Table 1.

PBRN Resource Center Listserv Discussion

Inquirer Name	PBRN	Question
Jessica Behm Date of inquiry: 10/30/2007	NORTHSTAR	We are a new PBRN with a focus on improving rural healthcare in North Dakota and adjacent areas. We are in the process of starting our first network research project, and we've encountered some issues with the Institutional Review Board (IRB). Because we are housed at the University of North Dakota, all of the IRB issues will be handled through the university's board. In accordance with the Federal guidelines, the university requires every investigator and research personnel to go through training on human subjects protection. They provide online educational modules, but they take approximately 2–3 hours to complete. We are concerned that many of our network members will not complete the training due to the length of the modules and time constraints.
		I am curious to hear about some of the practices your networks have employed in terms of IRB training. Have any of you been successful in creating and using some type of modified IRB training? Any suggestions you have would be greatly appreciated.
Respondent Name		Response
Geoffrey Goldsmith	OzarkNet	We faced the same issue here, and our work-around has been (whenever possible) to get our study classified as exempt by virtue of it being a quality improvement project instead of research. This also eliminates the need for informed consent for the patients. We pay the site staff and physicians to complete the IRB training.
Anne King	Oregon Rural Practice-based Research Network (ORPRN)	ORPRN is similar in that we use practice facilitators. Most of the time in our studies, the clinicians and staff are the ones being studied. In other words, their activities are considered “usual care,” and we are measuring what happens. In those cases, our IRB doesn't consider them “engaged in research” and so does not require the training. If they are doing activities that are considered research (such as obtaining consent and doing something not considered usual care), then we do have to have them do the training. They hate it, and we try to make it explicit in the contract with them that it's required. We've also started paying them for that hour or so that it takes to complete it.
Rowena J. Dolor	Duke Primary Care Research Consortium (PCRC)	We ran into a similar issue with the National Children's Study (NCS) Pilot. Although the consent was obtained by our research staff, the community providers had to undergo training because they were collecting study data (ie, filling out the NCS physical exam form).
		We had the providers do the minimum number of modules required by the IRB (2 online modules). We also gave them instructions on how to access the Website, and create a login and password. We printed out all the slides and accompanying text so they could refer to these documents when they had to take the online quiz.
Lee Green	Great lakes Into research Network (GRIN)	Most of our practices in our state-wide network are covered under IRBs other than that of the University of Michigan, which does not have standing to mandate its own human subjects protection course. The staff at each practice must adhere to their own IRB's requirements to satisfy the federal regulation. We've strongly encouraged practices without an existing IRB affiliation to complete a Federalwide Assurance (FWA) (http://www.hhs.gov/ohrp/humansubjects/assurance/filasurt.htm) with CRIRB, the Community Research IRB at Michigan State University. (GRIN is jointly sponsored by Michigan State University and University of Michigan.)
		We have found it acceptable at most places for us to put on a human subjects protection workshop at sites. We go out and bring lunch, and run through the important information with them. (It probably helps that I'm on the IRB here, so I have some credibility with the various other IRBs in teaching our on-site mini-courses.)
Debbie Graham	American Academy of Family Physicians National Research Network (AAFP NRN)	The AAFP IRB requires that researchers complete the online CITI (Collaborative Institutional Training Initiative) training. We have worked with the IRB to put together a set of CITI modules that are of importance to our practices that are participating in PBRN studies. We have come to an agreement that there are 5 modules (including the introduction) that are of most importance to the researchers at the practice level. These are the modules that the individuals at the practice level who participate in our research studies are required to complete. It generally takes 1–2 hours to complete these modules.
		In addition, with the help of one of our investigators, we have put together a slide presentation that presents all of the information in these 5 modules. The practice can make this presentation in their office, or we can provide paper copies of the presentation if they prefer to use paper. After going through the slide presentation, individuals then complete the CITI quizzes for the appropriate modules and print out their certificates. We are happy to make this slide presentation available to PBRNs that are interested.
Paul Smith	Wisconsin Research and Education Network (WREN)	WREN is blessed with a very understanding IRB. We are only required to have human subjects training certification for clinicians or staff who do the subject enrollment for projects that require informed consent. At the moment, they only have to do it once, although there may be a recertification process in the near future.
