Participation In Biomedical Research Research Articles

Access to and interest in human milk research opportunities among Black pregnant and postpartum people.

Concerns exist regarding biomedical research participation in marginalized and historically disadvantaged communities. The purpose of this study was to understand critical barriers to participation in human milk research from the perspective of Black pregnant and postpartum people. A national sample of Black pregnant and postpartum people (n = 104) was recruited to complete a cross-sectional online survey informed by the Life Course Perspective. Survey questions assessed research experiences and preferences, particularly related to human milk research, knowledge of historical events/policies targeting Black communities, and demographic characteristics. A socio-economic composite score was calculated as an indicator of socio-economic advantage. Survey data were summarized descriptively and potential correlates of research engagement were evaluated. Most (69%, n = 71) respondents reported previous participation in a research study, yet only 8 (8%) reported ever being asked to participate in a breastfeeding/chestfeeding or human milk study, and one respondent was unsure. Despite so few having been asked, 59% (n = 61) of respondents indicated they would donate breast/human milk to research if asked. Respondent characteristics associated with prior research participation included having greater socio-economic advantage (p = 0.027) and greater knowledge of discriminatory historical events/policies (p < 0.001). In contrast, the only respondent characteristic associated with willingness to donate human milk to research was younger age (p = 0.002). Our findings suggest that Black pregnant and postpartum people are interested in biomedical research, specifically human milk and lactation research. However, greater intentionality and targeted recruitment of this underrepresented population is needed to increase diversity among human milk and lactation study samples. Structural and community-based interventions, informed by community members, are needed to address concerns and improve participant engagement.

From vulnerable subjects to research partners: a critical policy analysis of biomedical research ethics guidelines and regulations

Over the last three quarters of a century, international guidelines and regulations have undergone significant changes in how children are problematised as participants in biomedical research. While early guidelines enacted children as vulnerable subjects with diminished autonomy and in need of special protection, beginning in the early 2000s, international regulatory frameworks defined the paediatric population as vulnerable due to unaddressed public health needs. More recently, ethical recommendations have promoted the active engagement of minors as research partners. In this paper, I adopt a post-structuralist approach to policy analysis to examine deep-seated assumptions and presuppositions underlying the changes in the problematisation of children as biomedical research participants over time. While biomedical research ethics focuses on the autonomy and vulnerability of minors, ethical guidelines are situated in specific sociocultural contexts, shaped, among other things, by contingent public health needs and changing conceptions of the value of research and science for society. In the process, I demonstrate the challenge of moving away from an approach that in taking adults as the model overshadows the complexity of children’s lived experiences as well as their personal, cultural, and social lives. The lack of acknowledgement of this complexity makes children vulnerable to epistemic injustice, which is particularly crucial to address in public involvement initiatives.

Hormonal Basis of Biological Sex Differences in Human Athletic Performance.

Biological sex is a primary determinant of athletic human performance involving strength, power, speed, and aerobic endurance and is more predictive of athletic performance than gender. This perspective article highlights 3 key medical and physiological insights related to recent evolving research into the sex differences in human physical performance: (1) sex and gender are not the same; (2) males and females exhibit profound differences in physical performance with males outperforming females in events and sports involving strength, power, speed, and aerobic endurance; (3) endogenous testosterone underpins sex differences in human physical performance with questions remaining on the roles of minipuberty in the sex differences in performance in prepubescent youth and the presence of the Y chromosome (SRY gene expression) in males, on athletic performance across all ages. Last, females are underrepresented as participants in biomedical research, which has led to a historical dearth of information on the mechanisms for sex differences in human physical performance and the capabilities of the female body. Collectively, greater effort and resources are needed to address the hormonal mechanisms for biological sex differences in human athletic performance before and after puberty.

