Abstract
BackgroundRegenerative medicine plays a major role in biomedicine, and given the ever-expanding boundaries of this knowledge, numerous ethical considerations have been raised.Main textRapid advancement of regenerative medicine science and technology in Iran, emerged the Iranian National Committee for Ethics in Biomedical Research 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 ethical considerations of various aspects of the field of regenerative medicine: (1) ethical principles of research on stem cells and regenerative medicine; (2) ethical considerations for research on stem cells (embryonic stem cells, epiblast stem cells, tissue-specific stem cells, stem cells derived from transdifferentiation, induced pluripotent stem cells [iPSCs], germline pluripotent stem cells, germline stem cells, and somatic cell nuclear transfer [SCNT] stem cells); (3) 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]); (4) ethical considerations for research on gametes in regenerative medicine; (5) ethical considerations for research related to genetic manipulation (human and animal) in regenerative medicine; (6) ethical 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; (10) ethical considerations for privacy and confidentiality; and (11) ethical considerations for obtaining informed consent.ConclusionThis article discusses the process of developing the present ethical guidelines and its practical points. We hope that it can play an important worldwide role in advancing ethics of research on stem cells and regenerative medicine.
Highlights
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 [1, 2]
This article discusses the process of developing the present ethical guidelines and its practical points
Main text The present ethical guideline has been developed by a research team and designed as a qualitative study
Summary
The present ethical guideline has been developed by a research team and designed as a qualitative study. 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 age after in vitro fertilization (IVF), which was legally obtained from surplus or non-transferable IVF embryos from infertility treatment or preimplantation genetic diagnosis. 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 can survive only until the age of 14 days and must be discarded. Some considerations include the following: (a) Researchers are only allowed to genetically manipulate human surplus or non-transferable IVF embryos obtained from infertility treatments or preimplantation genetic diagnosis. Ethical considerations have been formulated in terms of “informed consent to donate biological samples” and “informed consent to participate in research.”
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