Cloning a Review on Bioethics Legal Jurisprudence and Regenerative Issues in Iran
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Ethics of research on stem cells and regenerative medicine: upstanding guidelines in the Islamic Republic of Iran
Stalk Cell Research & Therapy volume 11, Article number:396 (2020) Cite this article
Abstract
Groundwork
Regenerative medicine plays a major role in biomedicine, and given the ever-expanding boundaries of this knowledge, numerous ethical considerations have been raised.
Main text
Rapid advancement of regenerative medicine science and applied science in Islamic republic of iran, emerged the Iranian National Committee for Ethics in Biomedical Inquiry to develop a comprehensive national ethical guideline. Therefore, the present ethical guideline which comprises eleven chapters was developed in 2019 and approved in early 2020. The titles of these chapters were selected based on the upstanding considerations of various aspects of the field of regenerative medicine: (one) ethical principles of research on stem cells and regenerative medicine; (two) ethical considerations for research on stem cells (embryonic stalk cells, epiblast stem cells, tissue-specific stalk cells, stem cells derived from transdifferentiation, induced pluripotent stalk cells [iPSCs], germline pluripotent stalk cells, germline stem cells, and somatic jail cell nuclear transfer [SCNT] stem cells); (three) ethical considerations for research on somatic cells in regenerative medicine (adult somatic cells, fetal tissue somatic cells, and somatic cells derived from pregnancy products [other than fetus]); (four) upstanding considerations for research on gametes in regenerative medicine; (5) ethical considerations for enquiry related to genetic manipulation (human and animate being) in regenerative medicine; (6) upstanding considerations for research on tissue engineering in regenerative medicine; (7) ethical considerations for pre-clinical studies in regenerative medicine; (8) ethical considerations for clinical trials in regenerative medicine; (9) ethical considerations for stem cells and regenerative medicine bio-banks; (x) upstanding considerations for privacy and confidentiality; and (eleven) ethical considerations for obtaining informed consent.
Conclusion
This article discusses the process of developing the present ethical guidelines and its practical points. Nosotros hope that information technology tin play an of import worldwide role in advancing ethics of research on stem cells and regenerative medicine.
Introduction
Regenerative medicine, especially the stem cells, plays a major role in biomedicine and introduces tremendous capacity for replacement, engineering, repair, or regeneration of cells, tissues, or organs to restore or maintain their normal functions [ane, two]. The rapid expansion of regenerative medicine science and its product commercialization has created numerous ethical concerns and considerations [3, 4]. The evolution and implementation of relevant research ethical guidelines has received special attention in many countries in an endeavor to accost these concerns, in addition to developing guidelines and standards for the production and employ of stalk cells and regenerative medicine products.
The kickoff national ethical guideline on stem cell research in Islamic republic of iran was issued in 2013. Advances in regenerative medicine and the number of related clinical trials indicated a serious demand to update this ethical guideline. In this regard, Iranian National Committee for Ethics in Biomedical Enquiry was commissioned to develop an updated comprehensive guideline for regenerative medicine. The updated version of ethical guideline was prepared in 2019 and formally approved by the committee in 2020. It was attempted to cover all areas of research that pertained to the numerous aspects of regenerative medicine. However, due to the prominent office of stalk cells in regenerative medicine, the term "stem cells" is mentioned separately in title of the present ethical guidelines.
Main text
The present ethical guideline has been adult by a research team and designed as a qualitative report. Enquiry group specialists included PhD in cell and developmental biological science, medical ethics, physicians, immunology, molecular genetics, polymer engineering, social medicine, medical biotechnology, and law. Data were collected through group discussions and proficient panels. The latest version was presented to the Iranian National Ethics Committee for Ethics in Biomedical Research for final review and approving. Supplementary Tabular array 1 provides a listing of all ethical codes of the present guideline, which is comprised of eleven chapters. A number of the important points in each affiliate are presented as follows:
- one.