		We also invited a representative from our IRB to conduct training using their slide presentation for a mass training at one of our annual meetings. This was a great way to train a large group at once and might be a way to jump-start your new network.
		The NIH (National Institutes of Health) has online human subjects training available, but I do not know how long it takes. Surely your IRB would accept the NIH training.
Barry Saver	UMass Family Medicine PBRN	Don't be too sure about the IRB honoring the NIH training. At my previous institution, they did NOT accept the NIH training, only the University of Miami one. [Editor's note: The University of Miami developed the CITI HSP training modules.] Good enough for NIH, not good enough for the IRB? Go figure.
Zsolt Nagykaldi	Oklahoma Physicians Research/Resource Network (OKPRN)	But please, make sure that yourIRB accepts these solutions. Some unfortunately will not accept “outside” resources and curricula as valid for any study run by university personnel (faculty) and/or supported by the university in any way.
Paul Smith	WREN	Zolt makes a key point. The most important thing to do is to sit down face-to-face with your IRB leaders and talk through what practice-based research is, what sort of minimal risk and exempt projects you plan to do in the future, and how your staff will support the practices and ensure protocol fidelity.
		PBRNs are a foreign concept to many IRBs, and educating them is a key to moving forward.
Chris Landon	Pediatric Diagnostic Center PBRN (PDCPBRN)	It is hard to read this message and the replies on how to get around physicians and nurses learning about ethical research. We have presented it as an opportunity, not a burden.
Jo Demarest	Advanced Practice Registered Nurse Research Network (APRNet)	Documentation of human subjects training is a requirement for membership into APRNet, and, to participate in our research, HIPAA training is also required. It might at first seem as if the training takes too much time, but to conduct studies ethically is most important of all. Everyone who takes the training learns something that they did not know before. The last thing a network needs is for the ethics of its research to be questioned. This is probably not the response you wanted, but in my opinion your network members will just need to bite the bullet and do it.
Cynthia L. Price	Southern Illinois Practice Research Organization (SIPRO)	Southern Illinois University School of Medicine (SIU) located in Springfield, IL, is the academic partner for the Southern Illinois Practice Research Organization (SIPRO), the community health center-based research network of the Southern Illinois Healthcare Foundation (SIHF). The Springfield Committee for Research Involving Human Subjects, SIU's IRB, requires research personnel to take human subjects protection training through CITI. This training consists of 17 educational modules.
		Our first SIPRO study will probably have a principal investigator (PI) from SIU with a co-PI from SIHF. Research staff that are considered “key personnel” will be required to take SIU's 17 training modules. When that time comes, I will offer some incentives for providers and staff to complete the training and suggest that the training be done over days or weeks (2–3 modules at a time).
Pete Smith	Building Investigative practices for Better Health Outcomes (BIGHORN)/ State Networks of Colorado Ambulatory Practices and Partners (SNOCAP)	I would also encourage you to go to the DHHS website and review the relevant guiding documents: http://www.hhs.gov/ohrp/policy/index.html. Most IRBs don't understand what we do, or how what we do fits into the existing Federal directives. We made a point of knowing the regulations inside and out, and therefore were able to negotiate a win-win with our IRB. For example, they were most concerned about our unaffiliated practices (not covered under the regional university-affiliated IRB or under any other local IRBs such as other hospitals). We have since joined our network to our regional not-for-profit AHEC (Area Health Education Center), which is the entity the IRB now deals with—our university rules prohibit us from starting our own 503(c)(3) non-profit organization. The AHEC (under our guidance) ensures compliance and assumes the risk so the IRB doesn't have to worry about problems if they get audited. We still need to train our practices, but as long as AHEC takes on the liability, the IRB doesn't much care how it is done. We use the AAFP National Research Network (NRN) CITI modules. We have it whittled down to about 45 minutes, and either do it at the practices over lunch or at our annual PBRN convocation.
Debbie Graham	AAFP NRN	Every IRB has its own specific requirements—some require NIH training, some require CITI, and some require a specific training put together by the institution. Sometimes you can work with your IRB to modify the requirement. We found that it is critical to create a working relationship with your IRB, keep the lines of communications open, and provide information on PBRN research so that they understand what you do.
