Librarian IRB Participation

Emmett Lombard*

While Institutional Review Boards (IRBs) are crucial for research integrity, the amount of librarian membership is limited. This study examines IRB rosters and membership criteria to describe librarian involvement. Surveys of IRB members assessed their views on the value of librarian membership and importance of literature review evaluation within IRB process. Results indicate low librarian representation and a de-emphasis on literature review importance to human subject research. These findings highlight need for increased librarian IRB involvement—including promoting importance of high-quality literature reviews—to further ensure human subject safety.

Introduction

College and university Institutional Review Boards (IRBs) review research involving human subjects to protect them from physical or psychological harm. IRBs strive to ensure that research is ethically acceptable, complies with institutional, state, and federal regulations, and promotes voluntary participation. Although research is arguably the main institutional construct with which academic librarians are associated, there seems to be relatively modest IRB involvement on parts of librarians (Harnett & Cantwell-Jurkovic, 2015).

Granted, IRBs commonly review research involving the health sciences (e.g., clinical trials, behavioral studies, health care delivery). Given this focus on human subjects, the IRB’s main concern is primary research methods, rather than secondary research (i.e., a librarian’s purview); this secondary research is often not even considered, let alone required. Therefore, it is unsurprising that librarians would not often be associated with IRBs. However, if IRBs are to best ensure human safety and institutional integrity, then perhaps 1) more attention to secondary research should be facilitated, and 2) librarians—arguably the colleagues with most secondary research tool expertise— should be involved in that facilitation. After all, how can a study be safe for humans if the researcher has not saturated the high-quality literature that addresses the study’s topic? This study aims to better understand and describe the reality of librarian IRB involvement in United States higher education along with IRB perceptions of secondary research as related.

Literature Review

Searching DE “Institutional review boards” in Library, Information Science & Technology Abstracts returned 64 results. Research methodology, including experimental design, was a major theme (Folkers & Bateman-House, 2018; Gray, 1975; Hoogland, 2023; Mehta, 2021; Rincon-Gonzalez et al., 2023). Folkers and Bateman-House (2018) assessed what they determined was lack of IRB scrutiny in terms of expanded online information access, while Hoogland (2023) outlined components of research protocol and preprotocol submission training. These studies emphasized IRB accountability and membership, though they did not solely focus on librarianship. Their focus on accountability and membership suggests potential relevance for considering how librarian involvement, especially regarding privacy concerns, might improve IRB operation.

Several authors also considered privacy in relation to human safety (Arango et al., 2016; Hoogland, 2023; Jungkunz, 2021; Park et al., 2018; Shen et al., 2022; Travis & Ramirez, 2020). Travis and Ramirez (2020) discussed knowledge aspects of Big Data and IRB implications for ethical usage. Shen et al. (2022) provided an “ethics checklist” that focused on procedural safeguards, including concerns about privacy in artificial intelligence (AI) contexts; their research indicated that existing guidance and laws are insufficient for privacy assurance. This growing focus on privacy within digital environments raises questions about areas where librarian expertise might expand IRB frames of reference, given librarianship’s history of privacy advocacy (e.g., ALA’s battles against the Patriot Act).

The vast majority of IRB literature focused on health care research, particularly primary research directly involving human subjects/patients. However, Jungkunz et al. (2021) focused more on secondary research as they deemed current literature and research insufficient concerning risk assessment. As a byproduct, they indirectly illuminated the importance of secondary research to the IRB process: methodology is crucial to research and to the literature review. Jungkunz et al. noted that identifying best methods (and perhaps just as importantly, methods that failed) lessens risk to human subjects. This emphasis on secondary research importance is relevant to this study as it suggests that the general, secondary research expertise competent librarians possess may be valuable to an IRB, especially at institutions that only support one board and have (by necessity) disciplinary-eclectic rosters.

More directly related to librarianship, Delgado and Greg (2020) viewed IRB and librarians in terms of information literacy instruction; they presented a law school library case study in which IRB orientation was part of mandatory training. Izenstark et al. (2021) discussed the librarian role as researcher. Although IRB was not their sole focus, its importance to the research process was acknowledged, as was the idea that librarians, especially library students, should become well acquainted with IRBs to conduct ethical human subject research and/or to be taken seriously as researchers.

