Mandating Evidence-Based Informed Consent Practices: A Critical Engagement with IRB Leader Focus Group Findings.

Mandating Evidence-Based Informed Consent Practices: A Critical Engagement with IRB Leader Focus Group Findings - PMC Skip to main content An official website of the United States government Here's how you know Here's how you know Search Log in Primary site navigation Search Log in Search PMC Full-Text Archive Search in PMC Journal List User Guide As a library, NLM provides access to scientific literature. Inclusion in an NLM database does not imply endorsement of, or agreement with, the contents by NLM or the National Institutes of Health. Learn more: PMC Disclaimer | PMC Copyright Notice Ethics Hum Res . Author manuscript; available in PMC: 2026 May 31. Published in final edited form as: Ethics Hum Res. 2026 Jan-Feb;48(1):12–27. doi: 10.1002/eahr.60029 Mandating Evidence-Based Informed Consent Practices: A Critical Engagement with IRB Leader Focus Group Findings Meredith V Parsons 1 , Erin D Solomon 2 , Kari Baldwin 3 , Jessica Mozersky 4 , James M DuBois 5 Author information Copyright and License information 1 Bioethics Research Center, Washington University School of Medicine 2 Bioethics Research Center, Washington University School of Medicine 3 Bioethics Research Center, Washington University School of Medicine 4 Medicine Bioethics Research Center, Washington University School of Medicine 5 Medical Ethics Bioethics Research Center, Washington University School of Medicine, 660 S. Euclid Ave., Mail Stop Code: 8121-022-07, St. Louis, MO, USA 63110 ✉ Email: M.parsons@wustl.edu Roles Meredith V Parsons : Staff Scientist Erin D Solomon : PhD , Senior Scientist Kari Baldwin : Senior Project Manager Jessica Mozersky : PhD , Assistant Professor James M DuBois : PhD, DSc , Bander Professor, Executive Director PMC Copyright notice PMCID: PMC13221716  NIHMSID: NIHMS2133988  PMID: 41474482 The publisher's version of this article is available at Ethics Hum Res Abstract Evidence-based informed consent practices (ECPs)—such as writing in plain language, formatting for readability, and assessing understanding using validated instruments —are underutilized in research practice. The Common Rule does not specifically require the use of ECPs. In this paper, we explore the wisdom of mandating ECPs either at the institutional or federal level. In Part I of the paper, we share findings from a series of six focus groups with IRB leaders on mandating ECPs. In general, IRB leaders had positive views toward plain language and optimal document formatting, but were skeptical about validated assessments of participant comprehension of consent information. They generally opposed federal and institutional mandates, preferring an educational approach to promoting ECPs. In Part II of the paper, we draw upon data from several of our studies and the literature to defend the conclusion that IRBs should experiment with mandates of ECPs. We accept that federal regulations may be insufficiently flexible. However, educational efforts alone have not sufficed and are not likely to increase adoption of ECPs. We believe institutional mandates will not actually lead to greater delays in review or investigator burden if rolled out with sufficient guidance and resources, which are readily available. Keywords: Implementation science, informed consent, research ethics, mandates, institutional review board, evidence-based practice Informed consent has been described as having a “magical” character insofar as it capable of radically separating criminal acts involving drugs and scalpels from acts of professional caring. 1 , 2 In the Nuremberg Code, the first major international code of research ethics, published in 1948 following Nazi experiments with humans, we are told that to satisfy the requirements of ethics and law, “the voluntary consent of the human subject is absolutely essential.” 3 , The Belmont report, which undergirds the regulatory framework for research in the US, declares “widespread agreement that the consent process can be analyzed as containing three elements: information, comprehension and voluntariness.” 4 , ¶C 1 If any of these three elements is lacking, then we do not have informed consent. The informed consent process in clinical research is often made up of two complementary elements: the document and the conversation. 5 , 6 The informed consent document acts as a supplement to the conversation, providing participants with the opportunity to refer to the study information at multiple timepoints, absorb the information in a different way, and generate a record of consent for the participant and study personnel alike. However, the informed consent document is not the sole tool for informed consent. The consent conversation creates an opportunity for participants and study personnel to discuss questions, review information that was misunderstood, and tailor the consent information to the needs of each individual participant. 5 , 6 Studies that have examined the effect of readability improvements to consent documents alone have shown only limited success in enhancing consent understanding. 7 , 8 However, studies that examine the effect of improvements to both informed consent documents and conversations have yielded more promising improvements to participant understanding of consent information. 9 By 2017, as the US federal government was preparing updates to the Common Rule, it was recognized that consent documents no longer served well their primary purpose of supporting informed consent; rather they “too often appear to be designed for protecting the legal interests of institutions conducting research than for helping someone make a decision about participation.” 10 , p. 614 Thus, it is no surprise that the update to the Common Rule required that: Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. (45CFR46.116(a)(5)(i) This is one small example of efforts to restore—or perhaps finally achieve even in part—the original aims of the consent process. Other efforts to reform the informed consent process have been grounded in the empirical study of informed consent. More than 30 years of multidisciplinary scientific work and over 80 million dollars of NIH funding has been devoted to the development of evidence-based informed consent practices (ECPs) in research. 11 , 12 This investment has yielded several ECPs and tools to enhance the informed consent document and conversation in research, including the use of plain language and optimal text formatting techniques (document-level), and validated assessments of a participant’s understanding of consent information (conversation-level). 7 , 13 , 14 Plain language utilizes simplified word choices, shorter sentences, and explanations of complex terminology to improve the readability of written consent documents. 13 , 15 , 16 Using plain language in informed consent documents is essential to being inclusive. Approximately 43% of the US population reads only at a basic or below basic level according to the National Assessment of Adult Literacy criteria; 17 , 18 others estimate that over 50% of adults in the US read below a 6 th grade reading level. 19 Formatting techniques such as increased white space, bolded font, and use of bullet points or informational figures facilitate clear communication within informed consent documents. 15 , 16 , 20 Research participants tend to prefer clear formatting and simple language, which has also been shown to enhance comprehension. 15 , 21 This practice too is especially beneficial for individuals with limited reading comprehension skills. 22 , 23 Using validated measures to assess understanding of consent information is an ECP that enhances the informed consent process through conversation. It involves a formalized discussion of consent information with a participant through a series of questions to determine how well they understand and appreciate the information. 7 , 24 Validated assessments help identify individuals who may need additional clarification or review of consent information or a proxy decision-maker. 25 For example, the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) is a tool developed to assess a research participant’s understanding of consent information and has been validated across multiple populations and research contexts. 