Interests Of Research Participants Research Articles

The rights and interests of participants as limits to clinical trials.

Point-8 of the Declaration of Helsinki requires that the rights and interests of research participants must always prevail over the scientific interests of the research. Recently, it has been proposed that point-8 be modified in the opposite direction, i.e., that it be acceptable for scientific interests to prevail over the interests of the participants. This article argues against this change and uses as an example what happened with the experimental SARS-CoV-2 vaccines versus placebo masked trials. When the high efficacy of the vaccines became evident, the question arose as to what should be done, whether to keep the trials masked until long-term efficacy, immunogenicity and safety data were obtained, or to break the masking and offer participants who received placebo the vaccine that had been shown to be efficacious. The latter was the correct attitude that translated point-8 into practice.

Leveraging oncology collaborative networks and biomedical informatics data resources to rapidly recruit and enroll rural residents into oncology quality of life clinical trials.

This study assesses the feasibility of biomedical informatics resources for efficient recruitment of rural residents with cancer to a clinical trial of a quality-of-life (QOL) mobile app. These resources have the potential to reduce costly, time-consuming, in-person recruitment methods. A cohort was identified from the electronic health record data repository and cross-referenced with patients who consented to additional research contact. Rural-urban commuting area codes were computed to identify rurality. Potential participants were emailed study details, screening questions, and an e-consent link via REDCap. Consented individuals received baseline questionnaires automatically. A sample minimum of n = 80 [n = 40 care as usual (CAU) n = 40 mobile app intervention] was needed. N = 1298 potential participants (n = 365 CAU; n = 833 intervention) were screened for eligibility. For CAU, 68 consented, 67 completed baseline questionnaires, and 54 completed follow-up questionnaires. For intervention, 100 consented, 97 completed baseline questionnaires, and 58 completed follow-up questionnaires. The CAU/intervention reached 82.5%/122.5% of the enrollment target within 2 days. Recruitment and retention rates were 15.3% and 57.5%, respectively. The mean age was 59.5 ± 13.5 years. The sample was 65% women, 20% racial/ethnic minority, and 35% resided in rural areas. These results demonstrate that biomedical informatics resources can be highly effective in recruiting for cancer QOL research. Precisely identifying individuals likely to meet inclusion criteria who previously indicated interest in research participation expedited recruitment. Participants completed the consent and baseline questionnaires with zero follow-up contacts from the research team. This low-touch, repeatable process may be highly effective for multisite clinical trials research seeking to include rural residents.

Chinese academic community speaks out on He Jiankui again: Consensus statement on the challenges and responses of science and technology ethics governance

Chinese academic community speaks out on He Jiankui again: Consensus statement on the challenges and responses of science and technology ethics governance

Caregivers' perception of adults with Down syndrome willingness to participate in research.

Historically, individuals with Down syndrome have been excluded from clinical research. Our objective was to assess the degree of interest adults with Down syndrome have in participating in research from the perspective of the caregivers who care for them. We conducted an online survey of N=390 caregivers of adults with Down syndrome and asked about interest in research participation and demographics. Caregivers were mostly family members, older than 55years, and White. Caregivers reported that the adult with Down syndrome that they cared for would be more comfortable participating in research that was physiological, such as research involving fit bits (70.2% would participate), exercise (63.3%) or diet apps (53.9%), whereas they would be less likely to participate in clinical trials involving more invasive procedures such as injections (10.9%) and laboratory exams like MRIs (32.0%). We found little difference by age or gender of the adult with Down syndrome or by caregiver education level. Our survey identified high interest for less invasive studies, illustrating acceptability of observational and lifestyle studies. More effort may be needed to understand fear and barriers to participation and to create tools and methods to increase interest in more invasive studies.

CBPR: AN EFFECTIVE APPROACH TO RECRUIT AND RETAIN MINORITY OLDER REFUGEE ADULTS IN COMMUNITY-BASED RESEARCH

Abstract Community based participatory research (CBPR) builds mutually beneficial partnerships between diverse communities and researchers, yielding improved communication among stakeholders, more interest in research participation among community older adults, and improved insights on health disparities. CBPR approaches have great utility for culturally appropriate research design, data collection and analyses, and dissemination with minority underserved communities. We describe outreach, research methods, and community capacity-building from three projects with refugee communities in Greensboro, NC: the Montagnard Hypertension Research Project; The Refugee Older Adults Needs Assessment Project; and the Elder Abuse and Neglect exploratory study. These projects were initiated by community leaders, with technical partnership provided by university researchers and students. We used community-centric methods, and collected a range of data including interviews, photographs, oral histories, surveys, and biological specimens. These efforts have advanced social justice and health equity agendas for both academic and community partners, working to advance health of older adults.

