Question

In a table/bullet point format. Summarize both sides of the ethical issue of stem cell research in drug development

1 page

No plagiarism please

Answer 1

Etical Issues at different stages of stem cell development

Phase of research	Ethical Issues
Informed consent for donation of materials for stem cell research	Diversity in views regarding reproductive materials may impedes with willingness to give consent
Research with human embryonic stem cell	1. Medical risk of oocyte retrieval 2.Protection of reproductive interests of women in infertility treatment 3. Payment to Oocyte donors 4. informed consent for Oocyte donor
Stem cell lines derived from another institution	conflicting legal and ethical standards
Stem Cell clinical trials	Risk and benefits of experimental intervention Informed consent is hard to get because of reasonable risks involved in the study

FDA considers stem-cell based products to be somatic cellular therapies that do not warrant a distinct regulatory approach

General Justification Of Research Risk

Criteria for IRB approval of research

• Risks to subjects are reasonable in relation to anticipated benefits
• Foreseeable risks and inconvenience are weighed against the anticipated benefits for the subjects involved in the study
• Withholding the treatment should not lead to serious harm such as death or irreversible mortality
• Children should not be enrolled in a clincical investigation unless necessary to answer an important scientific question pertaining to the health and welfare of the children
• Equitable selection of subjects, who are capable of giving informed consent, should be enrolled prior to children
• Eliminate any research procedures that do not relate to scientific objective of the study