Investigator Training

New England IRB strongly encourages scientific staff, researchers and prospective investigators to be well versed in the principles of Human Subject Protection. It is critical that all personnel involved in clinical trials have an understanding of research trials and the executive, regulatory and ethical responsibilities of investigators performing clinical trials.

To that end, New England IRB has compiled Ethical Mandates and Federal Regulations for the Conduct of Clinical Research, which includes the following list of contents. We encourage investigators and their staff to read this document and take the test at the end.

Part 1: Ethical Guidelines:

• The Nuremburg Code

• The Declaration of Helsinki

• Federal Guidelines

• The Belmont Report

Part 2: Informed Consent

• Section A: Dialog and Document

  • Walter Reed and Yellow Fever

  • The Legal Viewpoint

  • Canterbury v. Spence

  • Moore v. Regents of the University of California

  • Capacity to Consent

• Section B: Ethical and Regulatory Aspects of Informed Consent

  • The Process of Informed Consent

  • The Regulations

  • Additional Elements of Informed Consent

Part 3: Good Clinical Practice (GCP)

• Compliance

Questions

• Parts 1, 2 and 3