R. Jean Cadigan

Prepared patients: Internet information seeking by new rheumatology patients

OBJECTIVE To investigate to what extent and why new rheumatology patients access medical information online prior to first appointments and secondarily to ask whether they discuss information gained from the Internet with physicians. METHODS Research was conducted in a teaching rheumatology clinic with a nonrandom sample of 120 English-speaking adults presenting for first appointments in rheumatology. Quantitative and qualitative data were gained in pre- and postappointment patient surveys and interviews, including online information gathering prior to first appointment, demographics, health status, information usage in patient-physician interactions, and satisfaction. Data were analyzed for significant relationships across variables and for qualitative insights into quantitative outcome measures. RESULTS Of all patients, 87.5% looked up their symptoms or suspected condition prior to their first appointment and 62.5% of all patients sought that information on the Internet. Only 20% of online information seekers discussed that information with their physicians. Age and sex were significant predictors of Internet information seeking. Physician and patient appointment satisfaction was significantly higher when Internet information was discussed; however, most patients did not discuss their information seeking because they primarily feared being perceived as challenging their physician. CONCLUSION The majority of patients research their conditions online prior to initial appointments, but are unlikely to discuss that research with physicians even though discussion is related to higher satisfaction. Physicians may want to consider strategies for enabling communication about online research.

Neglected ethical issues in biobank management: Results from a U.S. study

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.

Stewardship Practices of U.S. Biobanks

Most U.S. biobanks do not create ongoing relationships with contributors but do practice stewardship over storing and sharing of specimens. 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.

RESEARCH PARTICIPANTS’ PERSPECTIVES ON GENOTYPE-DRIVEN RESEARCH RECRUITMENT

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.

Genomics, Biobanks, and the Trade-Secret Model

An alternative to traditional informed-consent approaches to human subjects could provide flexibility and increased participation. 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).

Biobanks in the United States: How to Identify an Undefined and Rapidly Evolving Population

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.

Advancing HIV research with pregnant women: navigating challenges and opportunities.

Objective:Concerns about including pregnant women in research have led to a dearth of evidence to guide safe and effective treatment and prevention of HIV in pregnancy. To better understand why these evidence gaps persist and inform guidance for responsible inclusion of pregnant women in the HIV research agenda, we aimed to learn what HIV experts perceive as barriers and constraints to conducting this research. Methods:We conducted a series of group and one-on-one consultations with 62 HIV investigators and clinicians to elicit their views and experiences conducting HIV research involving pregnant women. Thematic analysis was used to identify priorities and perceived barriers to HIV research with pregnant women. Results:Experts discussed a breadth of needed research, including safety, efficacy, and appropriate dosing of: newer antiretrovirals for pregnant women, emerging preventive strategies, and treatment for coinfections. Challenges to conducting research on pregnancy and HIV included ethical concerns, such as how to weigh risks and benefits in pregnancy; legal concerns, such as restrictive interpretations of current regulations and liability issues; financial and professional disincentives, including misaligned funder priorities and fear of reputational damage; and analytical and logistical complexities, such as challenges recruiting and retaining pregnant women to sufficiently power analyses. Conclusion:Investigators face numerous challenges to conducting needed HIV research with pregnant women. Advancing such research will require clearer guidance regarding ethical and legal uncertainties; incentives that encourage rather than discourage investigators to undertake such research; and a commitment to earlier development of safety and efficacy data through creative trial designs.

Underutilization of specimens in biobanks: an ethical as well as a practical concern?

“It’s totally false . . . that “if you build it they will come.” I thought if we build this [biobank] we’ll have people knocking on our door to use it” (Interview with a biobank director, 2011).Biobanks, organizations that acquire and store human speci-mens and associated data for future research use, may be essen-tial to realizing the promise of translational research—but not if researchers fail to come knocking on their doors. Indeed, lack of use of specimens and data by researchers may lead to biobank closure. Recent interviews and a national survey with US biobankers,

A Trade Secret Model for Genomic Biobanking

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.

Symptoms of depression and their management among low-income African-American and White mothers in the rural South

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. Womens 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.