Protecting welfare in human subjects research.

AAHRPP Full AccreditationThe Palmetto Health Institutional Review Board (IRB) was established in accordance with federal regulations to protect the rights and welfare of all human subjects who volunteer to participate in research studies conducted under the auspices of Palmetto Health.

The IRB oversees compliance with federal, state and organizational guidelines relating to research with human subjects. We are responsible for reviewing all research involving human subjects, ensuring equitable selection of research subjects, ensuring that potential research-related risks are minimized and that there is full disclosure so volunteers can make an informed decision to participate.


We have two institutional review boards at Palmetto Health:

  • Palmetto Health IRB #1 – meets the first Friday of each month
  • Palmetto Health IRB #2 – meets the third Friday of each month


Contact us at 803-434-2884 or Research-Assist@PalmettoHealth.org
 


IRB Process

Not Human Subject Research reviews and Exempt Human Subject Research reviews are generally completed within 14 days. Expedited reviews are generally completed within 14 days. Full committee reviews are generally completed within 30 days.

The timeframes listed above exclude the time required for Scientific Review Committee approval and the time a study is returned to the investigator for changes requested by the IRB staff or reviewer.


Investigator Manual
Investigator Manual


IRB Policies & Procedures
Policies and PGRs


eIRB Videos


IRB Checklists/Worksheets


IRB Forms/Templates


Regulatory Authority

Palmetto Health is a registered IRB Organization with the Office for Human Research Protections (OHRP), (IORG0000425).

Palmetto Health IRB #1 is registered with OHRP, (IRB00000715).

Palmetto Health IRB #2 is registered with OHRP, (IRB00000915).

Palmetto Health has an approved Federalwide Assurance (FWA) with OHRP, (FWA00000128).

Palmetto Health IRBs are organized and operate in compliance with FDA regulations 21 CFR Parts 50 and 56, DHHS regulations 45 CFR Part 46, and the International Conference on Harmonization (ICH) and The Common Rule as appropriate. The IRBs also function as the Privacy Board in compliance with portions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA Privacy Rule) that apply to research, as described in 45 CFR Parts 160 and 164. PH IRB utilizes a 21 CFR Part 11 compliant, electronic IRB platform (eIRB) for protocol submissions.


Membership

The IRBs are composed of persons who are sufficiently qualified, through experience and expertise, to review the research presented to them. Each board includes at least one member whose primary concerns are in nonscientific areas and one member who is not affiliated with the institution, or part ofthe immediate family of a person who is affiliated with the institution.


Online Training Modules

Humanitarian Use Devices


Resources and Links

 

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