‘Guidance should have been there 15 years ago’ research stakeholders’ perspectives on ancillary care in the global south: a case study of Malawi

BackgroundMedical researchers in resource-constrained settings must make difficult moral decisions about the provision of ancillary care to participants where additional healthcare needs fall outside the scope of the research and are not provided for by the local healthcare system. We examined research stakeholder perceptions and experiences of ancillary care in biomedical research projects in Malawi.MethodsWe conducted 45 qualitative in-depth interviews with key research stakeholders: researchers, health officials, research ethics committee members, research participants and grants officers from international research funding organisations. Thematic analysis was used to analyse and interpret the findings.FindingsAll stakeholders perceived the provision of ancillary care to have potential health benefits to study participants in biomedical research. However, they also had concerns, particularly related to the absence of guidance to support it. Some suggested that consideration for ancillary care provision could be possible on a case-by-case basis but that most of the support from research projects should be directed towards strengthening the public health system, emphasising public good above individual or personal benefits. Some researchers and ethics committee members raised concerns about potential tensions in terms of funding, for example balancing study demands with addressing participants’ additional health needs.ConclusionOur findings highlight the complexities and gaps in the guidance around the provision of ancillary care in Malawi and other resource-constrained settings more generally. To promote the provision of ancillary care, we recommend that national and international guidelines for research ethics include specific recommendations for resource-constrained settings and specific types of research.

Evidence and gap map report: Social and Behavior Change Communication (SBCC) interventions for strengthening HIV prevention and research among adolescent girls and young women (AGYW) in low- and middle-income countries (LMICs).

Evidence and gap map report: Social and Behavior Change Communication (SBCC) interventions for strengthening HIV prevention and research among adolescent girls and young women (AGYW) in low- and middle-income countries (LMICs).

Using Drosophila Oogenesis in the Classroom to Increase Student Participation in Biomedical Research.

Students that participate in undergraduate research benefit in multiple ways, including improved learning outcomes, increased enthusiasm for science, technology, engineering, and mathematics (STEM) fields, and increased likelihood of continuation into a STEM career. These benefits are even more pronounced for students that are traditionally under-represented in STEM, although these students often face barriers to participation in traditional apprenticeship-style research experiences. Course-based undergraduate research experiences (CUREs) are a promising and increasingly popular approach to increase undergraduate participation in research in a way that is inclusive of all students. Here, we describe how Drosophila oogenesis can be used as the basis for CUREs in a wide variety of courses. We provide an overview of our own oogenesis-based CURE, as well as suggestions for how this CURE could be adapted to accommodate a variety of schedules, course sizes, and institution types. Our goal is to simplify the process for CURE implementation in the hopes that a greater number of instructors choose to implement a CURE in their own courses.

Improving participant representation in the era of digital clinical studies.

Traditional clinical research relies on conventional strategies to invite and enroll research participants. However, these strategies often fail to reach potential participants from marginalized communities or that reflect the diversity of the nation, such as race, ethnicity, or geography. As we discuss here, the digital clinical study model sets the stage for improved and equitable participation in biomedical research.

Race/ethnicity and the relationship between trust in researchers and hypothetical research participation

AbstractBackgroundResearch participation by minority individuals is critical to address health disparities, and lack of trust in research/researchers (TIR) is a significant barrier to participation. Few existing studies examine the relationship between level of TIR and hypothetical research participation in a sufficiently diverse sample.MethodsThe survey was conducted among White, Black, Hispanic, and Asian community‐dwelling adults in New Jersey (N = 293 between October 2020 and January 2022). A 12‐item TIR measure based on published scales was developed with input from community partners. Respondents were also asked if they would participate in different types of research (i.e. survey, blood draw, medication study). Exploratory and confirmatory factor analysis was conducted to identify the underlying structure of TIR. Cluster analysis on research participation was conducted to determine patterns. Regression‐based mediation analysis was done to determine relationship between race/ethnicity, TIR, and hypothetical research participation.ResultsResponses were collected from 293 adults, with 38% reporting ages of 55 years or older. Factor analysis revealed three main factors on 9‐items related to Researchers as Fiduciaries (lowest score in Chinese adults), Equity in Research (highest score in White adults), and Transparency in Research. Cluster analysis revealed two major clusters: one cluster only willing to participate in anonymous health‐related surveys, and the other highly willing to participate in studies involving blood tests and genetic analysis. Only Chinese race/ethnicity was associated with lower Researchers as Fiduciaries scores (B = ‐0.54, 95% CI‐0.85 to ‐0.23, p = 0.0007), with the mediation model (Sobel Z of ‐3.22, p&lt;0.001, k2 = 0.13) showing a direct effect of ‐0.64 (95% CI ‐1.36 to 0.08, p = 0.08) and indirect effect of ‐0.69 (95% CI ‐1.06 to ‐0.32, p = 0.001) from Chinese race/ethnicity on participation willingness.ConclusionChinese respondents showed low trust in researchers to serve as their fiduciaries, which mediated their low willingness to participate in research involving more than health‐related surveys. All non‐White groups also endorsed inequity in treatment by researchers, but Hispanic and Black adults were still likely to be interested in minimal risk (blood draw, genetic analysis) research participation. These findings call for community‐specific approaches to enhance biomedical research participation among non‐White adults.

