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This paper describes the results of a multi-country survey of governance approaches for the use of digital contact tracing (DCT) in response to the COVID-19 pandemic. We argue that the countries in our survey represent two distinct models of DCT governance, both of which are flawed. The "data protection model" emphasizes privacy protections at the expense of public health benefit, while the "emergency response model" sacrifices transparency and accountability, prompting concerns about excessive governance surveillance. The ethical and effective use of DCT in the future requires a new governance approach that is better suited to this novel use of mobile phone data to promote public health." [ABSTRACT FROM AUTHOR]

Global health research partnerships are increasingly taking the form of consortia. Recent scholarship has proposed what features of governance may be necessary for these consortia to advance justice in global health. That guidance purports three elements of global health research consortia are essential — their research priorities, research capacity development strategies, research translation strategies — and should be structured to promote the health of the worst-off globally. This paper adopted a reflective equilibrium approach, testing the proposed ethical guidance against the experience of a global health research consortium with equity objectives. Case study research was performed with Future Health Systems (FHS), a health systems research consortium funded over two phases. Data on FHS Phase-2 were gathered through in-depth interviews with steering committee members and junior researchers and collection of consortium-related documents. Thematic analysis of the data for consistency with the proposed guidance generated recommendations for how the guidance might be better articulated and identified areas where it could usefully be expanded. Factors facilitating FHS alignment with the ethical guidance were also identified, including early engagement and partnership with low and middle-income country stakeholders, the learning developed during FHS Phase-1, and aspects of the grant program funding it. [ABSTRACT FROM AUTHOR]

Data are lacking with regard to participants' perspectives on return of genetic research results to relatives, including after the participant's death. This paper reports descriptive results from 3,630 survey respondents: 464 participants in a pancreatic cancer biobank, 1,439 family registry participants, and 1,727 healthy individuals. Our findings indicate that most participants would feel obligated to share their results with blood relatives while alive and would want results to be shared with relatives after their death. [ABSTRACT FROM AUTHOR]

Returning genetic research results to relatives raises complex issues. In order to inform the U.S. debate, this paper analyzes international law and policies governing the sharing of genetic research results with relatives and identifies key themes and lessons. The laws and policies from other countries demonstrate a range of approaches to balancing individual privacy and autonomy with family access for health benefit, offering important lessons for further development of approaches in the United States. [ABSTRACT FROM AUTHOR]

Genomic research results and incidental findings with health implications for a research participant are of potential interest not only to the participant, but also to the participant's family. Yet investigators lack guidance on return of results to relatives, including after the participant's death. In this paper, a national working group offers consensus analysis and recommendations, including an ethical framework to guide investigators in managing this challenging issue, before and after the participant's death. [ABSTRACT FROM AUTHOR]

As interest in comparative effectiveness research grows, questions have emerged regarding whether it is ever acceptable to alter informed consent requirements for research when patients are randomly assigned to widely-used therapies. This paper reports on interviews with Institutional Review Board members and researchers and on focus groups with patients from Geisinger and Johns Hopkins health systems. The objective was to elicit participants' views of the acceptability of four different disclosure and authorization models for low-risk pragmatic comparative effectiveness trials of widely-used therapies. Results suggest that although participants valued autonomous choice, many also believed that it was acceptable to streamline information disclosure and to use an opt-out process for eligible individuals who would prefer not to participate. This provides some preliminary evidence that relevant stakeholders find alternatives to traditional informed consent acceptable for low-risk pragmatic comparative effectiveness trials of widely-used therapies as long as a sufficient amount of choice is preserved. [ABSTRACT FROM AUTHOR]

Medical aid in dying (MAiD), despite being legal in many jurisdictions, remains controversial ethically. Existing surveys of physicians' perceptions of MAiD tend to focus on the legal or moral permissibility of MAiD in general. Using a novel sampling strategy, we surveyed physicians likely to have engaged in MAiD-related activities in Colorado to assess their attitudes toward contemporary ethical issues in MAiD. [ABSTRACT FROM AUTHOR]

The article focuses on antibiotic pipeline coordinators which incentivize research and development (R&D) of antibiotics as identified by the European Innovation Medicines Initiative's DRIVE-AB consortium. It comments on design aspects of pipeline coordinators including the utilization of technical and financial tools, portfolio management, and competence in technical and scientific matters. It mentions the role of small- and medium-sized businesses in antibiotic R&D and financing these efforts.

In June 2021, Missouri passed the "Second Amendment Preservation Act" (SAPA). Though SAPA passed easily and had gubernatorial support, many Missouri law enforcement agencies, including the Missouri Sheriff's Association, oppose it. Missing from this policy conversation, and deserving of analysis, is the voice of Missouri citizens. Using qualitative interview data and survey data, we explored what if anything Missouri gun owners knew about SAPA and what they perceived its effects would be on gun-related murders, suicides, gun thefts, and mass shootings. Most Missouri gun owners had not heard about SAPA and were ambivalent about its potential effect on gun safety outcomes. Our findings also indicate that respondents' attitudes toward SAPA and the impact of such policy on safety is driven by gun ownership (i.e., primary versus living in a household with firearms), partisan identification, and attitudes toward government firearm regulation. [ABSTRACT FROM AUTHOR]

The article focuses on a pilot study designing a delinked incentive for the devleopment of new, critically important antibiotics in Norway. It states the design process established a list of antibiotics that were critically important and required special measures to ensure a predictable supply, the use of augmented health technology assessment to assess value of the antibiotics, and design a functional delinked model to ensure one or more of the antibiotics has a predictable supply.