The first chapter pertains to general principles and is based on the upstanding principles of biomedical enquiry [five], which focuses on the challenges of stem cells and regenerative medicine. The principles consist of "integrity and validity of research activities," "transparency," "social justice," "primacy of the participant'southward health," "chance/do good assessment," "optimal use of biological samples," "respecting the rights of all participants in the research procedure," "ethical principles in enquiry with laboratory animals," and "prohibition of commercial relations in stem cell research."
- 2.
The second chapter contains the ethical considerations of research on stem cells also as research on products derived from stem cells.
- ii.i
Pluripotent stem cells, similar embryonic stem cells, have important upstanding considerations and challenges [vi]. In this guideline, some of the ethical considerations for embryonic stem cell use are as follows: (a) One of the authorized resources to produce embryonic stem cells is a human embryo less than 14 days of historic period afterward in vitro fertilization (IVF), which was legally obtained from surplus or non-transferable IVF embryos from infertility handling or pre-implantation genetic diagnosis. (b) Transplantation of embryonic stalk cells from a human to a "homo embryo or fetus" is prohibited. (c) Transplantation of embryonic stem cells (and other pluripotent stem cells) from an animal to a "human" or to a "human embryo or fetus" and chimera formation are not allowed, given the upstanding considerations that surround transplantation of pluripotent cells of various animal species.
- ii.2
Research on multipotent stalk cells, such as tissue-specific stalk cells, has less ethical considerations than pluripotent stem cells. In this guideline, tissue-specific stem cells are classified as developed stem cells (tissues after nativity), fetal stem cells, and stem cells derived from pregnancy products (e.chiliad., amniotic membranes, umbilical cord, placenta, and amniotic fluid). Although the fetus is considered a pregnancy production, its upstanding considerations are mentioned separately due to the importance of these considerations that pertain to the fetus. Based on this guideline, merely a human being fetus obtained from a therapeutic abortion, spontaneous abortion, or stillbirth can be used equally a source to produce fetal tissue stem cells. The individuals or groups who decide the need for ballgame should be contained from the research team and have no other conflict of interests.
- 2.3
In this guideline, the ethical considerations of "stalk cells derived from transdifferentiation" are mainly like to the ethical considerations of "tissue-specific stalk cells."
- 2.iv
Induced pluripotent stem cells (iPSCs) are functionally similar to embryonic stem cells. The upstanding considerations of these cells are less than embryonic stalk cells only in the source of prison cell product. In this guideline, authorized resources for product of iPSCs are similar to those allowed for "tissue-specific stem cells." Notwithstanding, upstanding considerations on research application of iPSCs are similar to inquiry application of "embryonic stem cells."
- 2.5
Germline stem cells and germline pluripotent stem cells are a blazon of cell-like pluripotent stem cell; yet, their differentiation capacity is less than both the embryonic stem cells and iPSCs. The upstanding considerations on research application of these cells are similar to research application of "embryonic stalk cells."
- 2.6
Somatic cell nuclear transfer (SCNT) stalk cells are produced by transferring the nucleus of a somatic cell into an enucleated egg (oocyte) and behave like embryonic stem cells. There are many ethical considerations for SCNT research [7, 8]. In this guideline, important ethical considerations include the following: (a) Production of SCNT stem cells with the aim of "human therapeutic cloning" is allowed, but the resulting embryo tin survive only until the age of xiv days then must be discarded. (b) The production of SCNT stem cells with the aim of "human reproductive cloning" is prohibited. (c) Human somatic prison cell nuclear transfer into an "brute egg" and product of a cytoplasmic hybrid (cybrid) are immune. Yet, the resulting embryo is only allowed to survive until the age of 14 days, and then, it must exist discarded. (d) Brute somatic cell nuclear transfer into a "homo egg" and production of a cybrid is prohibited.
- ii.i
- 3.
The 3rd chapter pertains to upstanding considerations for research on somatic cells in regenerative medicine. These considerations are somewhat similar to the ethical considerations of tissue-specific stem cells.
- 4.
The 4th chapter presents ethical considerations for research on gametes in regenerative medicine. According to this guideline, important authorized resources to supply human gametes for research include excess eggs from infertility treatments (egg sharing and unusable eggs) and eggs obtained from in vitro transformation of stem cells. Furthermore, fertilization of a human gamete with an animate being gamete and production of a hybrid is prohibited.
