Skip to main content
NCBI home page
NIHPA Author Manuscripts logoLink to NIHPA Author Manuscripts
. Author manuscript; available in PMC: 2015 Feb 17.
Published in final edited form as: J Am Board Fam Med. 2011 Sep-Oct;24(5):605–609. doi: 10.3122/jabfm.2011.05.110034

A Novel Protocol for Streamlined IRB Review of PBRN Card Studies

Michelle D Hamilton 1, Philip A Cola 2, Joshua J Terchek 1, James J Werner 1, Kurt C Stange 1,3
PMCID: PMC4331110  NIHMSID: NIHMS600766  PMID: 21900445

Abstract

Purpose

The “card study,” in which clinicians record brief information about patient visits during usual clinical care, has long been a rapid method for conducting descriptive studies in practice-based research networks (PBRNs). Since an increasingly stringent regulatory environment has made conducting card studies difficult, we developed a streamlined method for obtaining card study Institutional Review Board (IRB) approval.

Methods

We developed a protocol for a study of the card study method, allowing new card study proposals of specific research questions to be submitted as addenda to the approved Card Study Protocol.

Results

Seven card studies were proposed and approved under the Card Study Protocol during the first year post implementation, contrasted with one card study proposed in the previous year. New card study ideas submitted as addenda to an approved protocol appeared to increase IRB comfort with the card study as a minimal risk method while reducing the hurdles to developing new study ideas.

Conclusions

A Card Study Protocol allowing new study questions to be submitted as addenda decreases time between idea generation and IRB approval. Shortened turn-around times may be useful for translating ideas into action while reducing regulatory burden.

Keywords: practice-based research network, practice-based research, card study, weekly return, HIPAA, primary care research, institutional review board

Introduction

The majority of research conducted in the United States is basic science investigation carried out in academic medical centers.1 Discoveries from this research can take years or decades to translate into clinical practice2 and are often not directly applicable to clinical practice, since research conducted in highly controlled settings differs greatly from community medical offices, the setting where most medical care is delivered to most patients.3, 4

In response to concerns about the relevance and slow translation into practice of most research, two threads of solutions have emerged. One thread is the practice-based research network (PBRN), in which clinicians on the front lines of health care band together to generate relevant new knowledge.5–12 Another more recent development is the NIH Clinical and Translational Science Award (CTSA),13–15 which aims to transform the way research is conducted and translated into practice and community applications.10, 13–15 Many CTSAs involve collaboration with PBRNs.16

The Card Study and the Research Regulatory Environment

A staple PBRN study method developed by the Ambulatory Sentinel Practice Network (ASPN) more than two decades ago is the weekly return card,17,18 or “card study.”19 In card studies a question about clinical practice is refined by the network into a short series of observational data elements that can be quickly recorded on a pocket-sized data collection card during the course of routine practice.19 Card studies are used by many PBRNs for rapid turnaround pilot studies and have made important contributions of new knowledge to the published literature.19–24 Example study cards are included in the online appendix and in Figure 1.

Figure 1.

Figure 1

Open in a new tab

Identification of developmental delays card study data collection card.

Institutional Review Boards (IRBs) must review research protocols to ensure that the research is ethical and protects the rights and welfare of human subject participants.25 However, IRB review can be a difficult process for practice-based researchers, as these researchers struggle to learn and apply unfamiliar rules regarding research.16 A rapid cycle between raising and answering PBRN questions facilitates ongoing clinician engagement. The wide variation in how IRBs review research, 26 including observational research studies,27 creates confusion and can create a bottleneck in the PBRN research process.28,29

The card study has traditionally been a low risk method that often received expedited IRB review. However, the research regulatory environment has become more stringent30 since the card study method was first developed, increasing barriers to conducting PBRN card studies. Additional privacy regulations imposed by the Health Insurance Portability and Accountability Act (HIPAA)31 along with increased regulatory scrutiny cause IRBs to raise their threshold of concern, even for minimal risk observational studies, such as card studies.32–37 This challenge causes researchers and clinicians to modify study ideas, or forgo certain study designs altogether when IRB submission is viewed as “not worth the effort.”37

Streamlining the process of clinical and translational research while protecting participants is a major focus of CTSAs, and many have dedicated shared resources to research regulation. In Cleveland, the Clinical & Translational Science Collaborative worked to engage the experience of both our PBRN and Regulatory Shared Resources to develop, implement and evaluate a novel approach to streamline the process of IRB approval for card studies. This paper describes that process, and includes an appendix that can be adapted by other PBRNs, CTSAs and IRBs seeking to meet the joint aims of protecting research participants, developing PBRNs, and speeding the translation of clinical research questions into investigation and dissemination.

