Ethical and Regulatory Challenges with Autologous Adult Stem Cells: A Comparative Review of International Regulations
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DOI: 10.1007/s11673-017-9776-y
Abstract: Cell and tissue-based products, such as autologous adult stem cells, are being prescribed by physicians across the world for diseases and illnesses that they have neither been approved for or been demonstrated as safe and… read more here.
Keywords: stem cells; ethical regulatory; autologous adult; adult stem ... See more keywords
Ethical and Regulatory Considerations of Placental Therapeutics.
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DOI: 10.1016/j.clinthera.2021.01.003
Abstract: PURPOSE Placental therapeutics aim to treat placental disease; however, ethical and regulatory issues should be considered if the drug also potentially affects the fetus. Drugs that might transfer or edit genes carry a specific challenge… read more here.
Keywords: ethical regulatory; placental therapeutics; therapeutics ethical; regulatory considerations ... See more keywords
THE ADDED VALUE OF A MULTICOUNTRY NETWORK FOR PROMOTING ETHICAL AND REGULATORY STANDARDS IN CLINICAL TRIALS IN LOW- AND MIDDLE-INCOME COUNTRIES: THE EXPERIENCE OF THE ‘SWITCHING THE POLES NETWORK’
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DOI: 10.1136/bmjgh-2016-000260.10
Abstract: Background In 2008, we created the ‘Switching The Poles’ Clinical Research Network, by joining the forces of non-commercial clinical research groups in Benin, Burkina Faso, Cambodia, Cuba, the Democratic Republic of Congo, Ethiopia, India, Indonesia,… read more here.
Keywords: ethical regulatory; network; low middle; clinical trials ... See more keywords
Ethical and regulatory oversight of clinical research: The role of the Institutional Review Board
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DOI: 10.1177/15353702221078216
Abstract: The history of clinical research is, unfortunately, filled with examples of research studies that took advantage of and harmed research participants, to fulfill the research goals of scientists. Over time, we have created a system… read more here.
Keywords: oversight clinical; review; regulatory oversight; ethical regulatory ... See more keywords
Ethical, regulatory, and practical barriers to COVID-19 research: A stakeholder-informed inventory of concerns
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DOI: 10.1371/journal.pone.0265252
Abstract: Introduction SARS-CoV-2 (COVID-19) has caused death and economic injury around the globe. The urgent need for COVID-19 research created new ethical, regulatory, and practical challenges. The next public health emergency could be worse than COVID-19.… read more here.
Keywords: ethical regulatory; health; regulatory practical; covid research ... See more keywords