14 , 26 , 27 The UBACC requires very little staff training, can be administered in about five minutes, and can be adapted for a variety of study designs. 14 Using a validated assessment is important in many study designs because researchers frequently overestimate participant’s decision-making capacity, 28 , 29 and older adults and individuals with a very wide range of medical and psychiatric disorders are at heightened risk of diminished decision-making capacity. 30 – 33 Despite their demonstrated efficacy in promoting and ensuring participant understanding of study information, ECPs remain underutilized in clinical research, and efforts to integrate ECPs into clinical research practice have been largely unsuccessful. 25 , 34 , 35 Studies of current consent practices by clinical research professionals found that less than half of respondents were using validated assessments (44%) or optimized formatting techniques (42%) in their informed consent process, and just under two-thirds of respondents reported using plain language (63%). 25 , 35 Further, while IRB leaders have expressed concern with the complexity of consent documents and participant understanding of consent information, these factors are not often assessed during IRB review, and IRB leaders indicated limited familiarity and implementation of solutions to these challenges. 36 These challenges are not surprising given the limited guidance laid out in present-day federal regulations. Current language in the Common Rule describes the content required in informed consent, but it lacks specific information about how content should be communicated, or whether researchers need to verify that participants understand the information. The 2018 revised Common Rule states that consent information must “be organized and presented in a way that facilitates comprehension,” but does not provide specific information regarding reading level, font size, or other evidence-based standards for plain language or formatting. 15 , 16 , 37 Without clear expectations laid out by regulators, the implementation of these rules are left largely to the interpretation of IRBs tasked with their enforcement. The Common Rule requires additional protections or a legally authorized representative when participants have limited capacity to consent, but does not require assessment of capacity, much less specify how capacity should be assessed. 37 Our team developed ConsentTools.org , an online toolkit providing video tutorials, written guidance, and downloadable templates to help researchers implement ECPs in clinical trials. 38 The purpose of the toolkit is to make it easy for researchers to adopt ECPs. Elsewhere we report on our efforts to increase uptake of ECPs using the toolkit and systematic dissemination—efforts that were only very modestly successful, despite positive feedback on the quality and value of the toolkit. 34 Given the importance of ensuring informed consent in human subjects research, the absence of regulatory requirements of ECPs, and the challenges to voluntary uptake of ECPs among research professionals, our team conducted focus groups with IRB leaders to investigate the following research questions: What do IRB leaders think of ECPs? Do IRB leaders believe federal regulatory bodies should promote or require ECPs? In absence of federal requirements, what do IRB leaders think of institutional mandates that require informed consent practices beyond the Common Rule? In Part I of this paper, we report on the focus group findings. During the focus groups, we gained insight into how IRB leaders think about ECPs, their implementation, and the idea of mandates. In Part II, we engage specific ideas from the focus groups with data from our earlier projects and the broader literature. We make a case for IRBs requiring the use of ECPs because ECPs are important and underutilized, IRB leaders oppose new federal requirements, and their preferred educational and encouragement approach is likely to fail. I. A Focus Group Study with IRB Leaders In 2023, we enrolled 34 IRB leaders to participate in 1 of 6 focus groups. Recruitment materials were distributed through postings on the blog, online forum, and newsletter of the professional organization, Public Responsibility in Medicine and Research (PRIM&R), and via direct email invitation. The email list was created using publicly available information from U.S. medical schools in the top 200 research universities in the U.S. Potential participants completed an online pre-focus group survey administered via Qualtrics to provide screening and demographic information prior to being invited to a focus group. Eligible participants held leadership positions (e.g., director or chair) at an IRB in the U.S. that reviews biomedical clinical trial protocols. The study team reviewed survey responses and selected eligible participants to invite to a focus group, with the goal of enrolling individuals from a variety of IRB roles and settings. Table 1 provides a description of our sample. Table 1. IRB Leader Demographic Frequencies ( n =34) Gender Race Male 12 Black 3 Female 21 White 30 Prefer not to answer 1 More than one race 1 Age IRB Role 30–39 1 Director 22 40–49 13 Chair 7 50–59 13 Other 5 60–69 4 IRB Setting 70–79 3 Academic IRB 28 Hospital IRB 6 Open in a new tab Participants were invited to explore the ConsentTools toolkit before their scheduled focus group. Attendance ranged from 5 to 8 participants per group. Three members of the study team attended each focus group to facilitate the discussion, take notes, and provide technical support. Focus groups explored IRB leaders’ attitudes toward ECPs presented in the ConsentTools toolkit. First, participants were presented with a consent best practices tip sheet that provided two key information samples, one version without plain language or optimal formatting techniques, and another version using these ECPs. 27 Next, participants were shown a template version of the Revised University of California, San Diego Brief Assessment of Capacity to Consent (Revised UBACC), a validated assessment of consent understanding. 39 The Revised UBACC is an updated version of the assessment generated by the study team to include instructions for study personnel to administer and score the assessment, while storing the assessment in an Excel file for easy use and documentation in study records. These updates to the UBACC were reviewed and approved by the original developers of the tool. Participants were additionally asked about their attitudes toward mandating practices beyond the requirements of the Common Rule. Focus groups were audio recorded and professionally transcribed. Following the focus group, participants completed an online post-focus group survey via Qualtrics to provide demographic and payment information. Participants received a $100 gift card for completing the focus group and the two online surveys. The Washington University School of Medicine institutional review board approved this research (IRB ID #202303148). Qualitative analysis employed an inductive, team-based approach. 40 Following each focus group, the three members of the study team that attended the focus group met to identify the themes that emerged during the discussion. After completion of all focus groups, the full study team met and came to a consensus about these themes, triangulating findings from transcripts and focus group notes. 