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James Cholewinski
12:40 PM Stem cell research
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12:40 PM
Stem cell research http://stemcells.nih.gov/info/basics/pages/basics1.aspx Skip to main content U.S. Department of Health & Human Services Search Tips Info Center Research Topics Federal Policy Announ
From: James Cholewinski ([email protected]) This sender is in your safe list.
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Stem cell research
http://stemcells.nih.gov/info/basics/pages/basics1.aspxSkip to main contentU.S. Department of Health & Human Services
Search Tips
Info CenterResearch TopicsFederal PolicyAnnouncementsHomeInfo CenterStem Cell BasicsStem Cell Basics: Introduction
STEM CELL INFORMATIONFrequently Asked QuestionsWhat are stem cells?Can Stem Cells Help My Medical Condition?Are there ethical issues?What is the U.S. policy?More FAQsLinks to related resources
Stem Cell ResearchCenter for Regenerative MedicineNIH Stem Cell UnitCurrent ResearchUpcoming EventsFunding for ResearchScientific LiteratureToolsSite MapGlossaryDownloadsText Size: s M L
Stem Cell Basics
Introduction: What are stem cells, and why are they important?What are the unique properties of all stem cells?What are embryonic stem cells?What are adult stem cells?What are the similarities and differences between embryonic and adult stem cells?What are induced pluripotent stem cells?What are the potential uses of human stem cells and the obstacles that must be overcome before these potential uses will be realized?Where can I get more information?I. Introduction: What are stem cells, and why are they important?Stem cells have the remarkable potential to develop into many different cell types in the body during early life and growth. In addition, in many tissues they serve as a sort of internal repair system, dividing essentially without limit to replenish other cells as long as the person or animal is still alive. When a stem cell divides, each new cell has the potential either to remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell.
Stem cells are distinguished from other cell types by two important characteristics. First, they are unspecialized cells capable of renewing themselves through cell division, sometimes after long periods of inactivity. Second, under certain physiologic or experimental conditions, they can be induced to become tissue- or organ-specific cells with special functions. In some organs, such as the gut and bone marrow, stem cells regularly divide to repair and replace worn out or damaged tissues. In other organs, however, such as the pancreas and the heart, stem cells only divide under special conditions.
Until recently, scientists primarily worked with two kinds of stem cells from animals and humans: embryonic stem cells and non-embryonic "somatic" or "adult" stem cells. The functions and characteristics of these cells will be explained in this document. Scientists discovered ways to derive embryonic stem cells from early mouse embryos nearly 30 years ago, in 1981. The detailed study of the
biology of mouse stem cells led to the discovery, in 1998, of a method to derive stem cells from human embryos and grow the cells in the laboratory. These cells are called human embryonic stem cells. The embryos used in these studies were created for reproductive purposes through in vitro fertilization procedures. When they were no longer needed for that purpose, they were donated for research .)with the informed consent of the donor. In 2006, researchers made another breakthrough by identifying conditions that would allow some specialized adult cells to be "reprogrammed" genetically to assume a stem cell-like state. This new type of stem cell, called induced pluripotent stem cells (iPSCs), will be discussed in a later section of this document.
Stem cells are important for living organisms for many reasons. In the 3- to 5-day-old embryo, called a blastocyst, the inner cells give rise to the entire body of the organism, including all of the many specialized cell types and organs such as the heart, lungs, skin, sperm, eggs and other tissues. In some adult tissues, such as bone marrow, muscle, and brain, discrete populations of adult stem cells generate replacements for cells that are lost through normal wear and tear, injury, or disease.
Given their unique regenerative abilities, stem cells offer new potentials for treating diseases such as diabetes, and heart disease. However, much work remains to be done in the laboratory and the clinic to understand how to use these cells for cell-based therapies to treat disease, which is also referred to as regenerative or reparative medicine.
Laboratory studies of stem cells enable scientists to learn about the cells’ essential properties and what makes them different from specialized cell types. Scientists are already using stem cells in the laboratory to screen new drugs and to develop model systems to study normal growth and identify the causes of birth defects.
Research on stem cells continues to advance knowledge about how an organism develops from a single cell and how healthy cells replace damaged cells in adult organisms. Stem cell research is one of the most fascinating areas of contemporary biology, but, as with many expanding fields of scientific inquiry, research on stem cells raises scientific questions as rapidly as it generates new discoveries.
I. Introduction | Next
This page was last modified on Sunday, April 28, 2002 Contact Us Accessibility Privacy statement DisclaimerPage citation: Stem Cell Basics: Introduction. In Stem Cell Information [World Wide Web site]. Bethesda, MD: National Institutes of Health, U.S. Department of Health and Human Services, 2002 [cited Tuesday, October 21, 2014] Available at <http://stemcells.nih.gov/info/basics/pages/basics1.aspx>
U.S. Department of Health & Human Services (HHS) | USA.gov - Government Made EasyNational Institutes of Health (NIH), 9000 Rockville Pike, Bethesda, Maryland 20892NIH… Turning Discovery Into Health®Skip to main content
U.S. Department of Health & Human Services
Search Tips
Info CenterResearch TopicsFederal PolicyAnnouncementsHomeInfo CenterStem Cell BasicsWhat are the unique properties of all stem cells?