Evaluating Levels of Community Participation in a University-Community Partnership: The Jackson Heart Study.

Objective: This research was designed to evaluate the perceptions of the Jackson Heart Study (JHS) community relating to their levels of involvement in JHS activities that were developed to address health disparities and promote health education and health promotion. Methods: The participants for this study comprised 128 community members, who included JHS participants, as well as family members and other friends of the JHS who resided in the JHS community of Hinds, Madison, and Rankin Counties in Mississippi and attended the JHS Annual Celebration of Life. We used the Chi-Square test to analyze the participants’ responses to the survey questions developed to address the six areas of focus: (1) ways to increase participation in community outreach activities; (2) reasons for participating in community outreach activities; (3) interest in research participation; (4) factors influencing engagement; (5) Participants’ preferences for communicating; (6) Chronic disease prevalence. Results: Participants residing in rural counties perceived television and radio as a medium to increase participation; More female respondents cited trust working with the JSU JHS Community Outreach Center (CORC) as a reason for remaining engaged in the community outreach activities; younger participants under 66 years of age recommended social media as a way to increase participation; participants residing in the rural areas saw their participation in the community outreach activities as a way to address community health problems. Conclusions: The knowledge gained from the details provided by the JHS community members can be used to refine research studies in existence, while promoting their sustainability.

Challenges with text-based messaging platform to perform social needs assessments of patients presenting with COVID-19-like illness at an urban academic emergency department

ObjectivesTo evaluate the challenges encountered when using technology-based recruitment and electronic consenting to conduct social needs assessment of patients presenting with COVID-19-like illness at an urban academic emergency department. MethodsCOVID-19 Testing Registry (CTR) was established in the emergency department of UI Health in Chicago, Illinois. An online survey platform REDCap (Research Electronic Data Capture) was used, through which a standardized text message was sent to the mobile devices of eligible patients who tested positive for COVID-19. Patients were first provided with information on social services (e.g., health, food, transportation, housing). After e-consent, they were then asked to complete a social and health needs assessment on the first day and 14th day after COVID-19 testing. ResultsOut of 153 patients invited to participate in the survey, 32 (21%) opened the link and accessed the survey, 13 (8%) accessed the information on resources, 22 (14%) replied to the question on interest in research participation, while 17 (11%) expressed interest in learning about CTR. Ultimately, only 6 (4%) consented and only 1 (0.6%) eventually completed both surveys. The mean age for the total invited pool was 39 (±16), while mean age for those who consented was 37 (±11). ConclusionsIn our urban, mostly minority population, technology-based recruitment and electronic consent proved to be significantly low yield. In the future, CTR aims to further analyze predictors of lower patient engagement and widening disparity when using digital tools. Further data collection will be conducted using phone-call based procedures in patients who contracted COVID-19 in the first 6 months of the pandemic.

Engaging Community Perceptions of Research in Rural West Virginia

The purpose of this study was to engage rural communities across West Virginia (WV) as stakeholders in the research process, thereby enhancing shared trust, understanding, and interest in research participation and partnership. In collaboration with the WV Practice-Based Research Network and Mountains of Hope Cancer Coalition, a statewide team of the Community Engagement and Outreach Core of the WV Clinical and Translational Science Institute traveled throughout rural WV in 2018, to facilitate community focus groups. The purpose of these focus groups was to gain in-depth insights into the perceptions, concerns, and priorities that West Virginians have about health and research. The information collected in these focus groups guided the development of community-tailored curriculum and policy briefs to better engage and equip rural residents and researchers as partners moving forward. This research demonstrates that community-centered organizations and academic institutions can learn and build upon community strengths and expertise to engage a skeptical citizenry, address misunderstandings, and cultivate collaborative research capacity that addresses local health issues and priorities.

A survey study of the attitudes and experiences of adults with intellectual disability regarding participation in research.

Historically, people with intellectual disability have been exploited in and excluded from scientific research. To facilitate greater representation of adults with intellectual disability as research respondents, we sought to understand their interest in research participation and factors affecting their willingness to volunteer to participate, such as the core value of trust. Our survey measured attitudes of adults with intellectual disability towards research in general and research specifically involving adults with intellectual disability as respondents, as well as their prior research experiences, trust of researchers and interest in future research participation. Participants reported positive attitudes towards research and strong interest in future participation opportunities, and trust of researchers was positively correlated to both. The belief that 'research about adults with intellectual disability is very important' also predicted participants' interest in future research participation. Our findings indicate that adults with intellectual disability support the direct involvement of adults with intellectual disability in research as respondents. Trustworthy rapport with researchers and positive views about research foster greater inclusion of this population.