40 , 41 Three study team members then read the focus group transcripts to identify quotes that represented the key themes. The principal investigator and co-investigator reviewed and selected final quotes based on their representativeness of key themes. Qualitative analysis revealed IRB attitudes toward ECPs, federal regulatory bodies mandating ECPs, and IRBs mandating ECPs at the institutional level. Attitudes toward ECPs IRB leaders were asked to share their attitudes toward two ECPs for informed consent: 1) using plain language and formatting strategies to enhance participant understanding of the key information section of informed consent documents, and 2) using validated assessments of consent understanding to confirm participant comprehension of consent information. Formatting and Plain Language. The majority of IRB leaders felt very positively about formatting and plain language, viewing it as an essential communication strategy in the informed consent process of all studies, and particularly in the case of studies involving participants with impaired capacity to consent. “I think plain language is crucial…having a good consent form that’s concise, short, easy to read, and that somebody can get through pretty quickly is really important to convey what you need patients and families to know.” (Focus Group 3) Many IRB leaders reported that this practice was already built into their institutions’ informed consent templates, which researchers are frequently required to use. “We’ve actually already initiated a systematic introduction of that particular process in all our required language and offered template on the web in our system for all investigators. They’re mandated, actually, to use that. It’s all based on, again, eighth-grade understanding and language.” (Focus Group 5) Several IRB leaders ultimately felt that regardless of formatting and plain language strategies, informed consent must be a continuous process rather than a one-time interaction that can be satisfied in written form alone. They advocated for the importance of verbal communication strategies and multiple interactions to facilitate sustained understanding of consent information. “I do agree that plain language isn’t just about the form. It is about the way we speak and teach the information in the form too. It is a process.” (Focus Group 5) Validated Assessments. In contrast, IRB leaders shared far more skepticism about validated assessments of consent understanding. They expressed uncertainty in the value of a validated assessment versus informal methods of assessment (e.g., teach-back method), and worried that a validated assessment may be too rigid to adapt to a diverse array of study designs. “Yes, it’s a validated instrument, but it seems like it’s a validated instrument that you’re changing the responses for each and every time, so how do we know it remains valid to assess understanding when it’s applied to each individual study?” (Focus Group 6) “We already kind of do something—it’s somewhat like what you’re talking about, but it’s not a true checklist. What we do is called the teachback method. That’s where, when you go through everything, you ask them, “Does this make sense to you? Tell me what you’re hearing.”…In a way, it’s being done here, but I would not want it to be of a required checklist ‘cause I do work in compliance as well in the IRB, so in the end, it would—how do you regulate that? How do you keep an eye on that? It’s just another—yeah. I don’t know how you would handle that one.” (Focus Group 2) Others had concerns about research teams’ abilities to score the assessment and how it would affect exclusion criteria or the researcher’s rapport with the participant. “I don’t think we’d want to mandate it … it just may not be useful in all kinds of studies, and it’s not been a widely used practice so far, so it would be a big change to require this. I think we’d get pushback from our study teams who are already using these in-person detailed discussions and ongoing relationships with the study participants to make sure they understand things.” (Focus Group 1) “I think there also needs to be some consideration as to whom is going to administer this assessment because, if we’re trying to develop trust and cooperation between our investigators and our research participants, and then to have them question, do you really understand this or not after I’ve spent some time going over it with you, if we were to ask people to utilize it, I would probably include that it be done by an independent person so that we don’t jeopardize that relationship between the research team and the participant.” (Focus Group 1) Despite the majority view of skepticism about a validated assessment tool, a few IRB leaders had positive views of the practice. One saw value in using a validated instrument to structure already existing assessment conversations. Some expressed that while a validated assessment tool may not be appropriate for all studies, there were some instances (e.g., complex clinical trials) where such a tool would be worthwhile. “There’s part of me that loves the idea of doing this [validated assessments], but—so there’s a couple sides of it. If you’re using it as a tool to figure out where the participants don’t understand what’s happening with the study, and then you’re educating them about those areas where they didn’t understand, then it’s awesome.” (Focus Group 2) “I think it’s an especially helpful practice for study populations where there may be some question of cognitive capacity and especially for greater than minimal risk trials.” (Focus Group 6) Federal Mandates of ECPs For both validated assessments as well as plain language and formatting techniques, the vast majority of IRB leaders opposed the idea of new federal requirements. They anticipated difficulty evaluating and enforcing compliance and felt that the ECPs were somewhat subjective, and noted challenges with standardizing the practices across variable institutional cultures. “In an ideal world, … it’d be great to say, ‘Yes, you have to use plain language,’ but there’s not really any way to standardize that, enforce that. Every institution has different tools. Some institutions are gonna have the Flesch-Kincaid [readability measure], and other institutions are gonna have other ways they judge it.” (Focus Group 1) “I would agree that I think a central regulatory authority does not have the understanding of individual institutional culture and the understanding of risk/benefit for that particular institution and where they set the mark.” (Focus Group 5) They felt federal mandates are burdensome to researchers and IRBs, and often fail to offer sufficient clarity or flexibility to account for diverse study designs or encourage creative problem-solving among researchers and IRBs. “I think a mandate on the way it’s done could actually have the opposite effect of stifling the creativity behind it and the ability to open up time for OHRP to focus on the things that we really need guidance about that we wait a couple years to get or we make our own interpretation. I would rather have that sort of time.” (Focus Group 5) While IRB leaders voiced concerns with mandating both ECPs, they were especially opposed to mandating a validated assessment tool. “We would recommend do it this way or try this or try that, but mandating that investigative teams apply this, a certain [assessment] instrument, would be tough. Again, I don’t even think it should come from the IRB which instrument because they would be more expert at knowing their own study populations in terms of nuances, in terms of learning and challenges. I don’t know what other people think, but I would stay away from national regulation in terms of test feedback approaches.” (Focus Group 6) However, one IRB leader did acknowledge a gap in regulations regarding assessments of consent understanding and felt this was an area where current regulations could improve. “I agree that I wouldn’t necessarily be in favor of regulations requiring some sort of tool, but I do feel that this is an area in the regulations that is a little soft. I do believe there are patients who are consenting but are not fully understanding, and that is because there isn’t anything, I think, clearly stipulated in the regulations that says, somehow, this needs to be ascertained.” (Focus Group 4) IRB Requirements Beyond the Federal Common Rule IRB leaders were asked to share their thoughts on whether it is generally appropriate for IRBs to require informed consent practices that go beyond what is required by the Common Rule, and most acknowledged that going beyond the Common Rule is a complicated process. Many felt that the Common Rule sets the floor, not the ceiling, for informed consent. Some felt that the Common Rule requirements were complete and sufficient, but also said that there were times when they went beyond the Common Rule to comply with state laws or use institutional language. “I do agree that the rules are the floor, not the ceiling, but if you’re going to do something that goes above that, I think you have to balance the impact it has on the investigators and the research in general, and it shouldn’t be something that prohibits the research. If it’s enhancing the protection of human subjects, which, ultimately, that’s the job of the IRB, then I would say it’s worth it as long as that balance is in place.” (Focus