Public involvement and engagement in scientific research and higher education: the only way is ethics?

BACKGROUND: Involving and engaging the public in scientific research and higher education is slowly becoming the norm for academic institutions in the United Kingdom and elsewhere. Driven by a wide range of stakeholders including regulators, funders, research policymakers and charities public involvement and public engagement are increasingly seen as essential in delivering open and transparent activity that is relevant and positively impacts on our society. It is obvious that any activities involving and engaging members of the public should be conducted safely and ethically. However, it is not clear whether conducting activities ethically means they require ethical approval from a research ethics committee. MAIN BODY: Although there is some guidance available from government organisations (e.g. the UK Health Research Authority) to suggest ethical approval is not required for such activities, requests from funders and publishers to have ethical approval in place is commonplace in the authors' experience. We explore this using case studies from our own institution. CONCLUSION: We conclude that any public-facing activity with the purpose to systemically investigate knowledge, attitudes and experiences of members of the public as research and as human participants requires prior approval from an ethics committee. In contrast, engaging and involving members of the public and drawing on lived experience to inform aspects of research and teaching does not. However, lack of clarity around this distinction often results in the academic community seeking ethical approval 'just in case', leading to wasted time and resources and erecting unnecessary barriers for public involvement and public engagement. Instead, ethical issues and risks should be appropriately considered and mitigated by the relevant staff within their professional roles, be it academic or a professional service. Often this can involve following published guidelines and conducting an activity risk assessment, or similar. Moving forward, it is critical that academic funders and publishers acknowledge the distinction and agree on an accepted approach to avoid further exacerbating the problem.

Involving and engaging members of the public is recognised best practice in university research and teaching. Involvement and engagement activities (for instance, working with the public to design a research study) continue to increase in priority and are an important part of an academic's role. However, there is often confusion amongst researchers and educators around whether involving the public in these activities requires prior ethical approval, similar to what would be the case when inviting members of the public to participate in a clinical research study, or to donate samples such as blood for experiments. As an example, sometimes researchers are asked for ethical approval by scientific journals when trying to publish the findings from their public involvement and engagement work, when in fact this is not needed. The ongoing uncertainty about the difference between actual research on one hand and public involvement and engagement on the other hand wastes precious time and resources, and is a barrier for scientists to working with the public. We have developed guidance for academic staff on when ethical approval is and is not required, using examples from our own experience. We wrote this article to bring awareness to this problem; share our views with the wider academic community; encourage discussion around the problem and possible solutions; and ultimately contribute to educating on when research ethics approval is needed, and when not.

Combining postgraduate research training, public engagement, and primary school science education-a Superbugs Master (MSc) class.

Since 2018, the 'Superbugs' initiative at Cardiff University (United Kingdom) has been delivering projects that take a research-driven approach to public engagement, involving rigorous evaluation of the methodologies of delivery and the mechanics of communication. The overall aim of Superbugs is to raise awareness and improve public knowledge of microbiology, infection and antimicrobial resistance (AMR). In the present project, four postgraduate students were recruited to undertake research projects as part of their Master of Science (MSc) studies. After a period of literature appraisals, the students chose to focus on the topic of personal and food hygiene and were tasked with collecting information on effective strategies for educating young children. Taking advantage of a focus group of primary school teachers, the students then designed evidence-informed educational activities and the evaluation strategies by which the impact of these would be assessed. A pilot delivery of these activities was carried out in a community setting at a local public library, before final delivery as part of a school outreach workshop. The MSc students produced three new elements of educational material; a story book, a treasure hunt and an interactive card game, primarily built around the concepts of challenge and gamification. Feedback collected from primary school pupils aged 6-7 years old and teachers indicated that the activities developed were successful in both being engaging to young people and resulting in an improved knowledge on the chosen topics. Taken together, we present evidence that postgraduate research training, underpinned by active and service learning, represents a valid and effective way of delivering impactful public engagement. In turn, the experience holds benefit for the students not only in terms of their academic study and core scientific skills, but also their wider appreciation and confidence in being effective engagers and science communicators.

Superbugs online: co-production of an educational website to increase public understanding of the microbial world in, on, and around us.