Whereas Izenstark et al. (2021) discussed IRB value to librarians, some studies illustrated librarian value to IRBs. Farrell’s (2014) study showed how librarians can help integrate assessment, research, and IRB operations to create “research cultures.” Harvey (2003) envisioned how medical librarians can work within IRBs as advisors, or even full board members. Cantwell and Van Kampen-Breit (2015) identified three typical librarian roles in the IRB process (when librarians were involved): lead investigator, IRB reviewer, ex-officio member. They found librarians with full IRB appointments to be least common. However, Sullo and Gomes (2016) discussed how librarians were expanding their roles in academic health sciences, including the IRB. Lacroix (2021) also reviewed literature about Canadian librarians on IRBs; again, the context was usually health sciences. It is also worth noting that Harvey’s vision of medical librarians as full board members represent a notable perspective considering the traditionally perceived roles of librarians in health care settings as mostly supportive, rather than equal, participants.

Arguably the most in-depth work on the librarian/IRB connection was Harnett’s and Cantwell-Jurkovic’s (2015) Finding Your Seat at the Table: Roles for Librarians on Institutional Regulatory Boards and Committees. They found that IRB service is uncommon for librarians despite their own individual institutional research. They attribute this dearth to, among other things, lack of “scientific” background (despite many boards requiring at least one nonscientific member, and library science itself being considered a social science) and supervisor concerns about librarian workloads. Despite these challenges, their book shares experiences of librarians who did substantive IRB work.

The literature well informed this study. Most of it was published within the last 20 years, indicating increasing librarian interest in IRBs. Building on ideas raised from this literature, the purpose of this study was to expand on previous findings, including revisiting the state of librarian IRB membership as well as examining IRB investment in literature reviews as an application quality criterion.

Methodology

A convenience sample was obtained by reviewing Google search results sequentially until 100 American colleges and universities were identified that posted their IRB rosters on their public websites. This sampling approach was necessitated by the variable availability of IRB information across institutional websites.

The string (college OR university) AND (irb OR “institutional review board”) AND (roster OR membership) site:edu was searched in Google. The purpose of this search was to sample college and university websites to identify how many had librarians on their IRBs. Not all colleges and universities had their IRB rosters publicly available on their websites (which raises a question for a potential future study: should they?) Some institutions had multiple rosters to accommodate different boards.

Using the same Google search, IRB pages were then sampled to identify IRB membership criteria. This method’s purpose was to identify if schools encouraged, discouraged, or were unintentional regarding IRB librarian membership. Not all schools made their IRB membership criteria publicly available. Some schools posted both membership criteria and roster(s); some just roster(s); some just criteria; some neither roster(s) nor criteria. Therefore, the 100-school roster and 100-school criteria samples are not identical in terms of schools included.

A five-question survey was also created and emailed to 385 IRB members for additional insight into this study’s interests. Survey questions were designed to capture both current practices regarding librarian IRB membership and respondents’ perceptions of librarian value in the IRB process. Questions employed a combination of yes/no responses and 5-point Likert scales to enable both descriptive analysis and comparison of importance ratings. Questions were:

1. Do you see value in having a librarian IRB member(s): Yes or No?
2. Do you have at least one librarian IRB member: Yes or No?
3. Does your IRB(s) evaluate literature review quality of a research application: Yes or No?
4. If literature review quality is one of your IRB(s) evaluation criteria, then what is its importance to application approval (one being lowest importance, five highest)?
5. If literature review quality is one of your IRB(s) evaluation criteria, then how important do you think librarian input is/would be regarding it (one lowest, five highest)?
6. Comment(s):

Results

Of the 100-school sample that posted IRB rosters, 15 identified librarians as IRB members; none had more than one librarian. Comments are provided as written without edit. Of the 100-school sample that posted IRB membership criteria, the following criteria proved particularly noteworthy, if not completely relevant, to this study’s main purposes:

• Fifty required at least one IRB member to have “scientific” background and at least one to have “nonscientific” background; one required that a “scientist” be a member and did not require a nonscientist; one required a “nonscientist” member and did not require a scientist.
• Forty-four did not state membership criteria; five stated that this was intentional.
• Seventeen required that IRB membership be demographically diverse; sex and race were the most common demographics specified.
• Three universities required that IRB membership include representation from all their colleges; none required library representation.
• Five required that more than one “profession” or “discipline” be represented.
• Two required that faculty, staff, students, and community each have members.
• Two required an “ethicist.”
• One required a “children’s expert.”
• Zero had any specifications regarding librarians.

