Managing community engagement in research in Uganda: insights from practices in HIV/AIDS research.

BACKGROUND: Community engagement (CE) in research is valuable for instrumental and intrinsic reasons. Despite existing guidance on how to ensure meaningful CE, much of what it takes to achieve this goal differs across settings. Considering the emerging trend towards mandating CE in many research studies, this study aimed at documenting how CE is conceptualized and implemented, and then providing context-specific guidance on how researchers and research regulators in Uganda could think about and manage CE in research. METHODS: We conducted qualitative interviews and focus group discussions involving forty-one respondents who were experienced in HIV/AIDS biomedical research involving CE. Thirty-eight of these were directly or indirectly associated with Uganda's leading research institution in the field of HIV/AIDS. They included Principal Investigators, Community Liaisons Officers, Research Ethics Committee members and Community Advisory Board Members. Three respondents were from Uganda National Council for Science and Technology. Data were collected between August 2019 and August 2020, using audio-taped focus group discussions and key informant interviews, transcribed and analyzed manually to generate themes and subthemes. RESULTS: Three major themes emerged: goals or value of CE; the means of CE, and, the evaluation of CE. Goals or value of CE generated four subthemes representing the overarching goals of CE: (1) Promote communities' agency; (2) Generate and sustain trust; (3) Protect and promote communities' rights and interests; and, (4) Help studies optimize participation in the form of enrolment and retention of participants. What usually comes under the nomenclatures of methods, strategies, and approaches of CE, such as town-hall meetings, sports events, drama, and the like, should simply be understood as the means of CE, and it is not desirable to hold pre-conceived and fixed ideas about the best means to conduct CE in research since a lot depend on the context. Finally, the study found that despite CE's critical importance, which suggests the need to track and evaluate it, CE is currently intermittently evaluated, and for inadequate motivations. CONCLUSIONS: Existing guidance on how to conduct robust CE in research is no substitute for creativity, flexibility, and reflexivity on the part of both researchers and research regulators.

Randomized comparison of two interventions to enhance understanding during the informed consent process for research.

BACKGROUND/AIMS: Many investigators have tested interventions to improve research participant understanding of information shared during the informed consent process, using a variety of methods and with mixed results. A valid criticism of most consent research is that studies are often conducted in simulated research settings rather than ongoing clinical studies. The present study rigorously tested two simple and easily adoptable strategies for presenting key consent information to participants eligible to enroll in six actual clinical trials (i.e. six parent studies). METHODS: In collaboration with the study team from each parent study, we developed two consent interventions: a fact sheet and an interview-style video. The content of each of the intervention was based on the information shared in the consent form approved for each parent study. Participants were randomized to the standard consent process, or to one of the two interventions. Once exposed to the assigned consent mode, participants were asked to complete an assessment of understanding. The study was powered to determine whether those exposed to the fact sheet or video performed better on the consent assessment compared to those exposed to the standard consent. We also assessed participant satisfaction with the consent process. RESULTS: A total of 284 participants were randomized to one of the three consent arms. Assessments of understanding were completed with a total of 273 participants from July 2017 to April 2019. Participants exposed to the video had better understanding scores compared to those exposed to the standard consent form process (p value = 0.020). Participants were more satisfied with the video when compared to the standard consent. Participants who received the fact sheet did not achieve higher overall understanding or satisfaction scores when compared to the standard consent process. CONCLUSION: This randomized study of two novel consent interventions across six different clinical trials demonstrated a statistically significant difference in participant understanding based on overall scores among those exposed to the video intervention compared to those exposed to the standard consent.

A randomized study of multimedia informational aids for research on medical practices: Implications for informed consent.

