Accountability in Research Policies and Quality Assurance
ISSN: 0898-9621 (Print) 1545-5815 (Online) Journal homepage: http://www.tandfonline.com/loi/gacr20
Analysis of the Nature of IRB Contingencies Required for Informed Consent Document Approval R. Alexander Blackwood M.D., Ph.D., Ronald F. Maio D.O., M.S., Adam J. Mrdjenovich Ph.D., Terry M. VandenBosch Ph.D., R.N., C.I.P., C.C.R.P., Patricia S. Gordon M.B.A., B.S., Emily L. Shipman M.S.W. & Ted A. Hamilton M.S. To cite this article: R. Alexander Blackwood M.D., Ph.D., Ronald F. Maio D.O., M.S., Adam J. Mrdjenovich Ph.D., Terry M. VandenBosch Ph.D., R.N., C.I.P., C.C.R.P., Patricia S. Gordon M.B.A., B.S., Emily L. Shipman M.S.W. & Ted A. Hamilton M.S. (2015) Analysis of the Nature of IRB Contingencies Required for Informed Consent Document Approval, Accountability in Research, 22:4, 237-245, DOI: 10.1080/08989621.2014.956866 To link to this article: http://dx.doi.org/10.1080/08989621.2014.956866
Published online: 21 Apr 2015.
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Accountability in Research, 22:237–245, 2015 Copyright © Taylor & Francis Group, LLC ISSN: 0898-9621 print / 1545-5815 online DOI: 10.1080/08989621.2014.956866
Analysis of the Nature of IRB Contingencies Required for Informed Consent Document Approval R. Alexander Blackwood, M.D., Ph.D.,1 Ronald F. Maio, D.O., M.S.,1 Adam J. Mrdjenovich, Ph.D.,2 Terry M. VandenBosch, Ph.D., R.N., C.I.P., C.C.R.P.,1 Patricia S. Gordon, M.B.A., B.S.,1 Emily L. Shipman, M.S.W.,2 and Ted A. Hamilton, M.S.2 1 2
University of Michigan Medical School, Ann Arbor, Michigan, USA University of Michigan, Ann Arbor, Michigan, USA
The University of Michigan Human Research Protection Program formed a six-member committee to analyze the nature of Institutional Review Board (IRB) staff and board contingencies for the approval of informed consent documents. Of the 100 studies examined, 87% had one or more informed consent contingencies. “Omissions” in documentation (40%) and “better clarity” (24%) accounted for the majority, while “word– smithing” accounted for only 10%. This is one of the first studies to examine the nature of IRB contingencies as they relate to informed consent documents. Educational efforts targeting completeness in documentation and clarity on the part of study teams, and discouraging “word-smithing” on the part of IRBs, could reduce the number of informed consent contingencies and expedite the IRB approval process. Keywords: contingencies, informed consent, IRB
Institutional Review Boards (IRBs) are regulatory committees that are mandated to approve, oversee, and maintain ethical standards for human subjects research. IRBs apply specific regulatory criteria, which must be met before studies involving human subjects can begin (Department of Health and Human Services, 2009). The criteria for IRB approval include: (1) risks to subjects are minimized, (2) risks are reasonable in relation to anticipated benefits,
Address correspondence to R. Alexander Blackwood, M.D., Ph.D., Associate Professor of Pediatrics, University of Michigan Medical School, 1500 East Medical Center Drive, D5101 Medical Professional Building, SPC 5718, Ann Arbor, MI 48109-5718, USA. E-mail: [email protected]
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(3) subject selection is equitable, (4) voluntary informed consent is sought, and (5) informed consent is appropriately documented. Additionally, IRBs must ensure that eight basic elements of consent are included in the informed consent document and process (DHHS, 2009). For example, risks and benefits of the study as well as steps that will be taken to maintain the confidentiality of research data must be described in a way that is understandable to prospective subjects. IRBs generally review applications in two phases. First, IRB staff members screen the initial submission including the informed consent document. Second, the committee reviewer examines the submission and identifies contingencies that must be met before approval is issued. The Office of Human Research Protections (OHRP) understands the need for this process and uses the term “IRB approval with conditions” (contingencies) in its guidance (DHHS, 2010). Studies with contingencies that influence an IRB’s ability to judge whether regulatory criteria for approval are met are deferred and re-reviewed at a meeting of the convened board after contingencies have been completed. While the criteria for IRB approval and elements of informed consent are essential to ensure a rigorous review, there are controversial aspects of the review process such as the time investigators may spend revising written informed consent documents in response to contingencies (Abbott and Grady, 2011; Austin, 2006; Buchanan and Hvizdak, 2009; Dorsey et al., 2010; Emanuel et al., 2004; Federman et al., 2003; Geisser et al., 2011; Munung et al., 2011; While, 1996). An internal review of one IRB revealed that 92.3% of the studies were approved and 7.7% were deferred. Of the approved studies, approximately 70% contained contingencies (Chlebowski, 1984). Although the exact distribution of contingencies has not been well studied, a considerable proportion of overall contingencies involve changes to informed consent documents. A better understanding of the nature of these contingencies could help streamline the IRB review process, save resources, and enhance relationships between IRBs and investigators (Martín-Arribas et al., 2012). A well-prepared consent document that meets all criteria for IRB approval at initial submission can prevent delays in approval and, ultimately, better inform research subjects (AAHRPP, 2010; Bylerly, 2009). Despite internal analyses of the IRB review process conducted for quality assurances purposes with reference to turn-around-time, little information exists regarding the nature of IRB contingencies for informed consent documents. Thus, the purpose of this study was to examine the types of changes IRBs required in informed consent documents.
