Policy Applicability
Research Policies outlines in this handbook are applicable to all paid or non-paid Investigators including pre- and post- doctoral trainees, students, fellows , resident, consultants and vendors conducting and participating in sponsored and non-sponsored research at Charleston Area Medical Center, Inc and CAMC Health Education and Research Institute, Inc. facility and to all research studies that are subject to any federal agency audit and that are being conducted under the auspices of the CAMC/WVU-Charleston Division Institutional Review Board for the protection of Human Subject (CAMC/WVU-Charleston IRB).
In addition, CAMC Medical Staff who also hold a faculty appointment to West Virginia University, are required as part of their faculty appointment, to comply with all regulatory requirements and institutional policies and guidelines regarding research. Any proposal to involve humans or related data in a research study must be submitted to the CAMC/WVU-Charleston IRB and related committees for approval for approval prior to data collection, subject/patient recruitment, data manipulation, analysis interpretation, publication and presentation of data. This requirement applies to all Medical Staff who hold clinical and adjunct WVU faculty appointments and who conduct research with private patients and submit data for publication and presentation. Publication of study data should indicate the Medical Staff member's appropriate title(s) and your joint affiliation with both West Virginia University Charleston Division and the appropriate entity within the CAMC system (i.e Charleston Area Medical Center, CAMC Institute, etc.).
IRB Policies
(All forms in PDF format)
Chapter 1: Research Policy Overview
Chapter 2: Governing Principles of the IRB
Chapter 3: Research Approval Process
Chapter 4: Research Non-compliance
Chapter 5: Research Appeal Procedures
Chapter 6: Advisory Review Panel
Chapter 7: IRB and ISRB By-Laws
Chapter 8: Components of Institutional Research Approval
Chapter 9: Types of Human Subjects Research Review
Chapter 10: Continuing Review of Active Research
Chapter 11: Reporting of Adverse Events
Chapter 12: Consent and Assent
Chapter 13: Changing a Protocol and/or Consent Form
Chapter 14: Recruitment and Selection of Human Subjects
Chapter 15: Special Population as Human Research Subjects
Chapter 16: Investigational Drugs
Chapter 17: Drug Handling for Human Research
Chapter 18: Use of Medical Devices for Human Research
Chapter 19: Emergency Use of an Investigational Drug or Device
Chapter 20: Financial Assessment and Cost Monitoring of CAMC Patients as Human Subjects
Chapter 21: Procedures for Purchasing FDA Approved Products
Chapter 22: IRB Certification for Sponsored Research to External Funding Agencies
Chapter 23: Disclosure of Financial Interests Related to Sponsored Research
Chapter 24: Research Ethics
Chapter 25: Guidelines for Conducting Performance Measurements Involving Human Subjects
Central Institutional Review Board (NCI Studies Only)
Deviation Reporting Form
- Protocol Deviation/Violation Reporting Procedure
HIPAA Policy
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Research Review & Administration 