BACKGROUND/AIMS: Participant understanding is a key element of informed consent for enrollment in research. However, participants often do not understand the nature, risks, benefits, or design of the studies in which they take part. Research on medical practices, which studies standard interventions rather than new treatments, has the potential to be especially confusing to participants because it is embedded within usual clinical care. Our objective in this randomized study was to compare the ability of a range of multimedia informational aids to improve participant understanding in the context of research on medical practices. METHODS: We administered a web-based survey to members of a proprietary online panel sample selected to match national US demographics. Respondents were randomized to one of five arms: four content-equivalent informational aids (animated videos, slideshows with voice-over, comics, and text) and one no-intervention control. We measured knowledge of research on medical practices using a summary knowledge score from 10 questions based on the content of the informational aids. We used analysis of variance and paired t-tests to compare knowledge scores between arms. RESULTS: There were 1500 completed surveys (300 in each arm). Mean knowledge scores were highest for the slideshows with voice-over (65.7%), followed by the animated videos (62.7%), comics (60.7%), text (57.2%), and control (50.3%). Differences between arms were statistically significant except between the slideshows with voice-over and animated videos and between the animated videos and comics. Informational aids that included an audio component (animated videos and slideshows with voice-over) had higher knowledge scores than those without an audio component (64.2% vs 59.0%, p < .0001). There was no difference between informational aids with a character-driven story component (animated videos and comics) and those without. CONCLUSION: Our results show that simple multimedia aids that use a dual-channel approach, such as voice-over with visual reinforcement, can improve participant knowledge more effectively than text alone. However, the relatively low knowledge scores suggest that targeted informational aids may be needed to teach some particularly challenging concepts. Nonetheless, our results demonstrate the potential to improve informed consent for research on medical practices using multimedia aids that include simplified language and visual metaphors.

A Journey in Public Health Ethics.

While medical ethics has a long history, and research ethics guidance emerged more formally in the 1960s and 1970s, frameworks for public health ethics began to appear in the 1990s. The author's thinking about public health ethics evolved from consideration of some of the ethics and policy questions surfacing regularly in the HIV/AIDS epidemic. This essay discusses some of the shared commitments of public health and ethics, as well as how one might apply an ethics lens to public health programs, both generally and in the contexts of public health preparedness and obesity prevention.

A pilot study of simple interventions to improve informed consent in clinical research: feasibility, approach, and results.

BACKGROUND: Research suggests that participants do not always adequately understand studies. While some consent interventions increase understanding, methodologic challenges have been raised in studying consent outside of actual trial settings. This study examined the feasibility of testing two consent interventions in actual studies and measured effectiveness of interventions in improving understanding. METHODS: Participants enrolling in any of eight ongoing clinical trials were sequentially assigned to one of three different informed consent strategies for enrollment in their clinical trial. Control participants received standard consent procedures for their trial. Participants in the first intervention arm received a bulleted fact sheet summarizing key study information. Participants in the second intervention arm received the bulleted fact sheet and also engaged in a feedback Q&A session. Later, patients answered closed- and open-ended questions to assess patient understanding and literacy. Descriptive statistics, Wilcoxon -Mann -Whitney and Kruskal-Wallis tests were generated to assess correlations; regression analysis determined predictors of understanding. RESULTS: 144 participants enrolled. Using regression analysis, participants receiving the second intervention scored 7.6 percentage points higher (p = .02) on open-ended questions about understanding than participants in the control, although unadjusted comparisons did not reach statistical significance. CONCLUSIONS: Our study supports the hypothesis that patients receiving both bulleted fact sheets and a Q&A session had higher understanding compared to standard consent. Fact sheets and short structured dialog are quick to administer and easy to replicate across studies and should be tested in larger samples.

Ethics of Adaptive Designs for Randomized Controlled Trials.

Over recent decades, adaptive trial designs have been used more and more often for clinical trials, including randomized controlled trials (RCTs). This rise in the use of adaptive RCTs has been accompanied by debates about whether such trials offer ethical and methodological advantages over traditional, fixed RCTs. This study examined how experts on clinical trial methods and ethics believe that adaptive RCTs, compared to fixed ones, affect the ethical character of clinical research. We conducted in-depth interviews with 17 researchers from bioethics, epidemiology, biostatistics, and/or medical backgrounds. While about half believed that adaptive trials are more complex and may thus threaten autonomy, these respondents also expressed that this challenge is not insurmountable. Most respondents expressed that efficiency and potential for participant benefit were the main justifications for adaptive trials. There was tension about whether adaptive randomization in response to increasing information disrupts clinical equipoise, with some respondents insisting that uncertainty still exists and therefore clinical equipoise is not disrupted. These findings suggest that further discussion is needed to increase the awareness and utility of these study designs.

Development of a research ethics knowledge and analytical skills assessment tool.

