A training protocol compliance of 13% was observed in a research study of clinical research professionals.

OBJECTIVE: We attempted to conduct a randomized controlled trial of three different informed consent training formats to evaluate their effectiveness. We recruited 503 clinical research professionals, who received $50 for participation. Incidental findings showed unexpectedly low rates of compliance with completing the study training protocols, resulting in insufficient statistical power to test our original hypotheses. In this report, we conducted a secondary analysis of the data in which we characterize and evaluate the observed low compliance. This involved using literature on average reading times, speed-reading times, and video play speeds to calculate the timeframes required to complete the three training formats. RESULTS: Only 13% of participants completed the training in a reasonable timeframe. Furthermore, only 46% of participants completed the training in the minimum possible timeframe. These findings lead us to ask whether online research training is effective, since no training can be effective if participants do not actually complete the training. Given extensive requirements for educational training among clinical research professionals, we feel the burden of proof is on training programs to demonstrate that they have positive effects.

Seeking help as a strategy for ethical and professional decision-making in research: Perspectives of researchers from East Asia and the United States.

Background: A person's cultural background shapes how they interpret and navigate problems. Given that large numbers of international researchers work and train in the U.S. we sought to better understand how researchers use the decision-making strategy of seeking help to navigate ethical and professional challenges.Methods: Participants (N = 300) were researchers working or training in the U.S. who were born in East Asia (EA) or born in the U.S. They completed a screening survey; then a subset completed think-aloud interviews (n = 66) focused on how they would respond to three hypothetical research scenarios.Results: Thematic analysis of the transcripts showed that seeking help was a commonly endorsed strategy, with some nuances between groups. Themes included seeking help in the form of getting advice, seeking someone to help solve the problem, and gathering information. Endorsement of the seeking help strategy frequently depended on participants' relationships; desiring to seek help from people they trusted. Notably, EA participants tended to prefer seeking help in ways that avoided reputational harm to others.Conclusion: A better understanding of how researchers from different cultural backgrounds use decision-making strategies can inform how to make educational programs more inclusive and comprehensive to more effectively develop researchers' ethical and professional decision-making skills.

Barriers to Using Legally Authorized Representatives in Clinical Research with Older Adults.

Background: Older adults are at increased risk of cognitive impairments including Alzheimer's disease dementia. Legally authorized representatives (LARs) can provide informed consent when a participant is no longer able to, but little is known about barriers to incorporating them in research. Objective: Explore reasons for not asking and documenting participant decisions to appoint LARs among researchers conducting clinical intervention trials studying older adults or individuals with cognitive impairments. Methods: Mixed method design consisting of a survey (N = 1,284) and qualitative interviews (N = 40) regarding barriers to incorporating LARs. Participants were principal investigators and clinical research coordinators. Results: 37% (N = 469) had not asked and documented participant decisions about appointing LARs in the prior year. They had significantly lower confidence in resources available to incorporate LARs and lower positive attitudes compared to their counterparts who had done so. The majority (83%) had no trials studying individuals with cognitive impairments and reported LARs were not applicable. A minority (17%) had at least one trial studying individuals with cognitive impairments and reported being unaware of LARs. Qualitative findings indicate discomfort broaching a sensitive topic especially with individuals who are not yet impaired. Conclusion: Resources and education to increase awareness and knowledge of LARs are needed. Researchers studying older adults should, at minimum, have the knowledge and resources to incorporate LARs when necessary. Stigma and discomfort discussing LARs will need to be overcome, as early proactive discussions before a participant loses decisional capacity could enhance participant autonomy and facilitate recruitment and retention of older adults to research.

A randomized implementation trial to increase adoption of evidence-informed consent practices.

