Carolinas HealthCare System (CHS) Institutional Review Board operates under the guidance of the Ethical Principles and Guidelines for the Protection of Human Subjects of Research. This report, commonly referred to as the Belmont Report, contains ethical principles regarding all research involving human subjects as identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. All sites within CHS are required by CHS to conform to ethical principles of the highest standard as may be determined by the Department of Health and Human Services (DHHS) or Office of Civil Rights (OCR).
Prior to the initiation of any human subject involvement in research within CHS, the IRB must review:
- Risks to subjects
- Anticipated benefits to subjects and others potentially affected by the research
- Specific process of informed consent to be employed
The CHS IRB also serves as the Health Insurance Portability and Accountability Act (HIPAA) Privacy Board for the review of clinical research based on federal HIPAA regulations.
The CHS IRB consists of two committees, each of which meets monthly. The committees are composed of highly qualified individuals with scientific and non-scientific backgrounds, educated in and dedicated to ensuring the protection of human subjects in the conduct of clinical trials.
The IRB is experienced in the review of:
- Food and Drug Administration (FDA) and Office for Human Research Protection (OHRP) Regulated Studies
- Phase I-IV drug studies in all therapeutic areas
- Device Studies
- Biologic Studies
- Observational/Registry Studies
- Social-Behavioral Studies
CHS IRB complies with all federal regulations pertaining to the protection of human research subjects. CHS has a Federal Wide Assurance (FWA) and each IRB is registered with the OHRP.
FWA: 00000387 IORG: 0000740
Committee A - IRB00001088
Committee B - IRB00001103
Since 2006 Carolinas HealthCare System has outsourced IRB review of Phase III/IV industry-sponsored Drug Trials research to Copernicus Group IRB, an independent IRB.
Since 2012, Carolinas HealthCare System has outsourced IRB review of Levine Cancer Institute Oncology Clinical Trials to Chesapeake IRB, an independent IRB.
Jane Flax, Staff Assistant
Institutional Review Board