The article focuses on a simulation of rewards of market entry for the development of antibiotics. It comments on push- and pull-based monetary policy interventions to encourage research into antibiotics due to the lower profitability of antibiotic research compared to other fields of drug research. It talks about cash flow of antibiotic sales with &RD costs followed by Market Entry Rewards and the likelihood of the antibiotic reaching market approval.

The article focuses on a review of databases of small- to medium-sized businesses focusing on research and development (R&D) of antibacterial agents. It comments on retrospective grand funding by several U.S. agencies and public-private partnerships using the National Institutes of Health's database. It mentions multinational organizations supporting R&D and the European Union's Joint Programming Initiative on Antimicrobial Resistance to coordinate efforts in the antimicrobial resistance field.

The article discusses several of the ethical issues that patients and health care providers deal with when addressing requests for family balancing and determining whether assisted reproductive technology (ART) providers should perform preimplantation genetic screening for sex selection for nonmedical reasons. American medical ethics and opponents of social sex selection are examined, along with medical decision making and concerns about sexism and gender discrimination in the U.S.

The article discusses various aspects of the regulatory frameworks that govern pharmaceutical promotion and visits by sales representatives in places such as Canada, the U.S., and France. The World Health Organization’s 1988 Ethical Criteria for Medicinal Drug Promotion guidelines are addressed, along with the U.S. Food and Drug Administration's rules and the legal aspects of drug marketing. The French Public Health Code, deception, and the Health Canada agency's authority are assessed.

The informed consent process for genetic testing does not commonly address preferences regarding disclosure of results in the event of the patient's death. Adults being tested for familial colorectal cancer were asked whether they want their exome sequencing results disclosed to another person in the event of their death prior to receiving the results. Of 78 participants, 92% designated an individual and 8% declined to. Further research will help refine practices for informed consent. [ABSTRACT FROM AUTHOR]

We surveyed IRB chairs' perspectives on offering individual genetic research results to participants and families, including family members of deceased participants, and the IRB's role in addressing these issues. Given a particular hypothetical scenario, respondents favored offering results to participants but not family members, giving choices at the time of initial consent, and honoring elicited choices. They felt IRBs should have authority regarding the process issues, but a more limited role in medical and scientific issues. [ABSTRACT FROM AUTHOR]

The conflicts of interest that may arise in relationships between academic researchers and industry continue to prompt controversy. The bulk of attention has focused on financial aspects of these relationships, but conflicts may also arise in the legal obligations that faculty acquire through consulting contracts. However, oversight of faculty members' consulting agreements is far less vigorous than for financial conflicts, creating the potential for faculty to knowingly or unwittingly contract away important rights and freedoms. Increased regulation could prevent this, but it is unclear what forms of oversight universities view as feasible and effective. In this article, we report on a Delphi study to evaluate several approaches for oversight of consulting agreements by medical schools. The panel was comprised of 11 senior administrators with responsibility for oversight of faculty consulting relationships. We found broad agreement among panelists regarding the importance of institutional oversight to protect universities' interests. There was strong support for two specific approaches: providing educational resources to faculty and submitting consulting agreements for institutional review. Notwithstanding the complexities of asserting authority to regulate private consulting agreements between faculty members and companies, medical school administrators reached consensus that several approaches to improving institutional oversight are feasible and useful. [ABSTRACT FROM AUTHOR]

Public Health Law Research used a Delphi process to develop consensus expert standards for policy surveillance. Consensus was reached on a set of core standards for collecting, analyzing, publishing and maintaining legal datasets for monitoring important public health policies. Further efforts are needed to refine standards and develop the infrastructure for policy surveillance. [ABSTRACT FROM AUTHOR]

This article examines the laws and agency rules for how state health department employees can participate in policy development and campaign activities outside of their official capacity. With this information, agency leaders and other public sector employees can be supported in maximizing their contributions to advancing public health policies. [ABSTRACT FROM AUTHOR]

