Subject(s)
Biological Specimen Banks/ethics , Biomedical Research/ethics , Human Experimentation/ethics , Informed Consent/ethics , National Institutes of Health (U.S.)/ethics , Organizational Policy , Betacoronavirus , Biological Specimen Banks/history , Biomedical Research/history , COVID-19 , Codes of Ethics , Coronavirus Infections , HeLa Cells , History, 20th Century , History, 21st Century , Humans , Informed Consent/history , Pandemics , Personal Autonomy , Pneumonia, Viral , Racism/history , SARS-CoV-2 , United StatesSubject(s)
National Institutes of Health (U.S.)/standards , Reproductive Techniques, Assisted , Scientific Misconduct/trends , Big Data , Clinical Trials as Topic/standards , Conflict of Interest , Humans , National Institutes of Health (U.S.)/ethics , Reproductive Techniques, Assisted/ethics , Reproductive Techniques, Assisted/standards , Serial Publications/standards , United StatesABSTRACT
Some have argued that human fetal tissue research is unnecessary and/or immoral. Recently, the Trump administration has taken the drastic--and we believe misguided--step to effectively ban government-funded research on fetal tissue altogether. In this article, we show that entire lines of research and their clinical outcomes would not have progressed had fetal tissue been unavailable. We argue that this research has been carried out in a manner that is ethical and legal, and that it has provided knowledge that has saved lives, particularly those of pregnant women, their unborn fetuses, and newborns. We believe that those who support a ban on the use of fetal tissue are halting medical progress and therefore endangering the health and lives of many, and for this they should accept responsibility. At the very least, we challenge them to be true to their beliefs: if they wish to short-circuit a scientific process that has led to medical advances, they should pledge to not accept for themselves the health benefits that such advances provide.
Subject(s)
Fetal Research/legislation & jurisprudence , Animals , Capital Financing/ethics , Capital Financing/legislation & jurisprudence , Fetal Research/ethics , Government , Humans , Medical Missions/ethics , Medical Missions/legislation & jurisprudence , National Institutes of Health (U.S.)/ethics , National Institutes of Health (U.S.)/legislation & jurisprudence , United StatesABSTRACT
Implementing the National Institutes of Health's (NIH's) new single institutional review board (IRB) policy has caused a paradigm shift in IRB review across the country. IRBs and human research protection programs are looking more closely at their processes for ceding review and developing procedures to handle local review when relying on a single IRB. This article describes an NIH-funded network that proactively instituted a central IRB (CIRB) in 2012, anticipating the NIH future mandate. Lessons learned are described. There was a steep learning curve for IRBs and participating sites. IRB submission workload burden shifted from study teams to the data coordinating center, which created new workflow challenges, especially preparing hundreds of consent documents centrally. Despite difficulties encountered with CIRB review, this network is now fully functioning under a CIRB model. Further review and experience are needed to determine whether this shift in IRB review has eliminated duplicative review or regulatory burden from study teams.
Subject(s)
Biomedical Research/organization & administration , Ethics Committees, Research/organization & administration , Guideline Adherence/organization & administration , Biomedical Research/ethics , Efficiency, Organizational , Ethics Committees, Research/ethics , Guideline Adherence/ethics , Models, Organizational , Multicenter Studies as Topic/ethics , National Institutes of Health (U.S.)/ethics , National Institutes of Health (U.S.)/organization & administration , United States , Workflow , WorkloadABSTRACT
The NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is focused on developing new tools and neurotechnologies to transform our understanding of the brain, and neuroethics is an essential component of this research effort. Coordination with other brain projects around the world will help maximize success.
Subject(s)
National Institutes of Health (U.S.)/ethics , Neurosciences/ethics , Bioethics , Humans , National Institutes of Health (U.S.)/standards , Neurosciences/methods , Neurosciences/organization & administration , Practice Guidelines as Topic , United StatesABSTRACT
The new National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research was adopted primarily to simplify and speed the review of complex multisite clinical trials. However, speeding review requires overcoming a number of obstacles. Perhaps the most substantial obstacle is the time and effort needed to develop reliance agreements among the participating sites. We conducted 102 semistructured interviews with sIRB personnel, including directors, chairs, reviewers, and staff, from 20 IRBs that acted as sIRBs for multisite research, including 6 commercial/independent sIRBs, and 10 university-based academic and 4 federal sIRBs. Almost without exception, the interviewees agreed that reliance agreements were complex, difficult to develop, and time-consuming. A major problem for relying sites was that different agreements specified different responsibilities for the relying sites. Attitudes differed about whether these problems will be resolved as IRB staff and managers become more experienced with sIRBs. However it is clear that the process of developing reliance agreements must be simplified. Federal assistance in standardizing at least some sections of reliance agreements might reduce the difficulties involved.