METHODS As part of a University of Michigan (UM) Human Research Protection Program initiative to improve the informed consent process, a six member committee was established to analyze consent form contingencies from studies recently
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Nature of IRB Consent Contingencies
approved by the UM Medical School IRB (IRBMED) and the Institutional Review Board for Health and Behavioral Sciences (IRB-HSBS) on the Ann Arbor Campus. IRBMED consists of five separate boards and reviews studies from 20 clinical departments and eight basic science departments within the medical school, as well as the Department of Medical Education, School of Dentistry, and the Unit for Laboratory Animal Medicine. IRB-HSBS reviews studies from (a) colleges of Architecture, Engineering; Literature, Science, and the Arts; Pharmacy, and Public Policy, (b) schools of Art and Design, Business, Education, Information, Kinesiology, Law, Music, Natural Resources, Nursing, Public Health, and Social Work, and (c) the Institute for Social Research and UM Transportation Research Institute. The aforementioned six member committee consisted of an IRBMED Vice-Chair and an IRB-HSBS board member, as well as administrative and regulatory staff from the UM Office of Human Research Compliance Review (OHRCR) and IRBMED. To conduct the consent contingency analysis, data were extracted from an electronic IRB application system for all studies (N = 157) that had been approved by IRBMED and IRB-HSBS from 1/3/2012 to 5/10/2012. Of the 157 studies, 57 (36%) had either a waiver of consent (52) or a waiver of documentation of consent (5). These studies were excluded from further consideration, leaving a sample of 100 studies. Contingencies from IRB staff review and IRB board review were identified yielding 497 contingencies, which were divided equally among the six committee members. Members were instructed to categorize their contingencies independently based on their respective IRB related experiences and expertise. When the committee reconvened, the results were compared, and a set of defined categories was developed. The committee drew from the contingency narrative (i.e., the language used by the reviewer to describe the contingency) to develop the coding categories. The categories were as follows: (1) lay language (contingency required investigator to reduce technical jargon so prospective subjects might better understand the consent document), (2) better clarity (the word “change” or “modify” appeared in the narrative), (3) word-smithing (contingency required investigator to use alternate wording to improve writing style while not changing content), (4) include omissions (the word “add,” “insert,” or “update” was used to describe the contingency), (5) correct errors (contingency required investigator to “delete” or “remove” language from the consent document), and (6) typographical or grammatical changes. Each committee member coded their contingencies again using the categories above, which were checked for reliability. Next, additional analyses were conducted to determine which section of the informed consent document those contingencies appeared in, yielding the following areas: (1) general study information, (2) participation, (3) risks and benefits, (4) compensation, (5) confidentiality, (6) signatures, and (7) other. Statistical analysis was performed using chi-square with significance set at p < .05.
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RESULTS There were a total of 497 contingencies identified in 87 (87%) of the 100 studies in the sample. Of the 497 contingencies, 415 (84%) were in IRBMED approved studies and 82 (16%) were in IRB-HSBS approved studies. IRBMED approved 85 of the 100 studies and identified contingencies in 75 (88%) while IRB-HSBS approved 15 studies and identified contingencies in 12 (80%) of them. “Include Omissions” was the largest contingency category for both IRBs accounting for 40% of the total contingencies. It comprised 37% for IRBMED (Fig. 1) and 54% for IRB-HSBS (p < .01) (Fig. 2). “Better Clarity” comprised 24% of the total contingencies, 25% for IRBMED but only 16% for IRB-HSBS (p < .09). “Correcting Errors” accounted for 17% of the total contingencies, 18% of IRBMED contingencies, and 12% of IRB-HSBS contingencies and “Word-smithing” comprised 11% of total contingencies and 11 and 12% of the categories for IRBMED and IRB-HSBS, respectively. The smallest categories for both IRBs were “Typos/Grammatical Errors” which was 4-5% and “Lay Language” at 3-4%. The next step was the additional analysis, of where, specifically, contingencies occurred in the consent document. For both IRB-HSBS and IRBMED, “Include Omissions,” “Correcting Errors,” and “Better Clarity” collectively
Typos/Gram. Changes, 5% (21)
Lay Language, 4% (15)
Word-smithing, 11% (44) Include Omissions, 37% (155) Correct Errors, 18% (75)
Better Clarity, 25% (105) Figure 1: IRBMED categorization of consent-related contingencies from 415 in 75 studies.
