Q: What is the ePCRN?
A: The ePCRN is an electronic tool provided by the Federation of Practice-Based Research Networks (FPBRN) to member Primary Care Practice-Based Research Networks (PBRNs). The hardware was established with funding from the Institute of Practice-Based Research (IPBR) at the University of Minnesota through the National Institutes of Health under Contract # HHSN268200425212C, "Re-engineering the Clinical Research Enterprise."

Q: How much time is involved in signing up and participating in the ePCRN?
A: To become an ePCRN user, you will complete a 5-10 minute registration process called the Connectivity Demonstration. You will receive a "fob," which is a keychain-sized device with a random number display that allows secure login. After that, users' time commitment will vary according to their interest in the ePCRN, from minimal participation to high involvement. Physicians who wish to participate in research studies can choose which studies they are involved in (e.g., by study type or content area).

Q: Will it cost money to become a part of the ePCRN?
A: No. The ePCRN is free of charge.

Q: Does my clinic need to be using an electronic health record to become a part of the ePCRN?
A: No. Minimum technical requirements include: 1) Windows 2000 or newer operating system, and 2) access to the Internet.

Q: Am I expected to design a research study?
A: No. Participating in the ePCRN will facilitate your involvement in clinical studies, including randomized clinical trials (RCTs). If you are a principal investigator (PI) for a study and would like to use the ePCRN in enrolling patients across multiple sites, you may contact the IPBR director to learn about the application process.

Q: What if I do not feel qualified to do research? Is there training available?
A: The amount of training required will depend upon your level of research involvement and will vary from minimal (e.g., basic training in Human Subjects protection and informed consent processes) to more sophisticated requirements. Almost all training is available on the Internet, or can be facilitated by your local PBRN.

Q: How will I be compensated for my time while participating in the ePCRN?
A: There is no compensation for registering with the ePCRN. Compensation is generally available for participation in research studies. Some studies allocate a lump-sum for participation, while others allocate compensation according to the total number of patients enrolled or hours logged spent on the study. Depending on your clinic arrangements, reimbursement is sometimes given to the clinic and sometimes given to the PBRN member.

Q: Will the ePCRN or local network send research assistants to clinics to help with the studies?
A: Different studies require different levels of support, and so the nature and amount of research assistance will vary. Many PBRNs now provide some form of practice enhancement associate to assist with particular studies, or as a benefit of belonging to the PBRN.

Q: What if I change my mind about participating sometime in the future?
A: You are free to discontinue your participation in the ePCRN at anytime. Our staff will work with you in returning your fob device and removing your name from the registration.

Q: Are other providers in my clinic expected to participate in the ePCRN if I sign up? For example, if I am on vacation and one of my colleagues who is covering for me is alerted that a patient is eligible for participation in a research study - is this colleague expected to discuss the study and obtain informed consent?
A: No. The only person who can cover for an ePCRN registered member is another ePCRN registered member with appropriate training and their own ePCRN fob.

Q: Is it appropriate for resident physicians to become ePCRN Users?
A: Decisions regarding residents' involvement are up to your local PBRN.

Q: Will the ePCRN help me collect data regarding the quality of care performed at my practice?
A: The FPBRN is developing software with performance standards, and will begin by working with 100 clinics nationwide to establish patient data in data warehouses at the clinics. If your clinic is interested, please contact your PBRN director. The software for measuring performance standards will eventually be available to everyone.

Q: Will this compromise the confidentiality of my patients' data?
A: No. The only data transferred from the clinic to the ePCRN will be RCT data from patients who have given their informed consent. Procedures for data transfer in the ePCRN follow all HIPAA regulations and standard requirements for secure computers that store or access private data (see http://www1.umn.edu/oit/security/privatedata.html for more information).

Q: Which Human Subjects committee must approve my participation in a research study?
A: This depends on your organizational structure. If an organization takes part in research, then it will need to obtain an FWA (Federal Wide Assurance) number. Every FWA is associated with at least one institutional review board (IRB), who reviews research to ensure participants' safety. If your organization has an FWA, then you will generally be required to seek written approval from that IRB. If your organization does not have an IRB, you can sign - as an individual interested in research - a federally standardized "independent investigator agreement" with any IRB who will then serve as your IRB. Organizations cannot sign independent investigator agreements and must obtain an FWA. This process can be facilitated by your PBRN.

Q: Who takes care of local IRB applications and processes for attaining approval to proceed with a research study?
A: Local IRBs generally require that applications be from someone covered by the IRB. Many PBRNs (or research studies) will facilitate completion of the necessary forms, but final submission will generally require your signature .