Embryonic Stem Cells and FDA Approval

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Questions and Answers

What is the primary concern related to the differentiation of iPS cells?

High costs of research methods

Ethical implications of embryo manipulation

Resistance to differentiation and teratoma formation (correct)

Limitations in cell sourcing

What method has been suggested to circumvent the ethical roadblocks in stem cell research?

Inventing new ethical guidelines

Circumventing existing patents (correct)

Utilizing only adult stem cells

Developing methods for cloning

Which model predicts how iPS cells can be generated?

Experimental model

Gradient model

Stochastic model (correct)

Deterministic model

What has emerged due to the Bush administration's restrictions on federal funding for ESC research?

Development of iPS cells Signup and view all the answers

What remains a concern with the clinical application of iPS cells?

Safety and efficacy of the derived cells Signup and view all the answers

What unique ethical issues are associated with iPS cells?

Production of human gametes from iPS cells Signup and view all the answers

Which of the following ethical issues is no longer considered a major obstacle in iPS cell research?

Moral status of the early embryo Signup and view all the answers

What is the potential benefit highlighted regarding the research from ESC discoveries?

Faster production of genetically tailored stem cells Signup and view all the answers

What significant approval did the FDA give in March 2009 regarding stem cell therapy?

Approval for the first clinical trial of an ESC-derived therapy for spinal cord injuries Signup and view all the answers

How may induced pluripotent stem (IPS) cells impact the ethical debate surrounding stem cell research?

They may provide a non-embryonic source, thus reducing ethical concerns Signup and view all the answers

What characteristic distinguishes embryonic stem cells (ESCs) from totipotent stem cells?

ESCs are pluripotent whereas totipotent cells can differentiate into all cell types Signup and view all the answers

What is a notable challenge associated with the advancement of stem cell research according to the content?

Navigating the political, social, and ethical landscape complicates innovation Signup and view all the answers

What does the approval of ESC-derived therapies represent in the context of stem cell research?

The successful application of stem cell research in clinical medicine Signup and view all the answers

Which attribute of ESCs is emphasized in the content regarding their classification?

They can differentiate into all cell types but not generate an entire organism Signup and view all the answers

What role does law and policy play in the advancement of scientific innovation in stem cell research?

They can both hinder and promote scientific innovation through regulations Signup and view all the answers

What potential future development is suggested for induced pluripotent stem cells (IPS)?

They might be routinely available as a source of pluripotent stem cells Signup and view all the answers

What was a significant outcome of Obama's approach to ESC research?

It established an ethical framework for ESC research. Signup and view all the answers

Which statement best reflects the status of federal funding for ESC research?

Federal funding of ESC research is controversial but necessary. Signup and view all the answers

Which guideline is referred to as the 'industry standard' for ESC research?

The NAS guidelines. Signup and view all the answers

What challenge do IRBs face in relation to ESC research?

They may lack the expertise to address unique ethical issues in ESC research. Signup and view all the answers

What does the regulatory framework assure about the treatment of donors?

The rights of embryo donors are protected during research. Signup and view all the answers

What is a potential issue with the existing guidelines for ESC research?

Different organizations may create competing versions of the guidelines. Signup and view all the answers

What role does the federal common rule play in ESC research?

It serves as a guideline for all research including ESC research. Signup and view all the answers

Why is there a need for regulation of ESC research?

To ensure ethical practices and protection of donor rights. Signup and view all the answers

What is the primary reason for the resistance to paying women for egg donations used in research?

Concerns about ethical implications Signup and view all the answers

What is an ESCRO in the context of embryonic stem cell research?

An organization that oversees ESC research approvals Signup and view all the answers

Why did the NAS recommend against payments beyond transportation expenses for egg donors in 2005?

Without providing a solid argument or analysis Signup and view all the answers

What does the term 'significant bodily intrusion' refer to in the context of egg donation?

The medical procedures involved in egg extraction Signup and view all the answers

What was one of the arguments for implementing ESCROs alongside IRBs?