Methods

Development of a Single, Streamlined IRB Protocol for Card Studies

Given this clinical and regulatory environment, the PBRN Shared Resource began to investigate facilitation of efficient turnaround of card studies. In brainstorming with the CTSA Head of Regulatory Knowledge, a study of the card study method was suggested as a possible method for allowing easy review of specific card studies asking new study questions.

The Card Study Protocol

A parent study of the card study method, the Card Study Protocol, was developed by the PBRN Shared Resource. The objective of the Card Study Protocol is to understand the uptake of different card studies. The Card Study Protocol outlines a set of requirements for low risk card studies, such as collection of de-identified data, and describes a standard set of procedures including recruitment methods, data collection, data management, and privacy procedures. Specific new card studies are then added as addenda to the parent protocol, so long as the individual card studies fit the standard criteria.

The Card Study Protocol modifies the traditional process of conducting card studies through generating and submitting a protocol and IRB submission that must undergo new protocol review for each individual card study. The Card Study Protocol combines multiple de-identified and/or limited dataset (minimal risk) card studies into one continuous protocol, under one principal investigator. As new card studies are proposed, the Card Study Protocol is amended to include additional research questions and the clinician or researcher who proposes the new card study idea is added as a co-investigator to the parent protocol.

Results

Combing all minimal risk card studies into one study of the card study method facilitated IRB review, resulting in increased efficiency as the IRB does not have to revisit the issue of what a card study is each time an additional question is submitted. In addition, review of amendments is a more efficient process focused almost exclusively on “changes” compared with new protocol reviews requiring review of all aspects of a proposed study, including methods previously approved under separate IRB applications. The complete Card Study Protocol is included in the online appendix for those who wish to use this as a model for their own IRB applications.

The Card Study Protocol was submitted for IRB review in March of 2009 and approved in June of 2009, a quicker process than usual, attributed to meetings with the IRB regarding the proposed Card Study Protocol prior to submission. Seven card studies were proposed and approved as part of the protocol during the first year of use, compared to the previous year where one card study was proposed but not submitted to the IRB or implemented. The most recent card study addendum received approval in seven calendar days, compared with similar risk studies not tied to the Card Study Protocol having previously taken nearly one year to receive approval.

In addition, we are finding that the threshold for proposing ideas is reduced for PBRN members as well as academic health center investigators because of a sense that new ideas have a chance to get into the field quickly, while enthusiasm from initial idea generation is fresh. Similarly, IRB staff and members report that seeing new study ideas as addenda to a protocol that has already been reviewed and judged to be minimal risk makes it easier to understand the context and minimal risk nature of new card studies. This familiarity with the method increases the likelihood of identifying and determining the particular risks and benefits of the new question, data, and study sample.

While card studies under the Card Study Protocol are limited to low risk studies involving de-identified data, a wide range of study types are still possible. Card studies approved under the Card Study Protocol have included exploring patient visits, such as developmental surveillance in well-child health visits, the frequency of patients presenting information gathered online before visits, patients mentioning direct to consumer advertising in visits, and patients raising dental concerns during medical visits. A survey study of clinicians has also been included, stretching the notion of cards to include large, two-sided data collection forms.

Discussion

Engaging clinicians, patients, and questions from real world practice are vital to efforts to increase the relevance and utility of clinical research. Card studies are a tried and true method for accomplishing this, with continued relevance to complement or be applied to electronic data collection.19,38 We have found the Card Study Protocol described here to be feasible and useful in educating IRBs and PBRNs about each other, while facilitating safe and timely clinical research.

This Card Study Protocol is not appropriate for greater than minimal risk studies that may use extensions of the card study method.19 Such studies should undergo individual review. Our evaluation of this protocol is informal and based on a single IRB and handful of local PBRNs over a short period. However, we believe that this early experience and the face value of the idea of studying the card study method through a single protocol where additional minimal risk study questions are introduced through addenda justify sharing this idea with the PBRN and research regulatory communities so that additional experience can be gained and immediate benefits we observed can be realized by others. Further research should examine the longer-term effects of the Card Study Protocol on the relationships between PBRN investigators, IRB staff and relevant IRB members, as well as on protocol review time, participant safety, and the generation of new knowledge relevant to clinical practice. This work embodies a goal of the CTSA, to reduce regulatory burden for investigators in order to promote the conduct and growth of clinical/translational research.13–15, 39

Supplementary Material

Appendix: PBRN Shared Resource Card Study Protocol
Change corresponding author

Acknowledgments

This publication was made possible by the Case Western Reserve University/Cleveland Clinic CTSA Grant Number UL1 RR024989 from the National Center for Research Resources (NCRR), a component of the National Institutes of Health and NIH roadmap for Medical Research and the Practice-Based Research Network Core facility of the Case Comprehensive Cancer Center (P30 CA43703). Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NCRR or NIH. Dr. Stange’s time was supported in part by a Clinical Research Professorship from the American Cancer Society.