The Margin of Moral Duty of Human Being to Participate in Biomedical Research

The existing paradigm of biomedical research ethics, based on respecting the free and informed consent of the research participant, originates from the famous Nuremberg Trial (1947), where the Nazi doctors were convicted of killing and torturing prisoners using medical experiments in German Concentration Camps during World War II. Since the second half of the 20th century, several international instruments have been developed to protect the rights of persons involved in research, considering the voluntariness of participation. Nevertheless, scientific community started to discuss the moral basis of mandatory human participation in biomedical research. Even today, some scholars argue that biomedical research creates public goods in the form of health, safety, and knowledge enjoyed almost by all members of society. The moral duty to participate in research is due to the need for public participation in producing public goods. Others suggest that human beings have a moral obligation to take some risks to help others. So, the moral duty to participate in biomedical research relies on the principles of justice, beneficence, etc. Considering the importance of this issue for research ethics, this article discusses the doctrines and theories, including public goods, free-riding, and beneficence, to set the margin of the moral duty of human beings to participate in biomedical research.

Using Indigenous Standards to Implement the CARE Principles: Setting Expectations through Tribal Research Codes.

Biomedical data are now organized in large-scale databases allowing researchers worldwide to access and utilize the data for new projects. As new technologies generate even larger amounts of data, data governance and data management are becoming pressing challenges. The FAIR principles (Findable, Accessible, Interoperable, and Reusable) were developed to facilitate data sharing. However, the Indigenous Data Sovereignty movement advocates for greater Indigenous control and oversight in order to share data on Indigenous Peoples’ terms. This is especially true in the context of genetic research where Indigenous Peoples historically have been unethically exploited in the name of science. This article outlines the relationship between sovereignty and ethics in the context of data to describe the collective rights that Indigenous Peoples assert to increase control over their biomedical data. Then drawing on the CARE Principles for Indigenous Data Governance (Collective benefit, Authority to control, Responsibility, and Ethics), we explore how standards already set by Native nations in the United States, such as tribal research codes, provide direction for implementation of the CARE Principles to complement FAIR. A broader approach to policy and procedure regarding tribal participation in biomedical research is required and we make recommendations for tribes, institutions, and ethical practice.

Views of university students in Jordan towards Biobanking

BackgroundBiobanks are considered primary means+ of supporting contemporary research, in order to deliver personalized and precise diagnostics with public acceptance and participation as a cornerstone for their success.AimsThis study aims to assess knowledge, perception, and attitudes towards biomedical research and biobanking among students at the University of Jordan.MethodologyAn online questionnaire was designed, developed, and piloted. It was divided into 5 sections that included questions related to issues of biomedical research and biobanking as well as factors influencing the decision to participate.ResultsResponses from 435 students revealed that 52.9% previously heard of biobanks. There was an overwhelming acceptance for participation in biomedical, genetic, and biobanking research. A blood sample was the most preferred for donation. Protection of privacy, informed consent prior to donation, approval of an ethics committee, and trust towards researchers were the most important factors associated with willingness to participate. On the other hand, the vagueness of the type of research performed on the biospecimens and the unavailability of general research results to the donor had a negative connotation. There was no clear agreement on the type of informed consent preferred by students, but to be contacted and informed of research results was preferred by the majority. Students also preferred the disposal of biospecimens and information when deciding to withdraw from participation.ConclusionThere is strong enthusiasm among students to participate in biomedical research and biobanking with all rights reserved thus providing hope for a very promising future in Jordan.