STEM CELL INFORMATIONFrequently Asked QuestionsWhat are stem cells?Can Stem Cells Help My Medical Condition?Are there ethical issues?What is the U.S. policy?More FAQsLinks to related resourcesStem Cell ResearchCenter for Regenerative MedicineNIH Stem Cell UnitCurrent ResearchUpcoming EventsFunding for ResearchScientific LiteratureToolsSite MapGlossaryDownloadsText Size: s M L
Stem Cell Basics
Introduction: What are stem cells, and why are they important?What are the unique properties of all stem cells?What are embryonic stem cells?What are adult stem cells?What are the similarities and differences between embryonic and adult stem cells?What are induced pluripotent stem cells?What are the potential uses of human stem cells and the obstacles that must be overcome before these potential uses will be realized?Where can I get more information?
II. What are the unique properties of all stem cells?Stem cells differ from other kinds of cells in the body. All stem cells—regardless of their source—have three general properties: they are capable of dividing and renewing themselves for long periods; they are unspecialized; and they can give rise to specialized cell types.
Stem cells are capable of dividing and renewing themselves for long periods. Unlike muscle cells, blood cells, or nerve cells—which do not normally replicate themselves—stem cells may replicate many times, or proliferate. A starting population of stem cells that proliferates for many months in the laboratory can yield millions of cells. If the resulting cells continue to be unspecialized, like the parent stem cells, the cells are said to be capable of long-term self-renewal.
Scientists are trying to understand two fundamental properties of stem cells that relate to their long-term self-renewal:
Why can embryonic stem cells proliferate for a year or more in the laboratory without differentiating, but most non-embryonic stem cells cannot; andWhat are the factors in living organisms that normally regulate stem cell proliferation and self-renewal?Discovering the answers to these questions may make it possible to understand how cell proliferation is regulated during normal embryonic development or during the abnormal cell division that leads to cancer. Such information would also enable scientists to grow embryonic and non-embryonic stem cells more efficiently in the laboratory.
The specific factors and conditions that allow stem cells to remain unspecialized are of great interest to scientists. It has taken scientists many years of trial and error to learn to derive and maintain stem cells in the laboratory without them spontaneously differentiating into specific cell types. For example, it took two decades to learn how to grow human embryonic stem cells in the laboratory following the development of conditions for growing mouse stem cells. Likewise, scientists must first understand the signals that enable a non-embryonic (adult) stem cell population to proliferate and remain unspecialized before they will be able to grow large numbers of unspecialized adult stem cells in the laboratory.
Stem cells are unspecialized. One of the fundamental properties of a stem cell is that it does not have any tissue-specific structures that allow it to perform specialized functions. For example, a stem cell cannot work with its neighbors to pump blood through the body (like a heart muscle cell), and it cannot carry oxygen molecules through the bloodstream (like a red blood cell). However, unspecialized stem cells can give rise to specialized cells, including heart muscle cells, blood cells, or nerve cells.
Stem cells can give rise to specialized cells. When unspecialized stem cells give rise to specialized cells, the process is called differentiation. While differentiating, the cell usually goes through several stages, becoming more specialized at each step. Scientists are just beginning to understand the signals inside and outside cells that trigger each step of the differentiation process. The internal signals are controlled by a cell's genes, which are interspersed across long strands of DNA and carry coded instructions for all cellular structures and functions. The external signals for cell differentiation include chemicals secreted
by other cells, physical contact with neighboring cells, and certain molecules in the microenvironment. The interaction of signals during differentiation causes the cell's DNA to acquire epigenetic marks that restrict DNA expression in the cell and can be passed on through cell division.
Many questions about stem cell differentiation remain. For example, are the internal and external signals for cell differentiation similar for all kinds of stem cells? Can specific sets of signals be identified that promote differentiation into specific cell types? Addressing these questions may lead scientists to find new ways to control stem cell differentiation in the laboratory, thereby growing cells or tissues that can be used for specific purposes such as cell-based therapies or drug screening.
Adult stem cells typically generate the cell types of the tissue in which they reside. For example, a blood-forming adult stem cell in the bone marrow normally gives rise to the many types of blood cells. It is generally accepted that a blood-forming cell in the bone marrow—which is called a hematopoietic stem cell—cannot give rise to the cells of a very different tissue, such as nerve cells in the brain. Experiments over the last several years have purported to show that stem cells from one tissue may give rise to cell types of a completely different tissue. This remains an area of great debate within the research community. This controversy demonstrates the challenges of studying adult stem cells and suggests that additional research using adult stem cells is necessary to understand their full potential as future therapies.
