Advanced biopreservation technologies using subzero approaches such as supercooling, partial freezing, and vitrification with reanimating techniques including nanoparticle infusion and laser rewarming are rapidly emerging as technologies with potential to radically disrupt biomedicine, research, aquaculture, and conservation. These technologies could pause biological time and facilitate large-scale banking of biomedical products including organs, tissues, and cell therapies.

This exploratory study set out to pilot use of a Risk Innovation approach to support the development of advanced biopreservation technologies, and the societally beneficial development of advanced technologies more broadly. This is the first study to apply the Risk Innovation approach — which has previously been used to help individual organizations clarify areas of value and threats — to multiple entities involved in developing an emerging technology.

This article presents a framework of ethical analysis for anticipatory evaluation of advanced biopreservation technologies and employs the framework illustratively in three domains. The framework features four clusters of general ethical considerations: (1) Producing Benefits, Minimizing Harms, Balancing Benefits, Risk, and Costs; (2) Justice, Fairness, Equity; (3) Respect for Autonomy; and (4) Transparency, Trustworthiness, and Public Trust.

Research on advanced biopreservation — technologies that include, for example, partial freezing, supercooling, and vitrification with nanoparticle infusion and laser rewarming — is proceeding at a rapid pace, potentially affecting many areas of medicine and the life sciences, food, agriculture, and environmental conservation. Given the breadth and depth of its medical, scientific, and corresponding social impacts, advanced biopreservation is poised to emerge as a disruptive technology with real benefits, but also ethical challenges and risks. Early engagement with potentially affected groups can help navigate possible societal barriers to adoption of this new technology and help ensure that emerging capabilities align with the needs, desires, and expectations of a broad range of interested parties.

The application of advanced biopreservation to organs donated for transplantation may make possible their indefinite storage and thereby improve the utility and equity they provide to patients. The technology is still at a preclinical stage, with many difficult, scientific issues that remain to be answered. At the moment, however, the actual capabilities of the technology are too indefinite to begin formulating the statutes, regulations, and ethical guidance that will be needed to obtain the benefits expected from its use.

This article argues that beneath the veneer of legitimacy in the organ, tissue, and body part transplantation systems exists a horrifying history of human commodification whose vestiges surprisingly linger in contemporary supply and allocation systems. This history, as the Article demonstrates, dates back to the colonial period in the United States, where “grave robbing” became an important feature in the advancement of medicine. This legacy lives on.

The development of technologies for the biopreservation of infectious organisms requires careful analysis of benefits and risks. This article reviews the regulatory landscape and oversight responsibilities in the United States in respect to pathogen biopreservation. Focused on two globally significant pathogens, Cryptosporidium and Plasmodium, the article explores advantages and potential risks of biopreservation concerning biosafety, biosecurity and biocontainment.

This article explores how time-related metaphors frame advanced cryopreservation technologies in environmental conservation. Cryopreservation “stops” or “freezes” biological time and “buys time” desperately needed to preserve species and ecosystems. We advance a framing of these technologies as logistical, highlighting how they create opportunities to shift materials, knowledge, and decision-making power through space and time. As logistical technologies, advanced cryopreservation techniques require active planning in the present rather than deferring responsibility and accountability to the future.

In the evolving field of advanced biopreservation technologies, the development of suspended animation (SA) is inspired by real-world challenges. In the context of space exploration, SA is seen as a solution to enable humans to undertake missions far beyond low Earth orbit, including routine travel to other planets in our solar system and beyond. While work on the socio-ethical and legal implications (ELSI) of space exploration continues to evolve, NASA has committed to make ethics a priority issue, making this a fruitful field for further examination.

Biomedical research on advanced cryopreservation has spillover effects on innovation in the food and agricultural sector. Advanced biopreservation technology has three key domains of impact in the food system: (1) improving efficiencies in storage and utilization of gametes and organoids for plant and animal breeding; (2) isochoric methods for preservation of fresh food products; and (3) in biorepositories for storage of genetic resources for agriculturally significant plants and livestock species.

Physician prescribing practices contributed to the US opioid epidemic, leading to increased regulation of opioid prescribing. In some instances, prescribers are unscrupulous or corrupt. They are criminally investigated and subject to prosecution. Less egregious opioid prescribing infractions are addressed through state medical licensing boards. At stake are physicians’ licenses to practice medicine.

In the initial wave of the opioid crisis, uninformed prescribing practices and lax oversight were the drivers of opioid addiction and death. Although opioid prescriptions have decreased by 44.4 percent between 2011-2020,1 the number of deaths linked to prescription opioids has decreased only marginally.2 The marked fall in opioid prescribing without a concomitant reduction in opioid-related deaths suggests that an at-risk population continued to receive prescription opioids, whether directly or indirectly, from a medical professional. Currently, illicitly manufactured fentanyl (IMF) is the culprit for the majority of the approximately 81,000 annual opioid-related deaths.3 This finding has been misleadingly used to suggest that prescription opioids for chronic pain are no longer (and never were) a relevant concern,4 while the reality is that their lethal consequences are simply dwarfed by the marked rise in IMF deaths.5

We compared study characteristics of randomized controlled trials funded by industry (N=697) to those not funded by industry (N=835). RCTs published in high-impact journals are more likely to be blinded, more likely to include a placebo, and more likely to post trial results on ClinicalTrials.gov. Our findings emphasize the importance of evaluating the quality of an RCT based on its methodological rigor, not its funder type.

To evaluate how study characteristics and methodological aspects compare based on presence or absence of industry funding, Hughes et al. conducted a systematic survey of randomized controlled trials (RCTs) published in three major medical journals. The authors found industry-funded RCTs were more likely to be blinded, post results on a clinical trials registration database (ClinicalTrials.gov), and accrue high citation counts.1 Conversely, industry-funded trials had smaller sample sizes and more frequently used placebo as the comparator, used a surrogate as their primary outcome, and had positive results.

As increasing proportions of our global population age, transgender people are experiencing higher rates of dementia, and many are afraid to enter long-term care. Structural interventions such as advance directives may help mitigate fears around entering long-term care by managing specific anxieties that transgender people may have about dementia, loss of decision-making capacity, and discrimination in long-term care settings.

The exclusion of the elderly and people with disabilities from cancer clinical research without appropriate justification is discriminatory and is at odds with the ethos of EU principles, laws and research regulations. It further limits study generalizability. Several primary EU laws fronted by the European Charter prohibit engaging in disparate impact discrimination on the grounds of age and disability in all of EU tasks.

In this issue, Zakout discusses European Union (EU) legal provisions for inclusion of patients of all types in clinical trials.1 Shee highlights the unfortunate failure to include adequate numbers of older adults and adults with disabilities in clinical trials of anti-cancer agents. We agree with her argument that this is an ethical issue as well as a scientific and clinical issue.

The Cleveland Clinic Innovation Management and Conflict of Interest (“IM&COI”) Program implemented a policy on Conflicts of Interest in Clinical Practice in 2013. The policy requires review of financial interests greater than $20,000 in a year, or more than 5% equity in a company, when the clinician is prescribing or using products of the company with which they have a relationship. The IM&COI Committee developed definitions for low, medium and high levels of annual compensation and risk and uses a “Matrix” to guide disclosure based on these factors.