Study design, setting, and participants

We conducted a descriptive qualitative study [18] using semi-structured interview methods between February and May 2021. Eligible participants included administrators responsible for research integrity and COI issues at U.S. academic research institutions ranked in the top 75 nationally by research funding. We sampled participants from these institutions because the more research funding an institution has, the greater their TT activities [3]. Because prior research has shown that responsibility for research integrity and COI issues can reside in different offices across academic research institutions [12], we leveraged the AAMC Forum on Conflict of Interest in Academe (FOCI) to recruit eligible participants. FOCI serves as “a forum for the leadership in the biomedical arena who oversee and manage conflicts of interest to promote the highest ethical and professional standards in the conduct of their institutions” [19]. Members represent a wide range of U.S. universities, schools of medicine, and research hospitals, and either bear primary responsibility for research integrity and COI issues at their respective institutions or are knowledgeable about where these responsibilities reside. We recruited FOCI members via email to request an interview or referral to a more appropriate individual at the same institution—a recruitment strategy which has proven successful in previous studies of institutional approaches to conflict of interest [20]. We purposively sampled participants by funding status (public vs. private) to capture a range of perspectives across institution type.

Data collection

Interviews were conducted using a semi-structured guide developed by the investigative team (see Supplemental Digital S1 Appendix for interview guide). The interview guide was designed to be open-ended, non-leading and to elicit detailed information about ICOI in practice—the interactions, processes, and real-world challenges of the work. Key domains in the guide include: 1) interactions between the COI and TT offices, 2) processes for identifying and managing ICOI in the TT process, 3) strengths and challenges in the management of ICOI in TT, and 4) suggestions for additional policy guidance. Interviews were conducted over the phone by the lead author (MSM) and audio recorded. Verbal informed consent was obtained and recorded prior to all interviews. The University of Pennsylvania Institutional Review Board determined that the study was exempt (#843481).

Analysis

Audio recordings were transcribed, de-identified, and entered into NVivo for management and analysis. We utilized a descriptive qualitative content analysis approach, combining flexible coding to index the interview data with close examination, interpretation, and synthesis of the coded content [21, 22]. First, we performed a close reading of two transcripts to develop a codebook that included domains from the interview guide plus emergent themes identified during data collection. The codebook was reviewed by the investigator group, refined, and all codes defined. Second, two trained coders from the University of Pennsylvania’s Mixed Methods Research Lab (MW and RN) applied the codebook to all transcripts; inter-rater reliability queries (ĸ = .84 [range.75-.84]) were run periodically to ensure agreement and consistent application of codes. Third, the investigator group examined the content of individual codes across respondents to identify recurrent patterns in the data.

Participants

Of 43 administrators recruited to participate in the study, 25 were interviewed, for an overall response rate of 58%. Table 1 describes characteristics of participating respondents.

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Table 1. Characteristics of interview sample (N = 25).

https://doi.org/10.1371/journal.pone.0304519.t001

An “inherent conflict:” Tension between the aims of TT and COI offices

Across both public and private institutions, participants reported a growing emphasis on entrepreneurialism at their institutions. They associated this “entrepreneurial push” (Respondent [R] 18) with increased licensing activity, expanded support for faculty-led spin-out companies, and higher level of risk tolerance in institutional-industry partnerships.

Against this backdrop, participants reflected on what they perceived as a basic tension between the aims of TT and COI offices. They saw TT offices as focused primarily on advancing their institution’s entrepreneurial goals, which they contrasted with the COI office’s role in enforcing compliance with ICOI policies, ensuring research integrity, and protecting the institution’s reputation. Interviewees described this tension in terms of “competing priorities” (R12), “completely different interests” (R14), “cross purposes” (R9), or a “almost a natural opposition” (R6) between the two offices. As one participant stated, “their [the TT office’s] emphasis is focused on getting options and licenses and protecting intellectual property. My priority is protecting the institutional research for individual researchers” (R17). One participant expanded on the nature of the "struggle" between the aims of TT and COI offices:

We’re creating things to actually have them reach patients and advance the public good, we need to work with—we need to license them out to work with the for-profit sector. This is all normal and good but it is fascinating and a struggle to realize that their day-to-day activities are driven on getting the best deal and putting these technologies out and making money. And that inherent conflict with being part of a nonprofit institution is just something that I struggle with and being on the conflict of interest side, where then we’re reacting and managing.

(R19).

