Exclusion of Genetic Information From the Medical Record: Ethical and Medical Dilemmas

Increasingly, physicians and patients face dilemmas of whether to exclude genetic information from medical charts, posing critical challenges for practice, research, policy, and education. Physicians and patients are obtaining more genetic information, yet medical records are rapidly becoming electronic, threatening confidentiality. Tensions thus arise between potential medical benefits vs social risks of including information. Use of genetic testing is rapidly increasing through clinicians and direct-to-consumer marketing. Direct-to-consumer tests may be definitive or show only slightly increased disease probabilities, but with advances may have increasing clinical utility. Several institutions have also discussed including whole genome data in medical records. Genetic discrimination has occurred with α1-antitrypsin deficiency, Huntington disease, and other mutations, although the extent remains unclear, partly because such discrimination can be subtle or difficult to prove. Patients may be passed over for promotion or marginalized, but not fired

How IRBs View and Make Decisions about Social Risks

Whether and how irbs assess social risks remains unclear, with little empirical investigation. I contacted leaders of 60 IRBs, and interviewed IRB leaders from 34 (response rate = 55%) and additionally, 12 members and administrators. IRBs struggle to assess and balance social risks and benefits, and vary in whether, how, and how much to do so, and how to balance these against individual risks/benefits. Risks to a group affect individuals within it. Hence, social risks can include indirect individual risks, raising ambiguities. Dilemmas emerge: E.g., how much responsibility researchers and IRBs have for addressing broader health inequities. These data, the first to examine how IRBs make decisions about social risks, reveal how IRBs face critical challenges, dilemmas, and ambiguities

Views of the Process and Content of Ethical Reviews of HIV Vaccine Trials Among Members of US Institutional Review Boards and South African Research Ethics Committees

Given the ethical controversies concerning HIV vaccine trials (HVTs), we aimed to understand through an exploratory study how members of institutional review boards (IRBs) in the United States (US) and research ethics committees (RECs) in South Africa (SA) view issues concerning the process and content of reviews of these studies. We mailed packets of 20 questionnaires to 12 US IRB chairs and administrators and seven REC chairs to distribute to their members. We received 113 questionnaires (76 from the US and 37 from SA). In both countries, members tended to be white males with advanced academic degrees. Compared to the US, SA members called for ‘major changes’ in HVT protocols more frequently (p =  0.004), and were less likely to think that HVT participants understood risks and benefits (p =  0.033) or informed consent forms (p =  0.000). In both countries, members were divided on several critical issues (e.g. the minimum standard for treatment for HVT participants who became infected during the HVT), but agreed that they needed more training. Of the SA respondents, 40% reported that they were ‘self‐taught’ in ethics. This study, the first we know of to offer quantitative data comparing US vs. non‐US IRBs/RECs, thus suggests key similarities and differences (e.g. compared to SA respondents, US respondents appeared to overestimate participants' understanding of informed consent), along with needs for education. These initial exploratory data in this area have important implications for IRBs, RECs, policy‐makers and scholars concerning future practice, training, policy, and investigations in research ethics, and prevention and treatment of HIV and other diseases in the developing world and elsewhere

From “Male Bonding Rituals” to “Suicide Tuesday”: A Qualitative Study of Issues Faced by Gay Male Ecstasy (MDMA) Users

Use of MDMA and other club drugs has increased among gay men, but questions remain concerning the use, context, and popularity of these drugs; and views of their side effects. We interviewed in-depth 12 gay MDMA users in New York. MDMA had specific appeals to gay men, who often described isolation and stigmatization. Users underwent a period of initiation and social networks often became comprised of greater numbers of other users. Club environments fostered drug use and vice versa. Awareness of potential adverse effects varied and was minimized. Appropriate educational and prevention programs are needed to address these issues, and must take into account the specific contexts of these gay men's lives

