Human Subject Protection: It’s a Brand New Day

Jointly sponsored by
University of Cincinnati, Cincinnati Children’s Hospital,
the University of Kentucky and Schulman Associates IRB

Thursday, October 8, 2009
Northern Kentucky Convention Center

Overview
In the morning the first speaker will discuss the things that have stifled the enrollment of minorities in research and identify some solutions.  The next speaker will identify concerns about paying subjects and will also discuss consent in an emergency setting. The third speaker will describe challenges for IRBs in reviewing research involving the decisionally impaired. Following lunch, the first speaker will define personalized medicine and describe what type of research is needed for its development.  The second speaker will discuss the importance of and challenges for the clinical research coordinator. The conference will conclude with a provocative presentation regarding the strengths and weaknesses of IRB decision making and the speaker will suggest ways to improve it.

Agenda

8:00 - 9:00 am            Registration and Continental Breakfast

9:00 - 9:15 am            Welcome & Opening Remarks

John M. Isidor, JD
CEO, Schulman Associates IRB, Inc.

Sandra Degen, PhD
Vice President for Research
University of Cincinnati

Ada Sue Selwitz, MA
Director, Office of Research Integrity
University of Kentucky

9:15 - 10:15 am          Beyond the Legacy of Tuskegee:
Engaging African American Communities in Research

Stephen B. Thomas, PhD
Director, Center for Minority Health
University of Pittsburgh

Learning Objectives:

1. Describe the historical and social context that enabled the Tuskegee study to begin and to go on for 40 years.
2. Describe the most common misconceptions about the Tuskegee Study.
3. Describe how the aftermath of the Tuskegee Study strengthened protection of human subjects guidelines in the Belmont Report.
4. Identify the impact of Tuskegee on minority recruitment into research.
5. Describe new and innovative models for building trust needed to engage African Americans and other minority populations in research.

10:15 - 10:30 am        Break

10:30 - 11:30 am        Two Challenges to Informed Consent - Payment
for Participation and Research in Medical Emergencies

Neal W. Dickert, MD, PhD
Fellow, Cardiovascular Disease Fellowship Training Program
Emory University School of Medicine

Learning Objectives:

1. Define the concepts of coercion and undue inducement.
2. Demonstrate that payment is not coercive but that it can lead to undue induceme that warrants concern in protocols near the limits of approvability.
3. Identify the challenges of obtaining informed consent in clinical trials involving medical emergencies.
4. Define a new set of goals for obtaining consent in emergency situations.

11:30 - 12:30 pm       Enrolling Decisionally Impaired Adults in Research

Don Rosenstein, MD
Professor of Psychiatry and Director of the UNC Comprehensive Cancer Support
Program at the UNC Lineberger Comprehensive Cancer Center

Learning Objectives:

1. Identify the Regulatory and IRB considerations for research involving decisionally impaired adults.
2. Evaluate research for this population with more than minimal risk and no prospect of direct benefit.
3. Identify considerations in reviewing a Fragile X PET Protocol.
4. Describe concerns of a father raising a son with autism and mental retardation.

12:30 - 1:30 pm         Lunch

1:30 - 2:30 pm           Personalized Medicine: Problems and Perplexities for the IRB

P. Pearl O’ Rourke, MD
Director of Human Research Affairs at Partners HealthCare Systems in Boston and an Associate Professor of Pediatrics at Harvard Medical School

Learning Objectives:

1. Define personalized medicine.
2. Describe research needed to develop personalized medicine.
3. Identify IRB issues involving tissue and data banks and risk assessment of genetic issues.
4. Discuss Direct to Consumer genetic testing in personalized medicine.

2:30 - 3:15 pm           The Role of the Study Coordinator in Research

Carol Fedor, RN, ND, CCRC
Clinical Research Manager for The Center for Clinical Research at University Hospitals Case Medical Center

Learning Objectives:

1. Describe the current role of the Clinical research coordinator (CRC).
2. Identify the professionalization of the role of the CRC.
3. Discuss the ethical challenges of the CRC.