Group 4) “We really try to keep our IRB members and reviews focused on the criteria for approval as laid out in the Common Rule, in part because we think those are really very complete and sufficient criteria, and there’s a lot of leeway for interpreting them and applying them to a specific study. If we find our IRB reviews drifting away from those criteria for approval, we feel like that’s not really the role of the IRB and may not be fair and appropriate to our researchers to be considering other criteria.” (Focus Group 1) The decision of when and how to require consent practices beyond the Common Rule depended on multiple factors for IRB leaders. First, they considered the level of risk and type of research to determine whether additional consent practices were appropriate. For instance, clinical trials involving greater than minimal risk and participants with cognitive impairment were more often considered for additional consent practices than other studies. “I would also agree it really does depend. There’s not a one size fits all for all disciplines conducting research with human subjects. That can be a challenge if you apply something to clinical research and apply it in the same way to educational research.” (Focus Group 3) When determining what consent practices were appropriate, IRB leaders wanted to ensure any additional practices led to substantive improvements to the informed consent process, not simply adding administrative burden. “I want to make sure that, if we are looking at higher protections, we’re actually looking at protections, not just busy work.” (Focus Group 2) However, they also acknowledged limitations in their ability to require consent practices beyond the Common Rule, particularly in the case of trials involving industry sponsors or single IRB. “You can make recommendations, but you always get pushback that the research teams says, “Well, this is approved by the sponsor already so we don’t wanna go back and make any changes.” It’s like well, what are we supposed to be focusing on? We’re supposed to be focusing on providing the potential subject with enough information, but not overwhelm them.” (Focus Group 3) In instances where IRBs did require practices beyond the Common Rule, IRB leaders provided the processes at their institution that led to such a decision. This often included collaborating with advisory boards, deans of research, faculty, or physicians to develop new policies. They also noted that communicating with research teams and providing justifications for the IRB’s decisions was a valuable way to help researchers see the value of implementing practices beyond what the Common Rule requires. “It’s in places where there’s a lack of clarity [in the regulations] and so we do have to take an institutional stance on what does this mean. I found that that works much better when it works in concert… It’s been much more successful for us when we worked in collaboration with maybe deans for research or other folks who are faculty leaders who are doing research in that particular area or who have expertise in that area, in helping to build a policy that is appropriate for the research.” (Focus Group 3) “When we ask [researchers] to do things that aren’t specifically required by the regulations, we usually have a good justification for it, and just by talking to them at the outset when they’re designing their study, that seems to help things. Our investigators, they want to do things the right way, and that’s their intention too is to help our patients. I think we’re both coming at it from the same point of view, so that seems to help.” (Focus Group 4) However, IRB leaders also shared that when they did impose requirements beyond the Common Rule, it was often met with pushback from research teams, industry sponsors, and sometimes other IRB leaders. “Nothing is more troublesome to an investigator than inconsistency and going outside of what the institution has determined to be appropriate is a very big step.” (Focus Group 5) “Investigators don’t like it. Research teams don’t like it. Frankly, some of the IRB members don’t like it. We went through this exercise—it’s been about 10 years now. I could write a book of people who pushed back.” (Focus Group 5) IRB leaders were more inclined to support mandates of ECPs at the institutional level as opposed to federal mandates, but felt that recommending or encouraging ECPs would be most feasible. Many reported already using formatting and plain language in their informed consent templates, which researchers often used voluntarily or sometimes by institutional requirement. However, many IRB leaders also said that they would never mandate a specific validated assessment in order to preserve flexibility needed to adapt to different study designs. Overall, they preferred the idea of providing researchers with training and resources for ECPs rather than mandating them at the institutional level. “ Our institution does already require that there be some sort of comprehension check. I don’t think it’s a far stretch for the institution to then say and the method that you have to do that has to be validated. I don’t think that they would probably go very far if they required a very specific tool, because not every tool is going to work for every type of study” (Focus Group 3) “I think that’s where trainings come in…I don’t know one researcher that doesn’t want to be sure that their participants understand what’s going on. I think it would be more along the promotion rather than regulating.” (Focus Group 4) Similar to their view on federal mandates of ECPs, IRB leaders had concerns over the feasibility of evaluating and enforcing institutional mandates of ECPs, again noting that measuring compliance with mandated ECPs would be subjective. “With mandates without a baseline standard or rule by which you are measuring, they’re more or less pointless and lead to more confusion. Then how would one enforce a deviation from a mandate that doesn’t have a particular standard stated? Even back to font size or style, if that’s not clear upfront, then there is no objective way to enforce these mandates or guidelines, and it really becomes, again, subjective, and then you’re back to this reasonable person standard that, does this person understand?” (Focus Group 5) Many expressed that evaluating compliance would cause undue burden for both the IRB and research teams, making review times slower and inviting pushback from researchers. “Telling our PIs that they have to use [formatting and plain language] will add three weeks at least to the review process…That whole three weeks is gonna be text review of consent forms? We would have a revolt, just to be honest…The workflow would be incredibly disruptive.” (Focus Group 6) “I think programs are opposed to adding on layers and layers of things that are not absolutely required. I think the IRBs should be very specific about adding additional burden unless it’s absolutely needed, and it should provide additional protections to the research participants as well. Otherwise, I would be opposed.” (Focus Group 5) IRB leaders greatly preferred the idea of promoting or recommending ECPs through their institution, the US Office for Human Research Protections (OHRP), or professional organizations. They suggested IRBs sharing the ECPs resources with each other and research teams, allowing the flexibility to recommend ECPs when appropriate and the ability to use their discretion when evaluating compliance. “I think promotion is achievable. I think enforcement would be very, very difficult to do. I think it’s also somewhat subjective because…one person’s plain language is very different from another person’s plain language. Tools, recommendations, absolutely. Hard and fast enforcement, I think, would be a little more difficult.” (Focus Group 1) Despite the challenges IRB leaders experienced with institutional mandates beyond the Common Rule, they acknowledged that mandates from their office was the most likely way to broadly implement ECPs. They reported this would require their offices spending time to revise consent forms, and several suggested incorporating the practices in their IRB application process. IRB members also mentioned the need to slowly change their institutional culture in order to mitigate pushback from researchers they might receive if IRBs attempted to mandate too