Footnotes

There are no conflicting or competing interests.

References

  • 1.Green LA, Fryer GE, Jr, Yawn BP, Lanier D, Dovey SM. The ecology of medical care revisited. N Engl J Med. 2001;344(26):2021–2025. doi: 10.1056/NEJM200106283442611. [DOI] [PubMed] [Google Scholar]
  • 2.Balas EA, Boren SA. Managing clinical knowledge for health care improvement. In: Bemmel J, McCray AT, editors. Yearbook of Medical Informatics 2000: Patient-Centered Systems. Stuttgart, Germany: Schattauer Verlagsgesellschaft mbH; 2000. pp. 65–70. [PubMed] [Google Scholar]
  • 3.Nutting PA, Green LA. Practice-based research networks: reuniting practice and research around the problems most of the people have most of the time. J Fam Pract. 1994;38(4):335–336. [PubMed] [Google Scholar]
  • 4.Fortin M, Dionne J, Pinho G, Gignac J, Almirall J, Lapointe L. Randomized controlled trials: do they have external validity for patients with multiple comorbidities? Ann Fam Med. 2006 Mar-Apr;4(2):104–108. doi: 10.1370/afm.516. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 5.Nutting PA. Practice-based research: laboratories for outcomes and effectiveness research. Paper presented at: AHCPR Conference Proceedings. Primary Care Research: Theory and Methods; 1991; Washington, D.C. [Google Scholar]
  • 6.Nutting PA, Green LA. And the evidence continues to establish the feasibility of practice-based research. Fam Med. 1993;25(7):434–436. [PubMed] [Google Scholar]
  • 7.Nutting PA, Beasley JW, Werner JJ. Practice-based research networks answer primary care questions. JAMA. 1999;281(8):686–688. doi: 10.1001/jama.281.8.686. [DOI] [PubMed] [Google Scholar]
  • 8. [Accessed June 30, 2010.];AHRQ Practice-Based Research Networks (PBRNs) http://www.ahrq.gov/research/pbrn/pbrnfact.htm.
  • 9.Fagnan LJ, Handley MA, Rollins N, Mold J. Voices from left of the dial: reflections of practice-based researchers. J Am Board Fam Med. 2010;23(4):442–451. doi: 10.3122/jabfm.2010.04.090189. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 10.Westfall JM, Mold J, Fagnan L. Practice-based research--“Blue Highways” on the NIH roadmap. JAMA. 2007 Jan 24;297(4):403–406. doi: 10.1001/jama.297.4.403. [DOI] [PubMed] [Google Scholar]
  • 11.Green LA, Hames CG, Sr, Nutting PA. Potential of practice-based research networks: experiences from ASPN. Ambulatory Sentinel Practice Network. J Fam Pract. 1994;38(4):400–406. [PubMed] [Google Scholar]
  • 12.Green LA, Dovey SM. Practice based primary care research networks. They work and are ready for full development and support. BMJ. 2001;322(7286):567–568. doi: 10.1136/bmj.322.7286.567. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 13.Reis SE, Berglund L, Bernard GR, Califf RM, Fitzgerald GA, Johnson PC. Reengineering the national clinical and translational research enterprise: The strategic plan of the national clinical and translational science awards consortium. Acad Med. 2010;85 (3):463–469. doi: 10.1097/ACM.0b013e3181ccc877. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 14.Califf RM, Berglund L. Linking scientific discovery and better health for the nation: The first three years of the NIH’s Clinical and Translational Science Awards. Acad Med. 2010;85 (3):457–462. doi: 10.1097/ACM.0b013e3181ccb74d. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 15.Waldman SA, Terzic A. Clinical and translational science: From bench-bedside to global village. Clinical and Translational Science. 2010;3 (5):254–257. doi: 10.1111/j.1752-8062.2010.00227.x. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 16.Fagnan LJ, Davis M, Deyo RA, Werner JJ, Stange KC. Linking practice-based research networks and Clinical and Transitional Science Awards: new opportunities for community engagement by academic health centers. Acad Med. 2010;85(3):476–483. doi: 10.1097/ACM.0b013e3181cd2ed3. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 17.Green LA. The weekly return as a practical instrument for data collection in office based research. Fam Med. 1988;20(3):182–184. [PubMed] [Google Scholar]
  • 18.Green LA, Reed FM, Miller RS, Iverson DC. Verification of data reported by practices for a study of spontaneous abortion. Fam Med. 1988;20(3):189–191. [PubMed] [Google Scholar]
