Agenda

For detailed listing of events click here to download agenda.

Day 1 - Tuesday, March 7, 2006

7:00 - 8:00 Registration and Breakfast Buffet (provided)

8:00 - 8:05 Acknowledgements and Conference Moderator
Brenda Durosinmi, MPA, CIP, CIM  UNLV

8:05 - 8:20 Opening Remarks- Paul Ferguson, PhD, UNLV, Vice President For Research and Graduate Studies

8:20 - 9:15 Keynote Speaker - A Walk Through the History of Research Ethics:  With Lessons Learned...or Not
Ernest Prentice, PhD, University of Nebraska Medical Center, Associate Vice Chancellor for Academic Affairs

9:15 - 10:15 Panel I
Similar Challenges in Biomedical and Behavioral Research
Moderator: Paul Jones, EdD

Exposure to risks of biomedical research is typically faced only by the individual. In behavioral research the range of non-physical risks may have an impact on others including families, social groups, communities, ethnic populations and even entire societies.  But there are similar challenges faced in biomedical and behavioral research.  This session will delineate some of those challenges.

10:15 - 10:30 Refreshment Break

10:30 - 11:30 Breakout Session 1

1A: SBER Research: Exemptions and Ethical Dilemmas
The federal regulations for the protection of human subjects in research provide exemption categories designed to exclude many social and behavioral studies from the requirements of regulations.  Being outside the scope of the regulations, however, does not mean that research studies are outside the realm of ethical review.  This session will use a case study approach to review common questions about the applicability of the exemptions to social and behavioral research studies, and to illustrate ethical challenges that sometimes arise in exempt social and behavioral research activities. 

1B: Clinical Research Misconduct & Role of the IRB
  This session will discuss what constitutes clinical research misconduct and provide examples where misconduct occurred.  In addition, it will describe the role the IRB plays in the discovery and managing of those accused of misconduct.

1C: Ethical Issues in Human Subjects Research

Many ethical issues in human subjects research has evolved out of atrocities that have occurred over the past 50 years and has focused our attention to the ethical treatment of humans in research studies.  This session will describe some of the common ethical issues that investigators, IRBs and the community are presented with in reviewing studies involving human research subjects.

1D: Human Subjects Protections: Regulations and OHRP Guidance

This session will provide a review of the Department of Health and Human Services regulations for the Protection of Human Subjects (45CFR 46) and discuss current OHRP guidance on several challenging human subject protection issues.

1E: Lessons from the Trenches: Adversities of Non-Compliance from an Institutional Perspective

Non-compliance can occur within some of the most well constructed human research protection programs.  This session describes some of the lessons learned when non-compliance is found and describe how the university and the IRB dealt with finding the solutions to challenging issues.

1F: Las Vegas Confidential Series - Sensitive Populations and Topics:  Navigating Through the IRB

This session will review the study: Nature and Scope of Child Sexual Abuse in the Catholic Church.  The sensitive nature of this topic and the issues concerning the IRB will be the focus of this session.

11:30 - 12:45 Lunch Buffet (provided)

12:45 - 2:00 Breakout Session 2

2A: Risk, Burdens, Opportunities, and Challenges of Clinical Research

Clinical research presents special challenges that the IRB must address.  This session reveals the risks, burdens, opportunities, and challenges that occur with clinical research studies.

2B: Is it Human Subjects Research?

This session reviews the various types of research that involve human subjects and fall within the purview of review by the IRB.  Unique cases will be presented and discussed.

2C: Role of the IRB Lawyer

The federal regulations applicable to human subjects research do not require an attorney to be a member of the IRB.  However, an attorney can play a key role in assisting the IRB stay in compliance with applicable federal, state and local laws governing research with human participants.  This session will focus on how an attorney might function with the IRB.

2D: The IRB Administrative Office: How to Effectively Educate the IRB Committee and Research Community

An important component of any human research protection program is an educated IRB committee and research community.  Many IRB administrative offices are aware of this need to educate, but lack the resources and the time to supply the education.  This session presents an effective way to educate the IRB committee and research committee.

2E: Unanticipated Problems/Adverse Events Involving Risks to Subjects

This session will provide guidance regarding the HHS Regulations for the Protection of Human Subjects (45 CFR Part 46) related to the review and reporting of (a) adverse events, and (b) unanticipated problems involving risks to subjects or others.  Among the questions reviewed will be: What are unanticipated problems, and how do they relate to adverse events?  How do you determine which adverse events are unanticipated problems that need to be reported under 45 CFR Part 46?

2F: Las Vegas Confidential Series - Sensitive Populations and Topics: Alcohol and Other Legal Substance Research

Privacy concerns are a major stumbling block to public health surveillance, including bioterrorism surveillance and epidemiological research.   The Health Insurance Portability and Accountability Act (HIPAA) of 2002 imposes very strict standards for rendering health information.  This session will discuss the challenges and opportunities of data mining.

2:00 - 2:15 Refreshment Break

2:15 - 3:45 Panel II- Federal Update
Moderator: Paul Jones, EdD

3:45 - 4:00 Closing Remarks

 Day 2 Wednesday, March 8, 2006 >>

*Agenda is subject to change without notification.

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