many ECPs at once. “I’m personally sold at this point on the fact that to get broad uptake of [ECPs], it has to be something that the HRPP office is willing to do themselves…if we as an institution or as an HRPP are going to value that, it needs to be valued by us, not just by telling [research teams] to do it, but by being willing to do it ourselves. They send us something and we redo it using these principles.” (Focus Group 6) “If we were to actually mandate something, we would build it into the IRB application process ‘cause we always have questions or checks that the investigator has to fill out to make sure they’re doing something that is mandated by us. That’s how we control everything at our institution. That’s one way that they can be done.” (Focus Group 5) “I think researchers, they pay attention to what the IRB does, requests. Then they will build that then into their—it takes a while so I think of it as culture change. We’re trying to move this gigantic iceberg slowly. They’ll eventually build this into their processes, but only if they have to. Our researchers are really responsive to what we say or do or don’t do.” (Focus Group 3) II. The Case for Institutional Mandates Beyond the Common Rule Here we initiate a dialogue with the concerns IRB leaders expressed about mandating ECPs, while drawing heavily from the literature and a series of studies we conducted prior to the focus group study. Through our critical engagement with focus group participants and research data, we offer a series of recommendations for improving the informed consent process, again, in the spirit of initiating a conversation. Our focus group participants thoughtfully engaged with the topics of ECPs and mandates. IRB leaders support ECPs in general but oppose new mandates because they either feel they already require the most worthwhile ECPs or they feel that education and encouragement are more reasonable and effective approaches. Further, they have concerns with validated assessments; they preferred informal evaluation such as “teach-back” over what they viewed as one-size-fits all approaches. They were also concerned about how new mandates would be enforced: It may be subjective and difficult to determine whether someone used plain language, formatted the consent document to foster comprehension, and ascertained participant understanding in a valid manner; yet a regulatory requirement would force IRBs to make such determinations. They also felt that it is difficult to craft federal rules in a way that grants sufficient leeway for local conditions and study-specific factors. They were also not supportive of IRB mandates absent a federal mandate. In general, they advocated for education and encouragement as a way of increasing the use of ECPs. This approach has several clear advantages. It reduces variance and subjectivity in the IRB review of study materials. It avoids increasing workloads for investigators and for IRBs that would need to review compliance with institutional mandates. It would avoid delays and clashes when consent materials are developed and approved by study sponsors or IRBs at multiple sites. Below we engage with several of the key concerns or positions taken by IRB leaders and offer a series of specific recommendations before returning to the subject of mandates. Are IRBs Already Requiring ECPs? A few participants claimed that their IRB already required the use of plain language and optimal formatting of consent forms. That may be the case. However, a decade-old study found that IRB consent form templates were written on average at the 10 th grade reading level, 42 which is problematic when 43% of the US population reads only at a basic or below basic level. 17 , 18 Further, preliminary data gathered in preparation for our ECP implementation trial 34 indicated that even the new “key information” sections of consent forms, which are required to facilitate comprehension, lack appropriate guidance from IRBs. For example, of the 46 key information templates that we reviewed from a random selection of medical schools, 59% focused on content without offering guidance on plain language or formatting. Only 17% mentioned font size requirements and even fewer (7%) mentioned margin requirements. Most did not require a specific reading level (28%) or the use of plain language (41%). 43 Templates typically reflected the minimum expectations described in federal regulations, rather than more intensive recommendations promoted by the Secretary’s Advisory Committee on Human Research Protections (SACHRP). 43 , 44 The present focus group study might explain this: many IRBs do not want to get into the business of enforcement with the attending editorial tasks. Recommendation 1: We need software programs to assist in the evaluation of consent documents, specifically, their use of optimal formatting and of plain language. This is a very achievable programming task. Absent software, we may need a narrowly-focused preliminary review of documents of the sort NIH performs to ensure compliance with basic requirements such as font and margin sizes and perhaps overall grade level. How Burdensome and Rigid Are Assessments of Understanding? The tendency among IRB leaders to opt for informal methods of assessing understanding (e.g. teach-back method) appears in juxtaposition to their concerns with operationalizing a validated assessment. Informal methods of assessment have less standardization in their delivery and evaluation, making them vulnerable to deviations due to varying communication skills among research personnel, or the participant’s level of literacy or cognitive capacity. Research personnel vary in their level of experience and skill in the consent process, and researchers may overestimate their ability to informally assess consent understanding. 28 , 29 In contrast, formal assessments such as the Revised UBACC offer a more structured process for assessing understanding of consent information, helping to reduce inconsistencies across participants or research personnel. Past research has shown that the Revised UBACC, which is one example of a validated assessment, requires little training of research personnel, can be administered in as little as 5 minutes, and has been validated in multiple vulnerable populations, including individuals with impaired decision-making capacity. 14 , 26 IRB leaders’ skepticism toward the UBACC suggest a lack of familiarity with validated assessments, and IRB leaders may overestimate the burden that validated assessments impose on research teams. Concerns about a one-size-fits all approach may rest on an assumption that an assessment generates decisions; however, assessments simply provide valuable information in making decisions. A clinical researcher, seeing erroneous responses on an assessment, is now empowered to explore why consent information is misunderstood: Does the individual lack adequate English proficiency? Does the consent form use a lot of jargon, or it is too long and complex? Does the individual have a cognitive deficit? Was the consent process timed poorly, while the individual is anxious and overwhelmed by a new diagnosis? Would further discussion help? It may be appropriate to give clinical research personnel considerable discretion in determining how to use the results of validated assessments; yet, doing so can make both IRBs and clinical investigators uncomfortable. There are some examples of IRBs implementing institutional requirements of validated assessments of consent understanding in certain circumstances, 45 – 48 however we are unaware of any evaluations reporting the level of success of these mandates. Recommendation 2: While important data already exists on the usefulness and feasibility of assessing comprehension of consent information, we recommend further research on real-world applications to understand when the use of valid assessments adds value and when they do not; on how best to present assessments to participants to reduce embarrassment or discomfort; and on how results can be used not merely to exclude people from participation, but also to support informed participation. We encourage IRBs to foster such real-world trials and share these results with peers and researchers. Recommendation 3: As an initial mandate, require the use of validated assessments whenever a study has a risk of the magnitude that the IRB