- 5.
Chapter v addresses important upstanding considerations for inquiry related to genetic manipulation in regenerative medicine [9, 10]. Some considerations include the following: (a) Researchers are merely immune to genetically manipulate man surplus or non-transferable IVF embryos obtained from infertility treatments or pre-implantation genetic diagnosis. This embryo is not allowed to be transferred to the uterus, and this manipulated human embryo is but immune to survive for 14 days after IVF and must be discarded after this period. (b) In vivo genetic manipulation of a human fetus is prohibited. (c) Clinical trials of genetic manipulation in children (less than 18 years of historic period) are prohibited. This type of trial is only allowed in children diagnosed with life-threatening diseases that take no culling treatments. (d) Genetic manipulation for the purpose of man enhancement and eugenics and to produce a transgenic man is prohibited. (e) Genetic manipulation that causes suffering of animals or disruptions to their normal life process by irresolute their traits and characteristics should be avoided.
- 6.
Affiliate six deals with the ethical considerations for research on tissue engineering [11]. Clinical trials of tissue-engineered products should be performed by taking into consideration the degree of interaction with the torso, frequency, and duration of application as well as transplantation weather. Whatsoever hazardous material that has been used in the production of biomaterials should be disposed of or recycled with consideration for all condom standards.
- 7.
Affiliate seven includes the upstanding considerations of pre-clinical studies in regenerative medicine. This affiliate focuses on fauna ethics and is classified under the following headings: choice of a suitable fauna model, interventions in animal, brute housing and place of research, veterinarian personnel and care, and the procedure to end working with the animals. Some considerations include the following: (a) Animate being species tin be used if they are bred to be used in research studies. (b) Primate animals can be used but in studies carried out with an approach to the prevention, diagnosis or treatment of a inability or clinical conditions that are potentially chancy to human life, and when there is sufficient scientific justification for the report and research purpose, which could non exist achieved by using other fauna species. (c) Surgery or dissection of animals or other interventions that inflict like surgical pain on live non-anesthetized animals or those that practise not undergo total analgesia is strictly prohibited.
- 8.
Affiliate 8 is the upstanding guideline for clinical trials on stem cells and regenerative medicine. In add-on to the potential benefits of the use of a variety of cells and jail cell-based products in clinical trials, at that place are concerns about possible complications of their application, ethical challenges almost the design and comport of the clinical trials, and preparation of cells from a multifariousness of sources such every bit homo embryos [12, 13]. According to this guideline, stem cells' and regenerative medicine products' clinical trials can be only carried out when in that location is no effective treatment for the disease at the time of the inquiry or it is expected that the intervention will produce better results and fewer complications compared to the existing therapies, and based on the pre-clinical results and available scientific evidence. In cases where there is an effective handling, risks of interventions related to stem cells and regenerative medicine must be at a minimum and justifiable level, and its use should lead to potential advantages such as fewer complications, shorter recovery fourth dimension, increased quality of life, and reduced costs over an extended period of time. This guideline as well emphasizes that the results of animal studies are not necessarily indicative of cell behavior in humans. Therefore, condom and efficacy studies in animals may not correctly predict responses that occur in humans. For this reason, it is recommended that all necessary measures be taken to precisely examine and face up possible adverse effects in humans. The transplanted cells are living organisms and may remain in the torso for an extended catamenia of fourth dimension; therefore, accurate continuous and precise monitoring of subjects is required after transplantation.
- 9.
Chapter nine addresses the ethical guideline for stem cells and regenerative medicine bio-banks [xiv]. Biological samples must exist kept safely and should be labeled or coded. The samples should be preserved according to standard manners to ensure that they are not damaged or lost, and only authorized persons take access to bio-banks. Informed consent must be obtained earlier the biological samples are obtained from the donor or his/her legal representative. The bio-bank staff that has access to samples and biological data must respect privacy policies and avoid information transfer without legal authorization.
