① Ethical Issues In Tissue Engineering Essay

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Ethical Issues In Tissue Engineering Essay



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Bioethics - Biotechnology - Transgenic Organisms - GMO - Cloning - Don't Memorise

Induced pluripotent stem cells hold great promise, but care is needed to ensure their safety in translational clinical trials, despite the temptation to move quickly from bench to bedside. With these increased opportunities, however, come pressing policy issues of consent, control, and justice. The imperatives to minimize risks of harm, obtain informed consent, reduce the likelihood of the therapeutic misconception, and facilitate sound translation from bench to bedside are not unique to stem cell research; their application to stem cell research and therapy nonetheless merits particular attention.

Because stem cell research is both scientifically promising and ethically challenging, both the application of existing ethical frameworks and careful consideration of new ethical implications are necessary as this broad and diverse field moves forward. Current and potential therapeutic applications for stem cells are numerous. Stem cell researchers may be engaged in many different endeavors, including but not limited to seeking new sources of highly multipotent stem cells and methods of perpetuating them; creating induced pluripotent stem cell iPSC lines to study genetic disorders or explore pharmacogenomics; conducting animal or early-phase human studies of experimental stem cell interventions; or working with stem cells and biomaterials to develop organoids and other products for use in regenerative medicine, to name only a few possibilities.

In this review of selected major ethical issues in stem cell research and therapy, we briefly describe and discuss the most significant ethical implications of this wide-ranging and fast-moving field. Our discussion addresses research oversight in the historical context of human embryonic stem cell hESC research; clinical translation and uncertainty; the profound tension between the desire for clinical progress and the need for scientific caution; and issues of consent, control, commercialization, and justice arising from stem cell banking, disease modeling, and drug discovery. We seek to make stem cell scientists more aware of the need for clarity of discussion and to improve professional and public understanding of the ethical and policy issues affecting this important but early research.

A review this brief is necessarily general; our hope is that researchers can use this discussion as a starting point for more in-depth identification and analysis of issues pertinent to specific translational research projects [ 1 — 3 ]. The basic system of regulation and review of research involving humans and animals as subjects [ 4 , 5 ] is familiar to investigators. This has helped to emphasize that thinking about ethical issues should begin at the earliest stages of preclinical research. Ethics in both research and clinical settings is most effective when it is preventive. In this respect, stem cell research is not unique; stem cell researchers should ask themselves the same questions about the trajectory of their translational research as would any other biomedical researcher [ 6 ].

Oversight of cell-based interventions does, however, include additional features that, while adding complexity to the regulatory process, also make it easier to take a long view, by requiring attention to the use of stem cells at all research stages. Increasing pressures for the rapid clinical translation and commercialization of stem cell products underscore the value of this long view [ 7 — 14 ]. The ethical issues that all researchers face during clinical translation begin with the need to ask a meaningful question, the answer to which has both scientific and social value and can be reached by the study as designed when properly conducted [ 6 , 15 ].

The risks of harm and the potential benefits to society from the development of generalizable knowledge and, sometimes, potential direct benefit to patient-subjects must be weighed and balanced at each stage of the research. Sound justification is necessary to support moving from the laboratory into animal studies, and from animals into human subjects, as well as through relevant phases of research with humans [ 15 — 18 ]. To many researchers, these considerations are simply requirements of sound and responsible study design, as exemplified, for example, in US Food and Drug Administration FDA guidance documents and investigational new drug requirements [ 27 ]. It should come as no surprise, however, that research design and research ethics are closely intertwined [ 1 , 6 , 15 ].

Stem cell research may give rise to heightened concern in several of these areas. One such concern is clarity of language. Hopes that the ethical controversy surrounding hESCs would become irrelevant when new sources of highly multipotent stem cells became available have proven somewhat premature. A brief discussion thus seems warranted. The first hESC line was derived in , ushering in one of the most public, spirited, and intractable debates in research ethics: the moral status of the embryo from which hESCs are derived. To harvest hESCs, it is first necessary to destroy the 5-day-old preimplantation embryo. Opponents of hESC research argue that because the embryo is capable of developing into a human being, it has significant moral standing; therefore, its destruction is unethical.

Some proponents of hESC research deny that the embryo has any moral status; others grant it limited moral status but argue that the value of this limited status is far outweighed by the potential benefits that can result from hESC research [ 24 , 33 ]. The ethical implications of hESC research in the US have been reflected in federal funding policy and in research oversight. The NAS Guidelines for Human Embryonic Stem Cell Research , most recently amended in [ 34 ], comprehensively address permissible and impermissible categories of hESC research and recommend the establishment of embryonic stem cell research oversight committees ESCROs to assist in research review.

They also incorporate National Institutes of Health guidelines promulgated after a federal funding expansion, recommend oversight of research with human pluripotent stem cells, and address questions of consent from all donors of biomaterials, creation and use of embryos for research purposes, and animal-human chimeras. As stem cell research diversifies, its ethical oversight also becomes more diverse, and questions have been raised regarding the ongoing need for specialized committees like ESCROs and SCROs [ 9 , 10 ].

The NAS Guidelines are nonetheless likely to continue providing guidance for a variety of oversight bodies reviewing stem cell research [ 9 , 10 , 32 ]. Controversy about the derivation and use of hESCs led investigators to seek less ethically fraught but maximally useful types of stem cells [ 31 ]. The history of iPSCs is one of seeking efficient ways to induce pluripotency that minimize the risk of teratoma development [ 35 ].