Nature of IRB Consent Contingencies Typos/Gramm. Errors, 4% (3)
Lay Language, 2% (2)
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Word-smithing, 12% (10)
Correcting Errors, 12% (10)
Include Omissions, 54% (44) Better Clarity, 16% (13) Figure 2: IRB-HSBS categorization of consent-related contingencies from 82 in 12 studies.
accounted for 81.7% and 80.7% of the contingencies, respectively. These categories can be considered substantive as opposed to editorial-type changes. From the additional analyses, the area of the consent document in which contingencies were identified most frequently was that the consent document needed to clarify participation (35.5%; Fig. 3); however, this comprised 38.8% of the contingencies requested by IRBMED vs. 19.4% of the contingencies requested by IRB-HSBS (p < .01). The second most common reason for a contingency was because either the risk or the potential benefit of being in the study was unclear (18.7%). There was no significant difference noted between IRB-HSBS (11.9%) and IRBMED (20.0%) (p < .17). While incomplete general study information comprised 13.4% of the overall contingencies, it was identified significantly more frequently with IRB-HSBS (31.3%) than with IRBMED (9.9%; p < .001; Fig. 3). Contingencies related to compensation, confidentiality, appropriate signatures, or miscellaneous (other) items each accounted for less than 10% of the contingencies, and there was no significant difference between IRBs. Contingencies related to informed consent documents are from two groups of reviewers—the IRB staff and IRB board. IRB staff members perform initial reviews interacting with the study teams as needed for necessary changes to be made. When that phase is completed, the project application is presented to the full board for review, frequently resulting in additional contingencies. Staff contingencies outnumbered board contingencies by almost 3 to 1 (Table 1)
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40%
Total
Percent of Total Contingencies
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p < .001 30%
IRBMED IRB-HSBS
20%
10%
0%
Figure 3: Additional analyses of contingencies within informed consent documents.
Table 1: Staff vs. Full Board Contingencies Staff Board Contingencies Contingencies Total n (%) n (%) Contingencies
IRB Type IRBMED IRB-HSBS
317 (76) 59 (72)
98 (24) 23 (28)
Total Studies
Avg. Consent Contingencies/ Study
85 15
4.9 5.5
415 82
Table 2: Nature of Contingencies: Substantive vs. Editorial
Contingency Type Substantive Editorial-type
IRBMED Staff n (%)
IRBMED Board n (%)
IRB-HSBS Staff n (%)
IRB-HSBS Board n (%)
252 (79) 65 (21)
83 (85) 15 (15)
48 (81) 11 (19)
19 (83) 4 (17)
with the average number of consent-related contingencies per study being approximately 5 for both IRBs; however, 79–85 of contingencies were substantive (“Include Omissions,” “Correcting Errors,” “better Clarity”) as opposed to 15–21% “editorial” (“Typos and Grammar,” “Lay Language,” “Word-smithing”) across both IRBs and between IRB staff review and full board review (Table 2).
Nature of IRB Consent Contingencies
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DISCUSSION Most contingencies (80–85%) involved substantive changes, whereas editorial changes comprised a relatively smaller proportion. Almost 20% of all contingencies required were related to adequately informing subjects about the risks or potential benefits of participation. Although the purpose was not to draw comparisons between the two IRBs (due to dissimilarities in the types of studies reviewed), secondary analysis demonstrated that the majority of contingencies required by IRBMED involved participation (e.g., subject information, voluntary nature of participation, alternative treatment options, etc.), while the majority of contingencies required by IRB-HSBS were related to deficiencies in general study information such as title, introduction, and PI contact information. We understand that care must be taken to not overinterpret these results as the sample sizes are relatively small—particularly with regard to IRB-HSBS studies. However, this is one of the few studies that actually examines how IRBs regulate informed consent documents.
