Ethics, Standards and Identifying Risks in Clinical Research - ComplianceOnline Clinical Training 2011

This clinical research ethics training will impart an understanding to regulatory compliance and clinical study personnel on the importance of ethics in clinical research and impart a familiarity with the regulations to protect both the researcher and the subject.

Why Should You Attend:
Clinical research is conducted with the purpose of ultimately reducing the morbidity and/or mortality associated with disease. However, such research is ethically challenging because of potential conflicts of interest, a need to protect subjects from undue risk or the advancement of technology that my complicate protection of research subjects. Protecting the rights of research subjects is paramount. While ethicists often debate ethical principles of study conduct, discussion among members of the clinical research community who conduct and manage studies is undertaken far less frequently.

The webinar session will explore the principles and challenges of ethical conduct in clinical research. Participants will learn about the formal mechanisms that are in place to guide researchers and protect the rights and well being of research subjects.

Areas Covered in the Seminar:

• Overview of the main ethical principles to be considered in the development and conduct of research to protect both the researcher and the subject.
• Responsibilities of
• Research sponsors
• Clinical researchers
• Institutional Review Boards (IRBs)
• Description of the standards and requirements of informed consent.
• The role of drug safety committees.
• Ethical and regulatory issues relating to
  • Tissue procurement
  • Stem cell research
• Organ transplantation

Who Will Benefit:

• Management teams in pharmaceutical development
• Personnel involved in clinical trials within the pharmaceutical and biotechnology industries
• Service providers supporting pharmaceutical and biotechnology industries