Potential Research Participants Research Articles

Qualitative analysis of stakeholder perspectives on engaging Latinx patients in kidney-related research

BackgroundLatinx individuals are disproportionally burdened by kidney diseases compared to non-Latinx White individuals and are underrepresented in kidney-related research. We aimed to describe stakeholder perspectives on Latinx patient engagement in kidney-related research.MethodsWe conducted a thematic analysis of two online moderated discussions and an interactive online survey with open-text responses involving participants (i.e. stakeholders), with personal and/or professional experiences with Latinx patients with kidney diseases and their families/caregivers.ResultsAmong the eight stakeholders (Female:75%; Latinx ethnicity:88%), there were three physicians, one nurse, one patient with kidney disease who received a kidney transplant, one policy maker, one Doctor of Philosophy, and one executive director of a non-profit health organization. We identified five themes. The majority of themes and their respective subthemes (in parentheses) reflected barriers to engagement: Lack of personal relevance (unable to relate to research staff and marketing resources, and unclear benefit of research to self, family, and community); fear and vulnerability (immigration concerns, stigma with seeking care, skepticism of Western medicine); logistical and financial barriers (limited opportunities to enroll in clinical trials, out-of-pocket costs, transportation issues); and distrust and asymmetry of power (related to limited English proficiency or health literacy, and provider bias). The last theme centered on stimulating interest and establishing trust in the research process.ConclusionsTo overcome barriers to engagement in kidney-related research and establish trust among potential Latinx research participants, stakeholders recommended employing cultural responsiveness and community-based strategies. These strategies can help identify local health priorities, enhance research recruitment and retention strategies, and establish partnerships that continue to elevate research endeavors aiming to enhance the health of Latinx individuals with kidney diseases.

Perry Starlight, Ali Orbit and Kim Cosmos' alien encounter: creating a picturebook as information for children and parents participating in research

PurposeThis study explored whether the creation of an illustrated picturebook could explain the terms and practicalities of participatory, multi-method qualitative research to children aged four to eight years and their parents/carers, creating conditions to seek agreement to their participation, by using an age-appropriate design whilst adhering to ethical guidelines. The purpose of this paper is to explore how this was done addressing these issues.Design/methodology/approachDrawing on the researcher's previous professional experience working in children's publishing and taking an innovative and collaborative approach to giving information to child and parent/carer co-researchers, the researcher and an illustrator created a picturebook both as an eBook and a paperback book to recruit and explain research and co-researchers’ roles to young children and their parents/carers.FindingsThe picturebook successfully recruited 30 children and their parents/carers. Other children expressed their wish not to participate. These findings suggest that greater consideration should be given to the ways information is given to potential research participants, particularly the visual, material and paratextual elements of the information sheets and consent forms routinely used in research.Originality/valueThis paper offers insight into the publishing practicalities of creating innovative ways of giving information about research participation to children and parents/carers and how these ways might foster rich data collection.

Research Ethics during Pandemics: How IRBs Can Prepare.

The Covid-19 pandemic has raised a range of complex challenges for the research community in the United States. This essay uses Covid-19 as a model pandemic illness to consider two such issues that have yet to be fully explored in the ethics literature: first, whether the informed consent process should include a discussion of pandemic risks and, if so, how precisely these risks should be conveyed to potential research participants and, second, whether and under what circumstances vaccination status should be taken into consideration when enrolling subjects in non-pandemic-related studies during a pandemic.

Disclosing Conflicts of Interest to Potential Research Participants: Good for Nothing?

The growing commercialization of science has raised concerns about financial conflicts of interest (COIs). Evidence suggests that such conflicts threaten the integrity of research and the well-being of research participants. Trying to minimize these negative effects, federal agencies, academic institutions, and publishers have developed conflict-of-interest policies. Among such policies, recommendations or requirements to disclose financial COIs to potential research participants and patients have become commonplace. Here, I argue that disclosing conflicts of interest to potential research participants fails to achieve the weighty moral goals that presumably ground such policies. This is so either because disclosure is simply a wrong means for achieving some of the goals in question or because, although disclosure could be an appropriate means for some of those goals, the way in which it is implemented prevents fulfillment of the desirable moral aim.