Trust thyself: How older black and white adults consider Alzheimer’s disease research participation

AbstractBackgroundBlack or African Americans (B/AA) are twice as likely to develop Alzheimer’s disease (AD) but significantly under‐represented in AD research studies, particularly those involving cerebrospinal fluid and PET biomarkers. We previously did not find potential participants to reference Tuskegee Study of Untreated Syphilis (TSUS) as a common reason for non‐participation, but B/AA adults who expressed an interest in research participation were much less likely to follow through than White adults in the Atlanta area. The reason for this is not clear.MethodWe electronically surveyed 158 older B/AA and 216 older non‐Hispanic Whites from Georgia, Alabama, Pennsylvania, and Missouri to assess their trust in AD research and their local academic medical centers (AMC); motivating factors and sources of counsel for participating in a hypothetical AD research study; and knowledge of ethical violations including TSUS and the case of Henrietta Lacks.ResultCompared to White respondents, B/AA respondents were more likely to provide accurate (OR=2.51, 95%CI=1.42‐4.44 p=0.002) as well as inaccurate (OR=3.95, 95%CI=2.37‐6.56, p<0.001) details about TSUS, perceive less equity in AD research (proportional OR 2.10, 95%CI=1.43‐3.09, p<0.001), and report less equity in healthcare at researcher‐affiliated AMCs (proportional OR=2.63, 95%CI=1.73‐3.98, p<0.001) even if they themselves can receive quality care there. State of residence did not greatly influence accuracy of knowledge or perception of equity in research and healthcare. Personal or family history of dementia, altruism, support from a friend or family, and support from a trusted physician were top factors considered by both older B/AA and White adults prior to research participation. Knowledge of TSUS – not Lacks – among older B/AA adults was associated with a shift of trust from community leaders to one’s own healthcare experience at AMCs.ConclusionFamiliarity with TSUS – but not accuracy – impacted factors of mid‐ to low importance in older B/AA adults when considering research participation and, to a lesser degree, perception of healthcare equity. Positive personal healthcare experience can potentially enhance B/AA research participation even if it poorly improves perception of inequity in research and healthcare.

Book Review: Health research ethics: Safeguarding the interests of research participants

Book Review: Health research ethics: Safeguarding the interests of research participants

Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations.

Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and interests of research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance.

Engagement of Urban, Pregnant Puerto Rican Women in Health Disparities Research

Persistent challenges surround the recruitment of minority women from marginalized communities in health disparities research. These challenges include lack of the following: interest in research participation, trust, positive relationships between researchers and participants/community, and principal investigators from minority groups. The purpose of this article is to describe successful recruitment strategies used in health disparities research with pregnant Puerto Rican women and to suggest ways to ensure the future success of studies on health disparities. Suggested strategies include creating trust, facilitating active participation of stakeholders, and strengthening the research pipeline with undergraduate and graduate nursing students.

Participation in research: interest and opinions on participatory research among participants of asenior university

In gerontological research, older people are often used as test subjects. Participatory research means the active and equal involvement of those affected by the research question, i.e., the subjects and the academic researchers. But what is the interest in participatory research among older people who participate in an educational institution of the third age? In order to answer this question, participants of asenior university were interviewed. The survey was conducted as astandardized postal survey combined with an optional online survey of participants from the Senior University of Zurich (Switzerland). The sample consisted of 811 persons aged between 56 and 96years. Of the respondents 24% had already participated in aparticipatory research project and of these, older people and people with ahigh level of education were more likely to be involved, as were people who are more likely to be extraverted and who regularly volunteer. Of all respondents, 62% were interested in participatory research projects. In amultivariate perspective, interest depended on age, education, volunteering and experience with such research projects. The interest in participatory participation among Senior University members was high. This interest was more pronounced among people who already had experience with such projects. Further studies should evaluate the interest in research participation on the basis of implemented participatory projects and define optimal framework conditions.