Twenty-nine IRB members responded to the five-question email survey (7.5% response).

Additional comments to survey question 1 included:

• “I could see value in this. Honestly, I had never given it any thought. However, our librarians do conduct research, though it is rarely of the human subject type. Historically, our IRB tries to recruit members from departments and programs that regularly send protocols to us.”
• “Yes, because we must have a nonscientist to make quorum, and just because it is a very good member with attention to detail and fast turnaround, not because of their specific training background.”
• “Not at my institution. I run the IRB essentially alone; while we have a committee, I do all the work.”
• “Not particularly (i.e., no general value added in terms or research, content and/or admin knowledge/experience but certainly no detriment).”
• “Yes. Anyone willing to sit on the IRB and offer their input is valuable to the committee.”
• “Not especially.”
• “Yes, they could serve as IRB community members.”
• “No, but I honestly have not thought about it.”
• “I don’t know. I’m not familiar with what kind of research librarians do with human subjects.”

Additional comments to survey question number three included:

• “We do not. We see that as overreach.”
• “No, as we get proposals before research starts, generally speaking.”
• “Not really.”
• “Not explicitly.”
• “Yes, there has to be enough evidence that the research is not going to waste subjects’ time.”
• “Not really, although a literature review is included in the IRB proposal protocol. The literature generally only comes into play when determining discipline specific standards for intervention best practices, potential harm to the subject, etc.”
• “Yes, but it is not the highest of importance. Ethical treatment of participants is.”
• “Scientific evaluation is mostly the responsibility of the applicant’s department vetting prior to submission; reviewers often supplement this.”

Additional comments to survey question number four included:

• “We do not require a literature review. For full review cases that carry more than minimal risk, we ask for a brief description of relevant studies that support the methodology being proposed.”
• “As noted in the last item, we do not review literature review quality. However, if something were egregious in the description of the research project question, which does ask for literature connections, we would ask the researchers to address it.”
• “N/A we do not evaluate the lit review. We focus on the methodology.”
• “Our IRB does not consider literature review quality, nor would they have the expertise to do so. I think this would rank low (1) as having the expertise to evaluate it is not present.”
• “There is some evaluation of the value of the research, but there isn’t a formal criteria for the literature review.”
• “A literature review is always included in the study’s application.”
• “Literature review is only part of scientific benefit in the ratio to harm.”

Additional comments to survey question five included:

• “It is not one of our formal evaluation criteria.”
• “Maybe a 3. But honestly, I am not sure it would impact the approval process or changes the IRB application/protocol either.”
• “Pretty low—I would value the input of a specialist in the area being evaluated over that of a librarian.”
• “0, the librarian does not know the field, other peer researchers are the best bet.”
• “I like your idea, but it is just not feasible. You are asking the librarian to be an expert in the field of every research project. It would take hours of a librarian’s time on every project just to judge how complete the review is, let alone how good the summary of the literature is. It is just impossible for one person, the librarian, to look at all of the applications for each IRB meeting.”

Survey Comments Option

Responses to the optional survey question seeking additional comment(s) included:

• “The scientific IRB member also reviews the literature provided as background for the study. In addition, besides IRB review, there need to be Scholarly and Scientific Validity review. These two processes usually take care of the literature review quality.”
• “The focus on our IRB is on human subject protection. Efforts on more direct participant protection is what consumes the committee’s time and energy.”
• “It’s unclear here what is meant by review of literature. Do you mean is the review accurate, does it use appropriate citations, is it accurate and unbiased ... what type of review could a librarian provide that is not what a peer researcher could provide?”
• “We do not have a librarian and as for the lit review it is not part of our IRB to judge quality of IRB.”
• “We depend on scientific review of the application. This would mean that the background/research literature would be evaluated by experts in the field.”
• “Scientist/academic reviewers are adept at evaluating literature reviews and conducting their own if needed.”
• “We have no librarian. Our IRB is human subjects research not for secondary literature access.”