worries about potential public scandal if serious injury or death ensues. Obviously, the ethical imperative pertains to the potential harm of the participant rather than an appeal to institutional risk management, however this imaginative device may help institutions operationalize mandates of validated assessments. For example, this might include some gene editing trials or phase I clinical trials. In these greater-than-minimal-risk studies, use the assessments not only with individuals deemed at risk of decisional incapacity, but with all participants as a way of confirming or fostering comprehension. Is Education and Encouragement a Promising Path to Implementing ECPs? The first choice among IRB leaders to facilitate uptake of ECPs was via promotion, such as sharing ECPs as optional practices. This was often coupled with recommendations to educate researchers on ECPs. We heard repeatedly that most clinical researchers want to do the right thing, and we share this impression. At the same time, our past efforts at promoting ECPs through information pushes and education have increased our skepticism that these approaches will lead to behavior change. With NIH funding, we conducted a randomized implementation trial aimed at implementing ECPs with 1,284 clinical research professionals working in the US. We created the ConsentTools.org toolkit (described above). The experimental group received access to the toolkit and regular listserv or social media messages promoting the use of specific practices with links to resources. Although participants volunteered for the study, we found very low levels of engagement. For example, on average, only 1% of participants in the intervention group clicked on toolkit links found in any given listserv message. We also found very few significant intervention and control group differences in positive attitudes or intention to implement ECPs, and there were no significant differences between groups in adoption of ECPs despite ongoing reminders and messages about the toolkit to our intervention group. 34 . In follow up interviews, we found that nearly all participants saw value in the toolkit and praised its quality, but some cited a lack of time and knowledge required to implement ECPs as well as anticipated challenges with IRB review as reasons for not adopting ECPs. 25 , 34 , 35 In another follow up study with 503 clinical research coordinators (CRCs), we attempted to evaluate the outcomes of different educational approaches, including a video module with access to toolkit resources, a text-based module with toolkit resources, a more “standard” text-only online module, and a control group that received the assessments with no intervention. However, we were unable to test differences between these groups, because the study ended up underpowered after we discarded results from participants who failed to comply with our research training protocols. We found that only 13% of participants completed the study within a timeframe that was reasonable considering average reading speed or watching videos at normal speed. 49 We remained underpowered even when we assumed participants were “speed reading” more than 2 standard deviations above the mean, and watching videos at an incomprehensible speed of 2x. This was the case despite the fact that we disclosed how long participation was expected to take, participants were paid, they voluntarily consented to participation, and prior to assessments they checked a box verifying they completed their assigned training protocol. This finding generates very serious concerns about the online training habits of clinical research professionals. We would note that after 24 years of providing online training and more than 25 million course completions, we are unaware of any evidence that CITI Program training has any positive effects on enduring knowledge, skills, or behavior. 50 Why is this the case? Recommendation 4: IRBs should shift their focus from education as institutional risk management strategy and start examining how to improve the behavior of research professionals, who feel overworked and pressed for time. While IRBs can face challenges with understaffing and accusations of mission creep, IRBs uniquely have the ability to creatively explore these issues. Another study we conducted with CRCs indicated that job experience was most strongly associated with knowledge of good clinical practice. 51 It could be that training CRC mentors (or ECP champions) would be a promising approach to promoting ECPs within an institution while balancing concerns with limited IRB resources and remaining within the mission of the Common Rule. Why IRB Requirements May be the Most Promising Approach IRBs derive their authority from the Common Rule and may face significant pushback from research teams as well as institutional legal counsel if they begin mandating plain language, optimal formatting, and the use of validated assessments under specific conditions. 37 , 52 At the same time, there can be no informed consent without comprehension of the information presented. 4 We invest a tremendous amount of time and effort into producing consent documents that contain a lot of information; we invest far less time and effort into ensuring the information is understandable and in fact understood. Our freely available ConsentTools.org website makes the case for such an investment and provides tools to support the implementation of ECPs. Researchers and IRBs generally appreciate ECPs and care about research participants, but high workloads and well-established workflows are barriers to implementing ECPs. As one IRB leader noted during a focus group, researchers are likely to build ECPs into their processes “only if they have to” adding that “Our researchers are really responsive to what we say or do or don’t do.” Further, IRB leaders acknowledged that they do occasionally impose institutional requirements beyond what is explicitly stated in the Common Rule. For example, most IRBs mandate the use of consent form templates requiring language that complied with state laws or institutional policies (with exceptions for sponsored multi-site trials), and some have broad requirements for some kind of comprehension check in some studies. Further, the language of the Common Rule which requires that consent information be presented in “a way that facilitates comprehension” arguably provides a strong rationale for IRBs to exercise discretion in issuing institutional requirements of ECPs when appropriate. 37 Additionally, researchers are more likely to use plain language and optimal document formatting if they are used consistently in the consent templates provided by their IRB. 53 Similarly, the Common Rule requires that additional protections or legally authorized representatives be available when participants have limited capacity to consent to research. 37 Requiring the use of a validated assessment of consent understanding under certain circumstances, such as clinical trials involving individuals with cognitive impairment and greater than minimal risk, supports compliance with the Common Rule regulations. IRBs may mitigate pushback from researchers by accompanying additional requirements with simple presentations of the evidence supporting these practices. 7 , 24 Figure 1 provides a summary of the kinds of practices that IRBs might mandate in full or in part. Figure 1. Checklist for implementation of ECPs for IRBs. Open in a new tab Recommendation 5: IRBs that are well-resourced at institutions with successful clinical trial programs, should require ECPs in ways that are easily measurable and enforceable. This should follow a period of engagement with clinical research professionals at the institution to refine processes and provide time for preparation and dissemination of resources that will make compliance easy. Similar to NIH requirements for the inclusion of participants from across the lifespan, we recommend requiring a reasoned plan for implementing ECPs, which may include justifying exceptions to the requirements. Conclusions The informed consent process has been broken for a very long time. As just one anecdote, a member of our ECP implementation trial advisory board told us of a consent form he reviewed when he was asked to consent on behalf of his wife, who was being enrolled in an Alzheimer’s Disease trial. The consent form was over 40 pages long and used terminology that he found overwhelming. No one evaluated how well he understood the information, and the length and complexity of the consent form suggests an over-reliance on the consent document rather than the consent conversation. At the same time, he also shared that his wife found evaluations of her understanding to be embarrassing. This is a serious challenge that must be addressed when using validated assessments as part of a protocol. We do not think there are easy fixes. There are reasons why research institutions are trying to protect themselves from legal liability with highly technical and lengthy consent forms: Our society is litigious, and research is done precisely because we do not yet know the outcomes of experimental interventions. At the same time, a very large body of literature indicates that even when patients or research participants are willing to trust their physicians (or investigators) to select the best option for them, they want to be informed and they want to understand the relevant information. 