P1‐609: ACTNOW: A DEMENTIA RESEARCH ONLINE RECRUITMENT REGISTRY SITE

In recent years, interest has piqued in utilizing and evaluating online registries to address challenges in dementia research recruitment. The Alzheimer's Comprehensive Treatment Network of Oregon and Washington (ACTNOW) is an online recruitment registry site for community members interested in dementia research news and opportunities. ACTNOW began enrolling participants in February 2016 through event registration, current research studies, and provider referrals. Researchers at OHSU were interested in a) identifying ACTNOW registrant characteristics and b) the number of ACTNOW registrants that went on to enroll in research. We reviewed data from all participants who enrolled in ACTNOW from February 2016 to December 2018. Duplicate entries were removed. For our first aim, frequency analyses were conducted. For our second aim, we reviewed tracking records and communicated with study coordinators. 339 individuals completed the initial online questionnaire to receive newsletter updates; 292 (86%) ACTNOW registrants reported interest in research participation. 191 (56%) went on to complete a prescreening survey. Ages ranged from 24–96 years old and 130 (68%) identified as female. 100 (52%) reported memory changes, 73 (38%) reported a memory loss diagnosis (34 AD, 28 MCI, 11 other dementia). 133 (70%) said they would have a study partner available. 32 (17%) reported that they completed the survey on behalf of someone else. 85 (45%) added additional comments, which included the desire to help because of personal connection to dementia, concern about time commitment, and information about their known genetic risk for Alzheimer's disease. Although there was a protocol to monitor which registrants were enrolled in studies, it was rarely used and we were unable to address our second aim. ACTNOW registrants with and without memory changes are interested in participating in dementia research. Ages spanned from young adult to nonagenarians, and nearly 70% of registrants were female. Future research will include more specific questions to determine what types of studies registrants are interested in, specific demographics, and why they wanted to join a registry. Additionally, ACTNOW registrant recruitment and enrollment tracking protocols will be revised.

Interest in Research Participation Among Caregivers of Children with Neurodevelopmental Disorders

The goal of this study was to examine caregiver agreement to hear about local research opportunities by joining a clinical research registry. Data from this cross-sectional study were gathered, between 2014 and 2017, across two outpatient clinics: (1) a multidisciplinary Autism Spectrum Disorder (ASD) clinic (N = 5228) and (2) a general psychology clinic serving youth with, or at risk for, a neurodevelopmental disorder (NDD; N = 5040). Overall, more than 8 in 10 caregivers agreed to join the registry. Several child clinical characteristics, as well as racial and sociodemographic factors, were predictive of parental agreement. Findings suggest caregivers of youth with ASD and NDD are amenable to joining the local research enterprise, however further work is needed to understand why some caregivers decline.

Racial differences in two measures of trust in biomedical research.

Lack of trust toward medical research is a major barrier to research participation, particularly among some population groups. Valid measures of trust are needed to develop appropriate interventions. The study purpose was to compare two previously validated scales that measure trust in biomedical research - one developed by Hall etal. (H-TBR; 2006) and the other by Mainous etal. (M-TBR; 2006) - in relation to socio-demographic variables and attitudes toward research. Differences between Black and White respondents were explored. Two nearly identical surveys - one with H-TBR and the other with M-TBR - were systematically administered to a convenience sample. Internal consistency reliability of each scale was assessed. Associations were computed between scores on each scale with attitudes toward biomedical research and demographic variables (i.e., gender, age, race, and socioeconomic status). The difference between White and Black respondents on each TBR score while controlling for age, education, and race was also investigated. A total of 2020 participants completed the H-TBR survey; 1957 completed the M-TBR survey. Mean item scores for M-TBR were higher (F = 56.05, p < 0.001) among Whites than Blacks. Whites also had higher mean item scores than Blacks on H-TBR (F = 7.09, p < 0.001). Both scales showed a strong association with participants' perceived barriers to research (ps < 0.001) and significant, positive correlations with interest in research participation (ps < 0.001). Age and household income were positive predictors of TBR scores, but the effects of education differed. Both scales are internally consistent and show associations with attitudes toward research. Whites score higher than Blacks on both TBR scales, even while controlling for age and socioeconomic status.

Willingness of individuals with eating disorders to participate in health research.

This study examines the association between eating disorders (EDs) and willingness to participate in health research studies among community members. Data were collected from Health Street, a University of Florida community engagement initiative which aims to reduce disparities in healthcare and health research by direct engagement of community members. Among 8,226 community members, 3.9% (n = 324) reported a lifetime ED. For all six types of health research studies queried, individuals with a lifetime ED reported a higher willingness to participate in health research compared to individuals without a history. After adjusting for selected covariates, individuals with ED were significantly more likely than individuals without ED to say they would be willing to volunteer for research studies that: ask questions about health (OR: 7.601, 95% CI: [1.874, 30.839]); require an overnight stay in a hospital (OR: 2.041, 95% CI: [1.442, 2.889]); and provide no remuneration (OR: 1.415, 95% CI: [1.022, 1.958]). Furthermore, when compared to individuals with anxiety or depression, individuals with ED reported increased interest in research participation and increased willingness to participate in most types of research studies assessed. After stratifying by gender and race, we observed few differences in willingness to participate in research among individuals with ED. These findings contribute to our current understanding of participant recruitment and enrollment in ED health research. Underrepresented populations who often do not seek treatment for EDs endorsed a high willingness to participate. Future studies will likely benefit from including community members in ED research.