Previous | II. What are the unique properties of all stem cells? | Next
This page was last modified on Tuesday, April 28, 2009 Contact Us Accessibility Privacy statement DisclaimerPage citation: What are the unique properties of all stem cells?. In Stem Cell Information [World Wide Web site]. Bethesda, MD: National Institutes of Health, U.S. Department of Health and Human Services, 2009 [cited Tuesday, October 21, 2014] Available at <http://stemcells.nih.gov/info/basics/pages/basics2.aspx>
U.S. Department of Health & Human Services (HHS) | USA.gov - Government Made EasyNational Institutes of Health (NIH), 9000 Rockville Pike, Bethesda, Maryland 20892NIH… Turning Discovery Into Health®VII. What are the potential uses of human stem cells and the obstacles that must be overcome before these potential uses will be realized?There are many ways in which human stem cells can be used in research and the clinic. Studies of human embryonic stem cells will yield information about the complex events that occur during human development. A primary goal of this work is to identify how undifferentiated stem cells become the differentiated cells that form the tissues and organs. Scientists know that turning genes on and off is central to this process. Some of the most serious medical conditions, such as cancer and birth defects, are due to abnormal cell division and differentiation. A more complete understanding of the genetic and molecular controls of these processes may yield information about how such diseases arise and suggest new strategies for therapy. Predictably controlling cell proliferation and differentiation requires
additional basic research on the molecular and genetic signals that regulate cell division and specialization. While recent developments with iPS cells suggest some of the specific factors that may be involved, techniques must be devised to introduce these factors safely into the cells and control the processes that are induced by these factors.
Human stem cells are currently being used to test new drugs. New medications are tested for safety on differentiated cells generated from human pluripotent cell lines. Other kinds of cell lines have a long history of being used in this way. Cancer cell lines, for example, are used to screen potential anti-tumor drugs. The availability of pluripotent stem cells would allow drug testing in a wider range of cell types. However, to screen drugs effectively, the conditions must be identical when comparing different drugs. Therefore, scientists must be able to precisely control the differentiation of stem cells into the specific cell type on which drugs will be tested. For some cell types and tissues, current knowledge of the signals controlling differentiation falls short of being able to mimic these conditions precisely to generate pure populations of differentiated cells for each drug being tested.
Perhaps the most important potential application of human stem cells is the generation of cells and tissues that could be used for cell-based therapies. Today, donated organs and tissues are often used to replace ailing or destroyed tissue, but the need for transplantable tissues and organs far outweighs the available supply. Stem cells, directed to differentiate into specific cell types, offer the possibility of a renewable source of replacement cells and tissues to treat diseases including macular degeneration, spinal cord injury, stroke, burns, heart disease, diabetes, osteoarthritis, and rheumatoid arthritis.
Figure 3. Strategies to repair heart muscle with adult stem cells. Click here for larger image.© 2001 Terese Winslow
For example, it may become possible to generate healthy heart muscle cells in the laboratory and then transplant those cells into patients with chronic heart disease. Preliminary research in mice and other animals indicates that bone marrow stromal cells, transplanted into a damaged heart, can have beneficial effects. Whether these cells can generate heart muscle cells or stimulate the growth of new blood vessels that repopulate the heart tissue, or help via some other mechanism is actively under investigation. For example, injected cells may accomplish repair by secreting growth factors, rather than actually incorporating into the heart. Promising results from animal studies have served as the basis for a small number of exploratory studies in humans (for discussion, see call-out box, "Can Stem Cells Mend a Broken Heart?"). Other recent studies in cell culture systems indicate that it may be possible to direct the differentiation of embryonic stem cells or adult bone marrow cells into heart muscle cells (Figure 3).
Can Stem Cells Mend a Broken Heart?: Stem Cells for the Future Treatment of Heart DiseaseCardiovascular disease (CVD), which includes hypertension, coronary heart disease, stroke, and congestive heart failure, has ranked as the number one cause of death in the United States every year since 1900 except 1918, when the nation struggled with an influenza epidemic. Nearly 2,600 Americans
die of CVD each day, roughly one person every 34 seconds. Given the aging of the population and the relatively dramatic recent increases in the prevalence of cardiovascular risk factors such as obesity and type 2 diabetes, CVD will be a significant health concern well into the 21st century.
Cardiovascular disease can deprive heart tissue of oxygen, thereby killing cardiac muscle cells (cardiomyocytes). This loss triggers a cascade of detrimental events, including formation of scar tissue, an overload of blood flow and pressure capacity, the overstretching of viable cardiac cells attempting to sustain cardiac output, leading to heart failure, and eventual death. Restoring damaged heart muscle tissue, through repair or regeneration, is therefore a potentially new strategy to treat heart failure.
The use of embryonic and adult-derived stem cells for cardiac repair is an active area of research. A number of stem cell types, including embryonic stem (ES) cells, cardiac stem cells that naturally reside within the heart, myoblasts (muscle stem cells), adult bone marrow-derived cells including mesenchymal cells (bone marrow-derived cells that give rise to tissues such as muscle, bone, tendons, ligaments, and adipose tissue), endothelial progenitor cells (cells that give rise to the endothelium, the interior lining of blood vessels), and umbilical cord blood cells, have been investigated as possible sources for regenerating damaged heart tissue. All have been explored in mouse or rat models, and some have been tested in larger animal models, such as pigs.
A few small studies have also been carried out in humans, usually in patients who are undergoing open-heart surgery. Several of these have demonstrated that stem cells that are injected into the circulation or directly into the injured heart tissue appear to improve cardiac function and/or induce the formation of new capillaries. The mechanism for this repair remains controversial, and the stem cells likely regenerate heart tissue through several pathways. However, the stem cell populations that have been tested in these experiments vary widely, as do the conditions of their purification and application. Although much more research is needed to assess the safety and improve the efficacy of this approach, these preliminary clinical experiments show how stem cells may one day be used to repair damaged heart tissue, thereby reducing the burden of cardiovascular disease.
