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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.
Updates have been made to the Objectivity in Research (Potential Conflict of Interest) policy, the Research Financial Conflicts of Interest Disclosure procedure, and the Research Financial Disclosure Statement form. The policy has been modified to include additional and updated definitions and sections. The procedure has been altered to explain the completion of the Research Financial Disclosure Statement form, which was updated to simplify the reporting.
In addition, please be aware that the PHARR process will be fully implemented on January 1, 2013. All new studies will be required to undergo this review process along with the Institutional Review Board (IRB) process. An additional form and associated attachments must be uploaded into the eIRB system at the time of initial submission in the General Comments section.
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 will be piloted on in-patient clinical trials beginning July 1, 2012 and will be 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.
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
- Palmetto Health Administrative Research Review Policy (This policy and all PGRs associated with it will be effective Jan. 1, 2013)
- Budget Feasibility Analysis PGR
- Clinical Trial Registration PGR
- Community Research Education
- Effort Reporting PGR
- Coverage Analysis Creation PGR
- Internal Budget Creation PGR
- Not Engaged in Human Subjects Research PGR
- Request for Research Billing PGR
- Research Audits PGR
- Research Registration PGR
- Research Support Consultation PGR
- Objectivity in Research (Potential Conflict of Interest) Policy
- Debarment and Suspension in Research Projects Policy
- Research Misconduct Policy
- Publications/Presentation of Research Results Policy
- Budget Feasibility Analysis Template
- Coverage Analysis Template
- Effort Report Form
- Impacted Services Agreement
- Not Engaged In Human Subjects Research Form
- Palmetto Health Administrative Research Review (PHARR) form
- Request for Research Billing
- Research Financial Disclosure Statement
- Research Registration form
Palmetto Health Administrative Research Review (PHARR) Process Training
There will be training sessions regarding the PHARR process at 9 Medical Park, Room 130 on the following dates/times:
- Wednesday, October 17th – 2 p.m. (View/download the PowerPoint slides from this session)
- Monday, November 12th – 1:30 p.m.
- Monday, December 17th – 10 a.m.
To register for a session, email Research-Assist@PalmettoHealth.org.
Online Training Modules
- Overview of Palmetto Health Administrative Research Review
- Coverage Analyses, Internal Budgets, and Budget Feasibility Analyses
Clinical Research Professionals (CRP) Meetings
Research Administration sponsors bi-monthly luncheon meetings for clinical research professionals that are designed to provide pertinent continuing education programs and networking opportunities for investigators and research staff.
For more information about these meetings, please call (803) 434-4751.
- January 10, 2013 – Shanna Perry Wright, Privacy Officer for Palmetto Health, will be presenting a program on the Health Insurance Portability and Accountability Act (HIPAA).
- March 14
- May 16
- July 11
- September 12
- November 14
Palmetto Health encourages investigator initiated research. Explanation and tips on the protocol development and Palmetto Health’s review process can be found in the Clinical Research Handbook. Please feel free to contact the individuals listed in the document for assistance throughout your research project.
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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