R Jean Cadigan

University of North Carolina at Charlotte, Charlotte, North Carolina, United States

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Publications (26)161.65 Total impact


  • No preview · Article · Dec 2015 · The American Journal of Bioethics
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    ABSTRACT: In genomics research, it is becoming common practice to return individualized primary and incidental findings to participants and several ongoing major studies have begun to automatically transfer these results to a participant's clinical medical record. This paper explores who should decide whether to place genomic research findings into a clinical medical record. Should participants make this decision, or does a researcher's duty to place this information in a medical record override the participant's autonomy? We argue that there are no clear ethical, legal, professional, or regulatory duties that mandate placement without the consent of the participant. We conclude that informing participants of results, together with a clear explanation, relevant recommendations and referral sources, and the option to consent to placement in the medical records will best discharge researchers' ethical and legal duties towards participants.
    No preview · Article · Dec 2015 · The Journal of Law Medicine & Ethics

  • No preview · Article · Sep 2015 · IRB Ethics and Human Research

  • No preview · Article · Jun 2015 · BioSocieties

  • No preview · Article · Apr 2015 · Gastroenterology
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    ABSTRACT: Little is known about beliefs, understanding, and perceptions of biobanking among patients with inflammatory bowel diseases. We aimed to further understand perceptions of biobanking in the inflammatory bowel disease community. Subjects were recruited to participate in a 1:1 telephone interview on their perceptions of the risks and benefits of contributing specimens for research. These interviews informed a survey instrument evaluating perceptions of biobanking within Crohn's and Colitis Foundation of America Partners cohort. We used descriptive statistics to summarize participant responses, and bivariate statistics to compare willingness to participate in biobanking by disease and demographic factors. A total of 26 interviews were conducted. Various themes emerged from the interviews and aided in the development of the survey instrument. Concerns focused on storage, loss of confidentiality, outside uses, and life insurance discrimination. A total of 1007 individuals completed the survey. Overall, 397 (39.4%) reported that they would definitely donate samples, 568 (56.4%) would probably donate, 36 (3.6%) probably not, and 6 (0.6%) would definitely not donate. No significant differences in willingness to donate samples were seen for Crohn's disease versus ulcerative colitis (P = 0.25) or for remission versus active disease (P = 0.14). For sample-type preference, 956 (89.6%) would donate blood, 997 (93.5%) saliva, and 822 (77.1%) stool. Majorities of patients with inflammatory bowel disease demonstrated willingness to donate specimens for biobanking, albeit with concerns. Addressing these concerns will enhance participation and engagement and create greater alignment between the desires of research participants and the governance structure and operating policies of biobanks.
    No preview · Article · Dec 2014 · Inflammatory Bowel Diseases
  • 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.
    No preview · Article · Jun 2014 · Ethnicity and Health
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    R Jean Cadigan · Eric Juengst · Arlene Davis · Gail Henderson

    Full-text · Article · Apr 2014 · Genetics in medicine: official journal of the American College of Medical Genetics
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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.
    No preview · Article · Feb 2014 · Public Health Genomics
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    ABSTRACT: Objectives: 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. Design and methods: In this paper, we present data from the subset of 261 biobanks in our 2012 national survey that stores specimens from clinical sources, focusing on a number of ethical issues that have been raised in the literature. Results: 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 researchers have acquired, them. 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. Conclusion: 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.
    No preview · Article · Dec 2013 · Clinical biochemistry
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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.
    Full-text · Article · Dec 2013 · Science translational medicine
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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.
    No preview · Article · Dec 2013 · North Carolina medical journal
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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.
    Preview · Article · Dec 2013
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    ABSTRACT: Background Effective translational biomedical research hinges on the operation of 'biobanks,' repositories that 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 or hospitals, public health programs, and research studies. Forty-four percent of biobanks store pediatric specimens, and 36% include postmortem 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 of the immense diversity found in organizational features, including the very different history and primary goals that many biobanks have.
    No preview · Article · Jan 2013 · Genome Medicine
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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.
    No preview · Article · Dec 2012 · Biopreservation and Biobanking
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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.
    Full-text · Article · Sep 2012 · The Journal of Law Medicine & Ethics
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    Marsha Michie · R Jean Cadigan · Gail Henderson · Laura M Beskow
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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.
    Preview · Article · Aug 2012 · Genetics in medicine: official journal of the American College of Medical Genetics
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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.
    Full-text · Article · Dec 2011 · Journal of Empirical Research on Human Research Ethics
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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.
    Full-text · Article · Dec 2011 · Journal of Empirical Research on Human Research Ethics
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    Full-text · Article · Sep 2011 · Science