Digital tools and online presence have become a cornerstone in public engagement and involvement strategy and delivery. We here describe the co-production process behind launching a new multilingual resource for schools in the United Kingdom and beyond, jointly between university scientists, engagement professionals, primary and secondary teachers, and web designers. The 'Superbugs' website aims at raising awareness and increasing the public understanding of the microbial world in, on, and around us-with a focus on infection, hygiene, and antimicrobial resistance-and attracted >19,000 online visitors, >33,500 page views, and > 775,000 Twitter impressions over the past 24 months. Superbugs.online is available in English, Welsh, Irish, and Scottish Gaelic, thus making it accessible to everyone in the United Kingdom and Ireland, regardless of the language in which they receive and deliver their science education. The website is easy to navigate and features background information, quizzes, animations, videos, illustrated stories, interactive timelines, games, and protocols for home experiments. All materials are presented in a non-prescriptive way, aimed at allowing flexibility for the materials to be adapted to the individual needs of teachers and pupils alike. Our study has led to a demonstrable impact on the co-production team and on pupils and teachers as key stakeholders, based on a comprehensive evaluation of the co-production process itself, the impact of the end product, and the creation of lasting relationships with stakeholders and co-producers, for the mutual benefit of everyone involved.

Diversity in patient and public involvement in healthcare research and education-Realising the potential.

BACKGROUND: Patient and public involvement (PPI) is an increasing priority in health-related research and education. Attracting and supporting people from different demographic groups to give up their time and get involved is important to help ensure that all parts of society are empowered, represented and their voices heard in decisions that may affect their health and quality of life. OBJECTIVES: (1) To determine if a demographically diverse cross-section of society would be interested in contributing to healthcare research and education. (2) To understand factors that can act as barriers and enablers to effective and diverse PPI. METHOD: PPI survey data was collected via engagement events, with the aim of scoping interest in PPI from a diverse public. A Focus Group study involving members of the public, academic and professional service staff, was then conducted to gain a deeper understanding around the barriers and enablers of diversity within PPI. RESULTS: 71% of a diverse rich public indicated they would like to get involved in healthcare research and teaching. 76% of survey respondents indicated that they would be happy to share a personal or family experience of healthcare. The two biggest factors impacting on our cohort getting involved are' availability of time' and 'being aware of PPI opportunities'. These factors may disproportionally affect specific groups. Shared and individual PPI enablers and barriers were identified across all stakeholder groups within the Focus Group Study, as well as generic and novel factors that would impact on an institutions' ability to improve PPI diversity. CONCLUSION: These data points confirm a demographically diverse public's appetite to get involved in academic health research and teaching. This needs to be recognised and harnessed to ensure public contributor networks are representative of society. Equality Impact Assessments should be undertaken in relation to all PPI opportunities. There is a need to recognise the investment of time and resources required to build mutually beneficial relationships with diverse communities as well as the development of inclusive 'fit for purpose' PPI infrastructures to support the uptake of diverse PPI contributors. PUBLIC CONTRIBUTION: This study involved members of the public responding to a short survey. Public contributors made up one of the three focus groups. The School of Medicine lead public contributor was also involved in the preparation of this manuscript.

Overcoming the disconnect between scientific research and the public.

In biomedical research, there is no situation where public engagement (PE) and public involvement (PI) are not possible, important or even expected. Whether we work in the clinic or in the laboratory, all researchers have a duty to reach out, demonstrate the added value that science brings to society, and make a real difference to the way research is done. Here we outline the benefits of PE and PI for individual researchers and their employers, for members of the public, and for society at large. We offer solutions to overcome major challenges, including a step-by-step guide for researchers to embrace PE and PI in their career, and make a call to action for a cultural shift towards embedding PE and PI in our modern academic environment.

Long-acting cabotegravir and rilpivirine for HIV-1 suppression: switch to 2-monthly dosing after 5 years of daily oral therapy.