Effective medical innovation is a common goal of policymakers, physicians, researchers, and patients both in the private and public sectors. With the recent slowdown in approval of new transformative prescription drugs, many have looked back to the 'golden years' of the 1980s and 1990s when numerous breakthrough products emerged. We conducted a qualitative study of innovators (n=127) directly involved in creation of groundbreaking drugs during that era to determine what made their work successful and how the process of conducting medical innovation has changed over the past 3 decades. Transcripts were analyzed using standard coding techniques and the constant comparative method of qualitative data analysis to identify the positive features of and challenges posed by the past and present therapeutic innovation environments (70 of the 127 interviewees explicitly addressed these issues). Interviewees emphasized the continued central role played by individuals and the institutions they were a part of in driving innovation. In addition, respondents discussed the importance of collaboration between individuals and institutions to share resources and expertise. Strong underlying basic science was also cited to be a major contributing factor to the success of an innovation. The climate for modern-day medical innovation involves a greater emphasis on patenting in academia, difficulty negotiating the technology transfer process, and funding constraints. Regulatory demands or reimbursement concerns were not commonly cited as factors that influenced transformative innovation. This study suggests that generating future transformative innovation will require a simplification of the current technology transfer process, continued commitment to basic science research, and policy changes that promote meaningful collaboration between individuals from disparate institutions. [ABSTRACT FROM AUTHOR]

As exome and genome sequencing move into clinical application, questions surround how to elicit consent and handle potential return of individual genomic results. This study analyzes nine consent forms used in NIH-funded sequencing studies. Content analysis reveals considerable heterogeneity, including in defining results that may be returned, identifying potential benefits and risks of return, protecting privacy, addressing placement of results in the medical record, and data-sharing. In response to lack of consensus, we offer recommendations. [ABSTRACT FROM AUTHOR]

Although the Federal Common Rule requires that informed consent documents include all material information, it does not specify the content of materials used to recruit human subjects. In particular, there is no federal regulation relating to how payment for research participation is to be advertised. Rather, the FDA has issued guidance, advising researchers not to emphasize payment information. In order to determine how IRBs have interpreted this guidance, we coded the policies of the top 100 institutions by receipt of NIH funding, in order to determine whether they require, permit, or forbid researchers to disclose the amount of compensation in their recruitment materials. We found that the vast majority of institutions implicitly or explicitly permit such disclosures; however, there are a significant number of IRBs at each extreme, some discouraging or forbidding with others encouraging or mandating such disclosures. Such heterogeneity in local regulations suggests that IRB discretion may be imposing costs on human subjects and the scientific enterprise that outweigh the benefits. We suggest that this heterogeneity should be resolved towards a national consensus on permissibility. [ABSTRACT FROM AUTHOR]

Patient advocacy organizations (PAOs) advocate for increased research funding and policy changes and provide services to patients and their families. Given their credibility and political clout, PAOs are often successful in changing policies, increasing research funding, and increasing public awareness of medical conditions and the problems of their constituents. In order to advance their missions, PAOs accept funding, frequently from pharmaceutical firms. Industry funding can help PAOs advance their goals but can also create conflicts of interest (COI). Research indicates that bias may occur, even among well-meaning professionals, when people and organizations have financial COI. Industry funding may therefore influence PAOs to act in ways that favor the interests of their donors, which may increase the risk of harm to patients. This article extends the analysis developed in the Institute of Medicine report, Conflicts of Interest in Medical Research, Education, and Practice, and applies the analysis to understand PAOs and their relationships with industry. It argues that the preferred goal of institutional COI policies should not be to promote trust, but to promote trustworthiness and appropriately placed trust. [ABSTRACT FROM AUTHOR]

As part of 'Nanodiagnostics and Nanotherapeutics: Building Research Ethics and Oversight,' an empirical search was conducted to identify publicly available resources that guided understanding about human subjects issues in nanomedicine or nanotechnology including policy statements, guidance documents, or consent forms. The authors conducted 5,083 internet searches and analyzed 175 documents. Results show that very little guidance is publicly available and most documents focused on occupational and environmental concerns. [ABSTRACT FROM AUTHOR]

The concept of minimal risk plays a key role in federal regulations on the protection of human research subjects. Although there has been considerable discussion of the meaning of minimal risk, the question of how this concept should be interpreted in research involving pregnant women and fetuses has not been addressed. This essay reviews the literature on minimal risk and argues for an interpretation of that concept in the context of research involving pregnant women and fetuses. [ABSTRACT FROM AUTHOR]

Multiprofessional guidelines for fair access to and use of adult critical care services are desperately needed to define a consistent transparent standard of care: when such therapies have the potential to benefit and help a patient as they journey with illness and when they cannot. [ABSTRACT FROM AUTHOR]

The article comprises a conceptual framework to analyze the strengths and weaknesses of a global health convention. The analyses are inspired by Lawrence Gostin's suggested Framework Convention on Global Health. The analytical model takes a starting-point in events tentatively following a logic sequence: Input (global health funding), Processes (coordination, cooperation, accountability, allocation of aid), Output (definition of basic survival needs), Outcome (access to health services), and Impact (health for all). It then examines to what degree binding international regulations can create order in such a sequence of events. We conclude that a global health convention could be an appropriate instrument to deal with some of the problems of global health. We also show that some of the tasks preceding a convention approach might be to muster international support for supra-national health regulations, negotiate compromises between existing stakeholders in the global health arena, and to utilize WHO as a platform for further discussions on a global health convention. [ABSTRACT FROM AUTHOR]