INTRODUCTION: The goal of this project was to develop and validate a new tool to evaluate learners' knowledge and skills related to research ethics. METHODS: A core set of 50 questions from existing computer-based online teaching modules were identified, refined and supplemented to create a set of 74 multiple-choice, true/false and short answer questions. The questions were pilot-tested and item discrimination was calculated for each question. Poorly performing items were eliminated or refined. Two comparable assessment tools were created. These assessment tools were administered as a pre-test and post-test to a cohort of 58 Indian junior health research investigators before and after exposure to a new course on research ethics. Half of the investigators were exposed to the course online, the other half in person. Item discrimination was calculated for each question and Cronbach's α for each assessment tool. A final version of the assessment tool that incorporated the best questions from the pre-/post-test phase was used to assess retention of research ethics knowledge and skills 3 months after course delivery. RESULTS: The final version of the REKASA includes 41 items and had a Cronbach's α of 0.837. CONCLUSION: The results illustrate, in one sample of learners, the successful, systematic development and use of a knowledge and skills assessment tool in research ethics capable of not only measuring basic knowledge in research ethics and oversight but also assessing learners' ability to apply ethics knowledge to the analytical task of reasoning through research ethics cases, without reliance on essay or discussion-based examination. These promising preliminary findings should be confirmed with additional groups of learners.

Research ethics capacity development in Africa: exploring a model for individual success.

The Johns Hopkins-Fogarty African Bioethics Training Program (FABTP) has offered a fully-funded, one-year, non-degree training opportunity in research ethics to health professionals, ethics committee members, scholars, journalists and scientists from countries across sub-Saharan Africa. In the first 9 years of operation, 28 trainees from 13 African countries have trained with FABTP. Any capacity building investment requires periodic critical evaluation of the impact that training dollars produce. In this paper we describe and evaluate FABTP and the efforts of its trainees. Our data show that since 2001, the 28 former FABTP trainees have authored or co-authored 105 new bioethics-related publications; were awarded 33 bioethics-related grants; played key roles on 78 bioethics-related research studies; and participated in 198 bioethics workshops or conferences. Over the past nine years, trainees have collectively taught 48 separate courses related to bioethics and have given 170 presentations on various topics in the field. Many former trainees have pursued and completed doctoral degrees in bioethics; some have become editorial board members for bioethics journals. Female trainees were, on average, less experienced at matriculation and produced fewer post-training outputs than their male counterparts. More comprehensive studies are needed to determine the relationships between age, sex, previous experience and training program outputs.

Learning Health Care and the Obligation to Participate in Research.

This commentary responds to the article "Compulsory Research in Learning Health Care: Against a Minimal Risk Limit," by Robert Steel. Steel acknowledges that our ethics framework for a learning health care system, published in the 2013 special report Ethical Oversight of Learning Health Care Systems , includes an obligation on the part of patients to participate in learning activities, but he argues that this obligation does not go far enough. Steel, who provides an interesting justification for compulsory research participation in learning health care, claims that our obligation is limited to only minimal risk research. We take exception to that characterization insofar as it detracts from what we believe is most relevant for assessing learning activities, which is how much additional risk and burden a learning activity poses compared to clinical care alone. We also clarify that the level of additional risk is not the only morally relevant consideration in determining if a learning activity should be compulsory. Also important is whether the learning activity includes interventions or choices that engage values of importance to patients.

Streamlined versus traditional consent for low-risk comparative effectiveness trials: a randomized experimental study to measure patients' and public attitudes.

Aim: Streamlining consent for low-risk comparative effectiveness research (CER) could facilitate research, while safeguarding patients' rights. Materials & methods: 2618 adults were randomized to one of seven consent approaches (six streamlined and one traditional) for a hypothetical, low-risk CER study. A survey measured understanding, voluntariness, and feelings of respect. Results: Participants in all arms had a high understanding of the trial and positive attitudes toward the consent interaction. Highest satisfaction was with a streamlined approach showing a video before the medical appointment. Participants in streamlined were more likely to mistakenly think a signature was required. Conclusion: Streamlined consent was no less acceptable than traditional, signed consent. Streamlined and traditional approaches achieved similar levels of understanding, voluntariness and a feeling that the doctor-patient interaction was respectful.

Treating Workers as Essential Too: An Ethical Framework for Public Health Interventions to Prevent and Control COVID-19 Infections among Meat-processing Facility Workers and Their Communities in the United States.