Discussion

Although this study had no hypotheses—its goal is more to describe than predict—its results should not surprise. Related literature indicated little librarian IRB involvement, and this study further validated this assertion; if anything, it was somewhat impressive to find 15% of the IRB sample having librarian representation. However, survey comments illuminate three key barriers to greater librarian participation: limited awareness of librarian research expertise, undervaluing information literacy in IRB processes, misunderstanding IRB scope and responsibilities

Limited Awareness of Librarian Research Expertise

Survey responses revealed a significant knowledge gap regarding librarian scholarship and human subjects research capabilities. Two respondents explicitly acknowledged unfamiliarity, stating: “I don’t know. I’m not familiar with what kind of research librarians do with human subjects,” and “I could see value in this. Honestly, I had never given it any thought. However, our librarians do conduct research, though it is rarely of the human subject type.” These comments indicate lack of awareness about librarian human subject research requiring IRB oversight (e.g., patron usage studies, perception studies).

This misperception extends beyond research activities to fundamental understanding of librarian qualifications. One troubling comment suggested that librarians “could serve as IRB community members,” implying they are viewed as laypeople rather than scholars. Another respondent demonstrated limited understanding of librarian expertise, writing: “The value of a librarian would not be so much in evaluation of the quality of the lit review ... but rather in addressing ethical concerns regarding archival research.” This view overlooks librarians’ broader research competencies while assuming archival expertise that arguably most librarians do not possess. Such comments indicate serious need for library outreach and advocacy to communicate scope of librarian scholarship.

Undervaluing Information Literacy in IRB Processes

Responses that failed to recognize the connection between literature review quality and participant safety were concerning. The 1.85 average ranking for literature review importance in application approval reflects fundamental misunderstanding of how comprehensive secondary research informs risk assessment. Comments such as, “I think this would rank low as having the expertise to evaluate it is not present” suggest that since IRB members do not have the same level of expertise, supposedly, as the researcher/applicant, that they should not be held responsible for the lit review quality.

Multiple respondents prioritized subject expertise over information literacy skills when evaluating literature reviews. As one wrote, “the librarian does not know the field, other peer researchers are the best bet.” However, this perspective overlooks a crucial distinction: while content experts possess disciplinary knowledge, they may lack comprehensive search strategies essential for identifying all relevant research, including studies documenting potential risks or harmful methodologies. A person can have fantastic content knowledge; however, if they cannot locate high quality literature in a comprehensive fashion, that knowledge could be outdated, misinformed, or incomplete. Librarians’ information literacy expertise enables them to assess whether researchers have conducted due diligence in their literature reviews by examining search strategies, database selection, controlled vocabulary use, and methodological comprehensiveness.

Misunderstanding IRB Scope and Responsibilities

Survey responses revealed troubling perspectives on IRB authority regarding literature review evaluation. Four respondents characterized such evaluation as “overreach” or “inappropriate,” with comments like “I worry literature review quality is out of the IRB’s lane” and “We see that as overreach.” This resistance contradicts fundamental IRB responsibilities to ensure researchers understand potential risks before engaging human subjects.

Literature reviews should identify potential risks and past incidents of harmful methodologies (e.g., problematic research with vulnerable populations that later came under federal scrutiny). A well-informed literature review could be essential to human subject safety. This disconnect between safety concerns and understanding what has been done previously may indicate that some IRBs operate within incomplete risk assessment frameworks.

These findings collectively suggest that greater librarian IRB participation faces institutional barriers rooted in misperceptions about librarian expertise, undervaluation of information literacy skills, and narrow interpretations of IRB scope. Addressing these barriers could involve education about librarian research capabilities and critical relationship between comprehensive literature review and human safety.