Margaret Love	Kentucky Ambulatory Network (KAN)	I heartily echo the advice others have already provided. At KAN, we've tried to develop a collaborative relationship over time with the Univ. of Kentucky Office of Research Integrity and the Institutional Review Board (IRB)—educating/orienting the IRB leaders about PBRN research and demonstrating that we value the IRB principles, concerns, and oversight.
		At KAN's first member meeting in 2000, all attendees participated in a session jointly led by the Chair of the University of Kentucky's IRB and the Director of KAN (Dr. Kevin Pearce). Although the message from the IRB was a little scary sometimes (eg, how much trouble everyone could get into), the forum showed the IRB early on that we (KAN) respected its principles and processes, and we began to expose our community-based PBRN members to the IRB review concepts. That first year, Kevin Pearce and I also met with the IRB Chair to discuss how human subjects protection (HSP) processes and review might play out in KAN. I was astonished to hear potential scenarios of independent IRB review or charging a fee to non-university researchers for IRB review. However, the meeting helped me understand the IRB's perspective and, again, showed the IRB that we wanted to do this right. Later, when we had extramural support for a PBRN consultation, we hosted a workshop about IRB/HSP issues and practice-based research. The consultant was an expert in IRB and compliance issues for clinical trials at another university. Not only did KAN's faculty and staff attend, but other university researchers and a variety of our university's IRB leaders and staff members participated. It was a great opportunity to involve lots of perspectives in an open discussion about what could work and why and how. I credit our Network Director with the foresight to seek out the IRB.
		The education and orientation process did not stop there. Many KAN protocols were discussed extensively with the IRB staff, including its most senior staff members. Although it is best if conversations with IRB staff take place before we submit an IRB application, we have sometimes challenged IRB reviewers’ concerns. Also, KAN's research leadership (eg, Senior Research Coordinator, Mary Barron) reviews any KAN-related IRB submissions to make sure principal investigators do not unwittingly set precedents we do not want to live with down the road.
		So far, our community-based member clinicians have rarely had to complete HSP training in order to participate in KAN studies. At this point, no HSP training would be acceptable to our university other than the same lengthy training required of full-time university “key personnel” (Dunn & Chadwick book with on-line testing or CITI on-line modules and testing). So, our KAN research staff does the research, especially the consenting of patients into studies. Having a clinician refer patients to us for possible recruitment and consent is not the same as having the clinician recruit and consent the patient into the study. Also, when possible, KAN clinicians, not patients, are the subjects of the study.
		IRB review and HSP education requirements for PBRNs vary widely across institutions; they are challenging everywhere, but not insurmountable. Our Wisconsin colleague in PBRN research, Dr. John Beasley, has often said that IRB issues are an irresistible discussion topic. I think your query is proving him right!
Zsolt Nagykaldi	OKPRN	In summary, if I may, most networks would probably need a tiered system where central research personnel (eg, academic faculty, research assistance, practice facilitators, etc.) would have to eat the whole meal in order to qualify, whereas “community participants” would have the option of eating only the course(s) that match the activities they are actually involved with, which is mostly on-site patient recruitment. A reasonable clinician and staff remuneration for taking the 45 minutes module could be built into the grant proposal. This change alone could set all PBRNs in the country on a straight path and would actually improve compliance and cooperation between IRBs and PBRN researchers.
		Second, PBRN leader investigators should work with their IRBs on a practice-based research HSP curriculum, separate from the general basic science/clinical trials curriculum. Our HSP training, for example, includes an hour just on drug trials, which none of us (and none of the overwhelming majority of PBRNs) do. On the other hand, a body of key information pertaining to practice-based research is completely missing from the curriculum. So, we are teaching the wrong things to the wrong audience. This doesn't sound like improving research ethics. If that, too, could be changed (ie, setting up separate modules for basic, Phase I translational, and Phase II-III translational investigators), we could be the happiest bunch.
Pat Fontaine	Minnesota Academy of Family Physicians Research Network (MAFPRN)	Excellent summary of a good discussion. I think you point the way for future directions, Zsolt. The IRB training topic is obviously a good one for the Resource Center to develop, perhaps as a peer learning group session.