How local IRBs view central IRBs in the US

Background: Centralization of IRB reviews have been increasing in the US and elsewhere, but many questions about it remain. In the US, a few centralized IRBs (CIRBs) have been established, but how they do and could operate remain unclear. Methods: I contacted 60 IRBs (every fourth one in the list of the top 240 institutions by NIH funding), and interviewed leaders from 34 (response rate = 55%) and an additional 12 members and administrators. Results: These interviewees had often interacted with CIRBs, but supported local reviews, and offered advantages and disadvantages of each. Interviewees argued that local IRBs can provide "local knowledge" of subjects and PIs, and "curbside consults" with PIs, facilitating mutual trust. PIs may interact more fully and informally, and hence effectively with local IRBs. IRBs also felt additional responsibility to protect "their own" subjects. Respondents mentioned a few advantages of CIRBs (e.g., CIRBs may streamline reviews), though far more rarely and cursorily. Overall, interviewees were wary of CIRBs, which they saw as varying widely in quality, depending on who happened to be members. Both local and centralized IRBs appear to have unintended consequences. For instance, discrepancies arose between IRBs that appeared to reflect differences in institutional culture and history, and personalities of chairs and/or vocal members, more than in local community values per se, and thus do not seem to be the intent of the regulations. While some critics see CIRBs as solutions to many IRB problems, critical tradeoffs and uncertainties emerge. Conclusions: These data have critical implications for future policy and research. Debates need to evolve beyond simply a binary discussion of whether CIRBs should replace local IRBs, to examine how and to what degree different models might operate, and what the relative advantages and disadvantages of each are. While some critics see CIRBs as panaceas, certain problems appear likely to continue. Careful consideration needs to be given to whether the advantages of local IRBs outweigh the problems that result, and whether a system can be developed that provides these benefits, while avoiding the disadvantages of local IRBs

From anonymity to “open doors”: IRB responses to tensions with researchers

Background: Tensions between IRBs and researchers in the US and elsewhere have increased, and may affect whether, how, and to what degree researchers comply with ethical guidelines. Yet whether, how, when, and why IRBs respond to these conflicts have received little systematic attention. Findings: I contacted 60 US IRBs (every fourth one in the list of the top 240 institutions by NIH funding), and interviewed leaders from 34 (response rate = 55%) and an additional 12 members and administrators. IRBs often try to respond to tensions with researchers and improve relationships in several ways, but range widely in how, when, and to what degree (e.g., in formal and informal structure, content, and tone of interactions). IRBs varied from open and accessible to more distant and anonymous, and in the amount and type of “PR work” and outreach they do. Many boards seek to improve the quantity, quality, and helpfulness of communication with PIs, but differ in how. IRBs range in meetings from open to closed, and may have clinics and newsletters. Memos can vary in helpfulness and tone (e.g., using “charm”). IRBs range considerably, too, in the degrees to which they seek to educate PIs, showing them the underlying ethical principles. But these efforts take time and resources, and IRBs thus vary in degrees of responses to PI complaints. Conclusions: This study, the first to explore the mechanisms through which IRBs respond to tensions and interactions with PIs, suggests that these committees seek to respond to conflicts with PIs in varying ways – both formal and informal, involving both the form and content of communications. This study has important implications for future practice, research, and policy, suggesting needs for increased attention to not only what IRBs communicate to PIs, but how (i.e., the tone and the nature of interactions). IRBs can potentially improve relationships with PIs in several ways: using more “open doors” rather than anonymity, engaging in outreach (e.g., through clinics), enhancing the tone as well as content of interactions, educating PIs about the underlying ethics, and helping PIs as much and proactively as possible. Increased awareness of these issues can help IRBs and researchers in the US and elsewhere

Views and approaches toward risks and benefits among doctors who become patients

Objective: To understand how views and approaches concerning risks and benefits may be affected by dynamic contexts and processes related to clinical roles and relationships. Methods: We conducted two in-depth, semi-structured interviews with 50 doctors who became patients due to serious illnesses, concerning their experiences before and after diagnosis. Results: As patients, these doctors gained critical new insights into the processes and contexts of communication about risks and benefits. Doctors and patients often varied in how they viewed and weighed risks and benefits (e.g., as “good’ or “bad”). These data suggest a model in which patients undergo several dynamic processes: seeking statistics, accepting doctors’ framing of statistics, being influenced by media hype, seeing statistics as relevant or not, over-valuing risks, weighing the importance of risks and benefits, interpreting statistics as good or bad, accepting or denying statistics and odds, and making treatment decisions. These processes are affected by external factors (e.g., doctors ordering tests, framing statistics, and often over- versus under-valuing risks), and internal factors (e.g., depression, denial of illness, optimism versus pessimism, magical thinking – that doctors are immune to disease – and rationalizations). Conclusions: Doctors and patients are engaged in complex, dynamic processes that shape patients’ approaches toward risks and benefits. Practice Implications: These data highlight the need for increased attention toward these issues in medical educational and care

