Clinical Research Education - Regulations & Ethics Module

Clinical Research Education Program

	Regulations and Ethics in Clinical Research
	2009-2010
	Module Director: Jason E. Glenn, PhD

	Presented by: Institute for Translational Sciences Education Office

REGISTRATION FORM | AGENDA | CONTINUING EDUCATION | ACKNOWLEDGEMENT

OVERVIEW This course is designed for faculty, fellows, graduate students, and others interested in the regulations and ethics of research involving human subjects.

DESCRIPTION “Regulations and Ethics in Clinical Research” is a modular component of the clinical research course, Clinical Research: Tools and Techniques. This module consists of 10 weekly presentations by faculty from the Institute for the Medical Humanities, ITS Clinical Research Center (formerly GCRC), Sponsored Programs and other experts. These one-hour lecture/discussion sessions occur on Monday evenings beginning at 5:15 p.m., Children’s Hospital, Room 2.312. Refreshments are also available at 5:00 p.m.

OBJECTIVES Upon completion of this course, participants will be able to: (1) Describe regulatory and ethical issues important to clinical investigators and others involved in clinical research, and (2) Discuss important dimensions of research such as the history of federal regulations, federal oversight, and research subject advocacy.

TO REGISTER Complete and submit the registration form or contact the Institute for Translational Sciences - Education Office Office by e-mail creo.utmb@utmb.edu or phone (409)772-1484.
Those who have already registered for this year’s course, “Clinical Research: Tools and Techniques” do not need to register again for this module.

The course fee of $50 covers refreshments, handouts, letter of completion, and Risk Education, IRB, and GME designations. An additional $50 covers optional CME credit for physicians.

AGENDA
DATE	SESSION TITLE	PRESENTER	CE CREDIT	RESOURCES
10/12/09	Why Research Became Regulated Discusses the historical evolution of current standards for ethical conduct of human subject research.	Jason E. Glenn, PhD	CME Ethics, GME, Risk Edu
10/19/09	Ethical Issues Associated with Human Space Flight Research Discusses in-flight and ground-based space flight research including the organization and function of committees within NASA responsible for test subject safety.	Randal C. Reinertson, M.D., Ph.D.	CME Ethics, GME, Risk Edu
10/26/09	Overview of Federal Regulations for Conducting Clinical Research Discusses the Federal regulations governing clinical research, including regulatory application forms, study subject protection, and study data documentation, and relates these to "real world" clinical research practice.	Carmen Radecki Breitkopf, Ph.D.	CME Ethics, GME, Risk Edu
11/02/09	Monitoring and Oversight at the Federal Level Discusses IRB responsibilities, oversight and monitoring of FDA and NIH studies; including case studies of common violations found during inspections or audits.	To Be Announced	CME, Ethics, GME, Risk Edu
11/09/09	An Overview of Research Ethics Discusses why we should value research ethics, current standards for ethical conduct of human subject research and outlines the basic principles of the Belmont Report.	Harold Y. Vanderpool, Ph.D.	CME, Ethics, GME, Risk Edu
11/16/09	Ethics of Research on Prisoners Discusses the history of prisoner research including its expansion post Nuremberg. Describe proposals to revise prisoner research guidelines including unresolvable ethical conflicts.	Jason E. Glenn, PhD	CME, Ethics, GME, Risk Edu
11/23/09	Perspectives from an IRB Community Representative Discusses the roles of an IRB community member in protecting the welfare of human research subjects by being a responsible and informed representative of the public and its diversity.	Rabbi James L. Kessler	CME Ethics, GME, Risk Edu
11/30/09	Roles & Responsibilities of the Pl Discusses the legal issues governing clinical research, including research agencies/entities and roles and responsibilities of the Principle Investigator. Describe the Jesse Gelsinger case..	Toni D'Agostino	CME, Ethics, GME, Risk Edu
12/07/09	Research Subject Safety and Advocacy - An Ethical Imperative Discusses the elements of safe and responsible conduct of research, including the development and implementation of data and safety monitoring plans, adverse event reporting requirements, and the responsibilities of research subject advocates.	Michele A. Carter, Ph.D.	CME, Ethics, GME, Risk Edu
12/14/09	Assessing Risks and Benefits in Clinical Research Discusses the ethical, regulatory, and practical issues involved in assessing and communicating risks and benefits associated with clinical research studies.	Michele A. Carter, Ph.D.	CME, Ethics, GME, Risk Edu
	End of Module Course "Clinical Research: Tools & Techniques" continues See full agenda: Clinical Research: Tools & Techniques

EARN CREDIT

IRB This course has been designated by UTMB-Research Services as providing the preparatory framework for the required UTMB Internet-based training for human subject protections - CITI training module.

Risk Management Education credit is required for all UTMB faculty, fellows, and housestaff under the Medical Liability requirements. Sessions are approved by UTMB Risk Management to meet the annual requirement of up to 5.0 hours of Risk Management Education.

CME The University of Texas Medical Branch (UTMB) is accredited by the Accreditation Council of Continuing Medical Education to provide continuing medical education for physicians.
UTMB designates this educational activity for a maximum of 10 hours in AMA PRA Category 1 CreditsÔ. Physicians should only claim credit commensurate with the extent of their participation in the activity.
CME Ethics UTMB designates this educational activity for up to 10 hours in ethics/professional responsibility CME credit.

GME All sessions are approved by the UTMB GME Committee for the following general categories of graduate medical education:
Professionalism

ACKNOWLEDGEMENT
This course is part of the Institute for Translational Sciences Education Program, which is partially supported by a grant from the National Institutes of Health UL1RR029876.

(Page last updated 9/21/2009)