- x.
Chapter ten deals with the ethical guideline for privacy and confidentiality of data. Protection of participants' privacy in research on stem cells and regenerative medicine every bit well every bit confidentiality of their data is taken into account.
- xi.
Chapter eleven is the ethical guideline for obtaining informed consent. Upstanding considerations accept been formulated in terms of "informed consent to donate biological samples" and "informed consent to participate in research."
Conclusion
The present ethical guidelines address internationally related ethical considerations co-ordinate to national experts' opinions and will be revised and updated over fourth dimension, given the rapid increment in development of knowledge of stem cells and regenerative medicine. Nosotros hope that it can play an of import worldwide role in advancing ethics of research on stem cells and regenerative medicine.
Availability of data and materials
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Abbreviations
- IVF:
-
In vitro fertilization
- iPSCs:
-
Induced pluripotent stem cells
- SCNT:
-
Somatic cell nuclear transfer
- ACECR:
-
Iranian Academic Center for Didactics, Culture, and Research
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Acknowledgements
The authors express their appreciation to the ACECR Biomedical Research Ethics Committee, Royan Constitute Biomedical Research Ethics Committee, and the Iranian Quango for Stem Cell Sciences and Technologies (Vice-Presidency for Scientific discipline and Technology) that profoundly assisted with this research. Nosotros would like to express our deepest appreciation to the members of the expert panels for sharing their cognition and expertise to develop the present upstanding guidelines. An alphabetical listing of the members of the adept panels is presented: Ahmadbeigi Naser (PhD, Laboratory Hematology and Claret Banking), Bazmi Shabnam (MD, Forensic Medicine), Ghanei Mostafa (Physician, Lung Diseases), Ghazanfari Tooba (PhD, Medical Immunology), Hajifathali Abbas (MD, Hematology & Oncology), Issazadeh Nikzad (PhD, Quranic and Hadith Sciences), Javan Mohammad (PhD, Physiology), Karoji Morteza (PhD, Anatomical Sciences), Khansari Fatemeh (Doctor, Medical Ethics), Merghati Khoei Seyyed Taha (PhD, Jurisprudence and Islamic Law), Milanifar Alireza (PhD, Law; Medical Ethics), Mobasher Mina (MD, Medical Ethics), Mohaghegh Damad Seyyed Mostafa (PhD, Law), Mohammad Nejad Samad (PhD, Pharmacology), Motevaseli Eleheh (PhD, Medical Genetics), Movahedin Mansoureh (PhD, Anatomical Sciences), Nazari Tavakkoli Saeid (PhD, Jurisprudence and Islamic Law), Nazarian Hamid (PhD, Reproductive Biology), Nourani Mohammad Reza (PhD, Prison cell Biology), Nourmohammadi Gholamreza (PhD, Jurisprudence and Police force), Nozad Hojatollah (PhD, Stem Jail cell Biology), Piryaei Abbas (PhD, Anatomical Sciences), Rashidpouraie Roya (MD, Medical Ideals), Rezaei Aderyani Mohsen (Medico, Medical Ethics), Saeedinejad Yasaman (Master, Law and Criminology), and Seyedjafari Ehsan (PhD, Biotechnology).
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This research was supported by the Iranian National Committee for Ethics in Biomedical Inquiry.
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The authors declare that they have no competing interests. Dr. Ehsan Shamsi Gooshki is the secretary of the National Committee for Ethics in Biomedical Research at Ministry of Health and Medical Education.
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Afshar, 50., Aghayan, HR., Sadighi, J. et al. Ethics of enquiry on stalk cells and regenerative medicine: ethical guidelines in the Islamic Commonwealth of Islamic republic of iran. Stem Cell Res Ther 11, 396 (2020). https://doi.org/ten.1186/s13287-020-01916-z
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DOI : https://doi.org/10.1186/s13287-020-01916-z
Keywords
- Clinical trial
- Ideals
- Guideline
- Regenerative medicine
- Stalk cells
Source: https://stemcellres.biomedcentral.com/articles/10.1186/s13287-020-01916-z
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