BEST PRACTICES There were fewer “Lay Language” contingencies than anticipated at the onset of the project, which may suggest that Principal Investigators (PIs) are more adept at modifying technical jargon. Surprisingly, only 12% of the contingencies were deemed to be word-smithing, which, in the context of IRB review, is often used to denote arbitrary unnecessary changes in language. This could reflect a commitment by the IRB to focus on more substantive issues.
RESEARCH AGENDA Contrary to the presumption that IRB staff perform primarily editorial-type changes while the boards deal with substantive issues, the data seem to suggest that contingencies are distributed similarly between staff and board. Roughly 80–85% of the contingencies identified for this study were substantive in nature for both staff and board. Since the staff identifies 75% of contingencies prior to full board meetings, it may be that staff review enhances IRB board meeting time management as well as decreases IRB turn-around time. Future studies could examine qualitative differences that may exist between contingencies identified by IRB staff versus those identified by board members.
EDUCATIONAL IMPLICATIONS IRBs can use information about the nature of contingencies to train regulatory personnel and educate study teams. We hypothesize that “substantive errors”
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by study teams may be amenable to education programs targeting study teams, while “editorial” contingencies may require shifts in IRB personnel focus.
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ACKNOWLEDGMENTS We acknowledge the University of Michigan Office of the Vice-President for Research for their support of this project, especially Lois Brako, Assistant VicePresident for Research.
REFERENCES AAHRPP Advance: Enhancing Protection for Research Participants. (2010). From Accredited Organizations: Information for benchmarking now available. Available at https://admin.share.aahrpp.org/Website%20Documents/ AAHRPP_Advance_2010_Vol_07_%20No_03_Summer.PDF. Last accessed July 31, 2013. Abbott, L., and Grady, C. (2011). A systematic review of the empirical literature evaluating IRBs: What we know and what we still need to learn. Journal of Empirical Research on Human Research Ethics: JERHRE, 6(1): 3. Austin, D. H. (2006). Research and Development in the Pharmaceutical Industry. Washington, D.C.: Congress of the United States, Congressional Budget Office. Buchanan, E. A., and Hvizdak, E. E. (2009). Online survey tools: Ethical and methodological concerns of human research ethics committees. Journal of Empirical Research on Human Research Ethics: An International Journal, 4(2): 37–48. Byerly, W. G. (2009). Working with the institutional review board. American Journal of Health-System Pharmacy, 66(2): 176–184. Chlebowski, R. T. (1984). How many protocols are deferred? One IRB’s experience. IRB: A Review of Human Subjects Research, 6(5): 9–10. Department of Health and Human Services. (2010). Guidance on IRB Approval of Research with Conditions. Available at http://www.hhs.gov/ohrp/policy/ conditionalapproval2010.html. Last accessed July 31, 2013. Department of Health and Human Services, Office for Human Research Protections. (2009). 45 CRF 46, Subpart E. Available at http://www.hhs.gov/ohrp/ humansubjects/guidance/45cfr46.html#46. Last accessed July 31, 2013. Dorsey, E. R., de Roulet, J., Thompson, J. P., Reminick, J. I., Thai, A., White-Stellato, Z., and Moses III, H. (2010). Funding of U.S. biomedical research, 2003–2008. JAMA: The Journal of the American Medical Association, 303(2): 137–143. Emanuel, E. J., Wood, A., Fleischman, A., Bowen, A., Getz, K. A., Grady, C., and Eckenwiler, L. (2004). Oversight of human participants research: Identifying problems to evaluate reform proposals. Annals of Internal Medicine, 141(4): 282–291. Federman, D. D., Hanna, K. E., and Rodriguez, L. L. (2003). Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: National Academies Press.
Nature of IRB Consent Contingencies Geisser, M. E., Alschuler, K. N., and Hutchinson, R. (2011). A Delphi study to establish important aspects of ethics review. Journal of Empirical Research on Human Research Ethics, 6(1): 21.
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Martín-Arribas, M. C., Rodríguez-Lozano, I., and Arias-Díaz, J. (2012). Ethical review of research protocols: Experience of a Research Ethics committee. Revista Española de Cardiología (English Edition), 65(6): 525–529. Munung, N. S., Che, C. P., Ouwe-Missi-Oukem-Boyer, O., and Tangwa, G. B. (2011). How often are ethics approval and informed consent reported in publications on health research in Cameroon? A five-year review. Journal of Empirical Research on Human Research Ethics: An International Journal, 6(3): 93–97. While, A. E. (1996). Research ethics committees at work: The experience of one multilocation study. Journal of Medical Ethics, 22(6): 352–355.