In people who suffer from type 1 diabetes, the cells of the pancreas that normally produce insulin are destroyed by the patient's own immune system. New studies indicate that it may be possible to direct the differentiation of human embryonic stem cells in cell culture to form insulin-producing cells that eventually could be used in transplantation therapy for persons with diabetes.
To realize the promise of novel cell-based therapies for such pervasive and debilitating diseases, scientists must be able to manipulate stem cells so that they possess the necessary characteristics for successful differentiation, transplantation, and engraftment. The following is a list of steps in successful cell-based treatments that scientists will have to learn to control to bring such treatments to the clinic. To be useful for transplant purposes, stem cells must be reproducibly made to:
Proliferate extensively and generate sufficient quantities of cells for making tissue.Differentiate into the desired cell type(s).
Survive in the recipient after transplant.Integrate into the surrounding tissue after transplant.Function appropriately for the duration of the recipient's life.Avoid harming the recipient in any way.Also, to avoid the problem of immune rejection, scientists are experimenting with different research strategies to generate tissues that will not be rejected.
To summarize, stem cells offer exciting promise for future therapies, but significant technical hurdles remain that will only be overcome through years of intensive research.
Previous | VII. What are the potential uses of human stem cells and the obstacles that must be overcome before these potential uses will be realized? | Nexthttp://stemcells.nih.gov/info/pages/ethics.aspxhttp://www.wma.net/en/30publications/10policies/b3/index.htmlAdopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964and amended by the:29th WMA General Assembly, Tokyo, Japan, October 197535th WMA General Assembly, Venice, Italy, October 198341st WMA General Assembly, Hong Kong, September 198948th WMA General Assembly, Somerset West, Republic of South Africa, October 199652nd WMA General Assembly, Edinburgh, Scotland, October 2000 53rd WMA General Assembly, Washington DC, USA, October 2002 (Note of Clarification added)55th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added)59th WMA General Assembly, Seoul, Republic of Korea, October 200864th WMA General Assembly, Fortaleza, Brazil, October 2013
Preamble1. The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.
The Declaration is intended to be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs.
2. Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians. The WMA encourages others who are involved in medical research involving human subjects to adopt these principles.
General Principles3. The Declaration of Geneva of the WMA binds the physician with the words, “The health of my
patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient's best interest when providing medical care.”
4. It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician's knowledge and conscience are dedicated to the fulfilment of this duty.
5. Medical progress is based on research that ultimately must include studies involving human subjects.
6. The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best proven interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality.
7. Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights.
8. While the primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interests of individual research subjects.
9. It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.
10. Physicians must consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.
11. Medical research should be conducted in a manner that minimises possible harm to the environment.
12. Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional.
13. Groups that are underrepresented in medical research should be provided appropriate access to participation in research.
14. Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.
15. Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.
Risks, Burdens and Benefits 16. In medical practice and in medical research, most interventions involve risks and burdens.
Medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.
17. All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation.
Measures to minimise the risks must be implemented. The risks must be continuously monitored, assessed and documented by the researcher.
18. Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed.
When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify or immediately stop the study.
Vulnerable Groups and Individuals19. Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm.
All vulnerable groups and individuals should receive specifically considered protection.
20. Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group. In addition, this group should stand to benefit from the knowledge, practices or interventions that result from the research.
Scientific Requirements and Research Protocols
21. Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for research must be respected.
22. The design and performance of each research study involving human subjects must be clearly described and justified in a research protocol.
The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding funding, sponsors, institutional affiliations, potential conflicts of interest, incentives for subjects and information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study.
In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions.
Research Ethics Committees23. The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins. This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration.
The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No amendment to the protocol may be made without consideration and approval by the committee. After the end of the study, the researchers must submit a final report to the committee containing a summary of the study’s findings and conclusions.
Privacy and Confidentiality 24. Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.
Informed Consent 25. Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no individual capable of giving informed consent may be enrolled in a research study unless he or she freely agrees.
26. In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information.
After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.
All medical research subjects should be given the option of being informed about the general outcome and results of the study.
27. When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship.
28. For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.
29. When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorised representative. The potential subject’s dissent should be respected.
30. Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group. In such circumstances the physician must seek informed consent from the legally authorised representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research must be obtained as soon
as possible from the subject or a legally authorised representative.
31. The physician must fully inform the patient which aspects of their care are related to the research. The refusal of a patient to participate in a study or the patient’s decision to withdraw from the study must never adversely affect the patient-physician relationship.
32. For medical research using identifiable human material or data, such as research on material or data contained in biobanks or similar repositories, physicians must seek informed consent for its collection, storage and/or reuse. There may be exceptional situations where consent would be impossible or impracticable to obtain for such research. In such situations the research may be done only after consideration and approval of a research ethics committee.
Use of Placebo33. The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances:
Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or
Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention
and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.
Extreme care must be taken to avoid abuse of this option.
Post-Trial Provisions34. In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.
Research Registration and Publication and Dissemination of Results35. Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.
36. Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available.
Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.
