faculty, other introductions and notebook binder overview. Thomas E. Ball, MDiv, CIM, Executive Director, NAIL, Atlanta, GA, will facilitate this session.

8:30 a.m. Thursday
2014-02, Keynote Address, Fundamentals of Ethical Research, Beyond the Regulations

Speaker: Quincy J. Byrdsong, EdD, CIM, CIP, CCRP, Associate Vice President for Health Sciences, Virginia Commonwealth University, Richmond, VA.

9:30 a.m. Thursday
2014-03, Mock Board

This Mock Board will meet for the 16th year. It 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. Thomas E. Wasser, Ph.D., a 9-year Mock Board member will preside over the meeting. He is a Senior Scientist for Biostatistics at HealthCore, Inc., Macungie, PA.

11:00 a.m. Thursday

2014-04, HHS vs. FDA vs. ICH Regulations and Guidance

This speaker will address differences and similarities with the U.S. Federal Regulations and with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance. The discussion will focus on various differences and how these may be addressed. Jere Boyer, Ph.D., CIM, CIP, CCRP, Scientific and Human Subjects Protection Consultant, Clinical Research Management, Hinckley, OH will lead this session.

2014-05, Early IRB Career Workshop

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. Speaker: John C. Smith, MSW, CIM, CIP, IRB Director, Morehouse School of Medicine, Atlanta, GA.

1:00 p.m. Thursday

2014-06, Effectively Managing an IRB Office

This speaker will review best practices for managing IRB personnel and resources with emphasis on communication strategies, training, and monitoring. The speaker will identify common IRB issues and present solutions for administrative oversight of human subject research. Speaker: Sara Plaspohl, DrPH, CIM, CIP, Assistant Professor, Armstrong Atlantic State University, Savannah, GA.

2014-07, Research using Vulnerable Subjects, What the Regulations Don't Say

This session will define vulnerability in the context of human subject research, particularly in subject selection and informed consent. The speaker will discuss strategies which will best engage subjects and provide adequate protections for vulnerable populations. Speaker: Marjorie Speers, Ph.D., Retired President, AAHRPP, Washington, DC.

2:00 p.m. Thursday
2014-08, Writing IRB Policies and Procedures
This speaker will review the importance of having effective policies and procedures and describe mechanisms to translate policies and procedures into best practice user-friendly manuals. Speaker: Kristina Borror, PhD, Director, Compliance, OHRP, Rockville, MD.
2014-09, 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. Speaker: Mary Barnhart, MA, CIP, Director, Ethics, Education, Policy, and Compliance, Division of Social Services, University of Chicago, Chicago, IL.
3:00 p.m. Thursday
2014-10, Fundamentals of Informed Consent, It�s Not Just a Document
In this session, delegates will be exposed to several informed consents and will discuss language level, learning, interpretive services, and comprehension through the informed consent process. The IRBs role in determining level of understanding and comprehension will be visited. Speaker:
2014-11, The Emergence of Regional Network IRBs
There are approximately 4,000 institutional IRBs in the US plus a few hundred independent programs sometimes called central. This speaker will discuss how the drive to accelerate research, together with a renewed effort to rationalize the system of protecting human research subjects are leading to the emergence of IRBs serving regional and functional networks. The speaker will review the evolution of IRBs and describe the emerging models that exist. Speaker: Stuart Horowitz, PhD MBA, President, Institutions & Institutional Services, WIRB-Copernicus Group, Seattle, WA.

4:00 p.m. Thursday
2014-12, Q&A with the Experts

A panel of regulatory and civilian experts will take questions on topics that include contractual agreement as well as ANPRM. Moderator: TBD

2014-13, Ethical Considerations in Research on Investigational Drugs.

This speaker will discuss the new FDA guidance on risk-based monitoring and its impact on GCP auditing. Additionally, the facilitator will review 21 CFR 312 and discuss the regulatory expectations of clinical research involving investigational drugs. Invited speaker: FDA.

5:00 p.m. Thursday
2014-14, Committee Meetings
A. Top Ten
B. 2015 Convention Planning
C. Leadership Succession
D. Minority College and University Research Program Dialogue Group
2014-15, Networking Reception

Sponsored by TBD

8:00 a.m. Friday
2014-16, TBD
Speaker: George Gasparis, BS, CIP, President, PEER Consulting Group, Upper Saddle River, NJ.
2014-17, AAHRPP Accreditation:
What are the advantages of AAHRPP Accreditation, if any? What type of programs should seek accreditation? Is the accreditation really worth the money and trouble? Can my organization "get there?" Elyse I. Summers, J.D., President and CEO, Association for the Accreditation of Human Research Protection Programs, Inc., Washington, DC will lead this session.
9:00 a.m. Friday

2014-18, The Animal Foundation of Human Clinical Trials-Rules, Regulations, and IACUC:

This discussion will compare the duties of the IACUC to those of the IRB and briefly discuss the animal foundation of human clinical trials. Carol Clarke, DVM, DACLAM; US Department of Agriculture, Riverdale, MD is the speaker.

2014-19, Incidental Findings in Human Subjects Research

What are the ethical obligations to research subjects? This speaker will investigate the investigator-subject relationship, both conceptually and pragmatically, in the context of uncovering incidental findings during the course of a research study. The speaker will lead a discussion on whether investigators are obligated to inform subjects of health-related findings or obligated to keep promises of confidentiality and integrity of the research. Speaker: John Ponzillo, Pharm. D. Chairman, Institutional Review Board, Mercy Hospital, St. Louis, MO.
10:00 a.m. Friday

2014-20, Ethical Considerations in Research Design

The speaker will review a proposal based on design, statistical aspects, sample size, and possible outcomes. Discussion will include ways statistical aspects may affect participant safety and risk. Speaker: Thomas E. Wasser, PhD, CIM, Bio-statistician, at HealthCore, Inc., Macungie, PA.
2014-21, 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. Speaker: Ashli Owen-Smith, PhD, Investigator, Kaiser Permanente, Atlanta, GA.
11:00 a.m. Friday
2014-22, 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. Speaker: Kristina Borror, PhD., Director, Compliance, OHRP, Rockville, MD.

12:00 noon Friday
2014-23, Check out
12:30 pm Friday
2014-24, Make up class, Organizing IRB

The class participants will nominate a balanced skilled IRB for a given area of review. Speaker: Thomas E. Ball, MDiv., CIM, Executive Director, NAIL, Atlanta, GA.

2014-25, Closing Comments and Wrap-up

What worked well, what did not work well, and what should be changed for the 2015 convention.