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ISSN: 0898-9621 (Print) 1545-5815 (Online) Journal homepage: http://www.tandfonline.com/loi/gacr20
Analysis of the Nature of IRB Contingencies Required for Informed Consent Document Approval R. Alexander Blackwood M.D., Ph.D., Ronald F. Maio D.O., M.S., Adam J. Mrdjenovich Ph.D., Terry M. VandenBosch Ph.D., R.N., C.I.P., C.C.R.P., Patricia S. Gordon M.B.A., B.S., Emily L. Shipman M.S.W. & Ted A. Hamilton M.S. To cite this article: R. Alexander Blackwood M.D., Ph.D., Ronald F. Maio D.O., M.S., Adam J. Mrdjenovich Ph.D., Terry M. VandenBosch Ph.D., R.N., C.I.P., C.C.R.P., Patricia S. Gordon M.B.A., B.S., Emily L. Shipman M.S.W. & Ted A. Hamilton M.S. (2015) Analysis of the Nature of IRB Contingencies Required for Informed Consent Document Approval, Accountability in Research, 22:4, 237-245, DOI: 10.1080/08989621.2014.956866 To link to this article: http://dx.doi.org/10.1080/08989621.2014.956866
Published online: 21 Apr 2015.
Submit your article to this journal
Article views: 61
View related articles
View Crossmark data
Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=gacr20 Download by: [NUS National University of Singapore]
Date: 06 November 2015, At: 09:17
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Accountability in Research, 22:237–245, 2015 Copyright © Taylor & Francis Group, LLC ISSN: 0898-9621 print / 1545-5815 online DOI: 10.1080/08989621.2014.956866
Analysis of the Nature of IRB Contingencies Required for Informed Consent Document Approval R. Alexander Blackwood, M.D., Ph.D.,1 Ronald F. Maio, D.O., M.S.,1 Adam J. Mrdjenovich, Ph.D.,2 Terry M. VandenBosch, Ph.D., R.N., C.I.P., C.C.R.P.,1 Patricia S. Gordon, M.B.A., B.S.,1 Emily L. Shipman, M.S.W.,2 and Ted A. Hamilton, M.S.2 1 2
University of Michigan Medical School, Ann Arbor, Michigan, USA University of Michigan, Ann Arbor, Michigan, USA
The University of Michigan Human Research Protection Program formed a six-member committee to analyze the nature of Institutional Review Board (IRB) staff and board contingencies for the approval of informed consent documents. Of the 100 studies examined, 87% had one or more informed consent contingencies. “Omissions” in documentation (40%) and “better clarity” (24%) accounted for the majority, while “word– smithing” accounted for only 10%. This is one of the first studies to examine the nature of IRB contingencies as they relate to informed consent documents. Educational efforts targeting completeness in documentation and clarity on the part of study teams, and discouraging “word-smithing” on the part of IRBs, could reduce the number of informed consent contingencies and expedite the IRB approval process. Keywords: contingencies, informed consent, IRB
Institutional Review Boards (IRBs) are regulatory committees that are mandated to approve, oversee, and maintain ethical standards for human subjects research. IRBs apply specific regulatory criteria, which must be met before studies involving human subjects can begin (Department of Health and Human Services, 2009). The criteria for IRB approval include: (1) risks to subjects are minimized, (2) risks are reasonable in relation to anticipated benefits,
Address correspondence to R. Alexander Blackwood, M.D., Ph.D., Associate Professor of Pediatrics, University of Michigan Medical School, 1500 East Medical Center Drive, D5101 Medical Professional Building, SPC 5718, Ann Arbor, MI 48109-5718, USA. E-mail: [email protected]
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(3) subject selection is equitable, (4) voluntary informed consent is sought, and (5) informed consent is appropriately documented. Additionally, IRBs must ensure that eight basic elements of consent are included in the informed consent document and process (DHHS, 2009). For example, risks and benefits of the study as well as steps that will be taken to maintain the confidentiality of research data must be described in a way that is understandable to prospective subjects. IRBs generally review applications in two phases. First, IRB staff members screen the initial submission including the informed consent document. Second, the committee reviewer examines the submission and identifies contingencies that must be met before approval is issued. The Office of Human Research Protections (OHRP) understands the need for this process and uses the term “IRB approval with conditions” (contingencies) in its guidance (DHHS, 2010). Studies with contingencies that influence an IRB’s ability to judge whether regulatory criteria for approval are met are deferred and re-reviewed at a meeting of the convened board after contingencies have been completed. While the criteria for IRB approval and elements of informed consent are essential to ensure a rigorous review, there are controversial aspects of the review process such as the time investigators may spend revising written informed consent documents in response to contingencies (Abbott and Grady, 2011; Austin, 2006; Buchanan and Hvizdak, 2009; Dorsey et al., 2010; Emanuel et al., 2004; Federman et al., 2003; Geisser et al., 2011; Munung et al., 2011; While, 1996). An internal review of one IRB revealed that 92.3% of the studies were approved and 7.7% were deferred. Of the approved studies, approximately 70% contained contingencies (Chlebowski, 1984). Although the exact distribution of contingencies has not been well studied, a considerable proportion of overall contingencies involve changes to informed consent documents. A better understanding of the nature of these contingencies could help streamline the IRB review process, save resources, and enhance relationships between IRBs and investigators (Martín-Arribas et al., 2012). A well-prepared consent document that meets all criteria for IRB approval at initial submission can prevent delays in approval and, ultimately, better inform research subjects (AAHRPP, 2010; Bylerly, 2009). Despite internal analyses of the IRB review process conducted for quality assurances purposes with reference to turn-around-time, little information exists regarding the nature of IRB contingencies for informed consent documents. Thus, the purpose of this study was to examine the types of changes IRBs required in informed consent documents.