Many participants felt that they were able to have productive working relationships with colleagues in the TT office despite this tension. They explained that these productive working relationships were possible because of a shared sense that TT and COI offices played distinct but complementary roles in advancing the institution’s broader mission, explaining that the TT and COI offices were ultimately “on the same team” (R2) or “working under the same value system” (R9). One participant suggested that differing priorities of the TT and COI offices manifested in a “creative tension” that served the broader mission of the institution (R16).

Others, however, sensed that colleagues in the TT office and other institutional stakeholders failed to appreciate the role of the COI office, viewing it not as a partner, but as a drag on TT:

I think not just my technology transfer office, but most of my university perceives me as a rate limiting step where they don’t understand that it’s not just that I just stepped away from my desk and I’m refusing to push a button, but that the activities that we engage in my office are actually protecting individuals legally and reputationally.

(R17)

The perception of the COI office as a bureaucratic hurdle had consequences for communication between the COI and TT offices. As one participant noted:

I think we’re seen as a stop, and we’re still working to change the mindset to ‘we are here to help you,’ and we’re at stop right now because you loop us in once there’s an issue. If we were part of the design process or the brainstorming, we could just tell you what the rules are or the regulations, and then you could go from there without us stopping your process.

(R14)

Another participant reflected on personnel changes at the institution in the TT office, the conflict between corporate and academic norms, and the consequences of this tension for communication:

Yeah, so we had a group that we had brought in [to the TT office] to really push innovation and I think that the idea was to hire a lot of corporate people who had the other side of the picture in innovation. And so they brought a lot of those folks in and it really was, it did, that model just was not working well. So now they’ve kind of pulled back and they’ve gone back to the idea of, you know individuals who are more academically focused and more research focused. I think there was no appreciation for the gravity of human subject research with the corporate people that were being hired to manage our [TT] office in the last few years, yeah. It felt like the wild-wild west, and nobody was communicating and everybody’s out there kind of doing their moving and shaking and not really paying attention to what they were doing.

(R21)

Notably, several participants said that while they had initially had challenging relationships with colleagues in the TT office, they had been able to strengthen those relationships over time. They largely attributed these improved relationships to the development of trust and mutual understanding between the two offices. One trust-building strategy was to be more transparent about the COI office’s own priorities and processes:

I think it was really important to have them sit in on some of our discussions to hear what we think about when we look at some of these situations for them to really understand, oh, I get it. I get we’re trying to protect the science and the integrity of this research. And when they hear that, it really resonates with them and then that can be taken back to their shop.

(R9)

While some participants found that they had been able to work directly with TT colleagues to improve collaboration between offices, others noted that they had relied or would need to rely on senior leadership such as Vice Provosts (VP) for Research to foster a productive relationship:

We have a meeting next week with [the TT office], and the VP for Research will be present, to try to address what we’re doing and what we are trying to protect the university from. And then to see if, this is kind of our test case—to see if that will spark a willingness on their part to loop us in a little bit more than they currently do.

(R14)

Another participant described collaboration between the COI and TT offices being challenging prior to the arrival of a VP for Research who “took it upon themselves to say conflicts of interest, including institutional conflicts of interest, are a huge concern and should be addressed more broadly at the institution” (R25).

“It comes down to communication:” Timing, formalization, integration and automation

Participants at both public and private institutions consistently emphasized that communication and exchange of information with their institution’s TT office was essential to their ability to manage ICOI effectively. When asked to reflect on the strengths of their institution’s approach to ICOI, those who felt that their programs were generally successful often traced their strengths to good communication with the TT office:

I think honestly it comes down to communication…Our policies aren’t the best policy you’re going to see. Our processes aren’t the best process you’re going to see. You’ll find others with stronger, more rigorous programs and more sophisticated thinking than [University] on some of this. But we have really good communication with our tech transfer office and we’re good partners. And that fills some of those gaps.

(R2)

When prompted to reflect on ways in which their institution’s approach to managing ICOI could be strengthened, participants indicated a desire to improve communication with their TT office far more often than they spoke about improving policies or committee processes. Even participants who felt that they had strong relationships with colleagues in the TT office suggested that strengthening communication and information sharing between the offices would improve the management of ICOI.

While participants offered a number of ideas for improving communication between the COI and TT offices, their suggestions highlighted the importance of three dimensions of information sharing that they viewed as especially critical: timing, formalization, and integration and automation.