Unproven Interventions in Clinical Practice37. In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorised representative, may use an unproven intervention if in the physician's judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.
https://www2.bc.edu/~sarkodik/stemcellethics.htmJournal of Law, Medicine & Ethics, Winter 2000 v28 i4 p411Research guidelines: NIH issues guidelines for federally funded stem cell research. (National Institutes of Health) Christine Kirk.Full Text: COPYRIGHT 2000 American Society of Law & Medicine, Inc.
On August 25, 2000, following heated public debate,[1] the National Institutes of Health (NIH) published final guidelines for NIH-funded research involving the use of human stem cells.[2] The intent of the National Institutes of Health Guidelines for Research Using Human Pluripotent Stem Cells is to ensure that funded research is conducted in a legal and ethical manner,[3] and the Guidelines establish procedures to achieve this outcome.[4] Due to the astonishing medical promises of stem cell research, stem cell research has gained support from both private and public entities despite a number of serious ethical concerns raised by both opponents and proponents of the research.[5] This review summarizes the Guidelines and briefly addresses related legal and ethical concerns.
Human Stem Cell Research -- A Brief Description[6]
The research in question involves the use of human pluripotent stem cells. Pluripotent stem cells are cells that have not yet differentiated into specialized cells or tissues and that retain the ability to develop into nearly all components of the human body. More importantly, the cells are self-renewing in certain laboratory settings, making the production of ongoing cell lines composed of cells with nearly unlimited developmental potential possible. As a result, stem cells may be central to the development of more effective treatments for human maladies as diverse as Type-1 diabetes, Parkinson's disease, and spinal cord injury.[7]
Currently, most human stem cells used in research are derived either from excess embryos produced in fertility treatment or from aborted fetuses. Many researchers prefer stem cells from these sources because they are consistently pluripotent and because reliable laboratory techniques exist for their isolation and propagation. At present, this is not true of somatic cell nuclear transfer, which has been
proposed as an alternate source, or adult stem cells, which have been proposed as an ethically superior source of human stem cells.[8] Ethical concerns arise in relation both to the source of human stem cells as well as certain aspects of stem cell research, which will be discussed below.
Summary of the Guidelines[9]
The Guidelines establish procedural constraints that apply to any NIH-funded research using stem cells derived from human embryos or non-living fetal tissue. More specifically, NIH funds may support research using cells derived only from 1) embryos which were created for fertility treatment and which were in excess of clinical need; or 2) fetal tissue used in accordance with the Guidelines and with all applicable laws and regulations.[10]
The Guidelines include a number of directives for researchers.[11] For example, a researcher may not induce a person to create excess embryos for the purpose of deriving stem cells from them.[12] Moreover, researchers must ensure that informed consent is obtained from donors and that the consent addresses a variety of issues, including the following: potential use of cells for transplantation; direction for the use or non-use of identifying information about the donor; potential preservation of cells and/or cell lines for many years; the possibility that the cells and/or cell lines may have commercial value and that the donor will not receive any benefits from such commercialization; assurance that there is no direct medical benefit to the donor; and acknowledgment that donated embryos will neither be used for pregnancy nor survive the stem cell derivation process. Finally, researchers must follow standard NIH research procedures[13] as well as undergo review by an NIH working committee[14] on stem cell research.
If researchers do not comply with the Guidelines, they may be subject to increased oversight, ineligibility for present or future NIH funding, or, if federal or state law is broken, civil or criminal penalties. Lastly, the Guidelines specifically delineate several research areas that are not eligible for NIH funding. These include somatic cell nuclear transfer, animal-human cell combination, and human reproductive cloning.
The Legal and Ethical Context of the Guidelines
The primary legal issue specific to the Guidelines is whether the research they govern violates the Congressional ban on embryonic research.[15] Congress has banned the use of federal funds for research that damages human embryos.[16] However, under the Department of Health and Human Services' statutory interpretation, because stem cells do not themselves comprise a full embryo (the stem cell derivation process destroys the embryo), human pluripotent stem cells are not embryos subject to the research ban.[17] Accordingly, under this interpretation, NIH has been funding research using embryonic-source stem cells.
The distinction between stem cells derived from an embryo and the embryo itself requires consideration of one of the most vigorously debated ethical concerns: the status of the embryo as a "rights-bearing entity."[18] Disagreement over this issue underlies the positions of proponents and opponents of
research that uses human stem cells of embryonic or fetal tissue origin. Proponents stress the enormous potential value of the research and argue that it is ethically unacceptable not to use these stem cells when excess embryos and non-living fetal tissue would otherwise be destroyed.[19] Opponents argue that it is ethically unacceptable to sacrifice the rights of embryos to the needs of patients who would benefit from the research.[20] By restricting funding to research that uses only already derived stem cells and non-living fetal tissue, NIH has avoided taking a position on the rights status of the embryo or directly challenging the Congressional ban. However, the issue remains at the core of the debate surrounding human stem cell research.
While the Guidelines may avoid confronting the above issue, they do address several other ethical concerns raised by both proponents and opponents of human stem cell research. A central concern is that the research might be used toward applications such as reproductive cloning or the creation of animal-human hybrids. The Guidelines expressly state that such research is ineligible for funding.[21] Another concern is that donors might be coerced, paid, or otherwise induced either to create excess embryos or to have abortions for the sole purpose of making stem cells available for research or treatment use. Yet another concern is obtaining adequate informed consent, including consent to commercialization, transplantation, and extended preservation of stem cells and cell lines. The Guidelines' procedural, assurance, and documentation requirements attempt to address each of these issues. However, the Guidelines do not take up all concerns as to future implications of successful stem cell research nor do they have any direct force on research funded by entities other than NIH.