An Emergency Department Survey on Research Participation in the Patient With Suicidal Ideation or Suicide Attempt

The patient expressing suicidal ideation is a common mental health presentation in the emergency department (ED) but a notion exists that this psychiatric crisis precludes them from research participation. In order to better understand the potential research participation of suicidal patients, this study surveyed patients in the ED with suicide attempt or ideation. This was an anonymized survey study interviewing 50 patients in a tertiary care ED with a chief complaint of suicide attempt or suicidal ideation. A script was read by the research assistant regarding a hypothetical research study using ketamine to treat suicidality in the ED and asked to rate their interest in participation in the study as well as their interest in a 1-week follow-up call. Most patients (84%) reported that they would be interested in participating in this research project while 96% of all 50 patients would be interested in a follow-up phone call at 1 week. The data from this study should help other emergency medicine and psychiatry researchers advance projects in this underserved ED patient population.

Informed Consent: Research Staff's Perspectives and Practical Recommendations to Improve Research Staff-Participant Communication.

Informed consent (IC) is the process of communication between research staff and potential research participants. However, ensuring that participants clearly understand what research participation entails, raises significant challenges. The aim of this study is to provide insight into some communication barriers that research staff are confronted with and make practical recommendations to improve communication between research staff and participants. A qualitative research study using semi-structured interviews (n = 13) with research staff from Ghent University Hospital was conducted. Data were transcribed verbatim and coded thematically. Our results indicate that communication- and process-related factors affect the IC process. Emergent recommendations include communication training, more interactive information materials and the use of digital alternatives, increasing general knowledge about research participation and patient- and public involvement.

You've Got a Friend in Me: How Cognitively Unimpaired Older Adults Select a Study Partner to Participate with Them in Alzheimer's Disease Research.

Participants in Alzheimer's disease (AD) prevention studies are generally required to enroll with a study partner; this requirement constitutes a barrier to enrollment for some otherwise interested individuals. Analysis of dyads enrolled in actual AD trials suggests that the study partner requirement shapes the population under study. To understand if individuals can identify someone to serve as their study partner and whether they would be willing to ask that individual. We conducted semi-structured interviews with cognitively unimpaired, English-speaking older adults who had previously expressed interest in AD research by signing up for a research registry. We also interviewed their likely study partners. Audio-recorded interviews were transcribed and coded in an iterative, team-based process guided by a content analysis approach. We interviewed 60 potential research participants and 17 likely study partners. Most potential participants identified one or two individuals they would be willing to ask to serve as their study partner. Interviewees saw value in the study partner role but also understood it to entail burdens that could make participation as a study partner difficult. The role was seen as relatively more burdensome for individuals still in the workforce or with family responsibilities. Calls from the researcher to discuss the importance of the role and the possibility of virtual visits were identified as potential strategies for increasing study partner availability. Efforts to increase recruitment, particularly representative recruitment, of participants for AD prevention studies should reduce barriers to participation by thoughtfully designing the study partner role.

Overcoming barriers to informed consent in neurological research: Perspectives from a national survey.

The ethical recruitment of participants with neurological disorders in clinical research requires obtaining initial and ongoing informed consent. The purpose of this study is to characterize barriers faced by research personnel in obtaining informed consent from research participants with neurological disorders and to identify strategies applied by researchers to overcome those barriers. This study was designed as a web-based survey of US researchers with an optional follow-up interview. A subset of participants who completed the survey were selected using a stratified purposeful sampling strategy and invited to participate in an in-depth qualitative interview by phone or video conference. Data were analyzed using a mixed methods approach, including content analysis of survey responses and thematic analysis of interview responses. Over 1 year, 113 survey responses were received from US research personnel directly involved in obtaining informed consent from participants in neurological research. Frequently identified barriers to informed consent included: cognitive and communication impairments (e.g. aphasia), unrealistic expectations of research participants, mistrust of medical research, time constraints, literacy barriers, lack of available social support, and practical or resource-related constraints. Strategies to enhance informed consent included: involving close others to support participant understanding of study-related information, collaborating with more experienced research personnel to facilitate training in obtaining informed consent, encouraging participants to review consent forms in advance of consent discussions, and using printed materials and visual references. Beyond conveying study-related information, researchers included in this study endorsed ethical responsibilities to support deliberation necessary to informed consent in the context of misconceptions about research, unrealistic expectations, limited understanding, mistrust, and/or pressure from close others. Findings highlight the importance of training researchers involved in obtaining informed consent in neurological research to address disease-specific challenges and to support the decision-making processes of potential research participants and their close others.