METHODS As part of a University of Michigan (UM) Human Research Protection Program initiative to improve the informed consent process, a six member committee was established to analyze consent form contingencies from studies recently
Downloaded by [NUS National University of Singapore] at 09:17 06 November 2015
Nature of IRB Consent Contingencies
approved by the UM Medical School IRB (IRBMED) and the Institutional Review Board for Health and Behavioral Sciences (IRB-HSBS) on the Ann Arbor Campus. IRBMED consists of five separate boards and reviews studies from 20 clinical departments and eight basic science departments within the medical school, as well as the Department of Medical Education, School of Dentistry, and the Unit for Laboratory Animal Medicine. IRB-HSBS reviews studies from (a) colleges of Architecture, Engineering; Literature, Science, and the Arts; Pharmacy, and Public Policy, (b) schools of Art and Design, Business, Education, Information, Kinesiology, Law, Music, Natural Resources, Nursing, Public Health, and Social Work, and (c) the Institute for Social Research and UM Transportation Research Institute. The aforementioned six member committee consisted of an IRBMED Vice-Chair and an IRB-HSBS board member, as well as administrative and regulatory staff from the UM Office of Human Research Compliance Review (OHRCR) and IRBMED. To conduct the consent contingency analysis, data were extracted from an electronic IRB application system for all studies (N = 157) that had been approved by IRBMED and IRB-HSBS from 1/3/2012 to 5/10/2012. Of the 157 studies, 57 (36%) had either a waiver of consent (52) or a waiver of documentation of consent (5). These studies were excluded from further consideration, leaving a sample of 100 studies. Contingencies from IRB staff review and IRB board review were identified yielding 497 contingencies, which were divided equally among the six committee members. Members were instructed to categorize their contingencies independently based on their respective IRB related experiences and expertise. When the committee reconvened, the results were compared, and a set of defined categories was developed. The committee drew from the contingency narrative (i.e., the language used by the reviewer to describe the contingency) to develop the coding categories. The categories were as follows: (1) lay language (contingency required investigator to reduce technical jargon so prospective subjects might better understand the consent document), (2) better clarity (the word “change” or “modify” appeared in the narrative), (3) word-smithing (contingency required investigator to use alternate wording to improve writing style while not changing content), (4) include omissions (the word “add,” “insert,” or “update” was used to describe the contingency), (5) correct errors (contingency required investigator to “delete” or “remove” language from the consent document), and (6) typographical or grammatical changes. Each committee member coded their contingencies again using the categories above, which were checked for reliability. Next, additional analyses were conducted to determine which section of the informed consent document those contingencies appeared in, yielding the following areas: (1) general study information, (2) participation, (3) risks and benefits, (4) compensation, (5) confidentiality, (6) signatures, and (7) other. Statistical analysis was performed using chi-square with significance set at p < .05.