To ensure public awareness of ESC research Signup and view all the answers

What role do IRBs typically play in relation to embryonic stem cell research?

They ensure compliance with ethical standards Signup and view all the answers

Which of the following is a reason cited for the potential cost and delay caused by an additional layer of review in ESC research?

Increased administrative tasks Signup and view all the answers

What is the reason for limiting the creation of new ESC lines?

Ethical and legal interests needing protection Signup and view all the answers

What is suggested as a potential loss due to the Bush administration's funding policy?

Loss in knowledge from restricted research avenues. Signup and view all the answers

What type of line does the author claim symbolizes commitment to human life?

Cut-off lines defined by the Bush administration. Signup and view all the answers

What complication arises from the storage of frozen embryos according to the policy discussed?

Requirement of specialized facilities for storage. Signup and view all the answers

What was the impact of a freezer shutdown on the federally funded embryos?

Embryos would disqualify themselves if moved to a federally funded facility. Signup and view all the answers

What did the Director of the NIH testify regarding the funding policy?

It was harming the progress of ESC science. Signup and view all the answers

What symbolic issue does J. A. Robertson associate with embryo research?

Societal perceptions of human life and its value. Signup and view all the answers

What was a major concern regarding privately derived cell lines after the Bush announcement?

Obstruction in federal funding due to legitimacy issues. Signup and view all the answers

What aspect of the Bush policy did critics argue would be counterproductive for ESC science?

It limited the sources of embryonic stem cells available for study. Signup and view all the answers

Study Notes

FDA Approval and ESC Research

In March 2009, the FDA approved its first clinical trial involving embryonic stem cell (ESC)-derived therapy for spinal cord injuries, marking a significant advancement in translating laboratory research into clinical applications.
The development of induced pluripotent stem (iPS) cells offers potential non-embryonic alternatives to ESCs, which may reduce ethical concerns surrounding their use.

Controversies Surrounding ESCs

ESCs are derived from the embryo, are not totipotent, but are pluripotent, capable of developing into various cell types in the body.
The controversy over ESCs revolves around ethical concerns related to the creation and use of embryos, leading to complex political and social debates.

Regulatory Framework and Ethical Oversight

While federal funding for ESC research has been contentious, there is widespread agreement on the necessity for robust regulatory oversight to protect the rights of embryo donors and ensure ethical practices in research.
The National Academies of Sciences (NAS) established guidelines for ESC research, which became a standard for institutions receiving federal funding, promoting transparency and ethical conduct.

Embryonic Stem Cells Research Organizations (ESCROs)

To address the ethical complexities of ESC research, ESCROs were introduced to complement Institutional Review Boards (IRBs), ensuring that specialized expertise is applied to ESC-related ethical issues.
ESCROs operate alongside IRBs, providing necessary approvals for research involving ESCs to enhance oversight and public confidence.

iPS Cells and Ethical Considerations

iPS cells can be obtained from various somatic cells and raise new ethical issues, particularly concerning the potential to derive human gametes.
The ability to produce gametes from iPS cells could enable significant advancements in ESC research but may also complicate existing moral and ethical discussions.

Shifting Perspectives on Ethical Issues

While initial ethical debates around ESC research were significant, increased familiarity with the technologies has begun to diminish their perceived impact on scientific progress.
Ongoing discussions about the moral status of early embryos remain relevant but are no longer viewed as the primary barrier to innovation in stem cell research.

Conclusion: Future of ESC Research

The evolving landscape of stem cell research suggests optimism regarding the translation of scientific discoveries into clinical benefits, despite potential ongoing ethical challenges.

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Description

This quiz explores the significance of the FDA's first approval of a clinical trial involving embryonic stem cells (ESCs) and the ethical controversies surrounding their use. Additionally, it covers the advancements made with induced pluripotent stem (iPS) cells and the regulatory framework governing stem cell research. Test your knowledge on the science, politics, and ethics related to ESCs.