R Jean Cadigan

University of North Carolina at Chapel Hill, North Carolina, United States

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Publications (19)103.51 Total impact

  • R Jean Cadigan, Debra Skinner
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    ABSTRACT: Objective. This study examines experiences of depressive symptoms among a group of 32 low-income, African-American and White mothers of young children who resided in rural Eastern North Carolina, USA. Design. Women's experiences of depressive symptoms were elicited through a series of longitudinal ethnographic interviews, including an explanatory models interview specifically designed to elicit their beliefs about the causes, symptomatology and help-seeking behavior and management of depressive symptoms. Results. A content analysis of interview data indicated that most women (11 African-Americans and 15 Whites) reported having depressive symptoms currently or in the past. Both African-American and White women perceived the main causes of these symptoms as being relationship problems with a spouse, a partner, or a family member; lack of finances; and parenting stresses. There were no differences in the depressive symptoms African-American and White women reported, but there were differences in how they managed these symptoms and where they sought help. Most of the African-American women sought no formal treatment (i.e., pharmacotherapy and/or psychotherapy), but instead turned to their religious faith to deal with their feelings. White women were more likely to seek formal treatment. Conclusion. These findings provide insights into the ways in which women in one nonurban area in the USA explained and experienced depressive symptoms and demonstrate differences in help-seeking behaviors that can be linked to beliefs about depression and perceptions of societal responses to those who have it, as well as to perceptions of and experiences with the health-care system. Results have implications for the implementation of education, intervention, and treatment programs in more culturally sensitive ways.
    Ethnicity & health. 06/2014;
  • Genetics in medicine: official journal of the American College of Medical Genetics 04/2014; · 3.92 Impact Factor
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    ABSTRACT: Background/Aims: Efforts to improve individual and population health increasingly rely on large-scale collections of human biological specimens and associated data. Such collections or 'biobanks' are hailed as valuable resources for facilitating translational biomedical research. However, biobanks also raise important ethical considerations, such as whether, how and why biobanks might engage with those who contributed specimens. This paper examines perceptions and practices of community engagement (CE) among individuals who operate 6 diverse biobanks in the US. Methods: Twenty-four people from a diverse group of 6 biobanks were interviewed in-person or via telephone from March to July 2011. Interview transcripts were coded and analyzed for common themes. Results: Emergent themes include how biobank personnel understand 'community' and CE as it pertains to biobank operations, information regarding the diversity of practices of CE, and the reasons why biobanks conduct CE. Conclusion: Despite recommendations from federal agencies to conduct CE, the interpretation of CE varies widely among biobank employees, ultimately affecting how CE is practiced and what goals are achieved. © 2014 S. Karger AG, Basel.
    Public Health Genomics 02/2014; · 2.57 Impact Factor
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    ABSTRACT: Biobanks - collections of human biological specimens stored for future research use - are crucial for biomedical advancement. One of the most common ways that biobanks acquire specimens is to obtain residual or "leftover" samples originally collected for clinical care from hospitals, clinical laboratories and pathology departments. Little is known about the characteristics of biobanks that store specimens from clinical sources, or their policies and practices. In this paper, we present data from the subset of 261 biobanks in our 2012 national survey that store specimens from clinical sources, focusing on a number of ethical issues that have been raised in the literature. We document tremendous heterogeneity in the composition of these collections, the number and type of specimens stored, and number of requests for specimens per year. Most biobanks are part of larger organizations, mainly academic medical centers, and most report standardized systems for managing acquisition, storage, and release to researchers. Yet, there is considerable diversity in policies and practices regarding informed consent, return of research results, ownership of specimens and technology developed, utilization, and disposition of remaining specimens after researcher have accessed them. Responding to this variation presents significant challenges for those who manage the collections, demanding careful consideration and planning to maintain high quality practices in acquisition, storage, and release of specimens all the while striving to protect the rights of subjects.
    Clinical biochemistry 12/2013; · 2.02 Impact Factor
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    ABSTRACT: Biobanks require new governance models that address their ethical and regulatory challenges. One model relies on stewardship of specimens throughout their life course. Here, we discuss findings from our survey of 456 U.S. biobank managers that addressed whether and how biobanks steward their specimens. The findings reveal that most biobanks do not create ongoing relationships with contributors but do practice stewardship over storing and sharing of specimens. Biobanks now need guidance to fully articulate stewardship practices that ensure respect for contributors while facilitating research.