Democratising Ethical Regulation and Practice in Educational Research

This paper sets the context for questions covered in the Education Sciences Special Issue: Regulation and Ethical Practice for Educational Research: What are appropriate ethical appraisal and approval practices for particular contexts? How can ethics committees effectively support educational researchers and educational research? To do so, the paper argues for a democratising of ethical regulation and practice in educational research, which includes the decolonization agenda, to break away from enduring power imbalances in knowledge production. A key focus is on the regulation of educational research through ethics committees (whether institutional, regional and/or national) and how this affects research practice. While intended to help researchers to protect and benefit potential research participants, ethics committees themselves can have an important part to play in recognizing and removing barriers to inclusivity, as well as in erecting them, to maximise the benefits of educational research. To overturn the dominance of global North knowledge, for post-colonial research ethics regulation, broader conversations of researcher values and experiences in different parts of the world are needed. This paper explores how ethics committees’ expectations do and could shape researcher decision-making. It presents examples of approaches to ethical appraisal which would support empowerment and participation, not only for gatekeepers and participants but also for the research community, whether experienced researcher, ethics committee member or neophyte researcher. Evidence of ethical research practice which paves the way forward is drawn from a range of contexts to help acknowledge the enduring and wide-ranging impact of colonialism, neo-liberalism and neo-imperialism.

Laying the foundations of community engagement in Aboriginal health research: establishing a community reference group and terms of reference in a novel research field

BackgroundCommunity engagement or community involvement in Aboriginal health research is a process that involves partnering, collaborating and involving Aboriginal and Torres Strait Islander people or potential research participants to empower them to have a say in how research with Aboriginal communities is conducted. In the context of Aboriginal health, this is particularly important so that researchers can respond to the priorities of the community under study and conduct research in a way that is respectful of Aboriginal cultural values and beliefs. One approach to incorporating the principals of community engagement and to ensure cultural oversight and guidance to projects is to engage a community reference group. The aim of this study was to describe the process of establishing an Aboriginal community reference group and terms of reference. The community reference group was established to guide the research activities of a newly formed research collaboration aiming to to develop osteoarthritis care that meets the needs of Aboriginal and Torres Strait Islander people in Australia.MethodsAdopting a Participatory Action Research approach, this two-phase study was conducted in Victoria, Australia. In phase one, semi-structured research yarns (a cultural form of conversation used as a data gathering tool) were conducted collaboratively by Aboriginal and non-Aboriginal co-investigators to explore Aboriginal health stakeholder perspectives on establishing a community reference group and terms of reference. In phase two, recommendations in phase one were identified to invite members to participate in the community reference group and to ratify the terms of reference through a focus group. Data were analyzed using a framework analysis approach.ResultsThirteen people (eight female, four male) participated in phase one. Participants represented diverse professional backgrounds including physiotherapy, nursing, general practice, health services management, hospital liaison, cultural safety education, health research and the arts. Three themes were identified in phase one; Recruitment and Representation (trust and relationships, in-house call-outs, broad-spectrum expertise and Aboriginal majority); Purpose (community engagement, research steering, knowledge dissemination and advocacy) and; Function and Logistics (frequency and format of meetings, size of group, roles and responsibilities, authority, communication and dissemination). In phase two, six Aboriginal people were invited to become members of the community reference group who recommended changes which were incorporated into the seven domains of the terms of reference.ConclusionThe findings of this study are captured in a 10-step framework which describes practical strategies for establishing a community reference group and terms of reference in Aboriginal health research.