Association of Health Literacy and Numeracy with Interest in Research Participation.

There is much attention to recruitment of diverse populations in research, but little is known about the influence of health literacy and numeracy skills. To determine if health literacy and numeracy affect individuals' interest to participate in research studies. Cross-sectional survey data were pooled from 3 large studies conducted in the Mid-South Clinical Data Research Network. Adult patients enrolled in 1 of 3 Mid-South Clinical Data Research Network studies. The survey domains included demographic items, the 3-item Brief Health Literacy Screen (range 3-15), and the 3-item Subjective Numeracy Scale (range 3-18). The outcome was a sum index measure of a 7-item instrument (range 7-21) assessing individuals' interest in participating in different types of research, including research that involves taking surveys, giving a blood sample, participating via phone or internet, taking an investigational medication, meeting at a local community center or school, including family, or staying overnight at a hospital. Respondents (N = 15,973) were predominately women (65.5%), White (81.4%), and middle aged (M = 52.8years, SD = 16.5); 32.4% previously participated in research. Self-reported health literacy was relatively high (M =13.5 out of 15, SD = 2.1), and subjective numeracy skills were somewhat lower (M =14.3 out of 18, SD = 3.6). After adjustment for age, gender, race, income, education, and other characteristics, lower health literacy and numeracy skills were each independently associated with less interest in research participation (p < 0.001 for each). Prior research participation was associated with greater interest in future research participation (p < 0.001). After adjustment for factors known to be predictive of interest, individuals with lower health literacy or numeracy scores were less interested in participating in research. Additional work is needed to elucidate reasons for this finding and to determine strategies to engage these populations.

How Returning Aggregate Research Results Impacts Interest in Research Engagement and Planned Actions Relevant to Health Care Decision Making: Cohort Study.

BackgroundCollection of patient-reported outcomes measures (PROs) may augment clinical data and inform health research, improving care, yet approaches to sustaining interest among patient cohorts in research participation are needed. One approach may involve returning aggregate research results (ARRs), which may help patients contextualize personal experiences, prompt conversations with providers or family, and encourage information seeking. This model has been demonstrated for Web-based patient-centered registries. Studies with clinical cohorts may further elucidate the model, its impacts on interest in research participation and planned actions, and potential for participants to experience this as helpful or harmful—gap areas.ObjectiveWe sought to investigate the impacts of returning ARRs comprising summaries of PROs and clinical metrics to parents of children with rheumatic disease, assessing interest in future research participation among parents who viewed ARRs and plans for acting on returned information. Further, we sought to investigate reactions to viewing ARRs and how these reactions impacted planned actions.MethodsClinical and PRO data were obtained about children in a national clinical disease registry, summarized, and processed into annotated infographics, comprising ARRs for children’s parents. Parents who viewed ARRs (n=111) were surveyed about the information’s perceived value and their reactions. Reaction patterns were summarized using principal components analysis (PCA), and associations among reaction patterns and interest in research participation and planned actions were estimated using multivariate logistic regression.ResultsParental endorsement of the value of ARRs for understanding their child’s condition and making care decisions was high (across 10 topics for which ARRs were shared, 42.2%-77.3% of the parents reported information was “very valuable”). Most (58/111, 52.3%) parents reported being more interested in participating in research after viewing ARRs, with the remainder reporting that their interest levels were unchanged. Reactions to viewing ARRs reflected experiencing validation/affirmation and information burden based on PCA. Reactions were not associated with child demographic or clinical characteristics and PROs, except that parents from households with less education reported greater information burden than those from more educated households (P=.007). In adjusted models, parents with higher validation/affirmation scores had increased odds of reporting heightened interest in research participation (adjusted odds ratio [AOR] 1.97, 95% CI 1.18-3.30), while higher information burden scores were associated with decreased odds of planned discussions with their child (AOR 0.59, 95% CI 0.36-0.95) and increased odds of planned discussions with providers (AOR 1.75, 95% CI 1.02-3.00).ConclusionsReturning ARRs may foster a “virtuous cycle” of research engagement, especially where ARRs are experienced favorably and affect plans to share and discuss ARRs in support of a child’s chronic disease care and treatment. Reactions to ARRs vary with education level, underscoring the need for attention to equity for this model.