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RESULTS There were a total of 497 contingencies identified in 87 (87%) of the 100 studies in the sample. Of the 497 contingencies, 415 (84%) were in IRBMED approved studies and 82 (16%) were in IRB-HSBS approved studies. IRBMED approved 85 of the 100 studies and identified contingencies in 75 (88%) while IRB-HSBS approved 15 studies and identified contingencies in 12 (80%) of them. “Include Omissions” was the largest contingency category for both IRBs accounting for 40% of the total contingencies. It comprised 37% for IRBMED (Fig. 1) and 54% for IRB-HSBS (p < .01) (Fig. 2). “Better Clarity” comprised 24% of the total contingencies, 25% for IRBMED but only 16% for IRB-HSBS (p < .09). “Correcting Errors” accounted for 17% of the total contingencies, 18% of IRBMED contingencies, and 12% of IRB-HSBS contingencies and “Word-smithing” comprised 11% of total contingencies and 11 and 12% of the categories for IRBMED and IRB-HSBS, respectively. The smallest categories for both IRBs were “Typos/Grammatical Errors” which was 4-5% and “Lay Language” at 3-4%. The next step was the additional analysis, of where, specifically, contingencies occurred in the consent document. For both IRB-HSBS and IRBMED, “Include Omissions,” “Correcting Errors,” and “Better Clarity” collectively
Typos/Gram. Changes, 5% (21)
Lay Language, 4% (15)
Word-smithing, 11% (44) Include Omissions, 37% (155) Correct Errors, 18% (75)
Better Clarity, 25% (105) Figure 1: IRBMED categorization of consent-related contingencies from 415 in 75 studies.
Nature of IRB Consent Contingencies Typos/Gramm. Errors, 4% (3)
Lay Language, 2% (2)
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Word-smithing, 12% (10)
Correcting Errors, 12% (10)
Include Omissions, 54% (44) Better Clarity, 16% (13) Figure 2: IRB-HSBS categorization of consent-related contingencies from 82 in 12 studies.
accounted for 81.7% and 80.7% of the contingencies, respectively. These categories can be considered substantive as opposed to editorial-type changes. From the additional analyses, the area of the consent document in which contingencies were identified most frequently was that the consent document needed to clarify participation (35.5%; Fig. 3); however, this comprised 38.8% of the contingencies requested by IRBMED vs. 19.4% of the contingencies requested by IRB-HSBS (p < .01). The second most common reason for a contingency was because either the risk or the potential benefit of being in the study was unclear (18.7%). There was no significant difference noted between IRB-HSBS (11.9%) and IRBMED (20.0%) (p < .17). While incomplete general study information comprised 13.4% of the overall contingencies, it was identified significantly more frequently with IRB-HSBS (31.3%) than with IRBMED (9.9%; p < .001; Fig. 3). Contingencies related to compensation, confidentiality, appropriate signatures, or miscellaneous (other) items each accounted for less than 10% of the contingencies, and there was no significant difference between IRBs. Contingencies related to informed consent documents are from two groups of reviewers—the IRB staff and IRB board. IRB staff members perform initial reviews interacting with the study teams as needed for necessary changes to be made. When that phase is completed, the project application is presented to the full board for review, frequently resulting in additional contingencies. Staff contingencies outnumbered board contingencies by almost 3 to 1 (Table 1)
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40%
Total
Percent of Total Contingencies
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p < .001 30%
IRBMED IRB-HSBS
20%
10%
0%
Figure 3: Additional analyses of contingencies within informed consent documents.
Table 1: Staff vs. Full Board Contingencies Staff Board Contingencies Contingencies Total n (%) n (%) Contingencies
IRB Type IRBMED IRB-HSBS
317 (76) 59 (72)
98 (24) 23 (28)
Total Studies
Avg. Consent Contingencies/ Study
85 15
4.9 5.5
415 82
Table 2: Nature of Contingencies: Substantive vs. Editorial
Contingency Type Substantive Editorial-type
IRBMED Staff n (%)
IRBMED Board n (%)
IRB-HSBS Staff n (%)
IRB-HSBS Board n (%)
252 (79) 65 (21)
83 (85) 15 (15)
48 (81) 11 (19)
19 (83) 4 (17)
with the average number of consent-related contingencies per study being approximately 5 for both IRBs; however, 79–85 of contingencies were substantive (“Include Omissions,” “Correcting Errors,” “better Clarity”) as opposed to 15–21% “editorial” (“Typos and Grammar,” “Lay Language,” “Word-smithing”) across both IRBs and between IRB staff review and full board review (Table 2).
Nature of IRB Consent Contingencies
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DISCUSSION Most contingencies (80–85%) involved substantive changes, whereas editorial changes comprised a relatively smaller proportion. Almost 20% of all contingencies required were related to adequately informing subjects about the risks or potential benefits of participation. Although the purpose was not to draw comparisons between the two IRBs (due to dissimilarities in the types of studies reviewed), secondary analysis demonstrated that the majority of contingencies required by IRBMED involved participation (e.g., subject information, voluntary nature of participation, alternative treatment options, etc.), while the majority of contingencies required by IRB-HSBS were related to deficiencies in general study information such as title, introduction, and PI contact information. We understand that care must be taken to not overinterpret these results as the sample sizes are relatively small—particularly with regard to IRB-HSBS studies. However, this is one of the few studies that actually examines how IRBs regulate informed consent documents.
