The response many gay men took to the HIV epidemic in the United States was largely informal, especially given distant state and federal governments. The condom code, a set of informal norms that encouraged the use of condoms, is one instance of this informal response, which was wholly uncoordinated. Yet, it is not clear why these informal norms emerged or why they have since eroded. This paper explores how gay men in particular generated expectations and normative beliefs regarding condom usage, which helped to establish the condom code as an informal norm. Furthermore, the erosion of the condom code is viewed as a result of changing expectations, which change as bio-medical means of HIV treatment and prevention develop and as online and digital communities facilitate serosorting, all of which provide alternatives to condoms as a means of prevention and their associated informal norms. Future HIV prevention campaigns should recognize the extent to which informal norms coordinate and encourage preventative behavior, as well as how beliefs and expectations alter the informal norms people adopt.

The 21st Century Cures Act is a major act of legislation that contains numerous changes to drug and device regulation. The House of Representatives passed the Act after considerable interest group lobbying, but the bill and the key changes made during its drafting remain controversial. Using publicly disclosed records of written comments on the bill, we reviewed the key areas of lobbying activity and the compromises made in the final text. We focused on legislative provisions relating to management of the National Institutes of Health, incentives for medical product development, and approval standards for new drugs and devices. By the end of the first comment period, the Committee received 118 comments. Most respondents were patient organizations, professional societies, and pharmaceutical and device companies. Overall, the majority of public comments were positive, although public health and consumer organizations were underrepresented in the number of submitted comments. As the legislative process continued, the draft bill underwent several changes relating to NIH funding, market exclusivity provisions, and scrutiny of regulatory evidentiary standards. Understanding the key statutory provisions and how they have evolved could help patients, researchers, and advocates make more informed comments on the bill and future health care legislation.

Allied health professionals play an integral role in providing safe, affordable care to communities in need. Laws that define the permissible scope of practice for these professionals may take full advantage of these providers and may unnecessarily restrict safe and effective care. Nurse practitioners in many states may provide care independent of a physician; research reveals that this care is safe, affordable and accessible. Yet hurdles exist that prevent communities from securing the full benefit of NPs in independent practice. The scope of independent practice for allied dental providers varies greatly across the country, often including stringent supervision requirements. Emerging approaches to allowing allied dental providers to practice independently in certain settings or with dentist supervision via telemedicine and creating the intermediate provider, the dental therapist, may increase access to safe, affordable dental care. Research on the impact of laws that allow broader independent practice by NPs to ferret out the hurdles to full implementation of the spirit of such laws is needed. That research could support expanded independent scope for allied dental providers and other allied health care providers.

About 6,000 individuals participate in the U.S. transplant system as a living organ donor each year. Organ donation (most commonly a kidney or part of liver) by living individuals is a unique procedure, where healthy patients undergo a major surgical operation without any direct functional benefit to themselves. In this article, the authors explore how the ideal of informed consent guides education and evaluation for living organ donation. The authors posit that informed consent for living organ donation is a process. Though the steps in this process are partially standardized through national health policy, they can be improved through institutional structures at the local, transplant center-level. Effective structures and practices aimed at supporting and promoting comprehensive informed consent provide more opportunities for candidates to ask questions about the risks and benefits of living donation and to opt out voluntarily Additionally, these practices could enable new ways of measuring knowledge and improving the consent process.

There are compelling medical, ethical, and legal arguments that support mandating use of a central institutional review board (CIRB) for the review of clinical trials performed at multiple institutional sites. Progress against serious diseases depends on this.

Ethical, evidence-informed decision making is undermined by the grave concerns that have emerged over the trustworthiness of clinical trials published in biomedical journals. The inescapable conclusion from this growing body of research is that what we see, even in the most highly regarded peer-reviewed journals, cannot be trusted at face value. Concerns of inaccurate, biased, and insufficient reporting of trials are impossible to resolve without access to underlying trial data. Access to such data, including things like clinical study reports—huge, unabridged, detailed reports of clinical trials—would minimise the risk of distortions and selective publication. But the FDA, the world’s greatest custodian of those data, just sits on them. We see no reason why FDA should not publicly release clinical study reports with minimal redactions. The European regulator is already doing this, but FDA’s holdings are far greater. Data transparency is not simply an “opportunity” FDA might consider, but rather an ethical imperative. The Blueprint is good but does not go far enough. We do not need gates, barriers and committees between us and access to aggregate reports on drugs and other interventions which we are prescribing or using daily. Let’s leave the nannies at home.

During the early twentieth century, otologists began collaborating with organizers of the New York League for the Hard of Hearing to build a bridge to “adjust the economic ratio” of deafness and create new research avenues for alleviating or curing hearing loss. This collegiality not only defined the medical discourse surrounding hearing impairment, anchoring it in hearing tests and hearing aid prescription, but, in so doing, solidified the notion that deafness was a “problem” in dire need of a “solution.” Public health campaigns thus became pivotal for spreading this message on local and national levels. This paper focuses on how, from the 1920s to 1950s, as otologists became more involved with social projects for the deaf and hard of hearing — advocating lip-reading, community work, and welfare programs — at the same time, they also mandated for greater therapeutic regulation, control of hearing aid distribution, and standardization of hearing tests. The seemingly paradoxical nature of their roles continued to reinforce the stigmatization of deafness: with widespread availability of effective help, the hearing impaired were expected to seek out therapeutic or technological measures rather than live with their affliction.

