CAMC/WVU Research Policy Handbook

Section 1.0 Research Policy Overview

1.1 Research Policy Overview

1.2 Governing Principles of the IRB

1.3 The Research Approval Process

1.4 Noncompliance

1.5 Appeal Procedures

1.6 Advisory Review Panel

1.7 By-Laws for the Charleston Area Medical Center/West Virginia University Institutional Review Board

Section 2.0 Institutional Review and Approval for Human Subjects Research

2.1 The Components of Institutional Research Approval

2.2 Types of Review

2.3 Continuing Review

2.4 Reporting of Adverse Advents to the IRB

2.5 Consent and Assent

2.6 Changing a protocol and/or the consent form

2.7 Recruitment and Selection of Subjects

2.8 Special populations as subjects of research

2.9 Investigational Drugs

2.10 Drug Handling Procedures for Research Studies and the Role of the CAMC pharmacy

2.11 Use of Medical Devices for Research purposes

2.12 Emergency use of an investigational drug or device

2.13 Financial assessment and cost monitoring of CAMC patients enrolled in a research study

2.14 Procedures for Purchasing FDA Approved Products

2.15 IRB Certification for sponsored research to external funding agencies

Section 3.0 Research Ethics

3.1 Disclosure of financial interests related to sponsored research

3.2 Policy on Research Ethics

3.3 Guidelines for conducting performance measurement activities involving human subjects