UNASSIGNED: Tissue engineering is a multidisciplinary field that combines principles from cell biology, bioengineering, material sciences, medicine and surgery to create functional and viable bioproducts that can be used to repair or replace damaged or diseased tissues in the human body. The complexity of tissue engineering can affect the prospects of efficiently translating scientific discoveries in the field into scalable clinical approaches that could benefit patients. Organizational challenges may play a key role in the clinical translation of tissue engineering for the benefit of patients.
UNASSIGNED: To gain insight into the organizational aspects of tissue engineering that may create impediments to efficient clinical translation, we conducted a retrospective qualitative case study of one tissue engineering multi-site translational project on knee cartilage engineered tissue grafts. We collected qualitative data using a set of different methods: semi-structured interviews, documentary research and audio-visual content analysis.
UNASSIGNED: Our study identified various challenges associated to first-in-human trials in tissue engineering particularly related to: logistics and communication; research participant recruitment; clinician and medical student participation; study management; and regulation.
UNASSIGNED: While not directly generalizable to other types of advanced therapies or to regenerative medicine in general, our results offer valuable insights into organizational barriers that may prevent efficient clinical translation in the field of tissue engineering.

A shift from single to multi-site health studies enabled a range of research benefits including faster recruitment of larger and more diverse samples; increased statistical power, greater rigour, generalisability, and external reliability; and increased likelihood of impacting policy and clinical practice. However, ethical review of multi-site studies by Institutional Review Boards (IRBs) raises specific challenges compared with single site studies, with requirements to apply to multiple local IRBs increasing the burden on research, possibly endangering the integrity of the research process or inhibiting development of multi-site studies. The option of a single centralised IRB may offer a clearer, more consistent and efficient review process. This study presents a case report and commentary from 15 years engaging with IRBs in multiple sites in Ireland by the Intellectual Disability Supplement to the Irish Longitudinal Study on Ageing (IDS-TILDA). It examines the ethics review process for IDS-TILDA through its first four waves. While the majority of 48 IRBs granted ethical approval within 13 weeks, six IRBs took 21-47 weeks to approve, leading to delays in data collection of up to 11 months. Despite additional review time, no changes were required to the study protocol. Therefore, a critical impact of the process was the delay in starting data collection within a small number of organisations, and reduced involvement in the study for one organisation. The ethical review process with multiple IRBs increased the degree of complexity of the process, with added bureaucracy and far greater communication required across 48 IRBs, substantially adding to the resource commitment for the review process. The relatively quick approval from the majority of IRBs was partially a result of the longitudinal study building relationships with organisations throughout multiple waves. That other health studies may not accrue this benefit supports calls for a single IRB system for multi-site health studies.

This case study analyzes the expertise, potential conflicts of interest, and objectivity of editors, authors, and peer reviewers involved in a 2022 special journal issue on fertility, pregnancy, and mental health. Data were collected on qualifications, organizational affiliations, and relationships among six papers\' authors, three guest editors, and twelve peer reviewers. Two articles were found to have undisclosed conflicts of interest between authors, an editor, and multiple peer reviewers affiliated with anti-abortion advocacy and lobbying groups, indicating compromised objectivity. This lack of transparency undermines the peer review process and enables biased research and disinformation proliferation.Our study is limited by a few factors including: difficulty collecting peer reviewer data, potentially missing affiliations, and a small sample without comparisons. While this is a case study of one special issue, we do have suggestions for increasing integrity.

The ethical value-and to some scholars, necessity-of providing trial patients with post-trial access (PTA) to an investigational drug has been subject to significant attention in the field of research ethics. Although no consensus has emerged, it seems clear that, in some trial contexts, various factors make PTA particularly appropriate. We outline the atypical aspects of psychedelic clinical trials that support the case for introducing the provision of PTA within research in this field, including the broader legal status of psychedelics, the nature of the researcher-therapist/participant relationship, and the extended time-frame of the full therapeutic process. As is increasingly understood, the efficacy of psychedelic-assisted psychotherapy is driven as much by extrapharmacological elements and the cultural therapeutic container as by the drug itself. As such, we also advocate for a refocusing of attention from post-trial access to a broader concept encompassing other elements of post-trial care. We provide an overview of some of the potential post-trial care provisions that may be appropriate in psychedelic clinical trials. Although the World Medical Association\'s Declaration of Helsinki calls on researchers, sponsors, and governments to make provisions for post-trial access, such provision may feel impracticable or out-of-reach within psychedelic trials that are already constrained by a high resource demand and significant bureaucratic burden. We show how conceiving of post-trial provision as an integral site of the research process, and an appropriate destination for research funding, will serve to develop the infrastructure necessary for the post-legalisation psychedelic medicine ecosystem.

