Ethics in Research – An Intensive Training Course for Ethics in Behavioral Health Research
Module 1 – Historical and Cultural Foundations of Ethics
Introduction: Paul Stiles
Presentation: King Davis
This module builds the conceptual basis of the course. It includes a discussion of historical events that have influenced current ethical guidelines and Federal regulations. The terms epistemology and ethics will be differentiated as research and ethics are placed in a historical, cultural and ecological framework. Finally, several examples will be used to illustrate how ethics is a vital concern to all research involving human subjects.
Module 2 – Informed Consent
Introduction: Paul Stiles
Presentation: Paul Stiles, Roger Boothroyd and Hana Osman
In this module a brief chronology of how the informed consent concept arose will be provided. Informed consent will be clearing defined by the three elements that comprise the process. Researchers must be certain that subjects are well informed about all aspects of the study. Subjects must also voluntarily agree to participate. And the competence of subjects must be determined prior to consent. Also, the international context of informed consent will be touched upon.
Module 3 - Inclusion
Introduction: Paul Stiles
Presentation: Patricia Robinson
Stakeholder Panel Members: Mary Evans, Barbara Blitz & King Davis
In this module, issues to consider when selecting participants for a study will be identified. Several reasons for the importance of inclusion will be discussed. Special groups such as women, children and minorities and the policies and regulations that apply to them will be presented.
This section also provides a stakeholder panel comprised of a federal reviewer, a consumer and a minority perspective on inclusion.
Module 4 – Privacy, Confidentiality and Duties to Third Parties
Introduction: Paul Stiles
Presentation: John Petrila, Roger Boothroyd, Steven Banks and John Pandiani
In this module, privacy and confidentiality will be conceptualized within the framework of researcher privilege. The affects of federal regulations and HIPAA on privacy and confidentiality will also be addressed. In addition, the balance between privacy and public accountability will be reviewed and several examples of this notion will be provided.
Module 5 – Risk & Dissemination
Introduction: Paul Stiles
Presentation: John Petrila, Steve Banks, John Pandiani & Roger Boothroyd
Study design certainly has an impact on the risk to human subjects. Here, Steve Banks will describe the methodologies used in two studies and why it put subjects at risk. Emotional risk or adverse reactions are also an element to consider in research design. The types of emotional risk and methods to prevent these occurrences are discussed here. Several vignettes will be presented to allow users to contemplate practical instances of legal risk. Finally, this module explains how to ethically report and disseminate findings.
Module 6 – Institutional Review Boards
Introduction: Paul Stiles
Presentation: Paul Stiles
This unit reviews institutional review board rules and procedures as well as the process for reviewing IRB documents. Discussion of IRB review will cover each of these categories: exempt, expedited and full review. How to handle IRB applications that include special populations, including children and prisoners will be explained. Adverse event reports and modifications are explained from the perspective of an IRB member. An online IRB opinion survey and its results are also included.