Meat is a multi-billion-dollar industry that relies on people performing risky physical work inside meat-processing facilities over long shifts in close proximity. These workers are socially disempowered, and many are members of groups beset by historic and ongoing structural discrimination. The combination of working conditions and worker characteristics facilitate the spread of SARS-CoV-2, the virus that causes COVID-19. Workers have been expected to put their health and lives at risk during the pandemic because of government and industry pressures to keep this "essential industry" producing. Numerous interventions can significantly reduce the risks to workers and their communities; however, the industry's implementation has been sporadic and inconsistent. With a focus on the U.S. context, this paper offers an ethical framework for infection prevention and control recommendations grounded in public health values of health and safety, interdependence and solidarity, and health equity and justice, with particular attention to considerations of reciprocity, equitable burden sharing, harm reduction, and health promotion. Meat-processing workers are owed an approach that protects their health relative to the risks of harms to them, their families, and their communities. Sacrifices from businesses benefitting financially from essential industry status are ethically warranted and should acknowledge the risks assumed by workers in the context of existing structural inequities.

Length and complexity of US and international HIV consent forms from federal HIV network trials.

BACKGROUND: Informed consent is required in most clinical research with humans. While federal regulations state consent information should be understandable to participants, concerns have been raised that consent forms are overly long and complex. DESIGN: Consent forms from 2006 HIV network trials sponsored by the National Institutes of Health (NIH), Division of AIDS (DAIDS), were analyzed for complexity and length. Comparisons were made between US and international sites, template and site forms, adult and pediatric trials, and trial type. How randomization and placebos were explained was examined as these are frequently misunderstood. RESULTS: One hundred twenty-four consent forms (21 template and 103 site forms) were reviewed. Median readability was 9.2 grade level, although confidentiality sections were 12.35 median grade level. International sites' forms had lower readability than US forms (p = 0.025), template forms had lower readability than site forms (p = 0.046), and adult forms were less complex than pediatric (parent) forms (p < 0.0001). Median length of all forms was 22.4 pages; the 85 forms from adult studies had a median length of 27.4 pages. Sections describing randomization were a median length of 53 words. CONCLUSIONS: Consent forms are extremely long, exceeding recommendations for how much information readily can be processed. Networks should consider providing shorter consent templates, consistent with federal recommendations, given that sites' forms are based on these models. Further research should examine whether forms emphasizing key information (rather than providing details about all aspects of the research) improve understanding of research.

What Factors Predict Willingness to Join Low-Risk Pragmatic Clinical Trials?

Pragmatic clinical trials (PCTs) may improve the efficiency, relevance, and representativeness of research. While prior research has indicated that willingness to join a PCT is high, it is not universal among those asked in surveys exploring attitudes toward hypothetical PCTs. The objective of this study was to examine what factors predict willingness to join a hypothetical low-risk PCT comparing two blood pressure medicines. In our study, 2,618 respondents, recruited from three populations (adult patients from an academic health system, adult patients from an integrated delivery system, and adults from an online nationally representative panel), completed an online survey. Most respondents (90%) expressed willingness to participate in the hypothetical PCT. The two key predictors of expressed willingness to join low-risk PCTs were respondents' understanding of key features of PCTs, including how they differ from traditional research, and the degree of importance respondents perceived comparative research to have. Increasing awareness of the rationale for PCTs and understanding of these trials, including how they differ from explanatory trials, may increase prospective participants' willingness to contribute to this effort.

The ethical review of health care quality improvement initiatives: findings from the field.

Questions have been raised about whether and how health care quality improvement (QI) initiatives ought to be reviewed to address possible ethical issues associated with them. These questions have focused primarily on whether some QI initiatives meet the regulatory criteria for human subject research and should therefore be regulated and reviewed as such. Based on surveys of health care system professionals conducting QI initiatives and hospital CEOs, this issue brief finds that QI initiatives are routinely reviewed by a variety of internal mechanisms prior to implementation, although rarely through an institutional review board or another independent body charged specifically with ethical oversight of QI initiatives. Further research, the authors say, is needed to achieve a better understanding of how review mechanisms for QI initiatives are structured, including information on who reviews these activities, how they are reviewed, and whether such processes include an ethical assessment of the proposed QI initiative.