    Science translational medicine 12/2013; 5(215):215cm7. · 10.76 Impact Factor
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    ABSTRACT: BACKGROUND: Effective translational biomedical research hinges on the operation of "biobanks," repositories which assemble, store, and manage collections of human specimens and related data. Some are established intentionally to address particular research needs; many, however, have arisen opportunistically, in a variety of settings and with a variety of expectations regarding their functions and longevity. Despite their rising prominence, little is known about how biobanks are organized and function beyond simple classification systems ("government, academia, industry"). Methods: In 2012, we conducted the first national survey of biobanks in the U.S., collecting information on their origins, specimen collections, organizational structures, and market contexts and sustainability. From a list of 636 biobanks assembled through a multi-faceted search strategy, representatives from 456 U.S. biobanks were successfully recruited for a 30 minute online survey (72% response rate). Both closed and open-ended responses were analyzed using descriptive statistics. Results: While nearly two-thirds of biobanks were established within the last decade, 17% have been in existence for over 20 years. Fifty-three percent listed research on a particular disease as the most important reason for establishment; 29% listed research generally. Other reasons included response to a grant or gift, and intent to centralize, integrate, or harmonize existing research structures. Biobank collections are extraordinarily diverse in number and types of specimens and in sources (often multiple) from which they are obtained, including from individuals, clinics/hospitals, public health programs, and research studies. Forty-four percent of biobanks store pediatric specimens, and 36% include post-mortem specimens. Most biobanks are affiliated in one or multiple ways with other entities: 88% are part of at least one or more larger organizations (67% of these are academic, 23% hospitals, 13% research institutes). The majority of biobanks seem to fill a particular "niche" within a larger organization or research area; a minority are concerned about competition for services, although many are worried about underutilization of specimens and long term funding. Conclusions: Effective utilization of biobank collections and effective policies to govern their use will require understanding the immense diversity found in organizational features, including the very different history and primary goals that many biobanks have.
    Genome Medicine 01/2013; 5(1):3. · 4.94 Impact Factor
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    ABSTRACT: As part of a larger organizational study, we sought to survey biobanks in the United States. However, we encountered two problems with this population. First, no common definition of biobanks exists. Second, no census is available of these facilities from which to sample in order to implement a survey. In light of these problems, we employed a multifaceted approach using electronic searches of PubMed, RePORTER, and Google. In addition, we systematically searched for biobanks housed within universities that have NIH-designated Clinical and Translational Science Awards (CTSA). We expanded this part of the search by looking for biobanks among all members of the American Association of Medical Colleges (AAMC). Finally, we added banks to our database found previously by other researchers and banks found via correspondence with our colleagues. Our search strategy produced a database of 624 biobanks for which we were able to confirm contact information in order to conduct our online survey. Another 140 biobanks were identified but did not respond to our requests to confirm their existence or contact information. In order to maximize both the uniqueness of banks found and the greatest return on effort for each search, we suggest targeting resources that are already organized. In our work, these included the CTSA, AAMC, and part of the Google searches. We contend that our search provides a model for analysis of new fields of research and/or rapidly evolving industries. Furthermore, our approach demonstrates that with the appropriate tools it is possible to develop a systematic and comprehensive database to investigate undefined populations.
    Biopreservation and Biobanking 12/2012; 10(6):511-7. · 1.50 Impact Factor
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    ABSTRACT: Genomic biobanks present ethical challenges that are qualitatively unique and quantitatively unprecedented. Many critics have questioned whether the current system of informed consent can be meaningfully applied to genomic biobanking. Proposals for reform have come from many directions, but have tended to involve incremental change in current informed consent practice. This paper reports on our efforts to seek new ideas and approaches from those whom informed consent is designed to protect: research subjects. Our model emerged from semi-structured interviews with healthy volunteers who had been recruited to join either of two biobanks (some joined, some did not), and whom we encouraged to explain their concerns and how they understood the relationship between specimen contributors and biobanks. These subjects spoke about their DNA and the information it contains in ways that were strikingly evocative of the legal concept of the trade secret. They then described the terms and conditions under which they might let others study their DNA, and there was a compelling analogy to the commonplace practice of trade secret licensing. We propose a novel biobanking model based on this trade secret concept, and argue that it would be a practical, legal, and ethical improvement on the status quo.
    The Journal of Law Medicine &amp Ethics 09/2012; 40(3):612-629. · 1.17 Impact Factor
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    ABSTRACT: Purpose:Genotype-driven research recruitment complicates traditional study roles and may leave those recruited worried about unwelcome surprises from their DNA. This study investigated the ways that individuals experience genotype-driven recruitment, and conceptualize their roles as research participants.Methods:Individual interviews were conducted with the participants of a genotype-driven study on cystic fibrosis. The eligibility criteria included the presence of one of two genetic variants. We interviewed 24 of these participants: 9 had cystic fibrosis and 15 had been selected from a biobank as "healthy volunteers."Results:Participants with cystic fibrosis expressed no concerns about the eligibility criteria and saw themselves as part of a close-knit research community. However, biobank participants were unsure about why they had been selected and how they should think about themselves relative to the study. They sometimes reacted with anxiety to genetic information that they perceived to connect them with cystic fibrosis.Conclusion:Being recruited for a study on the basis of one's genotype may raise uncertainties about the meaning and implications of the genotypic information. People without the disease under study may require especially clear and detailed explanations of what researchers already know about their genetic makeup, in terms of future risk for themselves or their children.Genet Med advance online publication 30 August 2012.