  • 19.Westfall JM, Zittleman LK, Staton EW, et al. Card studies for observational research in practice. Ann Fam Med. 2011;9(1):63–88. doi: 10.1370/afm.1199. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 20.Flocke SA, Orzano AJ, Selinger HA, et al. Does managed care restrictiveness affect the perceived quality of primary care? A report from ASPN. Ambulatory Sentinel Practice Network. J Fam Pract. 1999;48(10):762–768. [PubMed] [Google Scholar]
  • 21.Vinson DC, Manning BK, Galliher JM, Dickinson LM, Pace WD, Turner BJ. Alcohol and sleep problems in primary care patients: a report from the AAFP National Research Network. Ann Fam Med. 2010 Nov-Dec;8(6):484–492. doi: 10.1370/afm.1175. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 22.Vinson DC, Galliher JM, Reidinger C, Kappus JA. Comfortably engaging: which approach to alcohol screening should we use? Ann Fam Med. 2004 Sep-Oct;2(5):398–404. doi: 10.1370/afm.83. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 23.Froom J, Culpepper L, Grob P, et al. Diagnosis and antibiotic treatment of acute otitis media: report from International Primary Care Network. BMJ. 1990 Mar 3;300(6724):582–586. doi: 10.1136/bmj.300.6724.582. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 24.Froom J, Culpepper L, Green LA, et al. A cross-national study of acute otitis media: risk factors, severity, and treatment at initial visit. Report from the International Primary Care Network (IPCN) and the Ambulatory Sentinel Practice Network (ASPN) J Am Board Fam Pract. 2001 Nov-Dec;14(6):406–417. [PubMed] [Google Scholar]
  • 25.Protection of Human Subjects - Title 45, Code of Federal Regulations, Part 46 - Office for Human Research Protections (OHRP), HHS.
  • 26.Grady C. Do IRBs protect human research participants? JAMA. 2010;304 (10):1122–1123. doi: 10.1001/jama.2010.1304. [DOI] [PubMed] [Google Scholar]
  • 27.Green LA, Lowery JC, Kowalski CP, Wyszewianski L. Impact of institutional review board practice variation on observational health services research. Health Serv Res. 2006 Feb;41(1):214–230. doi: 10.1111/j.1475-6773.2005.00458.x. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 28.Pace WD, Staton EW, Holcomb S. Practice-Based Research Network Studies in the Age of HIPAA. Ann Fam Med. 2005 May 1;3 (Suppl 1):S38–45. doi: 10.1370/afm.301. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 29.Wolf LE, Croughan M, Lo B. The challenges of IRB review and human subjects protections in practice-based research. Med Care. 2002;40(6):521–529. doi: 10.1097/00005650-200206000-00009. [DOI] [PubMed] [Google Scholar]
  • 30.Baily MA. Harming through protection? N Engl J Med. 2008;358 (8):768–769. doi: 10.1056/NEJMp0800372. [DOI] [PubMed] [Google Scholar]
  • 31. [Accessed January 1, 2011, 2004.];HIPAA Privacy Rule: Information for Researchers. http://privacyruleandresearch.nih.gov/
  • 32.Reich Warren T., editor. Nuremberg code 1946. Encyclopedia of Bioethics. Vol. 4. The Free Press; New York: 1978. pp. 1764–1765. [Google Scholar]
  • 33.Shamoo AE. Future challenges to human subject protection. The Scientist. 2000;14 (13):35–37. [Google Scholar]
  • 34.Advisory Committee on Human Radiation Experiments (ACHRE) Final Report. Washington, D.C: U.S. Government Printing Office; Oct, 1995. [Google Scholar]
  • 35.Office of Protection from Research Risks. Letter of March 22, 1999, from OPRR to VA Greater Los Angeles Healthcare System. [Google Scholar]
  • 36.Thompson RE. Are human research subjects safe enough? (Ethical Aspects) Physician Executive. 2003 Jul; [PubMed] [Google Scholar]
  • 37.Pentecost MJ. HIPAA and the law of unintended consequences. J Am Coll Radiol. 2004;1(3):164–5. doi: 10.1016/j.jacr.2003.12.023. [DOI] [PubMed] [Google Scholar]
  • 38.Pace WD, Staton EW. Electronic data collection options for practice-based research networks. Ann Fam Med. 2005 May;3(Suppl 1):S21–29. doi: 10.1370/afm.270. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 39.Kim S, Ubel P, De Vries R. Pruning the regulatory tree. Nature. 2009;457:534–535. doi: 10.1038/457534a. [DOI] [PubMed] [Google Scholar]

Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

Appendix: PBRN Shared Resource Card Study Protocol
NIHMS600766-supplement-Appendix__PBRN_Shared_Resource_Card_Study_Protocol.doc (772KB, doc)
Change corresponding author
NIHMS600766-supplement-Change_corresponding_author.doc (27KB, doc)

RESOURCES