BEST PRACTICES There were fewer “Lay Language” contingencies than anticipated at the onset of the project, which may suggest that Principal Investigators (PIs) are more adept at modifying technical jargon. Surprisingly, only 12% of the contingencies were deemed to be word-smithing, which, in the context of IRB review, is often used to denote arbitrary unnecessary changes in language. This could reflect a commitment by the IRB to focus on more substantive issues.
RESEARCH AGENDA Contrary to the presumption that IRB staff perform primarily editorial-type changes while the boards deal with substantive issues, the data seem to suggest that contingencies are distributed similarly between staff and board. Roughly 80–85% of the contingencies identified for this study were substantive in nature for both staff and board. Since the staff identifies 75% of contingencies prior to full board meetings, it may be that staff review enhances IRB board meeting time management as well as decreases IRB turn-around time. Future studies could examine qualitative differences that may exist between contingencies identified by IRB staff versus those identified by board members.
EDUCATIONAL IMPLICATIONS IRBs can use information about the nature of contingencies to train regulatory personnel and educate study teams. We hypothesize that “substantive errors”
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by study teams may be amenable to education programs targeting study teams, while “editorial” contingencies may require shifts in IRB personnel focus.
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ACKNOWLEDGMENTS We acknowledge the University of Michigan Office of the Vice-President for Research for their support of this project, especially Lois Brako, Assistant VicePresident for Research.
REFERENCES AAHRPP Advance: Enhancing Protection for Research Participants. (2010). From Accredited Organizations: Information for benchmarking now available. Available at https://admin.share.aahrpp.org/Website%20Documents/ AAHRPP_Advance_2010_Vol_07_%20No_03_Summer.PDF. Last accessed July 31, 2013. Abbott, L., and Grady, C. (2011). A systematic review of the empirical literature evaluating IRBs: What we know and what we still need to learn. Journal of Empirical Research on Human Research Ethics: JERHRE, 6(1): 3. Austin, D. H. (2006). Research and Development in the Pharmaceutical Industry. Washington, D.C.: Congress of the United States, Congressional Budget Office. Buchanan, E. A., and Hvizdak, E. E. (2009). Online survey tools: Ethical and methodological concerns of human research ethics committees. Journal of Empirical Research on Human Research Ethics: An International Journal, 4(2): 37–48. Byerly, W. G. (2009). Working with the institutional review board. American Journal of Health-System Pharmacy, 66(2): 176–184. Chlebowski, R. T. (1984). How many protocols are deferred? One IRB’s experience. IRB: A Review of Human Subjects Research, 6(5): 9–10. Department of Health and Human Services. (2010). Guidance on IRB Approval of Research with Conditions. Available at http://www.hhs.gov/ohrp/policy/ conditionalapproval2010.html. Last accessed July 31, 2013. Department of Health and Human Services, Office for Human Research Protections. (2009). 45 CRF 46, Subpart E. Available at http://www.hhs.gov/ohrp/ humansubjects/guidance/45cfr46.html#46. Last accessed July 31, 2013. Dorsey, E. R., de Roulet, J., Thompson, J. P., Reminick, J. I., Thai, A., White-Stellato, Z., and Moses III, H. (2010). Funding of U.S. biomedical research, 2003–2008. JAMA: The Journal of the American Medical Association, 303(2): 137–143. Emanuel, E. J., Wood, A., Fleischman, A., Bowen, A., Getz, K. A., Grady, C., and Eckenwiler, L. (2004). Oversight of human participants research: Identifying problems to evaluate reform proposals. Annals of Internal Medicine, 141(4): 282–291. Federman, D. D., Hanna, K. E., and Rodriguez, L. L. (2003). Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: National Academies Press.
Nature of IRB Consent Contingencies Geisser, M. E., Alschuler, K. N., and Hutchinson, R. (2011). A Delphi study to establish important aspects of ethics review. Journal of Empirical Research on Human Research Ethics, 6(1): 21.
Downloaded by [NUS National University of Singapore] at 09:17 06 November 2015
Martín-Arribas, M. C., Rodríguez-Lozano, I., and Arias-Díaz, J. (2012). Ethical review of research protocols: Experience of a Research Ethics committee. Revista Española de Cardiología (English Edition), 65(6): 525–529. Munung, N. S., Che, C. P., Ouwe-Missi-Oukem-Boyer, O., and Tangwa, G. B. (2011). How often are ethics approval and informed consent reported in publications on health research in Cameroon? A five-year review. Journal of Empirical Research on Human Research Ethics: An International Journal, 6(3): 93–97. While, A. E. (1996). Research ethics committees at work: The experience of one multilocation study. Journal of Medical Ethics, 22(6): 352–355.
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