Education, Residency Programs & Research  > Research Division  > Compliance 

Compliance

Contact Us:
803-434-2884
Research-Assist@PalmettoHealth.org

Research Compliance at Palmetto Health is an integral component to ensure the institution’s compliance with federal, state, and local regulations regarding research. This office coordinates the research contracting/subaward review within Palmetto Health, establishes appropriate research billing/coding mechanisms, provides biostatistical support for protocol development and data analysis, offers research grant support services, and administers periodic audits to those conducting research. In addition, Research Compliance administers the Palmetto Health Administrative Research Review (PHARR) process.

Palmetto Health Institutional Review Board and Research Compliance  announces a new process for scientific merit and scholarly validity review for retrospective chart reviews and qualitative research studies. Please refer to the attached FAQs and Attestation Form.

FAQs
Attestation Form


Palmetto Health Administrative Research Review (PHARR) Process
The Palmetto Health Administrative Research Review (PHARR) process provides a standard method for research compliance issues to be assessed. Items to be reviewed include conflict of interests, scientific validity of projects, research/subaward contracts, financial feasibility, etc. A full listing of the review areas can be found in Flowchart 1 below. This process will be integrated into the already established IRB review process Flowchart 2. An investigator submitting their study within the eIRB system will complete an additional form and attach the completed form and appropriate documentation within the eIRB system at the time of study submission (Flowchart 3).

The process was piloted on in-patient clinical trials beginning July 1, 2012 and is required for all studies beginning January 1, 2013. For further explanation, please review this letter from Dr. James Raymond, Senior Vice President and Chief Medical Officer.
Flowchart 1
Flowchart 2
Flowchart 3

An important component of the PHARR process is the review of potential conflicts of interest. This portion of the PHARR process will go into effect on August 1, 2012. The Research Financial Disclosure Statement forms from Investigators and any other person who contributes to the scientific development or execution of the project will be required with all new study submissions to the Institutional Review Board. This will ensure our compliance with the new federal regulation, 42 CFR 50 Subpart F–Promoting Objectivity in Research. The Objectivity of Research (Potential Conflict of Interest) policy and associated procedures are found in the Policy and PGR section below. You may also refer to the financial disclosure review process outlined in this flowchart.

The Scientific Review Committee review will continue throughout the piloting of the PHARR process since it was established by Palmetto Health prior to the initiation of the new review process. Please be aware that the review by the Scientific Review Committee (SRC) takes approximately 10 days per iteration. For example, the SRC may make recommendations for improving your protocol and require re-review of the study. Therefore, each review will take 10 days for a total of 20 days. The SRC review takes place prior to Institutional Review Board (IRB) review.

Due to the initiation of the new review process, the expected time for completion of the entire PHARR review (excluding the SRC review process) is unavailable. However, it is expected that reviews for studies that are categorized by the IRB as not human subjects, exempt, and expedited will align closely with the IRB review timing (approximately 14 days). The review time for studies reviewed by the full IRB board will vary depending on the complexity of the study. For example, an investigational device (IDE) study that is industry sponsored and involves Medicare patients will need to have a contract negotiated (Corporate Counsel Review), undergo review by Palmetto Health's Credentialing Committee (Medical Privileges Review), and obtain pre-approval by Palmetto GBA (Medicare Administrative Contractor Review). These processes may take approximately two to three months to complete. On the other hand, a relatively simple investigator-initiated study may only take approximately 30 days (similar to the IRB review time). Please note that a PHARR approval letter will not be issued until a Palmetto Health IRB approves the study.

Policies and PGRs

Forms/Templates

Education

Online Training Modules

Clinical Research Forum (CRF) Meetings
The Research Division hosts bi-monthly meetings for those interested in clinical research including investigators, research staff professionals, and IRB members. These meetings are designed to provide pertinent continuing education programs and networking opportunities for the attendees.

For more information about these meetings, please call (803) 296-2179.

Meeting Schedule

  • January 16, 2014: Clinical Data Warehouse available through Health Sciences South Carolina (HSSC)
  • March 13, 2014
  • May 1, 2014
  • July 17, 2014
  • September 11, 2014
  • November 13, 2014

Investigator-Initiated Research
Palmetto Health encourages investigator initiated research. Explanation and tips on the protocol development and Palmetto Health’s review process can be found in the Investigator's Guide. Please feel free to contact the individuals listed in the document for assistance throughout your research project.

Resident Research
Palmetto Health supports the scholarly efforts of our residents and fellows. The process for resident and fellow research is outlined in Flowchart 4. The Richland Memorial Hospital Research and Education Foundation recognizes the importance of resident involvement in research activities as part of a comprehensive graduate medical education experience. It therefore wishes to support meritorious, resident-initiated projects primarily in the areas of health care delivery and social science research and to a lesser extent in clinical and basic research through the Grant In Aid program. More information, including the clinical research handbook, call for proposals and necessary applications, can be found on the residency section of the Palmetto Health website at http://residency.palmettohealth.org/body.cfm?id=356

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