Impediments to communication and relationships between infertility care providers and patients

Background Infertility patients generally see provider-patient communication and relationships as important, but as often insufficient, raising critical questions regarding why these gaps persist, and how they might best be addressed. Methods Semi-structured interviews of approximately one hour each were conducted with 37 ART providers and patients (17 physicians, 10 other health providers, and 10 patients) and were thematically analyzed. Results Patients see clinicians’ interactions as ranging widely from good to bad, related to several specific barriers and factors. Patients and providers may differ in their physical and emotional experiences, expectations concerning treatment outcomes and uncertainties, and time frames and finances, generating dynamic processes and tensions. Characteristics of particular providers, clinics and patients can also vary. Infertility patients tend to find only one outcome acceptable – a “take home baby” – rather than partial success, as is the case with many other diseases. Yet most IVF cycles fail. Many patients must pay considerable out-of-pocket expenses for infertility treatment, exacerbating disappointments and frustrations. Providers often work in competitive, entrepreneurial markets, and “hype” their potential success. After treatment failures, providers may feel guilty and withdraw from patients. Yet these behaviors can antagonize patients more than physicians realize, aggravating patient stresses. Several providers described how they understood patients’ needs and perceptions more fully only after becoming infertility patients themselves. Interactions with not only physicians, but other providers (e.g., nurses and staff) can play key roles. Patients may be willing to understand these impediments, but providers often communicate these obstacles and reasons poorly or not at all, furthering tensions. Conclusions These data, the first to examine several critical aspects of challenges that infertility providers and patients face in communication and relationships, suggest that several key dynamic processes and factors may be involved, and need to be addressed. While prior research has shown that infertility patients value, but often feel disappointed in relationships with clinicians, the present data highlight several specific impediments, and thus have critical implications for future practice, research, guidelines and education

Consenting for Molecular Diagnostics

The growing use of molecular diagnostics poses a wide range of issues and questions concerning informed consent that researchers, health care providers, and others will increasingly need to address. Molecular diagnostics are advancing more rapidly than our ability to decide how best to respond to their complex medical, ethical, legal, psychological, and social implications. Although some of these issues resemble those posed by prior tests, the newness and ever-faster spread of these tests, the advent of large-scale electronic databases, and the many inherent uncertainties involved present new challenges and dilemmas that require careful attention to determine how best to proceed. Obtaining appropriate informed consent will require considerable resources, which many researchers and providers may not fully appreciate. For example, for whole genome sequencing (WGS)2 and whole exome sequencing (WES), most researchers have indicated that they were willing to spend 30 minutes or less on obtaining informed consent (1). Yet the complexity of the information involved will probably often require significantly longer interactions

How much is a child worth? Providers’ and patients’ views and responses concerning ethical and policy challenges in paying for ART

Infertility treatments remain expensive and in many countries are covered by little, if any, insurance, raising critical questions concerning how patients and providers view and make decisions regarding these challenges. In-depth semi-structured interviews of approximately 1 hour were conducted with 37 IVF providers and 10 patients (17 physicians, 10 other providers and 10 patients), and were systematically analyzed. These data suggest current insurance policies and legislation pose critical ethical and logistical challenges for both patients and providers. These individuals face multiple uncertainties about costs and insurance, related to unclear causes of fertility, treatment length, costs and outcomes, and odds that insurers will cover expenses. Insurers frequently decline to agree to reimbursement beforehand, and decide only afterwards, case-by-case, generating stress. Patients and providers thus may not be able to predict how best to allocate limited resources. Providers may advocate for patients, but are usually unsuccessful. Patients may adopt several strategies: e.g., moving/seeking treatment elsewhere, switching or feeling “stuck” in jobs because of insurance, seeking “free” medications, going into debt, or using funds intended for other purposes. Patients do not perceive and respond to resource limitations as fixed phenomena—i.e., patients do not see treatment simply as “affordable” or not. Rather, patients face quandaries of how much to keep spending—how much a child is worth—and are forced to make complex risk/benefit calculations. Couples can disagree, straining relationships. In sum, these data, the first to explore how providers and patients struggle, view, and make decisions regarding limited insurance and resources for infertility, raise several critical ethical and policy issues. These data suggest that individuals have difficulty translating profoundly life-altering, deeply personal quests for meaning and fulfillment into purely economic terms. These findings thus have important implications for future policy, practice, research, and patient and provider education