First Report: Rare RNF213 Variant Associated with Familial Moyamoya Disease in an African American Family

ObjectiveTo investigate potential genetic susceptibility for moyamoya disease (MMD) in an African American family. Materials and methodsNeurovascular imaging and analyses of MMD susceptibility genes RNF213 and/or ACTA2 in a young proband with MMD and two first-degree relatives. ResultsThe proband presented with pseudobulbar affect and chorea, then had a right hemispheric ischaemic stroke and rapidly fatal course. One relative had a mild haemorrhagic thalamic stroke and clinically silent ischaemic infarct. Despite evidence of slowly progressive disease, he remained clinically stable. Another relative was neurologically intact with normal cerebrovascular imaging to date. All three have the rare R4131C (p.Arg4131Cys or p.R4131C, c.12391C>T) variant of the RNF213 gene. They are the first Black people and only the 5th family worldwide known to harbour this variant. MMD was confirmed in both of the patients with neurological events. ConclusionsOur report provides compelling evidence that MMD is a clinically complex, heritable genetic disease. It supports the probable pathogenicity of R4131C. Furthermore, it illustrates the wide phenotypic spectrum of R4131C, from asymptomatic carrier to late presenting, mild disease to catastrophic, rapidly fatal childhood disease. To our knowledge, this is also the first report of heritable MMD in a Black family. Finally, this study highlights the importance of racially and ethnically diverse participants in biomedical research.

Understanding Willingness to Participate in HIV Biomedical Research: A Mixed Methods Investigation.

Biomedical research often enrolls people living with HIV (PLWH) receiving effective treatment to complete invasive procedures. This mixed methods study characterized determinants of willingness to undergo specific biomedical procedures among PLWH. In 2017, 61 participants (77% Black) from Miami completed a quantitative assessment examining willingness to participate. A subset of 19 participants completed an in-depth qualitative interview. Across all procedures, there was greater willingness to participate if asked by a primary care provider and if experimental results were shared. However, half of participants reported that they would experience undue influence (i.e., excessive persuasion) to participate from their primary care provider. In thematic analyses, altruism and personal benefit were identified as facilitators while medication changes, confidentiality, and perceived stigma were identified as barriers to participation in HIV biomedical research. Addressing participants' expectations and mitigating potential undue influence from primary care providers could optimize the ethical conduct of HIV biomedical studies.

Gender and Power Dynamics of Social Relationships Shape Willingness to Participate in Biomedical HIV Prevention Research Among South African Adolescents and Young Adults.

Background: Understanding young women and men's perceived barriers and facilitators to participation in biomedical HIV prevention research is important for designing youth friendly services (YFS) and acceptable technologies, which are necessary for preventing high sustained HIV incidence in South Africa. This study explores the multileveled barriers and facilitators to young men and women's willingness to participate in hypothetical biomedical HIV prevention research.Methods: Eight age- (16–18 and 19–24 years) and gender-stratified focus group discussions (FGDs) were conducted using semi-structured interview guides to explore young South African women and men's willingness, perceived barriers, and facilitators to participating in biomedical HIV prevention research. FGD transcripts were uploaded to NVivo and coded collaboratively with youth study team members. Thematic analysis using Bronfenbrenner's ecological model (individual, inter-personal, community, and societal) was used to guide a deductive coding procedure, which was documented and compared by gender.Results: Thirty-one participants from Durban and 34 from Soweto participated in FGDs. Individual facilitators for participation were discussed more by young men and included financial incentives and altruism. Concerns about side-effects of biomedical products were a common barrier. Interpersonal relationships with peers, intimate partners and caregivers influenced young people's willingness to participate in HIV prevention research, more so among young women. For young women, gendered power dynamics and distrust of intimate partners and parents influenced both communication regarding participation and willingness to participate in research that is often stigmatized, due to societal norms around women's sexuality. On a societal level, participants expressed distrust in medical and research institutions, however a sense of community that was developed with the study staff of this project, was a motivator to participate in future studies.Discussion: At each level of the ecological model, we found participants expressed gendered barriers and facilitators for participation. Gender norms as well as distrust of partners, parents, and health care professionals were key barriers that cut across all levels. At each level participants discussed facilitators that were youth-engaged, underscoring the need to implement YFS, establish trust and address gender inequities within future biomedical HIV prevention studies wishing to engage and retain South African youth.