Developing and Implementing Electronic Consent Procedures in Response to Covid-19 Restrictions.

ABSTRACTThe Covid‐19 pandemic resulted in unprecedented restrictions on many public, private, and workplace activities throughout the United States and elsewhere. When restrictions were imposed, we were conducting a type III hybrid effectiveness‐implementation trial in 10 pediatric trauma centers. In response to several pandemic‐based restrictions, we had to develop procedures for engaging with potential research participants while limiting nonclinical, in‐person interactions. This manuscript describes the procedures and challenges of obtaining electronic informed consent and assent in a multisite trauma center‐based research study. We developed, tested, and trained staff to implement three options for obtaining informed consent. Twenty‐five participants were enrolled in the effectiveness‐implementation multisite trial during the first six months of utilization of the consent options, with eleven of these individuals enrolled using hybrid or electronic consent procedures. The challenges we identified involving electronic consent procedures included confusion over who would complete the electronic consent process and difficulties reconnecting with families. Lessons learned can strengthen electronic consent and assent procedures for future studies. More research is needed to further strengthen this process and increase its utilization.

Informed consent in a tuberculosis genetic study in Cameroon: information overload, situational vulnerability and diagnostic misconception

Concerns around comprehension and recall of consent information by research participants have typically been associated with low health and research literacy levels. In genomics research, this concern is heightened as the scientific and ethical complexities of genetics research, such as biobanking, genetic susceptibility, data sharing, and incidental findings may be more difficult for potential research participants to understand. However, challenges to research participants’ comprehension of consent information may be compounded by factors beyond health and research literacy levels. To identify factors that may impact research participants’ understanding and recall of consent information, we designed a qualitative study to explore whether participants enrolled in a tuberculosis genetics study (TBGEN-Africa) in Cameroon understood the objectives of the study, the risks and benefits and certain key aspects of the study such as biobanking and data sharing. The results showed that research participants had limited understanding and/or recall of the TBGEN-Africa study goals and methods. Some participants were of the opinion that TBGEN-Africa was not a genetics study because tuberculosis is not an inheritable condition. Factors that may have hindered understanding and/or recall of study information are diagnostic misconception (research participants consider research as part of medical diagnosis), and information overload and situational vulnerability (consent at a time of physical and emotional distress). There is a need for improved practices to support research participants’ understanding of consent information in genetics studies including designing the consent process in ways that minimize psychological distress and diagnostic/therapeutic misconception.

Embracing the uncertain—figuring out our own stories of flexibility and ethics in the field

In this paper, I document my fieldwork struggles in Kolkata India, to propose some common guiding notions of flexibility in the field. I argue that in moments of uncertainty, ethical judgment of the researcher should be a central guiding force while figuring out what flexibility looks like in the field. By detailing how I improvised research methods and ethics in the field based on the context of place, everyday lives of people in global South, and the political moment when the research was conducted, I offer two insights in the paper. First, I suggest that, apart from focusing on the prospects of information collection, it is important to be mindful of the daily practices of the potential research participants and the context of place while choosing qualitative methods, if the place is known to us prior to the fieldwork. However, having this awareness might not ensure that all methods choices will work in the field. Therefore, second, during the process of adapting to challenges and (re)strategizing research methodologies, I argue that being flexible should be viewed as more in line with being ethical and maintaining good practice in the field. In doing so, this paper calls for a broader ethical understanding that prioritizes compassion towards participants as well as oneself, which might necessitate going beyond institutionally defined regulations, to create a more inclusive geographical knowledge production process.

Solidarity and the ethics of exposing others to risk in medical research.