Conducting research during disease outbreaks can be ethically challenging as evidenced in the 2014-2016 Ebola outbreak in West Africa and COVID-19 pandemic. Yet, there has been little empirical research conducted for understanding the views and perspectives of different stakeholders regarding ethical issues in conducting research during disease outbreaks. This preliminary study was conducted to empirically explore African public health research stakeholders\' views about research ethics issues during infectious disease outbreaks in Africa. We conducted an online survey of 330 participants attending the International Conference on Re-emerging and Emerging Infectious Disease (ICREID) meeting that took place from 13-15 March 2019 in Addis Ababa, Ethiopia to elicit their views on various research ethics complexities experienced in the 2014 Ebola outbreak. Study results revealed some divergent views on several ethical themes including: ethics of using unregistered interventions in outbreaks; acceptable study design; ethics review processes; risks-benefit assessment; exclusion of pregnant women and children; and biological sample and data sharing. Majority (76.3%) of respondents felt that in the absence of available standard treatments or prevention modalities, the use of investigational interventions can be ethically justifiable if there is a strong scientific rationale and favorable risk-benefit ratio. Regarding conventional placebo-controlled trials during outbreaks with high case fatality rates, respondents that considered this unethical were more than three times those that felt such design were ethically justifiable. We were somewhat surprised that a majority (almost 60%) of respondents were satisfied with the exclusion of pregnant women and children in clinical trials during outbreaks. All respondents concurred with the prioritization of informed consent for research during an outbreak. Based on our findings, research ethics guidance is needed to equip research stakeholders in dealing with ethical complexities arising in the conduct of research during emerging disease outbreaks-especially regarding using experimental interventions; placebo trial design; inclusion or justified exclusion of pregnant women and children; and biological sample/data sharing. The findings will be used in ongoing efforts of developing a consultative and coherent African-centric framework to support ethical conduct of research for future emerging infectious disease outbreaks in Africa.

The benefits of biomedical research involving humans are well recognised, along with the need for conformity to international standards of science and ethics. When human research involves radiation imaging procedures or radiotherapy, an extra level of expert review should be provided from the point of view of radiological protection. The relevant publication of the International Commission for Radiological Protection (ICRP) is now three decades old and is currently undergoing an update. This paper aims to provoke discussions on how the risks of radiation dose and the benefits of research should be assessed, using a case study of diagnostic radiology involving volunteers for whom there is no direct benefit. Further, the paper provides the current understanding of key concepts being considered for review and revision-such as the dose constraint and the novel research methods on the horizon, including radiation biology and epidemiology. The analysis revisits the perspectives described in the ICRP Publication 62, and considers the recent progress in both radiological protection ethics and medical research ethics.

The 2012 Menlo Report was an effort in which a group of computer scientists, US government funders, and lawyers produced ethics guidelines for research in information and communications technology (ICT). Here we study Menlo as a case of what we call ethics governance in the making, finding that this process examines past controversies and enrols existing networks to connect the everyday practice of ethics with ethics as a form of governance. To create the Menlo Report, authors and funders relied on bricolage work with existing, available resources, which significantly shaped both the report\'s contents and impacts. Report authors were motivated by both forward- and backward-looking goals: enabling new data-sharing as well as addressing past controversies and their implications for the field\'s body of research. Authors also grappled with uncertainty about which ethical frameworks were appropriate and made the decision to classify much network data as human subjects data. Finally, the Menlo Report authors attempted to enrol multiple existing networks in governance through appeals to local research communities as well as taking steps towards federal rulemaking. The Menlo Report serves as a case study in how to study ethics governance in the making: with attention to resources, adaptation, and bricolage, and with a focus on both the uncertainties the process tries to repair, as well as the new uncertainties the process uncovers, which will become the site of future ethics work.

Author affiliation disclosures are arguably a critical yet poorly understood and largely unregulated phenomenon in scholarly and scientific publishing. First, this paper argues that affiliation attribution practices are burdened by misunderstandings and misuses. Second, it suggests that universities, research institutions and publishers should urgently engage in a conversation aimed at clearly defining expectations and promoting best practices. Third, it introduces affiliation contribution statements as a concrete initiative in the direction of increased accuracy, transparency, and accountability.

Many studies that seek to cure HIV must ask participants to interrupt their antiretroviral treatment. In such circumstances, is it permissible to include a placebo group in the study? We explain why doing so is a scientific and an ethical necessity, and more benign than imagined.

Fair inclusion of research subjects is necessary to ensure that post-acute sequelae COVID-19 (PASC) research results benefit all members of society. Scientists should conduct research on a broad sample of individuals who represent clinically relevant factors influencing a disease. Without demographic diversity and sociological and environmental variability, research outputs are less likely to apply to different populations and would thus increase health disparities. The goal of this narrative literature review and ethical analysis is to apply fair selection criteria to PASC research studies. We briefly highlight the importance of fair subject selection in translational research and then identify features of PASC, as well as PASC research, that hinder fair inclusion of research participants. We will demonstrate that determining an adequate and representative sample is not simply a matter of ensuring greater diversity; rather, fairness requires a broader evaluation of risks, burdens, and benefits specific to underrepresented populations. We provide recommendations to ensure fair subject selection in PASC research and promote translation toward positive health outcomes for all individuals, including the most vulnerable.