Introduction: Several evidence-informed consent practices (ECPs) have been shown to improve informed consent in clinical trials but are not routinely used. These include optimizing consent formatting, using plain language, using validated instruments to assess understanding, and involving legally authorized representatives when appropriate. We hypothesized that participants receiving an implementation science toolkit and a social media push would have increased adoption of ECPs and other outcomes. Methods: We conducted a 1-year trial with clinical research professionals in the USA (n = 1284) who have trials open to older adults or focus on Alzheimer's disease. We randomized participants to receive information on ECPs via receiving a toolkit with a social media push (intervention) or receiving an online learning module (active control). Participants completed a baseline survey and a follow-up survey after 1 year. A subset of participants was interviewed (n = 43). Results: Participants who engaged more with the toolkit were more likely to have tried to implement an ECP during the trial than participants less engaged with the toolkit or the active control group. However, there were no significant differences in the adoption of ECPs, intention to adopt, or positive attitudes. Participants reported the toolkit and social media push were satisfactory, and participating increased their awareness of ECPs. However, they reported lacking the time needed to engage with the toolkit more fully. Conclusions: Using an implementation science approach to increase the use of ECPs was only modestly successful. Data suggest that having institutional review boards recommend or require ECPs may be an effective way to increase their use.

Responding to Sexual Abuse in Health Care: Development of a Guide for Patients.

This report details the development of a stakeholder- and evidence-informed online resource guide for patients that provides information to raise awareness about sexual abuse in health care, the value of chaperones, and options for responding to sexual abuse. The guide was developed to reflect lessons learned from 10 years of researching physician wrongdoing (ie, sexual violations, improper prescribing, and unnecessary invasive procedures), a 5-year National Institutes of Health-funded mixed-methods study of 280 cases of egregious wrongdoing in medicine, and an expert working group. Focus groups were conducted with 22 patients from diverse backgrounds to obtain feedback on the acceptability of the guide. Thematic analysis of the focus groups yielded 6 key themes: 1) empowering patients, 2) recognizing and responding to sexual abuse, 3) educating patients about reporting options, 4) educating patients on availability of chaperones, 5) balancing trust and mistrust, and 6) using simple language. Qualitative data from the focus groups (ie, audio files and detailed notes taken by the research team) suggested that the guide effectively informed and empowered patients to recognize and effectively respond to sexual misconduct in health care. The guide is publicly available and has been disseminated nationally to patient health advocates and public health agencies.

Assessing the climate for research ethics in labs: Development and validation of a brief measure.

The environment researchers work in influences their ethical decisions and behavior. A "climate" for research ethics in a research lab exists when members of the lab perceive that the group values and is committed to principles of research ethics. In this study, we aimed to develop a short, reliable and valid measure assessing perceptions of climate for research ethics at the lab level. The resulting measure, Lab Climate for Research Ethics, was developed using standard scale development guidelines. In a large sample of postdoctoral researchers (N = 570), we found preliminary evidence that the new measure has adequate internal consistency reliability. It was also correlated with an existing measure of climate for research ethics and was not correlated with social desirability, demonstrating evidence of construct validity. The new measure can be used in a variety of contexts, including research administrators seeking information about climate within labs across an institution and researchers who study lab environments.

Understanding the Use of Optimal Formatting and Plain Language When Presenting Key Information in Clinical Trials.

Recent revisions to the Common Rule require that consent documents begin with a focused presentation of the study's key information that is organized to facilitate understanding. We surveyed 1,284 researchers working with older adults or individuals with Alzheimer's disease, supplemented with 60 qualitative interviews, to understand current use and barriers to using evidence-based formatting and plain language in key information. Researchers reported using formatting in 42% of their key information sections, and plain language in 63% of their key information sections. Perceived barriers included lack of knowledge, Institutional Review Board, other members of their team, and the burden associated with implementation. Education and training are required to increase adoption of the practices.

Development of a Resource Guide to Help Patients Receive Appropriate Care.

After 10 years researching physician wrongdoing (i.e., sexual violations, improper prescribing, and unnecessary procedures), we developed a resource guide to help patients receive appropriate care and respond to inappropriate care. We gathered evaluative patient feedback, engaged physicians, and disseminated the guide. It is available at beforeyourvisit.org.

Perceived barriers to assessing understanding and appreciation of informed consent in clinical trials: A mixed-method study.