A review of literature regarding informed consent in dentistry reveals a paucity of information and minimal scholarship devoted to this subject. But this begs the question about informed consent somehow being different for dentistry than for medicine or other healthcare delivery. My account draws distinctions where appropriate but is rooted in the premise that informed consent is an ethical construct applicable to vulnerable people as patients independent of what type of treatment or body part being considered. This paper highlights the crucial importance of the process of informed consent and refusal in dentistry, underscoring its important place in oral healthcare. This paper will not address the unique circumstances involving consent in those without capacity or focus on informed consent in the research setting; our focus will be on those patients with full decisionmaking capacity in the clinical setting. I will emphasize the importance of disclosure of treatment options and highlight the benefits of shared-decision-making in the informed consent process.

This article describes overlapping links among incarceration, poor health, race, and stigma, and stigma's impact on the health of former prisoners and their families and communities. The authors include policy recommendations to reduce the impact of incarceration and stigma.

This article discusses the relationship between stress, physical health, and well-being in cultural context, offers examples of laws, policies, and programs to promote mental health and well-being, and examines how collective impact supports mental health and well-being.

The Food and Drug Administration (FDA), as a matter of long-standing policy, does not inform the public of instances whereby applications for new drugs or new indications for existing drugs have been rejected by the agency or withdrawn from consideration, nor does it disclose the agency’s analyses of the data submitted with such applications. This lack of transparency is unjustified and prevents patients, researchers, and healthcare providers from gaining insight into why a drug’s application was not approved. The FDA’s policy is particularly troubling in cases where the agency has found a currently marketed drug to be ineffective or unsafe for a newly proposed indication. Disclosure of the FDA’s findings in such cases would promote public health by encouraging healthcare providers to avoid prescribing drugs for unapproved (off-label) uses that the agency has deemed to be potentially dangerous or ineffective. The FDA’s counterpart agencies in Europe and Canada have demonstrated the feasibility of disclosing information on rejected and withdrawn drug marketing applications. The FDA should follow suit and allow the American public to know when a drug is deemed unsafe or ineffective for a certain use.

The NIH has initiated a plan to mandate use of central IRBs for all multi-site research. This manuscript argues against the mandate, proposing that there is inadequate evidence to support the purported gains in efficiency and that the ethical integrity of research may suffer with any exclusion of the local review voice.

This study examined the extent to which concussion management plans at National Collegiate Athletic Association (NCAA) member schools were in line with NCAA Concussion Policy and best practice recommendations in absence of any process to ensure compliance. Most schools' concussion management plans were in compliance with 3 (60%) or 4 (25.6%) of the NCAA's 4 required components. Annual athlete education and acknowledgement was the requirement least often included, representing an area for improvement. Further, schools tended to more often include best practices that were more medically-oriented (e.g., including baseline examination), compared to best practices that were less medical in nature (e.g., avoiding flagrant head hits).

Informed consent is the single most important concept for understanding decision-making capacity. There is a steady pull in the clinical world to transform capacity into a technical concept that can be tested objectively, usually by calling for a psychiatric consult. This is a classic example of medicalization. In this article I argue that is a mistake, not just unnecessary but wrong, and explain how to normalize capacity assessment.

Returning the locus of capacity assessment to the attending, the primary care doctor, and even to ethics consultation in today's environment will require a substantial effort to undo a strong but illusory impression of capacity assessment. Hospital attorneys as well as clinical ethicists with a sophisticated understanding of health law can be in the vanguard of this reorientation.

Smoking remains the leading cause of preventable disease and death in the United States, killing approximately 480,000 people each year. This crushing health burden falls disproportionately, and recent CDC data shows that large disparities in adult cigarette smoking remain. One factor in these disparities is the use of flavors. Menthol cigarettes and other flavored tobacco products are used at higher rates by vulnerable populations including youth and young adults, African Americans, women, Hispanics and Asian Americans. This is no accident; the tobacco industry has long targeted these same groups. Given FDA's failure to act to ban flavored tobacco products, states and municipalities are considering taking matters into their own hands to protect their communities from these dangerous products. The authors will explore state and local authority to restrict the sales of these products and review the evidence base indicating that removing flavored tobacco products – and menthol combustible products in particular - from the market would significantly reduce the toll of illness and death caused by these products.

This article analyzes the relationship between the structure of federal Title IX investigations and the existing evidence addressing the emotional and mental health needs of sexual harassment and sexual assault victims. The article argues that federal requirements for investigating sexual harassment should be restructured so as to address the challenges stigma poses for the realization of Title IX's objectives.

This paper explains why informed consent for randomized comparative effectiveness research (CER) must include risks of standard care. Disclosures of such risks are both legally and ethically required and, for reasons discussed in the paper, should remain so.

A main objective of this study is to assess the opinions of 50 behavioral health patients on selective control over their behavioral and physical health information. We explored patients' preferences regarding current consent models, what health information should be shared for care and research and whether these preferences vary based on the sensitivity of health information and/or the type of provider involved. The other objective of this study was to solicit opinions of 8 behavioral health providers on patient-driven granular control of health information and potential impact on care.

Electronic surveys were implemented at an outpatient Behavioral Health facility that provides care for behavioral health patients with non-serious mental illnesses. The Patient Survey included questions regarding patients' demographics and about their concerns and preferences for data sharing for care and research. The Provider Survey included questions about their view on the current consent process and perceptions on barriers and facilitators to implement patient-controlled granular consent models.

This novel study provides valuable preliminary data that can help guide future studies to better understand privacy choices of this underrepresented patient group.