OBJECTIVES: Long-acting formulations of cabotegravir (CAB) and rilpivirine (RPV) have demonstrated efficacy in Phase 3 studies. POLAR (NCT03639311) assessed antiviral activity and safety of CAB+RPV long-acting administered every 2 months (Q2M) in adults living with HIV-1 who previously received daily oral CAB+RPV in LATTE (NCT01641809). DESIGN: A Phase 2b, multicenter, open-label, rollover study. METHODS: LATTE participants with plasma HIV-1 RNA less than 50 copies/ml who completed at least 300 weeks on study were eligible. Participants elected to switch to either CAB+RPV long-acting Q2M or daily oral dolutegravir/RPV for maintenance of virologic suppression. The primary endpoint was the proportion of participants with HIV-1 RNA greater than or equal to 50 copies/ml at Month 12 (M12) per the Food and Drug Administration Snapshot algorithm. The incidence of confirmed virologic failure (CVF, two consecutive HIV-1 RNA measurements greater than or equal to 200 copies/ml), as well as safety, laboratory, and patient-reported outcomes (HIV Treatment Satisfaction and preference questionnaires) were also assessed. RESULTS: Of 97 participants enrolled, 90 chose to receive CAB+RPV long-acting and seven chose dolutegravir/RPV. At M12, no participant had HIV-1 RNA greater than or equal to 50 copies/ml or met the CVF criterion in either treatment group. No new safety signals were identified. Total treatment satisfaction was high at Baseline and remained stable through M12 across both treatment groups. Overall, 88% (n = 77/88) of long-acting arm participants preferred CAB+RPV long-acting to oral CAB+RPV. CONCLUSION: CAB+RPV long-acting maintained virologic suppression in participants who had previously received daily oral CAB+RPV for at least 5 years in LATTE, with a favorable safety profile. Most participants preferred CAB+RPV long-acting to their prior oral CAB+RPV regimen at M12.

ECMO Flow as a Sign of Intraabdominal Hemorrhage After Prolonged CPR.

Although life-saving, cardiopulmonary resuscitation (CPR) has been associated with traumatic injuries in adult patients surviving cardiac arrest. In addition to rib and sternal fractures, intraabdominal injuries have also been shown to occur, particularly after prolonged external cardiac massage. Early detection of these injuries remains difficult and is often masked by concomitant hemodynamic instability and the higher likelihood of other injuries such as retroperitoneal hemorrhage. Accurate diagnosis is further complicated when venoarterial (VA) extracorporeal membrane oxygenation (ECMO) is instituted. As such, it is imperative for ECMO providers to maintain a high index of suspicion for intraabdominal/intraperitoneal solid organ injury and hemoperitoneum when managing patients who survive prolonged cardiac arrest. Furthermore, fluctuating or low ECMO circuit flow rates despite volume infusion may serve as indicators of intraabdominal bleeding and should be promptly assessed.

Development of a denaturing high-performance liquid chromatography screening method for SMAD4 in juvenile polyposis syndrome.

BACKGROUND: Juvenile polyposis syndrome is an inherited condition associated with the development of gastrointestinal polyps and subsequent cancer. An efficient denaturing high-performance liquid chromatography (DHPLC) screening method has been developed to detect mutations in SMAD4, which account for around 20% of reported cases. METHODS: The nucleotide sequences of polymerase chain reaction (PCR)amplified SMAD4 exons were examined using WAVEMAKER software to determine suitable DHPLC conditions. Multiple wild-type controls were characterized by DHPLC, and known mutations analysed where available. RESULTS: DHPLC elution profiles for wild-type and variant SMAD4 alleles were successfully characterized across a range of column oven temperatures. CONCLUSIONS: DHPLC analysis of SMAD4 has been refined to an efficient screening protocol that uses the minimal number of column oven temperatures for reliable mutation detection.

Effect of tattoos on perceptions of credibility and attractiveness.

This study examined the effects of tattooing on perception of a male's and a female's credibility and attractiveness. 74 undergraduates viewed a photograph of a tattooed or nontattooed male or female model and then rated dimensions of the models' credibility and attractiveness. Analysis indicated that, although the models' attractiveness ratings were not affected by having a tattoo, their credibility ratings were generally lower when wearing a tattoo than when not wearing one.