54 – 56 We can do better in delivering this through incremental changes and local mandates. If IRBs begin mandating specific features of the consent process, researchers and sponsors will adopt these practices if only to avoid delays at some study sites. Acknowledgements: The authors would like to thank the Public Responsibility in Medicine and Research (PRIM&R) for their assistance in participant recruitment. This research was supported by National Institute on Aging grant 5R01 AG058254–01A1 and the National Center for Advancing Translational Sciences grant UL1TR002345. Footnotes Human Subjects Protection Statement: The Washington University School of Medicine institutional review board approved this research (IRB ID #202303148). Contributor Information Meredith V. Parsons, Bioethics Research Center, Washington University School of Medicine. Erin D. Solomon, Bioethics Research Center, Washington University School of Medicine. Kari Baldwin, Bioethics Research Center, Washington University School of Medicine. Jessica Mozersky, Medicine Bioethics Research Center, Washington University School of Medicine. James M. DuBois, Medical Ethics Bioethics Research Center, Washington University School of Medicine, 660 S. Euclid Ave., Mail Stop Code: 8121-022-07, St. Louis, MO, USA 63110. References 1. DuBois JM. Ethics in mental health research: Principles, guidance, and cases. Oxford University Press; 2008:x, 236 p. [ Google Scholar ] 2. Kipnis K Vulnerability in Research Subjects: A Bioethical Taxonomy. In: National Bioethics Advisory Commission, ed. Ethical and policy issues in research involving human participants Volume II commissioned papers and staff analysis. National Bioethics Advisory Commission; 2001:G1–G13. [ Google Scholar ] 3. The Nuremberg Code. 1948. [ Google Scholar ] 4. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. 1979. April 18, 1979. http://ohsr.od.nih.gov/guidelines/belmont.html [ PubMed ] [ Google Scholar ] 5. Lentz J, Kennett M, Perlmutter J, Forrest A. Paving the way to a more effective informed consent process: Recommendations from the Clinical Trials Transformation Initiative. Contemporary Clinical Trials. 2016/07/01/ 2016;49:65–69. doi: 10.1016/j.cct.2016.06.005 [ DOI ] [ PubMed ] [ Google Scholar ] 6. Shah P, Thornton I, Turrin D, Kopitnik NL, Hipskind JE. Informed Consent. StatPearls [Internet]. StatPearls Publishing; 2024. [ PubMed ] [ Google Scholar ] 7. Flory J, Emanuel EJ. Interventions to Improve Research Participants’ Understanding in Informed Consent for Research: A Systematic Review. JAMA : the journal of the American Medical Association. Oct 6 2004;292(13):1593–601. doi: 10.1001/jama.292.13.1593 [ DOI ] [ PubMed ] [ Google Scholar ] 8. Spellecy R, Tarima S, Denzen E, et al. Easy-to-Read Informed Consent Form for Hematopoietic Cell Transplantation Clinical Trials: Results from the Blood and Marrow Transplant Clinical Trials Network 1205 Study. Biol Blood Marrow Transplant. Oct 2018;24(10):2145–2151. doi: 10.1016/j.bbmt.2018.04.014 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 9. Nishimura A, Carey J, Erwin PJ, Tilburt JC, Murad MH, McCormick JB. Improving Understanding in the Research Informed Consent Process: A Systematic Review of 54 Interventions Tested in Randomized Control Trials. BMC Medical Ethics. 2013;14:28. doi: 10.1186/1472-6939-14-28 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 10. Menikoff J, Kaneshiro J, Pritchard I. The Common Rule, Updated. New England Journal of Medicine. 2017;376(7):613–615. doi:doi: 10.1056/NEJMp1700736 [ DOI ] [ PubMed ] [ Google Scholar ] 11. Dubois JM, Bante H, Hadley WB. Ethics in Psychiatric Research: A Review of 25 Years of NIH-funded Empirical Research Projects. AJOB primary research. Jan 1 2011;2(4):5–17. doi: 10.1080/21507716.2011.631514 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 12. Burns PB, Rohrich RJ, Chung KC. The Levels of Evidence and Their Role in Evidence-Based Medicine. Plastic and Reconstructive Surgery. Jul 2011;128(1):305–10. doi: 10.1097/PRS.0b013e318219c171 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 13. Jefford M, Moore R. Improvement of informed consent and the quality of consent documents. The Lancet Oncology. May 1 2008;9(5):485–493. doi: 10.1016/S1470-2045(08)70128-1 [ DOI ] [ PubMed ] [ Google Scholar ] 14. Jeste DV, Palmer BW, Appelbaum PS, et al. A New Brief Instrument for Assessing Decisional Capacity for Clinical Research. Archives of General Psychiatry. Aug 2007;64(8):966–74. doi: 10.1001/archpsyc.64.8.966 [ DOI ] [ PubMed ] [ Google Scholar ] 15. Kim EJ, Kim SH. Simplification Improves Understanding of Informed Consent Information in Clinical Trials Regardless of Health Literacy Level. Clinical trials. Jun 2015;12(3):232–6. doi: 10.1177/1740774515571139 [ DOI ] [ PubMed ] [ Google Scholar ] 16. The Plain Language Action and Information Network. Federal Plain Language Guidelines. United States Government. https://www.plainlanguage.gov/guidelines/ [ Google Scholar ] 17. Berkman ND, Sheridan SL, Donahue KE, Halpern DJ, Crotty K. Low Health Literacy and Health Outcomes: An Updated Systematic Review. Annals of internal medicine. 2011/07/19 2011;155(2):97–107. doi: 10.7326/0003-4819-155-2-201107190-00005 [ DOI ] [ PubMed ] [ Google Scholar ] 18. Kutner M, Greenberg E, Baer J. National Assessment of Adult Literacy (NAAL). 2005. https://nces.ed.gov/NAAL/PDF/2006470.PDF [ Google Scholar ] 19. Schmidt E Reading the numbers: 130 million American adults have low literacy skills, but funding differs drastically by state. APM Research Lab. American Public Media; 2022. March 16, 2022. https://www.apmresearchlab.org/10x-adult-literacy [ Google Scholar ] 20. Campbell G, Dixon MD, Lohani M, et al. Therapeutic Misconception about Research Procedures: Does a Simple Information Chart Improve Understanding? Ethics & human research. 2022;44(2):18–25. doi: 10.1002/eahr.500120 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 21. Holmes-Rovner M, Stableford S, Fagerlin A, et al. Evidence-based patient choice: a prostate cancer decision aid in plain language. BMC Medical Informatics and Decision Making. 2005/06/20 2005;5(1):16. doi: 10.1186/1472-6947-5-16 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 22. Campbell FA, Goldman BD, Boccia ML, Skinner M . The effect of format modifications and reading comprehension on recall of informed consent information by low-income parents: a comparison of print, video, and computer-based presentations. Patient Education and Counseling. 2004;53(2):205–216. doi: 10.1016/S0738-3991(03)00162-9 [ DOI ] [ PubMed ] [ Google Scholar ] 23. Davis TC, Berkel HJ, Holcombe RF, Pramanik S, Divers SG. Informed Consent for Clinical Trials: a Comparative Study of Standard Versus Simplified Forms. JNCI: Journal of the National Cancer Institute. 1998;90(9):668–674. doi: 10.1093/jnci/90.9.668 [ DOI ] [ PubMed ] [ Google Scholar ] 24. Gilbert T, Bosquet A, Thomas-Anterion C, Bonnefoy M, Le Saux O. Assessing Capacity to Consent for Research in Cognitively Impaired Older Patients. Clinical Interventions in Aging. 2017;12:1553–1563. doi: 10.2147/CIA.S141905 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 25. Solomon ED, Mozersky J, Baldwin K, et al. Perceived barriers to assessing understanding and appreciation of informed consent in clinical trials: A mixed-method study. Journal of Clinical and Translational Science. 