3:15 - 3:30 pm           Break

3:30 - 4:30 pm           How Do IRB Members Make Decisions? Research Speculations?

Ivor Pritchard, PhD
Senior Advisor to the Director in the Office for Human Research Protections (OHRP) in the Department of Health and Human Services

Learning Objectives:

1. Identify potential problems from flawed IRB decisions.
2. Discuss possible causes for poor IRB decisions.
3. Describe a model for rational decision-making.
4. Identify how existing psychological research can illustrate patterns in deviations from rational decisions.
5. Describe how IRB decision-making can be improved.

Conference Objectives
The purpose of this conference is to provide information to institutional review board (IRB) members, IRB administrators, clinical investigators, research sponsors, contract research organizations and members of the clinical research community about current issues regarding the protection of human subjects.

At the end of this conference attendees should be able to:

1. Describe the challenges in enrolling minority populations in research.
2. Identify the ethical concerns with paying research subjects.
3. Discuss the challenges in enrolling decisionally impaired subjects.
4. Identify the complexities of reviewing research involving personalized medicine.
5. Explain the ethical concerns facing a clinical research coordinator.
6. Describe how to improve IRB decision-making.

Target Audience
The target audience includes physicians and others who conduct human subject research, IRB Board members and staff, research sponsors and CROs, government regulators and members of the clinical research community.

Continuing Education Information
Nursing CEU and CME credit hours will be available to conference attendees.

This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of  Cincinnati Children’s Hospital Medical Center,  University of Cincinnati, Schulman Associates Institutional Review Board, Inc., the University of Kentucky. Cincinnati Children’s is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Cincinnati Children’s designates this educational activity for a maximum of 5.75 AMA PRA Category 1 Credit(s) ™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Approved contact hours: 5.75 continuing education contact hours for nurses are approved by the Ohio Board of Nursing through the OBN Approver Unit at the University of Cincinnati, College of Nursing Continuing Education Program, (OBN-011-93).   Contact hours are valid in most states. Program #091008-1.

Certificates of Attendance
Continuing medical and nursing education credit certificates as well as certificates of attendance will be provided upon request. When you register for the event please indicate which type of certificate you are requesting. Following the event a link to an evaluation form will be emailed to you. When your completed form is received, the certificate will be emailed to you.

Registration and Login

Registration is on-line at http://webcentral.uc.edu/researchetc_cal/calendar. You must pre-register for this event. The registration deadline is September 17, 2009. Please register early as seating is limited. Follow the on screen login instructions. Note that there is a New User login option at the bottom of the page.

 
Conference Cost
The conference is jointly sponsored by the University of Cincinnati, Cincinnati Children’s Hospital, the University of Kentucky, and Schulman Associates IRB, Inc. as a service to the clinical research community. The University of Cincinnati and Cincinnati Children’s Hospital are offering this event at the discounted fee of $90.00. This fee includes conference materials, lunch and refreshments. Continuing education credit hours are available at no additional fee. Payment must be received prior to the event and is non-refundable after the day of the conference.

Conference Location
The conference will be held at the Northern Kentucky Convention Center, One W. RiverCenter Boulevard, Covington, Kentucky 41011. 

From Cincinnati/Northern Kentucky International Airport
Take I-275 East to I-71/75 North. Exit 192/Covington-Fifth Street. On Fifth Street, go six blocks; turn left on Madison to RiverCenter Blvd. The Convention Center is to the right.

From Lexington, KY
Take I-75 North to Exit 192/Covington-Fifth Street.  On Fifth Street, go six blocks; turn left on Madison to RiverCenter Blvd. The Convention Center is to the right.

From Cincinnati, OH
Take I-75 South to Exit 192/Covington-Fifth Street.  On Fifth Street, go six blocks; turn left on Madison to RiverCenter Blvd. The Convention Center is to the right.

This event is presented by the University of Cincinnati Office of Research and the Children’s Hospital Office of Research Compliance and Regulatory Affairs. For additional information contact Dawn O’Neill at dawn.oneill@uc.edu or Mina Busch at mina.busch@cchmc.org.