The ethical justifiability of the invitation of others to participate in research and their deliberate exposure to risks of harm is not a common topic in bioethics. If, however, some offers ought not to be made and the corresponding actions ought not to be facilitated, invitations to, and the conduct of, a medical study involving humans needs justification. This paper addresses this issue by linking the search for medical knowledge with solidarity. The argument begins with the observation that scientific research is aimed at general knowledge, which is a necessary condition of the social value of research. The applicability of this knowledge to many makes it potentially a public good; that is, a good that is available freely to all. For knowledge to be a public good, a social decision to make it freely available to all needs to be made. It is proposed that this decision be grounded in society's, and so in both researchers' and potential research participants', commitment to solidarity and its obligations of provision, sharing, support, and loyalty. These obligations imply, among other things, an imperfect obligation to participate in research and the corresponding entitlement of the investigators to invite others to participate in research, and so to expose them to its risks during implementation. This entitlement is exercised in an environment shaped by the standards and protections of research ethics and the relevant institutional arrangements.

Attitudes Toward Payment for Research Participation: Results from a U.S. Survey of People Living with HIV

Little is known about how payment affects individuals' decisions to participate in HIV research. Using data from a U.S. survey of people living with HIV (N = 292), we examined potential research participants’ attitudes toward payment, perceived study risk based on payment amount, and preferred payment forms, and how these factors vary by sociodemographic characteristics. Most respondents agreed people should be paid for HIV research participation (96%) and said payment would shape their research participation decisions (80%). Men, less formally educated individuals, and members of some minoritized racial-ethnic groups were less likely to be willing to participate in research without payment. Higher payment was associated with higher perceived study risks, while preferences for form of payment varied by age, gender, education, race-ethnicity, and census region of residence. Findings suggest payment may influence prospective research participants’ risk–benefit calculus and participation, and that a one-size-fits-all approach to payment could differentially influence participation among distinct sociodemographic groups.

Equipoise in Clinical Trials: Enough Uncertainty in Whose Opinion?

Equipoise in Clinical Trials: Enough Uncertainty in Whose Opinion?

Stroke survivors\u2019 preferences regarding study participation in rehabilitation research

BackgroundTo pursue high quality research, successful participant recruitment is essential, but recruitment rates are often low. This is specifically true in target populations with impairments, for instance, among stroke survivors. Previous studies focusing on recruitment have mainly relied on information from professionals, and there is therefore a need to contribute with new methodological insights to how potential rehabilitation research participants describe their interest and preferences to participate in research. The purpose of this study was to generate knowledge about stroke survivors’ interest in participating in rehabilitation research, reasons for being interested or not, and preferred forms and foci of rehabilitation interventions. An additional aim was to describe preferences regarding survey administration modes and processes for recruitment to studies.MethodThis cross-sectional study recruited Swedish residents who had sustained a stroke, initially by using advertisement on the National Stroke Association’s website, flyers posted at local occupational and physical therapy offices and at local stroke/senior organization meetings. Secondly, participants were recruited through a local stroke register. The survey, administered either in a paper form returned by postal mail; online or as a phone interview with 128 stroke survivors.ResultsMost of the participants were interested in participating in rehabilitation research, particularly younger persons (p = 0.001) and those closer to stroke onset (p = 0.047). Contribution to research, possibility to try new rehabilitation interventions and meeting others in the same situation were reasons that attracted an interest to participate. Other important aspects were related to motivation, individual needs, as well as how skilled the people who provided the intervention were. Participants preferred group-based programs, and programs focusing on regaining lost functions were highly requested. A majority wanted to be contacted through postal mail (70%) and most of them (90%) used the paper form to respond to the survey.ConclusionsA range of personal and external aspects, including challenges related to digitized administration modes, should be considered to achieve high participation rates in rehabilitation research targeting stroke survivors. The importance of addressing individual needs and prerequisites in an individualized manner should not be underestimated and might be a useful strategy to recruitment success.