Conclusion

According to this study’s findings, not much has changed over the years concerning librarians and IRBs as there are still relatively few on board. This could be disappointing itself, in terms of perceptions regarding academic librarianship; however, coupled with the finding that a literature review is low IRB priority, if a priority at all, then disappointment turns into concern.

The survey responses suggest that IRBs do not necessarily disregard secondary research’s importance to human subject research, but that they may misunderstand, or make assumptions about, secondary research efficacy. Such assumptions may reflect broader challenges in higher education regarding information literacy evaluation. Institutions vary in their understanding of contemporary information seeking and evaluation, which may explain why some IRBs may appear to be satisfied with proposals—and may assume that proposals are well-grounded in the literature—without closer scrutiny.

The findings suggest that IRBs offer a potential venue for addressing information literacy concerns within research contexts. Demonstrating to IRBs the importance of solid understanding of literature to human subject research could provide opportunities to highlight information literacy expertise and its relationship to research integrity. This is especially relevant at smaller institutions that have only one IRB composed of only a few disciplinary experts. Study comments about IRBs not having sufficient expertise to evaluate all literature reviews particularly apply at single-IRB schools, which represent a large percentage of institutions in the U.S. A librarian may not be expert on all matters but can at least help ensure IRB applications are informed through overall competent approaches to secondary research.

Questions about literature review competence may become increasingly relevant as research demographics shift. Some faculty in professional programs (e.g., allied health, business, engineering) never completed theses or dissertations. If they intended to be practitioners not scholars, they may not have as strong a research background as might be assumed of faculty who completed such research in graduate school. Additionally, more undergraduate students are now encouraged to conduct human subject research and may have varying levels of preparation for understanding what has already been done and not done, let alone how to best locate, evaluate, and use information. Librarians could potentially help evaluate literature shortfalls within IRB parameters in all these regards and could provide outreach to help prospective researchers with IRB applications before they even submit them.

Despite—and because of—this study’s simplicity, it has limitations. One is its sample sizes. There are thousands of IRBs at work in American higher education; however, only some were sampled for their membership roster(s) and criteria, and only 29 IRB members out of thousands answered this study’s questions. Additionally, in an attempt to gain more participation, the study included only a small number of questions, which were also concisely worded (i.e., easier to be misinterpreted). For example, regarding ‘literature review,’ one respondent stated/asked, “it’s unclear here what is meant by review of literature. Do you mean is the review accurate, does it use appropriate citations, is it accurate and unbiased ... what type of review could a librarian provide that is not what a peer researcher could provide?”

Despite its limitations, the study’s findings still offer insights into the state of librarian IRB participation and IRB perception of secondary research importance. Identifying more complex questions for future studies would require a better understanding of how librarians are already involved. There are plenty of quotes from the survey that can be used to further pursue research, and while responses were few, they provide enough data to design a more complex study.

The findings also suggest several directions for future research. One possibility involves examining higher education perception regarding librarianship, specifically whether faculty status correlates with how IRB members perceive librarian expertise. Is there a correlation between librarian faculty status and IRB involvement? This study did not ask whether librarians had faculty status, and a few comments relegated potential librarian participation within the role of community representative. Perhaps a survey of librarians at institutions with different faculty status models could be conducted and IRB participation rates between faculty-status versus non-faculty-status librarians compared. Qualitative interviews about barriers/facilitators to IRB involvement could also be conducted to provide deeper insight. For example, is there higher and/or different regard for librarian IRB membership at an institution if librarians are faculty? The question of whether librarian IRB involvement improves IRB integrity merits investigation as does the topic of overall institutional perception about librarians.

One colleague who reviewed this article was surprised that no respondent mentioned ghost citations or the impact they could have on designing ethical research from the start. As chatbots become more prevalent in the research landscape, this represents an intriguing concern related to secondary research assumptions for both researchers and IRBs. A study examining potential correlation between chatbot awareness and IRB concern regarding secondary research could reveal important findings.

In sum, there are other possible inquiries that librarian/IRB involvement presents. This study raised questions about the current state of involvement (or noninvolvement), suggesting that academic librarians may need to consider how to address these findings, not only for their own professional development but for institutional and overall human subject research improvement.

Acknowledgments

I thank the editor and reviewers for their help with this article.