INTRODUCTION: Participants and research professionals often overestimate how well participants understand and appreciate consent information for clinical trials, and experts often vary in their determinations of participant's capacity to consent to research. Past research has developed and validated instruments designed to assess participant understanding and appreciation, but the frequency with which they are utilized is unknown. METHODS: We administered a survey to clinical researchers working with older adults or those at risk of cognitive impairment (N = 1284), supplemented by qualitative interviews (N = 60). RESULTS: We found that using a validated assessment of consent is relatively uncommon, being used by only 44% of researchers who had an opportunity. Factors that predicted adoption of validated assessments included not seeing the study sponsor as a barrier, positive attitudes toward assessments, and being confident that they had the resources needed to implement an assessment. The perceived barriers to adopting validated assessments of consent included lack of awareness, lack of knowledge, being unsure of how to administer such an assessment, and the burden associated with implementing this practice. CONCLUSIONS: Increasing the use of validated assessments of consent will require educating researchers on the practice and emphasizing very practical assessments, and may require Institutional Review Boards (IRBs) or study sponsors to champion the use of assessments.

How are US institutions implementing the new key information requirement?

Recent revisions to the Federal Policy for the Protections of Human Subjects require that informed consent documents begin with a "concise and focused presentation" of the key information a participant requires. Key information "must be organized and presented in a way that facilitates comprehension." The regulations do not specify what information be included, nor how it must be presented to facilitate comprehension. It is unknown how institutions and Institutional Review Boards (IRBs) are interpreting the current regulations. We conducted a review of randomly sampled available key information templates at 46 US medical institutions to determine how they are implementing the new regulations.

Judging scandal: Standards or bias in politics.

As the number of political scandals rises, we examined the circumstances that might influence how a politician would be judged as a result of a scandal. Specifically, we hypothesized that ingroup bias theory and shifting standards theory would produce different patterns of judgements. In two studies, we found support for the ingroup bias theory, such that participants rated the fictitious politician's public approval and perceived character as higher if the politician was a member of their own political party (i.e. their ingroup) than if the politician was a member of the another political party (i.e. their outgroup). These results may explain, in part, why people may judge politicians involved in scandal more or less harshly depending on whether they are an ingroup member or outgroup member.

Formation of the Inclusive Environments and Metrics in Biology Education and Research (iEMBER) Network: Building a Culture of Diversity, Equity, and Inclusion.

The Inclusive Environments and Metrics in Biology Education and Research (iEMBER) network is a newly forming national community of practice that engages diversity, equity, and inclusion stakeholders in interdisciplinary collaborative projects. iEMBER was initiated with incubator funding from the National Science Foundation program for Research Coordination Networks in Undergraduate Biology Education. In June 2017, biology education researchers, social scientists, biologists, and program and policy administrators, all with interests in diversity, equity, and inclusion, met to lay the foundation for the iEMBER network. iEMBER provides a distinct forum to coordinate efforts through networking, professional development, and the initiation of collaborative research. iEMBER advances science, technology, engineering, and mathematics reform focused on diversity, equity, and inclusion through the initiation of research teams at the iEMBER biennial conference and outreach efforts at discipline-specific meetings and conferences. The focus of iEMBER is on understanding how to create inclusive, supportive, and engaging environments to foster the success of all biology students and trainees. This report focuses on the structure of the iEMBER network, two takeaways that emerged from the 2017 conference (interdisciplinary networking/collaboration and intradisciplinary broadening participation strategies), and ways for prospective members to engage in ongoing dialogue and future events. Learn more at http://iember.org .

A Mixed-Methods Investigation of Clicker Implementation Styles in STEM.

Active learning with clickers is a common approach in high-enrollment, lecture-based courses in science, technology, engineering, and mathematics. In this study, we describe the procedures that faculty at one institution used when implementing clicker-based active learning, and how they situated these activities in their class sessions. Using a mixed-methods approach, we categorized faculty into four implementation styles based on quantitative observation data and conducted qualitative interviews to further understand why faculty used these styles. We found that faculty tended to use similar procedures when implementing a clicker activity, but differed on how they situated the clicker-based active learning into their courses. These variations were attributed to different faculty goals for using clicker-based active learning, with some using it to engage students at specific time points throughout their class sessions and others who selected it as the best way to teach a concept from several possible teaching techniques. Future research should continue to investigate and describe how active-learning strategies from literature may differ from what is being implemented.