Community engagement in research in sub-Saharan Africa: current practices, barriers, facilitators, ethical considerations and the role of gender - a systematic review.

meaningful community engagement is increasingly being considered the major determinant of successful research, innovation and intervention uptake. Even though there is available literature recommending community engagement in health research, there are still knowledge gaps in how communities might be best engaged in Sub-Saharan Africa. We, therefore, synthesized the existing literature on the current practices, barriers and facilitators, ethical considerations, and gender mainstreaming in the engagement of communities in research in sub-Saharan Africa. this synthesis was developed following the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA). A combination of keywords and medical subject headings was used to search MEDLINE, EMBASE, Global Health Library through OVID SP, the Cochrane Library, PsychINFO, CINAHL, WHO Afro Library, WHO Global Index Medicus and the National Institute for Health Research, for all literature published between 1 January 2000 to 31 July 2021. thirty articles met our inclusion criteria. The key reported facilitators of effective community engagement in research included appropriate community entry and engagement of stakeholders. Barriers to effective community engagement in research included the availability of prohibitive cultural, historical and religious practices; geographical/spatial limitations, difficulties in planning and executing community engagement activities and communication barriers. Awareness creation and sensitization on the research through drama, social media, documentaries, and community durbars are some of the existing practices adopted in engaging communities in research. Gender mainstreaming was not considered appropriately in the engagement of communities in research, as only a few studies made provisions for gender considerations, and most of the time, interchanging gender for sex. Respect for autonomy, privacy and informed consent were the main ethical issues reported. gender mainstreaming and ethical standards were reported as important, but not explored in depth. Gender as a social construct needs to be carefully integrated in the entire research cycle. Clear ethical concerns within a research project have to be co-discussed by the research team, community members and potential research participants.

Studying adolescent information behavior in the context of making everyday life decisions: Methodological issues, concerns, and possible solutions

This paper presents the main methodological issues met with during the research on adolescent everyday life information behavior in the context of making informed decisions, which was carried out in Croatia from 2018 to 2020. It does not focus on the research results, but rather on the methodological issues and concerns that had occurred stemming from the specific life period of the population being investigated, and on the ways the researchers delt with them. They are offered as potentially useful for consideration to those who will investigate adolescent information behavior in other contexts. Six main methodological dilemmas arose while planning the design of research methodology coming out from six questions: what would be the appropriate research approach and design to investigate adolescent information behavior in the context of making informed everyday life decisions, what would be the developmentally appropriate way to investigate the phenomena, how to gain access to the potential adolescent research participants, how to negotiate an adult researcher’s position when interacting with adolescents, how to get adolescent participants’ trust needed to collect rich data and what ethical issues need to be considered. We offer an overview of the dilemmas and concerns, as well as the ways they were dealt with, acknowledging the contribution of those scholars who had responded to similar challenges in the past.

Return of individual research results from genomic research: A systematic review of stakeholder perspectives.

Despite the plethora of empirical studies conducted to date, debate continues about whether and to what extent results should be returned to participants of genomic research. We aimed to systematically review the empirical literature exploring stakeholders' perspectives on return of individual research results (IRR) from genomic research. We examined preferences for receiving or willingness to return IRR, and experiences with either receiving or returning them. The systematic searches were conducted across five major databases in August 2018 and repeated in April 2020, and included studies reporting findings from primary research regardless of method (quantitative, qualitative, mixed). Articles that related to the clinical setting were excluded. Our search identified 221 articles that met our search criteria. This included 118 quantitative, 69 qualitative and 34 mixed methods studies. These articles included a total number of 118,874 stakeholders with research participants (85,270/72%) and members of the general public (40,967/35%) being the largest groups represented. The articles spanned at least 22 different countries with most (144/65%) being from the USA. Most (76%) discussed clinical research projects, rather than biobanks. More than half (58%) gauged views that were hypothetical. We found overwhelming evidence of high interest in return of IRR from potential and actual genomic research participants. There is also a general willingness to provide such results by researchers and health professionals, although they tend to adopt a more cautious stance. While all results are desired to some degree, those that have the potential to change clinical management are generally prioritized by all stakeholders. Professional stakeholders appear more willing to return results that are reliable and clinically relevant than those that are less reliable and lack clinical relevance. The lack of evidence for significant enduring psychological harm and the clear benefits to some research participants suggest that researchers should be returning actionable IRRs to participants.