Although the rapidly developing science has reduced risks of harm and has increased the efficiency of pluripotent cell line creation to some extent, safety and efficacy concerns remain [ 36 ]. Indeed, the most recent advance in inducing pluripotency - stimulus-triggered acquisition of pluripotency, or STAP [ 37 ] - was widely heralded [ 38 ] but has since been called into question [ 39 ]. Obokata and colleagues [ 37 ] presented data suggesting that subjecting somatic cells to various stresses could quickly and safely produce iPSCs, but their results have not proven reproducible.

In research with iPSCs as well as with other types of stem cells, it is essential that preclinical studies in animal models and other media be sufficient to justify the progression to clinical trials. Toxicity and the risk of tumorigenicity must be assessed for all stem cell-based products, especially when genetically modified, in order to minimize the risks of harm as far as feasible before moving to humans [ 11 , 12 , 16 , 17 , 26 , 40 ].

Concern about the research use of animals - especially non-human primates - in preclinical research, including iPSC research, is growing and must be addressed; at the same time, researchers are increasingly aware that good animal models are often unavailable or inadequate to predict effects in humans. Thus, considerable uncertainty continues to surround first-in-human trials and other early-phase studies using stem cells, even as the rapid pace and apparently improving safety of iPSC creation tempt the field to move rapidly into clinical research and even therapeutic applications [ 5 , 25 , 41 ]. Clinical trials of iPSCs and other highly pluripotent stem cell interventions generally enroll patients as subjects at all trial stages, as using healthy volunteers may raise safety concerns or compromise the value of the data.

All clinical trials must, of course, be carefully designed, rigorously justified, and properly conducted in order to protect the rights, interests, and welfare of trial subjects and contribute to generalizable knowledge [ 11 , 12 , 15 — 17 , 25 , 26 , 35 , 40 ]. Stem cell researchers can and should benefit from the lessons learned by gene transfer researchers: rapid transition to clinical applications without sufficient understanding of the mechanisms of effect is both inefficient and unwise [ 11 , 12 , 25 , 42 ]. The Geron trial provides just one instructive example. The product, oligodendrocyte progenitor cells OPCs , is thought to remyelinate spinal cord axons. The trial was to enroll a small number of patient-subjects with recent serious spinal cord lesions.

Its design caused controversy because the subjects were enrolled very soon after a serious injury, making understanding and consent challenging in this first-in-human trial and in addition making it potentially difficult to distinguish between spontaneous recovery of function and remyelination attributable to the intervention. Patients with older lesions, though very probably in a better position to make decisions about trial participation, have scar tissue that makes remyelination unlikely or impossible. The outcome had the potential to discourage pioneering stem cell research in the future [ 25 , 43 , 44 ]. Nonetheless, identifying the optimal time for post-injury intervention, both to maximize the potential for assessing effects on remyelination and to promote an optimal decision-making process by patient-subjects, is of ongoing concern to spinal cord injury researchers studying cell-based interventions [ 45 ].

More recently, discussions of ethical and design issues in particular stem cell trials for example, macular degeneration [ 2 ] and cardiovascular disease [ 3 ] highlight the difficult balance between the imperatives of caution and progress for first-in-human trials in high-profile areas like stem cell intervention research. Disclosure and discussion of uncertainty with potential subjects in stem cell trials are essential in order to reduce the incidence of therapeutic misconception, whereby research subjects and also investigators and oversight bodies view research as a treatment modality or significantly overestimate the likelihood of direct benefit or both [ 19 — 22 , 41 ]. Many types of multipotent and highly multipotent stem cells have been identified as potentially suitable for clinical applications.

Some of the most significant challenges faced in clinical application include how quickly to move forward in the face of great promise, great uncertainty, and great clinical need; how to regard research with investigational interventions that are difficult to standardize and impossible to undo; and how to define and describe these uncertainties in the consent process. A growing number of prestigious academics from both science and bioethics are calling attention to these challenges [ 2 , 24 , 26 , 42 ]. One prominent scientist commentator compares the current state of stem cell research with the histories of HSC transplantation and gene transfer research, citing several principles: risks of harm should be commensurate with the severity of the condition under study, preclinical animal models remain critically important, and gaining insight into therapeutic mechanisms is essential to the success of a line of clinical research.

Similarly, in an international survey of stem cell scientists and scholars of ethical issues in stem cell research, a prolific bioethics research group has identified increasing concerns arising from pressures for clinical translation, commercialization, and oversight of new stem cell technologies [ 14 ]. Essayer d'autre coupe de cheveux college essay advisors harvard descriptive essay about a frightening experience. Essay on research gap the quality of mercy essay. Importance of freedom of speech essay. Short essay on my family trip les types de plan en dissertation.

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Descriptive essay on my school compound best music to write an essay. Intro for research essay. Essay about remarkable person essay about sentence structure advantages and disadvantages of working at night essay essay on media law: narrative essay about violence. Unlike most conflicts that can be disputed with facts and objective truths, ethical issues are more subjective and open to opinions and interpretation.

Philosophers divide ethics into three different categories. These include metaethics, normative ethics and applied ethics. Metaethics deals with the root source of our ethics, normative ethics involves defining right and wrong behavior and applied ethics is the discussion of ethics in light of issues that provoke controversy. It's necessary to consider all three types of ethics when diving into the topic of what constitutes an ethical issue, although applied ethics is the best example of ethical issues.

The problem with ethical issues, such as whether capital punishment should be allowed or the morality of euthanasia, is that there generally is no single accepted answer. These ethical issues are hotly debated because the answer often comes down to personal opinion or philosophy. Ethics can give more than one answer, and sometimes that answer is not universally correct. For example, capital punishment is an ethical issue that is difficult to discuss. Should people have the power to decide whether other people should live or die according to the severity of their crimes? And if so, what exactly is the tipping point at which people can, or should, be sentenced to death?

These questions require one to consider what is right and what is wrong, as well as the responsibility of others to keep people accountable for their actions.

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