The Research Ethics Symposium

During their Tenure at Baylor College of Medicine, all graduate students and postdoctorals (clinical and basic science) are required to participate in formal training in the ethics of biomedical research. The purpose of the course is to provide that training. Class attendance is monitored to ensure compliance. Class exercises will guide students in learning how to contend with an array of ethical challenges that may confront the biomedical scientist. Strategies to promote ethical behavior in the conduct, proposal and reporting of research are covered along with federal and college guidelines and policies regarding scientific misconduct, data management and ownership, authorship and peer review, conflicts of interests and human and animal research. The course format includes lectures and case discussions centered around specific issues. Discussions are provided concerning the protection of human subjects’ confidentiality, safety, and privacy during the conduct of clinical trials.

Credits: 8 contact hours. The class is offered twice a year, in June and August.
This symposium fulfills, the NIH requirement for ethics training for all NIH-funded trainees.

Lecture	Title (Objectives)	Presenter
1	Integrity of Scientific Research 1. Definition of Scientific Misconduct 2. Process of Handling Charges 3. Protecting Whistleblowers 4. Notebook, Ownership of Results, Authorship & Peer Review	Dr. H. Gilbert
2	Conflicts of Interest 1. Disclosures and Management 2. Special Issues in Clinical Trials	Dr. B. Brody
3	Special Issues in Drug and Device Development 1. IND and IDE 2. Acc. # Regulatory Approval	Dr. B. Brody
4	Animal Research 1. History of Animal Research 2. Interagency Principles 3. System for Review of Animal Protocols	Dr. L. McCullough
5	Human Subjects Research 1. Human Subjects Research Overview 2. History of Regulatory Schemes 3. Basic Principles (Declaration of Helsinki, Belmont Report) 4. Current Regulatory Scheme (NIH and FDA)	Dr. B. Brody
6	Human Subjects Research (Continued) 1. Special Types of Human Subjects Research 2. Reproductive Research 3. Genetic Research (including stem cell and cloning) 4. Chart review and Stored Biologic Material Research	DR. B. Brody
7	Human Subjects Research (Continued) 1. Introduction to Basic System of Consent 2. Introduction to Role of the IRB	Dr. K. Motil
8	Special Populations in Human Subjects Research 1. Pediatric Research 2. Research on Cognitively Impaired Subjects 3. Research on Women of Child Bearing Potential 4. Research on Subjects in Other Countries	Dr. L. McCullough