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Agenda Day 2 For detailed listing of events click here to download agenda. Day 2 - Wednesday, March 8, 2006 7:00 - 8:00 Breakfast Buffet (provided) 8:30 - 9:00 Guest Speaker - Jeffrey Cohen, PhD, CIP 3A: International Research: Challenges and Opportunities While we cannot impose our standards for written documentation on other cultures, we do not relax our standards for ethical conduct of research for a meaningful consent process. This session will focus on the special attention that should be given to local customs and to local cultural and religious norms in drafting written consent documents or proposing alternative consent procedures.
3B: Research Involving Vulnerable Populations The federal regulations require that IRBs give special consideration to protecting the welfare of vulnerable subjects. Who should be categorized as vulnerable and factors to assist in the protection of these volunteers will be discussed.
3C: IRB and IBC Oversight of Recombinant DNA Research Reciprocal communication on a regular basis between the IRB and the IBC for Human participant research projects involving recombinant DNA, gene transfer, microorganisms, viruses, or biological toxins is essential in order for the IRB to fulfill its functions relative to human participant research. The why and how will be discussed from a federal regulatory prospective.
3D: Common Findings of Non-Compliance OHRP Educational Division will discuss common findings of noncompliance with 45 CFR Part 46 based on compliance determination letters.
3E: Preparing for Clinical Inspections The Food and Drug Administration representative will discuss how to successfully prepare for clinical inspections.
3F: Las Vegas Confidential Series - Sensitive Populations and Topics: Alcohol and Other Legal Substance Research Research on alcohol and other legal substances can present special challenges. This session describes some of these unique challenges and discusses innovative guidelines that IRBs have instituted to aid the researcher in the protection of human subjects and in its IRB review of this research.
10:15 - 10:30 Refreshment Break 4A: Informed Consent - Consistencies and Differences in Biomedical and Behavioral Research Informed Consent is one of the most important components of a research study involving human subjects. This session will describe some of the unique challenges that can occur with both biomedical and behavioral research and provide a summary of the similarities and differences that each type of research presents.
4B: Human Subject Protection Issues in Device Research Investigational device research presents its own challenges for IRBs. This presentation will discuss the sponsor's interrelationship with the IRB, the IRB's attention to device issues when performing initial and continuing review of device research, and the importance of the informed consent process for device research.
4C: Evidence-based Ethical Problem Solving Finding ways within the flexibility of the federal regulations to use those procedures that have proven empirically to be the most ethically and scientifically satisfactory instead of one-size-fits all application of simple precedents will be the focus of this session.
4D: HIPAA, Research, and the IRB The Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”) and its applicability to research and standards for the protection of certain health information will be discussed at this session.
4E: Mission Creep This session will discuss the looming issues surrounding mission creep and its impact on the campus community.
4F: Las Vegas Confidential Series - Sensitive Populations and Topics: Informed Consent: How do you know if participants “understand”? How can we tell if the Informed Consent has really informed? Practical tools will be discussed to help insure participants are well informed.
11:45 - 1:00 Lunch Buffet (provided) 5A: Medical Device 101: Who, What, Where, When, and How? Basic medical device information will be discussed in this session.
5B: Key Lawsuits in Human Subject Research Human research participants have become savvier in knowing their rights and their expectation of ethical treatment when enrolled in a research study. They are holding researchers and their institutions accountable. This session will discuss some of the current lawsuits sustained by researchers and their institutions.
5C: Privacy and Confidentiality: Liability and Limits Unveiling the distinct differences in privacy and confidentially with techniques to ensure participant protection will be the focus of this session.
5D: The IRB Office: Administration and Records Records management is one of the most important aspects of any institutions human protection program. This session will focus on the aspects of IRB records management.
5E: Research in Educational Settings Three sets of federal laws and regulations sometimes come into play in school-based research: The regulations of the federal policy for the protection of human subjects - also known as the Common Rule, the Family Educational Rights and Privacy Act (FERPA) regulations governing access to student's education records, and the Protection of Pupil Rights Amendment (PPRA) law governing the administration of surveys, analyses or evaluations involving sensitive personal information. This session will provide an overview of how the three sets of federal requirements apply, and tips for researchers and IRBs considering research involving these requirements.
5F: Las Vegas Confidential Series - Sensitive Populations and Topics: Conducting Field Research - Challenges and Opportunities A case study will provide information to overcome the challenges researchers and IRBs can face during the review process and the implementation of qualitative research projects.
2:15 - 2:30 Refreshment Break Surreptitious Monitoring of Electronic Traffic (Internet, cell phones, chat rooms, land line taps) The electronic age has opened a completely new arena of accessing research participants. What protections can and should be offered to these participants will be discussed.
3:45 - 4:00 Closing Remarks |
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