Conclusion
While the Guidelines do not address every legal and ethical issue raised by human stem cell research, they do set forth several basic principles. Such a framework may be informative not only to researchers funded by NIH, but also to those working under the aegis of non-profit research foundations or for-profit private companies. This is especially true in the absence of widely applicable legal restrictions or widely accepted ethical constraints on such research. For both supporters and opponents, the Guidelines provide a useful reference point in the determination of appropriate legal and ethical parameters for this promising and controversial research.
References
[1.] During the public comment phase, NIH received approximately 50,000 comments. These ranged from suggestions that there is no need for any such federal guidelines to contentions that the research was in violation of the U.S. Department of Health and Human Services (DHHS) appropriations law prohibiting research involving human embryos. Comments came from a wide variety of persons and entities, including private citizens, members of Congress, religious organizations, and scientific societies. See "Summary of Public Comments on Draft Guidelines," National Institutes of Health Guidelines for Research Using Human Pluripotent Stem Cells (visited October 6, 2000) <http://www.nih.gov/news/stemcell/ stemcellguidelines.htm>.
[2.] "National Institutes of Health Guidelines for Research Using Human Pluripotent Stem Cells," 65 Fed. Reg. 51,975, Aug. 25, 2000; BNA's Health Law Reporter, 9 (2000): at 1350 [hereinafter cited as Guidelines].
[3.] See, e.g., "Testimony on Pluripotent Stem Cell Research Guidelines" (reporting testimony of two National Institutes of Health directors before the Senate Appropriations Subcommittee on Sep. 7, 2000) (visited October 6, 2000) <http:// www.ninds.nih.gov/about_ninds/ testimony_stemcell_090700.htm>.
[4.] Id.
[5.] See, for example, Ethical Issues in Human Stem Cell Research, Executive Summary of the National Bioethics Advisory Commission (September 1999) (visited October 11, 2000) <http:// bioethics.gov/stemcell_exec_intro.htm>.
[6.] For a review of stem cell basics, see Pluripotent Stem Cells: A Primer (May 2000) (visited Oct. 6, 2000) <http:// www.nih.gov/news/stemcell/primer.htm>.
[7.] For further discussion of stem cell research and potential applications, see "Statement of Harold Varmus, M.D., Director, National Institutes of Health" before the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies, December 2, 1998 (visited Oct. 6, 2000) <http:/ /nih.gov/news/stemcell/statement.htm >.
[8.] See the "Scope of Guidelines and General Issues" section of the Guidelines, supra note 2.
[9.] See Guidelines, supra note 2.
[10.] Id.
[11.] The Guidelines list more than 15 procedural directives for the conduct of funded research. These are summarized in the text above or may be read in full in the Guidelines themselves. See Guidelines, supra note 2.
[12.] There also must be a clear separation of the decision to undergo fertility treatment from the decision to donate excess embryos for research.
[13.] Standard procedural safeguards include institutional review board (IRB) scrutiny and the provision of documentation and assurances of compliance.
[14.] See Guidelines, supra note 2.
[15.] See M. Biven, "Administrative Developments: NIH Backs Federal Funding for Stem Cell Research," Journal of Law, Medicine &Ethics, 27, no. 1 (1999): at 96-97.
[16.] Id.
[17.] Id.
[18.] The main issue is whether the embryo is a fully realized human with accompanying rights or a potential human whose full rights begin at some point later in pregnancy or at birth.
[19.] See, for example, Senate Health Appropriations Subcommittee Hearings, April 26, 2000. See also "Testimony on Pluripotent Stem Cell Research Guidelines, September 2000," reporting the testimony of two NIH directors before the Senate Appropriations Subcommittee, September 7, 2000 (visited October 6, 2000) <www.ninds.nih.gov/about_ninds/ testimony_stemcell_090700.htm >.
[20.] Opponents often characterize proponents' arguments as "utilitarian" at best and have compared stem cell research to medical experiments conducted by the Nazis in World War II, as in this comment by Senator Sam Brownback (R-KS): "... like what happened in World War II. [The Nazis figured that] these people are going to be killed, why not experiment on them ...." See Senate Health Appropriations Subcommittee Hearings, April 26, 2000. See also D. Irving, "Stem Cell Research: Some Pros and Cons," Canadian Physicians for Life (visited Oct. 11, 2000) <http:// physiciansforlife.ca/stemcelll.html>.
[21.] Certain additional research areas are also defined as ineligible. See Guidelines, supra note 2.
http://www.humancloning.orghttp://www.humancloning.org/myths.htmlThe Top Ten Myths about Human Cloningby Gregory E. Pence1. Cloning Xeroxes a person.Cloning merely re-creates the genes of the ancestor, not what he has learned or experienced. Technically, it re-creates the genotype, not the phenotype. (Even at that, only 99% of those genes get re-created because 1% of such a child's genes would come from those in the egg - mitochondrial DNA). Conventional wisdom holds that about half of who we are comes from our genes, the other half, from the environment.