    Genetics in medicine: official journal of the American College of Medical Genetics 08/2012; · 3.92 Impact Factor
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    ABSTRACT: Genotype-driven recruitment is a potentially powerful approach for studying human genetic variation but presents ethical challenges. We conducted in-depth interviews with research participants in six studies where such recruitment occurred. Nearly all responded favorably to the acceptability of recontact for research recruitment, and genotype-driven recruitment was viewed as a positive sign of scientific advancement. Reactions to questions about the disclosure of individual genetic research results varied. Common themes included explaining the purpose of recontact, informing decisions about further participation, reciprocity, "information is valuable," and the possibility of benefit, as well as concerns about undue distress and misunderstanding. Our findings suggest contact about additional research may be least concerning if it involves a known element (e.g., trusted researchers). Also, for genotype-driven recruitment, it may be appropriate to set a lower bar for disclosure of individual results than the clinical utility threshold recommended more generally.
    Journal of Empirical Research on Human Research Ethics 12/2011; 6(4):3-20. · 1.49 Impact Factor
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    ABSTRACT: In the debate about whether to return individual genetic results to research participants, consideration of the nature of results has taken precedence over contextual factors associated with different study designs and populations. We conducted in-depth interviews with 24 individuals who participated in a genotype-driven study of cystic fibrosis: 9 of the individuals had cystic fibrosis, 15 had participated as healthy volunteers, and all had gene variants of interest to the researchers. These interviews revealed that the two groups had different ideas about the meaningfulness of genetic results. Our findings point to the importance of understanding research context, such as participants' relationship with the researcher and whether they have the disease condition under study, when considering whether to return individual results.
    Journal of Empirical Research on Human Research Ethics 12/2011; 6(4):30-40. · 1.49 Impact Factor
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    ABSTRACT: To explore the views of university-based investigators conducting genetic research with human specimens regarding ownership and retention of specimens, and knowledge of related institutional review board and university policies. Data were collected in three phases: a qualitative pilot study of 14 investigators; a web-based survey taken by 80 investigators; and follow-up, in-depth interviews with 12 survey respondents. Investigators named a variety of single or multiple owners of human specimens and often expressed confusion regarding specimen ownership. Most associated ownership with rights to control, and responsibilities to maintain, specimens. Investigators viewed specimens as "precious" resources whose value could be increased through long-term or infinite retention, particularly in light of anticipated technological advances in genome science. Their views on ownership and retention were shaped by perceptions of institutional review board policies as immortalized in subject informed consent documents, rather than knowledge of actual policies. Long-term retention of human specimens makes confusion about ownership particularly problematic. Given findings that investigators' views on ownership and retention are largely guided by their perception of university policies, the need for clear, consistent policies at the institution level is urgent.
    Genetics in medicine: official journal of the American College of Medical Genetics 06/2011; 13(6):569-75. · 3.92 Impact Factor
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    ABSTRACT: Genomic biobanks—repositories of human DNA and/or associated data, collected and maintained for biomedical research—present ethical challenges different from those traditionally associated with medical research. Historically, when researchers obtained and used tissue samples, it was for defined purposes and the nature of the research was disclosed to contributors, who were asked to consent to the specific research project. With genomic biobanks, in contrast, the entity holding the samples may not be involved in the research, and future uses of the samples may be unknown. Although traditional research promised confidentiality and/or anonymity to participants, advances in DNA technology may render these safeguards meaningless (1–3). As a consequence, many ethicists argue that traditional informed consent may be illusory if not impossible (1, 4) and that different approaches to the ethics of genetic sample collections are needed (5, 6).
    Science 04/2011; 332(6027):309-10. · 31.20 Impact Factor
  • Science 01/2011; 333. · 31.03 Impact Factor
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    ABSTRACT: This paper reports the results of a qualitative linguistic analysis of interviews with persons who were asked to contribute DNA samples to a genomic biobank. We compare this folk discourse of biobanking to the expert discourse reflected in an extensive biomedical literature. Our most significant finding concerns the social nature of giving informed consent: whereas medical research practice treats it as an event, our subjects talk about it as a discursive process. Our subjects also expound fascinating folk theories of genetics and discuss their views of the sample contribution itself, revealing some remarkable folk-legal theories of that transaction.