Abstract P588: A Rare RNF213 Variant is Associated With Moyamoya Disease in an African American Family

Objective: To investigate potential genetic susceptibility for moyamoya disease (MMD) in an African American family. Methods: A young girl with MMD (proband), her father and paternal half-brother underwent cerebrovascular imaging with MRI and MRA. Cerebral angiography was also performed on the girl and her father. Genetic analysis of the MMD susceptibility gene RNF213 was conducted on all three relatives, while ACTA2 gene was analysed in the proband only. Results: The proband presented with pseudobulbar affect and chorea, then subsequently had a right hemispheric ischaemic stroke and rapid, ultimately fatal clinical decline. Detailed family history raised suspicion for familial MMD and investigation of her relatives. Her father had a small haemorrhagic thalamic stroke without residual neurologic deficits; a clinically silent ischaemic infarct was incidentally discovered on neuroimaging. He remains clinically stable despite slowly progressive disease on imaging. Her brother is neurologically intact and has normal cerebrovascular imaging to date. They are all heterozygous for the rare Arg4131Cys variant in RNF213. They are the first Black people and only the 3rd, 4th and 5th people in the world known to harbour this variant. MMD was confirmed in the girl and her father with cerebral angiogram. Conclusions: This study illuminates the clinical and genetic complexity of familial MMD. It underscores the importance of genetic testing and surveillance cerebrovascular imaging even in asymptomatic relatives of probands with MMD. Although the clinical significance of Arg4131Cys remains unclear, modest variant-disease segregation in this family is consistent with a growing body of evidence supporting its probable pathogenicity. Furthermore, our study illustrates its wide phenotypic spectrum, from asymptomatic carrier to late presenting, mild disease to fulminant, rapidly fatal childhood disease. To our knowledge, this is also the first report of heritable MMD in a Black family. We demonstrate the value of considering diseases more predominant in one specific ancestry when evaluating patients from other ethnic backgrounds. Finally, we highlight the importance of racially and ethnically diverse participants in biomedical research.

Asians and Asian Subgroups are Underrepresented in Medical Research Studies Published in High-Impact Generalist Journals.

Including diverse participants in biomedical research is essential to reduce health disparities. Weassessed the inclusion of Asians in original research studies conducted in North America and published from 2015-2016in sixhigh-impact generalist journals: New England Journal of Medicine, Journal of the American Medical Association (JAMA), JAMA Internal Medicine, JAMA Pediatrics, Annals of Internal Medicine, and Pediatrics. We determined race reporting method, participant percentage, and reporting of outcomes or implications of findings for Asians and Asian subgroups. Of 1077 studies, 263 articles (24.4%) identified Asians as a distinct race/ethnicity; the median percentage of Asians per study was 3.8%. Of the 263 articles, 28 (10.6%) studies reported outcomes for Asians; nine (3.4%) articles included information about Asian subgroups. Asians are underrepresented in high-impact medical research studies in North America. Efforts to improve study enrollment, data collection, and reporting of findings of Asians in studies remain essential to improve health outcomes for this population.

Demographic and prosocial intrapersonal characteristics of biobank participants and refusers: the findings of a survey in the Netherlands

Research in genetics relies heavily on voluntary contributions of personal data. We aimed to acquire insights into the differences between participants and refusers of participation in a Dutch population-based biobank. Accordingly, we assessed the demographic and prosocial intrapersonal characteristics of respondents who participated (n = 2615) or refused to participate (n = 404) in the Lifelines biobank and databank. Our results indicated that health-related values critically influence participation decisions. The participation threshold for Lifelines was determined by an absence of health-related values and of trust in government. Therefore, considering these factors in communication and recruitment strategies could enhance participation in biomedical research. No indications were found of a stronger general prosociality of participants or their trust in researchers beyond the context of biobanking. This emphasizes the contextual understanding of the decision of participation in biobanking. Our findings may contribute to improving recruitment strategies by incorporating relevant values and/or highlighting prosocial benefits. Moreover, they foreground the need to address trust issues in collaborations between data repositories and commercial companies. Future research should explore how prosocial intrapersonal characteristics drive participation and withdrawal decisions and relate to contextual attributes.