Cloning cannot re-create what in us came from the environment; it also cannot re-create memories. The false belief that cloning recreates a person stems in part from the common, current false belief in simplistic, genetic reductionism, i. e., that a person really is just determined by his genes. No reputable geneticist or psychologist believes this.
2. Human cloning is replication or making children into commodities.Opponents of cloning often use these words to beg the question, to assume that children created by parents by a new method would not be loved. Similar things were said about "test tube" babies, who turned out to be some of the most-wanted, most-loved babies ever created in human history.
Indeed, the opposite is true: evolution has created us with sex drives such that, if we do not carefully use contraception, children occur. Because children get created this way without being wanted, sexual reproduction is more likely to create unwanted, and hence possibly unloved, children than human cloning.
Lawyers opposing cloning have a special reason for using these pejorative words. If cloning is just a new form of human reproduction, then it is Constitutionally protected from interference by the state. Several Supreme Court decisions declare that all forms of human reproduction, including the right not to reproduce, cannot be abridged by government.
Use of words such as "replication" and "commodification" also assumes artificial wombs or commercial motives; about these fallacies, see below.
3. Human cloning reduces biological diversity.Population genetics says otherwise. Six billion people now exist, soon to be eight billion, and most of them reproduce. Cloning requires in vitro fertilization, which is expensive and inefficient, with only a 20% success rate. Since 1978, at most a half million babies have been produced this way, or at most, one out of 12,000 babies.
Over decades and with such great numbers, populations follow the Law of Regression to the Mean. This means that, even if someone tried to create a superior race by cloning, it would fail, because cloned people would have children with non-cloned people, and resulting genetic hybrids would soon be normalized.
Cloning is simply a tool. It could be used with the motive of creating uniformity (but would fail, because of above), or it be used for the opposite reason, to try to increase diversity (which would also fail, for the same reason).
4. People created by cloning would be less ensouled than normal humans, or would be sub-human.A human who had the same number of chromosomes as a child created sexually, who was gestated by a woman, and who talked, felt, and spoke as any other human, would ethically be human and a person. It is by now a principle of ethics that the origins of a person, be it from mixed-race parents, unmarried parents, in vitro fertilization, or a gay male couple hiring a surrogate mother, do not affect the personhood of the child born. The same would be true of a child created by cloning (who, of course, has to be gestated for nine months by a woman).
Every deviation from normal reproduction has always been faced with this fear. Children greeted by sperm donation, in vitro fertilization, and surrogate motherhood were predicted to be less-than-human, but were not.
A variation predicts that while, in fact, they will not be less-than-human, people will treat them this way
and hence, such children will harmed. This objection reifies prejudice and makes it an ethical justification, which it is wrong to do. The correct response to prejudice is to expose it for what it is, combat it with reason and with evidence, not validate it as an ethical reason.
5. People created by cloning could be used for spare organs for normal humans.Nothing could be done to a person created by cloning that right now could not be done to your brother or to a person's twin. The U. S. Constitution strongly implies that once a human fetus is outside the womb and alive, he has rights. Decisions backing this up give him rights to inherit property, rights not to suffer discrimination because of disability, and rights to U. S. citizenship.
A variation of this myth assumes that a dictator could make cloned humans into special SWAT teams or suicidal bombers. But nothing about originating people this way gives anyone any special power over the resulting humans, who would have free will. Besides, if a dictator wants to create such assassins, he need not wait for cloning but can take orphans and try to indoctrinate them now in isolated camps.
6. All people created from the same genotype would be raised in batches and share secret empathy or communication.Pure science fiction. If I wanted to recreate the genotype of my funny Uncle Harry, why would my wife want to gestate 5 or 6 other babies at the same time? Indeed, we now know that the womb cannot support more than 2-3 fetuses without creating a likely disability in one. Guidelines now call for no more than two embryos to be introduced by in vitro fertilization, which of course is required to use cloning.
Such assumptions about cloned humans being created in batches are linked to nightmarish science fiction scenarios where humane society has been destroyed and where industrialized machines have taken over human reproduction. But this is just someone's nightmare, not facts upon which to base state and federal laws.
7. Scientists who work on human cloning are evil or motivated by bad motives.The stuff of Hollywood and scary writers. Scientists are just people. Most of them have kids of their own and care a lot for kids. No one wants to bring a handicapped child into the world. Movies and novels never portray life scientists with sympathy. This anti-science prejudice started with Mary Shelley's Frankenstein and continues with nefarious scientists working for the Government on The X Files.
People who call themselves scientists and grandstand for television, such as Richard Seed and Brigette Boisselier of the Raelians, are not real scientists but people who use the aura of science to gain attention. Real scientists don't spend all their time flying around the world to be on TV but stay at home in their clinics doing their work.
8. Babies created by cloning could be grown in artificial wombs.Nope, sorry. Medicine has been trying for fifty years to create an artificial womb, but has never come close to succeeding. Indeed, controversial experiments in 1973 on live-born fetuses in studying artificial wombs effectively shut down such research.
Finally, if anything like such wombs existed, we could save premature babies who haven't developed lung function, but unfortunately, we still can't - premature babies who can't breathe at all die. Thus, any human baby still needs a human woman to gestate him for at least six months, and to be healthy, nine months. This puts the lie to many science fiction stories and to many predictions about cloning and industrial reproduction.