    02/2010;
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    ABSTRACT: To determine factors associated with breastfeeding in rural communities. We combined qualitative and quantitative data from the Family Life Project, consisting of: (1) a longitudinal cohort study (N=1292) of infants born September 2003-2004 and (2) a parallel ethnographic study (N=30 families). Demographic characteristics, maternal and infant health factors, and health services were used to predict breastfeeding initiation and discontinuation using logistic and Cox regression models, respectively. Ethnographic interviews identified additional reasons for not initiating or continuing breastfeeding. Fifty-five percent of women initiated breastfeeding and 18% continued for at least 6 months. Maternal employment at 2 months and receiving WIC were associated with decreased breastfeeding initiation and continuation. Ethnographic data suggested that many women had never even considered breastfeeding and often discontinued breastfeeding due to discomfort, embarrassment, and lack of assistance. Breastfeeding rates in these rural communities lag behind national averages. Opportunities for increasing breastfeeding in rural communities include enhancing workplace support, maximizing the role of WIC, increasing hospital breastfeeding assistance, and creating a social environment in which breastfeeding is normative.
    Maternal and Child Health Journal 06/2008; 12(3):402-14. · 2.24 Impact Factor
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    ABSTRACT: This study evaluates the psychometric properties and criterion validity of the Religious Social Support (RSS) Scale in a diverse, representative community sample of new mothers (N = 1,156). Results indicated that two factors best represented the RSS. Criterion validity was established by demonstrating that the RSS was associated with relational and health outcomes. However, these associations were reduced to statistical insignificance once a general measure of social support was included as a covariate. There were no indications that race moderated either the psychometric properties of the RSS or the relationships between social support and outcomes. Qualitative analyses indicated that religious social support is a salient construct in the lives of women that we studied and suggested ways to improve future developments of RSS scales.
    Journal for the Scientific Study of Religion 03/2008; 47(1):147-159. · 1.35 Impact Factor
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    ABSTRACT: The empirical literature on the ethical, legal, and social implications (ELSI) of biobanking has almost entirely relied on the perspectives of those outside of biobanks, such as the general public, researchers, and specimen contributors. Little attention has been paid to the perspectives and practices of those who operate biobanks. We conducted a study of U.S. biobanks consisting of six in-depth case studies and a large online survey (N = 456), which was developed from the case study results. The case studies included qualitative interviews with a total of 24 personnel. Both interview and survey questions focused on how biobanks operate, and what policies and practices govern their relationships with specimen contributors and the researchers who use the specimens. Analysis revealed unexpected ethical dilemmas embedded in those policies and practices that highlight a need for practical planning. In this paper, we review three issues seldom explored in the ELSI literature: 1. the discrepancy between biobankers’ hope that the bank will exist “permanently” and the fact that funding is limited; 2. the lack of planning for what will happen to the specimens if the bank closes; and 3. the concern that once collected, specimens may be underutilized. These dilemmas are missing from current public representations of biobanks, which instead focus on the intrinsic value in storing specimens as essential to the advancement of translational research. We argue that attention to these issues is important for biobanking, and that greater transparency of these policies and practices will contribute to promoting public trust in biobanks.
    Life Sciences, Society and Policy. 9(1).
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    ABSTRACT: Increasing the engagement of racial and ethnic minorities in genomic research may help alleviate health disparities. This paper examines community perceptions of the relationships between race, genes, environment, and health disparities, and it discusses how such perceptions may influence participation in genomic research. We conducted semi-structured interviews with 91 African American, Latino, and white lay community members and community leaders in North Carolina. Using constant comparison methods, we identified, compared, and developed linkages between conceptual categories and respondent groups. Participants described gene-environment interactions as contributing to group differences in health outcomes, expressed the belief that genetic predisposition to disease differs across groups, and said that social conditions trigger group-level genetic differences and create poorer health outcomes among African Americans. Given the regional presence of major research institutions and the relatively high education level of many participants, this sample may not reflect the perspectives of those most disparately affected by health disparities. Members from multiple community sectors share perceptions and may respond to similar approaches when attempts are made to increase participation in genomic research. Researchers may inadvertently fuel the perception that health disparities experienced by minorities are rooted in the shared genomes of a particular group as distinct from those of other groups. The way researchers use race and ethnicity in recruitment, analysis, and communication of research findings inaccurately implies that there are genetic differences between races, when categories of social experience or ancestry may more accurately characterize health differences. Understanding these issues is crucial to designing effective community engagement strategies, recruitment plans, and messages about genomic research, which could ultimately help to lessen health disparities.
    North Carolina medical journal 74(6):470-476.