Grady Ponce de Leon Center, Research Oversight Committee Submission Form

This form should be submitted at the same time or before Emory IRB submission and must be submitted before GROC application. The Committee meets on the second Friday of each month. Review will occur within 30 days of submission. If urgent approval is absolutely required, please email idpresearch@emory.edu with justification for the urgent request.

Guidelines for Clinical Research at the Ponce de Leon Center

The primary mission at Ponce is patient care. Our research program is a vital part of this mission, as it informs our efforts to offer state-of-the-art HIV treatment. To ensure that our research efforts add value to the health service environment and the patient experience of care, the Ponce de Leon Center has established Guidelines for conducting clinical research. These Guidelines are designed to promote efficient coordination between our patient care mission and our research programs by specifying both the process through which approval for research at the Ponce de Leon Center occurs and general policies for the conduct of clinical research at Ponce. The intent is to ensure that our research activities work synergistically with the clinical service mission to maximize the health and well being of our patients. Adherence to the Guidelines is overseen by the Ponce de Leon Center Research Steering Committee, whose primary function is to assist investigators in determining the feasibility of their projects and to help facilitate the seamless implementation of research at the Ponce de Leon Center. The Guidelines for Clinical Research at Ponce are as follows:

General guidelines for research at Ponce:
1. Research teams must ensure that their study protocols are implemented such that they do not interfere with patient clinic appointments or any aspect of routine healthcare. Study visits are never a substitute for patient care visits.
2. Federal and state regulations prohibit the use of clinical resources for the conduct of research (funded or unfunded). Investigators must therefore ensure that only personnel and resources covered by sponsored funds be utilized for the conduct of their research projects at the Ponce de Leon Center. Employees and clinical staff supported by clinical funding sources (e.g., the Ryan White Program) cannot participate in research related activities. Also note that supplies purchased by the Ponce de Leon Center for patient care cannot be used for research.
3. As a result of our growing clinical and research activities, operational space has become a challenge at the Ponce de Leon Center. While efforts are being made to address this challenge, investigators are strongly encouraged to consider alternative sites during the planning stages of their projects (especially for large projects that have significant space requirements), and to design their projects to minimize space need at Ponce.
4. The Ponce de Leon Center has a unique patient population that includes several vulnerable groups for whom the potential for over-recruitment for research is of paramount concern. Investigators must, therefore, demonstrate that there is no significant overlap between their studies and other on-going studies at Ponce in order to ensure that no undue research burden is placed on these vulnerable populations (e.g. children, adolescents, persons with co-occurring substance use disorders, patients with HCV or HBV co-infection, patients with cancer).
Ponce de Leon Center Research Approval
1. All research conducted at Ponce and/or that requires the enrollment of Ponce patients and/or access to medical records from Ponce visits, must receive approval by the Ponce de Leon Center Research Steering Committee prior to Grady Research Oversight Committee (GROC) submission sign off. The approval process requires submission of a Ponce de Leon Research Steering Committee review form. This form should be submitted as early as possible in the development of research proposals that will involve Ponce patients and resources, though no later than Emory Institutional Review Board (IRB) submission.
2. Outside agencies (e.g., CDC, Health Departments) performing medical record reviews and other related activities that involve access to Ponce patients and their medical information are required to obtain approval by the Ponce de Leon Center Research Steering Committee if their projects require an IRB review.
3. All intramural and extramural grant applications that propose to enroll Ponce patients, and/or involve access to their medical records, or other relevant information, require approval by the Ponce de Leon Center Research Steering Committee. Upon approval, an application support letter will be issued by Dr. Wendy Armstrong.
4. Review will occur within 30 days of submission. Expedited approval may be considered in special situations and for studies limited to medical record review only. If urgent approval is absolutely required, the investigator must email the Ponce de Leon Center Research Steering Committee Chair, Dr. Igho Ofotokun (iofotok@emory.edu) with justification for the urgent request.
5. Once approved, research should be re-submitted for approval if there is a significant modification in the study design or implementation, such as modifications impacting sample size, resulting in new study procedures, changes in recruitment methods, etc.
6. Research that is ongoing at Ponce de Leon Center as of January 1, 2016, will not require committee review unless significant modifications as listed above occur. However, a submission form is still required for each study for tracking purposes.