2021;5(1):e164. e164. doi: 10.1017/cts.2021.807 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 26. Seaman JB, Terhorst L, Gentry A, Hunsaker A, Parker LS, Lingler JH. Psychometric Properties of a Decisional Capacity Screening Tool for Individuals Contemplating Participation in Alzheimer’s Disease Research. Journal of Alzheimer’s disease : JAD. May 7 2015;46(1):1–9. doi: 10.3233/JAD-142559 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 27. Bioethics Research Center. Optimizing Key Information. Washington University School of Medicine. 2023. https://consenttools.org/optimizing-key-information/ [ Google Scholar ] 28. Montalvo W, Larson E. Participant Comprehension of Research for Which They Volunteer: A Systematic Review. Journal of nursing scholarship : an official publication of Sigma Theta Tau International Honor Society of Nursing / Sigma Theta Tau. Nov 2014;46(6):423–31. doi: 10.1111/jnu.12097 [ DOI ] [ PubMed ] [ Google Scholar ] 29. Palmer BW, Harmell AL, Pinto LL, et al. Determinants of Capacity to Consent to Research on Alzheimer’s disease. Clinical gerontologist. 2017;40(1):24–34. doi: 10.1080/07317115.2016.1197352 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 30. Jeste DV, Depp CA, Palmer BW. Magnitude of Impairment in Decisional Capacity in People with Schizophrenia Compared to Normal Subjects: An Overview. Schizophrenia bulletin. Jan 2006;32(1):121–8. doi: 10.1093/schbul/sbj001 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 31. Kim SYH, Cox C, Caine ED. Impaired Decision-Making Ability in Subjects with Alzheimer’s Disease and Willingness to Participate in Research. The American journal of psychiatry. 2002 2002;159(5):797–802. doi: 10.1176/appi.ajp.159.5.797 [ DOI ] [ PubMed ] [ Google Scholar ] 32. Stewart RA, Liolitsa D. Type 2 Diabetes Mellitus, Cognitive Impairment and Dementia. Diabetic Medicine. 1998;16:93–112. [ DOI ] [ PubMed ] [ Google Scholar ] 33. Vogels RLC, Scheltens P, Schroeder-Tanka JM, Weinstein HC . Cognitive Impairment in Heart Failure: A Systematic Review of the Literature. European Journal of Heart Failure. 2007;9:440–49. [ DOI ] [ PubMed ] [ Google Scholar ] 34. Solomon ED, Mozerskly J, Goodman M, et al. A randomized implementation trial to increase adoption of evidence-informed consent practices. Journal of Clinical and Translational Science. 2023; [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 35. Solomon ED, Mozersky J, Wroblewski MP, et al. Understanding the Use of Optimal Formatting and Plain Language When Presenting Key Information in Clinical Trials. Journal of empirical research on human research ethics : JERHRE. Feb-Apr 2022;17(1–2):177–192. doi: 10.1177/15562646211037546 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 36. Kane III EI, and Gallo JJ. Perspectives of IRB chairs on the informed consent process. AJOB Empirical Bioethics. 2017/04/03 2017;8(2):137–143. doi: 10.1080/23294515.2016.1253628 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 37. Subpart A of 45 CFR 46 : Basic HHS Policy for Protection of Human Subjects (As revised on January 19, 2017, and amended on January 22, 2018 and June 19, 2018) (2018). [ Google Scholar ] 38. Bioethics Research Center. ConsentTools. Washington University School of Medicine. Accessed September 18, 2023. www.ConsentTools.org [ Google Scholar ] 39. Bioethics Research Center. Assessments. Washington University School of Medicine. https://consenttools.org/assessments/ [ Google Scholar ] 40. Patton MQ. Enhancing the quality and credibility of qualitative analysis. Health Serv Res. Dec 1999;34(5 Pt 2):1189–208. [ PMC free article ] [ PubMed ] [ Google Scholar ] 41. Krueger RA. Analyzing and reporting focus group results. vol 6. The Focus Group Kit. SAGE Publications, Inc. ; 1998. [ Google Scholar ] 42. Paasche-Orlow MK, Brancati FL, Taylor HA, Jain S, Pandit A, Wolf M. Readability of Consent Form Templates: A Second Look. Irb. 2013;35(4):12–19. [ PubMed ] [ Google Scholar ] 43. Mozersky J, Wroblewski MP, Solomon ED, DuBois JM. How are US institutions implementing the new key information requirement? Journal of Clinical and Translational Science. Jan 10 2020;4(4):365–369. doi: 10.1017/cts.2020.1 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 44. New “Key Information” Informed Consent Requirements (2018). [ Google Scholar ] 45. Office of Human Research Compliance. Assessing Capacity to Consent in Adults: Guidance for Researchers. Weil Cornell Medicine. Updated 8/17/2021. https://research.weill.cornell.edu/sites/default/files/pi_guidance_assessing_capacity_to_consent_guide.pdf [ Google Scholar ] 46. Human Research Protection Program. Assessment of Decision Making Capacity in Adults Participating in a Research Study. Duke University Health System. https://irb.duhs.duke.edu/sites/default/files/2022-04/decision_making_capacity_4-15-2021.pdf [ Google Scholar ] 47. Office of Research Integrity. Vulnerable Populations - Impaired Consent Capacity Adults. University of Kentucky. 2025. https://www.research.uky.edu/office-research-integrity/vulnerable-populations-impaired-consent-capacity-adults [ Google Scholar ] 48. Jeste Dilip, Braff David, Dunn Laura, et al. Procedures for Determination of Decisional Capacity in Persons Participating in Research Protocols. The UCSD Task Force on Decisional Capacity, University of California San Diego. https://irb.ucsd.edu/_files/researchers/DecisionalCapacityAssessment1.pdf [ Google Scholar ] 49. Solomon ED, Mozersky J, Parsons MV, Baldwin K, Goodman M, DuBois JM. A training protocol compliance of 13% was observed in a research study of clinical research professionals. BMC research notes . Aug 1 2024;17(1):214. doi: 10.1186/s13104-024-06870-0 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 50. CITI Program. Get to Know the CITI Program. Accessed August 19, 2024. https://about.citiprogram.org/ 51. Mozersky JT, Antes AL, Baldwin K, Jenkerson M, DuBois JM. How do clinical research coordinators learn good clinical practice? A mixed methods study of factors that predict uptake of knowledge. Clinical trials. 2020;17(2):166–175. doi: 10.1177/1740774519893301 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 52. Klitzman RL. How IRBs view and make decisions about consent forms. Journal of empirical research on human research ethics : JERHRE. Feb 2013;8(1):8–19. doi: 10.1525/jer.2013.8.1.8 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 53. Larson EL, Teller A, Aguirre AN, Jackson J, Meyer DD. Assessing Usefulness and Researcher Satisfaction with Consent Form Templates. Journal of clinical and translational science. 2017;1(4):256–259. doi: 10.1017/cts.2017.296 [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] 54. Schneider C The practice of autonomy: Patients, doctors, and medical decisions. Oxford Unviersity Press; 1998:xxii, 307 p. [ Google Scholar ] 55. Gordon EJ. Living organ donors’ stories:(unmet) expectations about informed consent, outcomes, and care. Narrative Inquiry in Bioethics. 2012;2(1):1–6. [ DOI ] [ PubMed ] [ Google Scholar ] 56. McIntosh T, Walsh H, Baldwin K, et al. Evaluating ApoL1 Genetic Testing Policy Options for Transplant Centers: A Delphi Consensus Panel Project with Stakeholders. Clin J Am Soc Nephrol. Jan 8 2024; [ DOI ] [ PMC free article ] [ PubMed ] [ Google Scholar ] ACTIONS View on publisher site PDF (456.0 KB) Cite Collections Permalink RESOURCES Similar articles Cited by other articles Links to NCBI Databases Follow NCBI NCBI on X (formerly known as Twitter) NCBI on Facebook NCBI on LinkedIn NCBI on GitHub NCBI RSS feed Connect with NLM NLM on X (formerly known as Twitter) NLM on Facebook NLM on YouTube National Library of Medicine 8600 Rockville Pike Bethesda, MD 20894 Web Policies FOIA HHS Vulnerability Disclosure Help Accessibility Careers NLM NIH HHS USA.gov Back to Top

Related documents

• CONTENT ANALYSIS OF FREE AND PRIOR INFORMED CONSENT IMPLEMENTATION: BASIS FOR POLICY INTERVENTION#201448
• Justification of deferral of consent in the ACT-GLOBAL adaptive platform trial in stroke.#412880
• Implementing informed consent in federated medical research: a blueprint designed to safeguard data subject rights in Germany.#331273
• Implementing informed consent in federated medical research: a blueprint designed to safeguard data subject rights in Germany.#327005
• The 21st Century Challenge to Autonomy and Informed Consent#717510