Abstract A087: Community Research Navigators (CRN): The bridge to increasing Latino participation in clinical research

Abstract The participation of underserved ethnic minorities in biomedical research is critical to achieving progress in health equity. Increasing ethnic minority including Latino accrual in biomedical research, including clinical trials, is a formidable challenge that requires improving participant trust and commitment and overcoming of barriers to participation. Latinos make up about 18% of the US population. Yet Latinos are not adequately targeted in research studies, currently constituting only 7.6% of NIH clinical trial participants and only about 2%-5% of participants in cancer clinical trials. The National Cancer Institute (NCI) has recommended patient navigation as a research strategy that may be adapted to overcome ethnic minority biomedical research and clinical trial participation barriers. City of Hope has participated in training community research navigators (CRN) to increase diversity participation. These CRNs are trained to address gaps in knowledge, medical mistrust, access to participation, and engagement of under-represented groups in biomedical research. The research navigator draws from the patient navigation and promotora model and the community-engaged research approach. CRNs' curriculum include the importance of biomedical to disease prevention, diagnosis, and treatment; the value to group and family participation, Clinical Trials, HIPPA, human subject protection, ethics; patient-provider communication, cost and coverage, and family communication and decision making. In total, we trained and mentored a team of 30 CRNs from our community partner Pomona's Health Promoters for increased public education and Latino participation in research. CRNs were 25-74 years old, 97% female, 96% foreign-born, and 54% &amp;lt; high school education. Their pre- and post-test results showed an increase in willingness to participate in research (p &amp;lt; .005); increase in knowledge of the importance of biomedical including clinical research (p &amp;lt; .000); and an increase in confidence in improving community's attitude and knowledge about clinical research (p &amp;lt; .000). Our findings suggest that the CRN training is effective in improving appropriate knowledge and confidence to conduct community research navigation. This approach holds the promise of utility and applicability to address barriers to research enrollment and increase Latino biomedical research participation. Citation Format: Mayra Serrano, Marisela Garcia, Rick Kittles, Kimlin Tam Ashing. Community Research Navigators (CRN): The bridge to increasing Latino participation in clinical research [abstract]. In: Proceedings of the Eleventh AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2018 Nov 2-5; New Orleans, LA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl):Abstract nr A087.

Factors associated with biomedical research participation within community-based samples across 3 National Cancer Institute-designated cancer centers.

Engaging diverse populations in biomedical research, including biospecimen donation, remains a national challenge. This study examined factors associated with an invitation to participate in biomedical research, intent to participate in biomedical research in the future, and participation in biomedical research and biospecimen donation among a diverse, multilingual, community-based sample across 3 distinct geographic areas. Three National Cancer Institute-designated cancer centers engaged in community partnerships to develop and implement population health assessments, reaching a convenience sample of 4343 participants spanning their respective catchment areas. Data harmonization, multiple imputation, and multivariable logistic modeling were used. African Americans, Hispanic/Latinos, and other racial minority groups were more likely to be offered opportunities to participate in biomedical research compared to whites. Access to care, history of cancer, educational level, survey language, nativity, and rural residence also influenced opportunity, intent, and actual participation in biomedical research. Traditionally underserved racial and ethnic groups reported heightened opportunity and interest in participating in biomedical research. Well-established community partnerships and long-standing community engagement around biomedical research led to a diverse sample being reached at each site and may in part explain the current study findings. However, this study illustrates an ongoing need to establish trust and diversify biomedical research participation through innovative and tailored approaches. National Cancer Institute-designated cancer centers have the potential to increase opportunities for diverse participation in biomedical research through community partnerships and engagement. Additional work remains to identify and address system-level and individual-level barriers to participation in both clinical trials and biospecimen donation for research.

Diversity and Inclusion in Unregulated mHealth Research: Addressing the Risks

mHealth devices and applications, with their wide accessibility and ease of use, have the potential to address persistent inequities in biomedical research participation. Yet, while mHealth technologies may facilitate more inclusive research participation, negative features of some unregulated use in research - misleading enrollment practices, the promotion of secondary mHealth applications, discriminatory profiling, and poorer quality feedback due to dependencies on biased data and algorithms - may threaten the trust and engagement of underrepresented individuals and communities. To maximize the participation of currently disenfranchised groups, those involved in unregulated mHealth research must become aware of potential risks, adopt targeted education policies, audit algorithms for hidden biases, and engage citizen scientists and other community members to identify and forestall possible harms.