9. Only selfish people want to create a child by cloning.First, this assumes that ordinary people don't create children for selfish reasons, such as a desire to have someone take care of them in old age, a desire to see part of themselves continue after death, and/or the desire to leave their estate to someone. Many people are hypocritical or deceived about why they came to have children. Very few people just decide that they want to bring more joy into the world, and hence create a child to raise and support for life as an end-in-himself. Let's be honest here. Second, a couple using cloning need not create a copy of one of them. As said above, Uncle Harry could be a prime candidate.
On the other hand, if a couple chooses a famous person, critics accuse them of creating designer babies. Either way, they can't win: if they re-create one of their genotypes, they are narcissistic; if they choose someone else's genes, they're guilty of creating designer babies.
In general, why should a couple using cloning have a higher justification required of them than a couple using sexual reproduction? If we ask: what counts as a good reason for creating a child, then why should cloning have any special test that is not required for sexual reproduction? Indeed, and more generally, what right does government have to require, or judge, any couple's reasons for having a child, even if they are seen by others to be selfish?
Couples desiring to use cloning should not bear an undue burden of justification.
10. Human cloning is inherently evil: it can only be used for bad purposes by bad people.No, it's just a tool, just another way to create a family. A long legacy in science fiction novels and movies make the word "cloning" so fraught with bad connotations that it can hardly be used in any discussion that purports to be impartial. It is like discussing equal rights for women by starting to discuss whether "the chicks" would fare better with equal rights. To most people, "cloning" implies selfish parents, crazy scientists, and out-of- control technology, so a fair discussion using this word isn't possible. Perhaps the phrase, "somatic cell nuclear transplantation" is better, even if it's a scientific mouthful. So if we shouldn't call a person created by cloning, a "clone," what should we call him? Answer: a person.
http://learn.genetics.utah.edu/content/stemcells/scissues/HOME STEM CELLS THE STEM CELL DEBATE: IS IT OVER?The Stem Cell Debate: Is It Over?Stem cell therapies are not new. Doctors have been performing bone marrow stem cell transplants for
decades. But when scientists learned how to remove stem cells from human embryos in 1998, both excitement and controversy ensued.
The excitement was due to the huge potential these cells have in curing human disease. The controversy centered on the moral implications of destroying human embryos. Political leaders began to debate over how to regulate and fund research involving human embryonic stem (hES) cells.
Newer breakthroughs may bring this debate to an end. In 2006 scientists learned how to stimulate a patient's own cells to behave like embryonic stem cells. These cells are reducing the need for human embryos in research and opening up exciting new possibilities for stem cell therapies.
Both human embryonic stem (hES) cells and induced pluripotent stem (iPS) cells are pluripotent: they can become any type of cell in the body. While hES cells are isolated from an embryo, iPS cells can be made from adult cells.The Ethical Questions
Until recently, the only way to get pluripotent stem cells for research was to remove the inner cell mass of an embryo and put it in a dish. The thought of destroying a human embryo can be unsettling, even if it is only five days old.
Stem cell research thus raised difficult questions:Does life begin at fertilization, in the womb, or at birth?Is a human embryo equivalent to a human child?Does a human embryo have any rights?Might the destruction of a single embryo be justified if it provides a cure for a countless number of patients?Since ES cells can grow indefinitely in a dish and can, in theory, still grow into a human being, is the embryo really destroyed?Problem Solved?
With alternatives to hES cells now available, the debate over stem cell research is becoming increasingly irrelevant. But ethical questions regarding hES cells may not entirely go away.
For now, some human embryos will still be needed for research. iPS cells are not exactly the same as hES cells, and hES cells still provide important controls: they are a gold standard against which the "stemness" of other cells is measured.
Some experts believe it's wise to continue the study of all stem cell types, since we're not sure yet which one will be the most useful for cell replacement therapies.
An additional ethical consideration is that iPS cells have the potential to develop into a human embryo, in effect producing a clone of the donor. Many nations are already prepared for this, having legislation in place that bans human cloning.
Stem Cell Research Legislation
Regulations and policies change frequently to keep up with the pace of research, as well as to reflect the views of different political parties. Here President Obama signs an executive order on stem cells, reversing some limits on federal research funding. (White House photo by Chuck Kennedy)
Governments around the globe have passed legislation to regulate stem cell research. In the United States, laws prohibit the creation of embryos for research purposes. Scientists instead receive "leftover" embryos from fertility clinics with consent from donors. Most people agree that these guidelines are appropriate.
Disagreements surface, however, when political parties debate about how to fund stem cell research. The federal government allocates billions of dollars each year to biomedical research. But should taxpayer dollars be used to fund embryo and stem cell research when some believe it to be unethical? Legislators have had the unique challenge of encouraging advances in science and medicine while preserving a respect for life.
U.S. President Bush, for example, limited federal funding to a study of 70 or so hES cell lines back in 2001. While this did slow the destruction of human embryos, many believe the restrictions set back the progress of stem cell research.
President Obama overturned Bush's stem cell policy in 2009 to expand the number of stem cell lines available to researchers. Policy-makers are now grappling with a new question: Should the laws that govern other types of pluripotent stem cells differ from those for hES cells? If so, what new legislation is needed?
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