References

Arango J., Chuck T., Ellenberg S. S., Foltz B., Gorman C., Hinrichs H., McHale S., Merchant K., Seltzer J., Shapley S., & Wild G. (2016). Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency. Ther Innov Regul Sci. Jul;50(4):480-486. doi: 10.1177/2168479016635220.

Cantwell, L., & Van Kampen-Breit, D. (2015). Librarians and the Institutional Review Board (IRB): Relationships matter. Collaborative Librarianship, 7(2), 66–78.

Delgado, A., Ewing, G., & Rosenof, L. (2020). Strategies for redesigning library research training programs. AALL Spectrum, Sep/Oct, 34–37.

Farrell, R. (2014). Action research, assessment, and Institutional Review Boards (IRB): Conflicting demands or productive tension for the academic librarian? New Review of Academic Librarianship, 20(2), 167–184.

Folkers KM, Bateman-House A (2018). Improving Expanded Access in the United States: The Role of the Institutional Review Board. Ther Innov Regul Sci. May;52(3):285-293. doi: 10.1177/2168479018759661.

Gray, BH (1975). An assessment of institutional review committees in human experimentation. Medical Care, 13(4), 318–328.

Harnett, S. M., & Cantwell-Jurkovic, L. P. (Eds.). (2022). Finding your seat at the table: Roles for librarians on institutional regulatory boards and committees. Rowman & Littlefield Publishers.

Harvey, S. (2003). Institutional Review Boards: Another way for hospital librarians to add value to their organization. Journal of Hospital Librarianship, 3(2), 99–102.

Hoogland (2023). “Theirs was not to make reply, theirs was not to reason why.” Hypothesis: Journal of the Research Section of MLA, 35(1), 1–6.

Izenstark, A. A., Jackson, A., Sandelli, H., Roberts, A., & Lindsay, A. (2021). So you want to publish: Becoming a researcher. College & Research Libraries News, 82(1), 10–13.

Jungkunz, M., Köngeter, A., Mehlis, A., Winkler, K., Schickhardt, E. C., & Christoph. (2021). Secondary use of clinical data in data-gathering, non-interventional research or learning activities: Definition, types, and a framework for risk assessment. Journal of Medical Internet Research, 23(6), N.PAG-N.PAG.

Labaree, R. V. (2010). Working successfully with your institutional review board. College & Research Libraries News, 71(4), 190–193.

Lacroix, D. (2021). Canadian librarians as research ethics board members: An exploratory case study. Partnership: The Canadian Journal of Library & Information Practice & Research, 16(1), 1–9.

Mehta P, Raymond J, Han MK, Larson T, Berry JD, Paganoni S, Mitsumoto H, Bedlack RS, & Horton DK. (2021). Recruitment of patients with amyotrophic lateral sclerosis for clinical trials and epidemiological studies: Descriptive study of the national ALS registry’s research notification mechanism. Journal of Medical Internet Research, 23(12), e29514.

Park, Y. R., Yoon, Y. J., Koo, H., Yoo, S., Choi, C.-M., Beck, S.-H., & Kim, T. W. (2018). Utilization of a clinical trial management system for the whole clinical trial process as an integrated database: System development. Journal of Medical Internet Research, 20(4), 1.

Rincon-Gonzalez L, Selig WKD, Hauber B, Reed SD, Tarver ME, Chaudhuri SE, Lo AW, Bruhn-Ding D, & Liden B. (2023). Leveraging patient preference information in medical device clinical trial design. Therapeutic Innovation & Regulatory Science, 57(1), 152–159.

Shen, F. X. S., Monette, B. C., Kimble, P., Rauch, S., Baker, S. L., & Justin, T. (2022). An ethics checklist for digital health research in psychiatry: Viewpoint. Journal of Medical Internet Research, 24(2), N.PAG-N.PAG.

Sullo, E., & Gomes, A. W. (2016). A profession without limits: The changing role of reference librarians. Medical Reference Services Quarterly, 35(2), 145–157.

Travis, T. A., & Ramirez, C. (2020). Big data and academic libraries: The quest for informed decision-making. portal: Libraries & the Academy, 20(1), 33–47.