StemCell Therapy

J Diabetes Sci Technol. 2009 Jul; 3(4): 781788.

Published online 2009 Jul.

Institute for Genome Sciences and Policy, Duke University, Durham, North Carolina

With the rising number of individuals affected with diabetes and the significant health care costs of treatment, the emphasis on prevention is key to controlling the health burden of this disease. Several genetic and genomic studies have identified genetic variants associated with increased risk to diabetes. As a result, commercial testing is available to predict an individual's genetic risk. Although the clinical benefits of testing have not yet been demonstrated, it is worth considering some of the ethical implications of testing for this common chronic disease. In this article, I discuss several issues that should be considered during the translation of predictive testing for diabetes, including familial implications, improvement of risk communication, implications for behavioral change and health outcomes, the Genetic Information Nondiscrimination Act, direct-to-consumer testing, and appropriate age of testing.

Keywords: ethics, genetic testing, risk

Type 2 diabetes mellitus (T2DM) is a prevalent, chronic condition associated with extensive morbidity, decreased quality of life, and increased utilization of health services.1 Approximately 23 million people in the United States are affected with diabetes, and more than twice that number are prediabetic.2 The annual risk of developing T2DM for the average person living in the United States with normal glucose levels is approximately 0.7% per year.3

The polygenic nature of T2DM has been a major challenge to identifying genes involved in the pathogenesis of this diseaseknowledge that could give rise to new treatments and tests. However, following the completion of the Human Genome Project and HapMap and the development of high-throughput technologies, scientists are in a much better position to tackle the complex genetic underpinnings of T2DM.4 The rise of genetic and genomic studies has aligned with the increasing incidence rate of T2DM (). A number of commercial tests have already been developed that assay a panel of genetic variants in several genes identified from genome-wide association studies of T2DM. Among the best studied of these are two very closely linked single nucleotide polymorphisms (SNPs) in the transcription factor 7-like 2 (TCF7L2) gene.5 More than 20 studies have replicated the association between these two SNPs in TCF7L2 and increased T2DM risk. The largest pooled analysis reported an overall odds ratio of 1.37 with a single copy of the higher-risk allele at one of the TCF7L2SNPs.6 In comparison, individuals with a positive family history for T2DM are at a 26 times increased risk compared to those without a family history.710

Unlike single-gene testing for Mendelian disorders that produce a relatively certain prediction of disease, genomic testing for complex diseases like T2DM will generate disease riskinformation. Some of the ethical issues of genome risk profiling or predispositional testing overlap with single-gene testing used primarily for diagnosis, although additional issues related to predispositional testing include challenges of communicating risk information (particularly low risks), uncertainty of disease risk and psychosocial impact of at-risk status, and ensuring patient comprehension. Of substantial importance is that individuals are informed about these and other issues when they are deciding if the test is appropriate for them. Although written informed consent may not be warranted, a discussion with a physician or other professional such as a genetic counselor can serve to educate and encourage careful consideration of the benefits and risks of testing as well as alternatives to testing. This article presents an overview of several issues that should be considered as genome risk profiling for T2DM becomes integrated into clinical care.

As with any type of genetic testing, it is important to consider the impact of testing on family members. Predisposition testing for T2DM and other chronic diseases raises familial implications on two levels. The implication of test results for biological family members raises the issue of whether and how to discuss the results with other family members.12 Tested individuals may be reluctant to share the results due to fear it will disrupt relationships, be hesitant of having to contact estranged and distant family members, and feel guilt.1316 Those who opt to share the results with family members may have difficulty accurately communicating the results17,18 or minimize the seriousness of the finding.19 Although a positive test result could be inferred from changes in lifestyle and preventive medical procedures, individuals undergoing testing should ascertain the wishes of other family members prior to discussing their test results.20 Furthermore, as many individuals choose to undergo genetic testing for the sake of their children, they will need to understand when and how best to discuss the results with their children.21,22 Family members who decide to learn of their relative's results must also decide how they'll act upon them (e.g., getting themselves tested), if at all.

Second, given that environment can substantially influence risk for T2DM and other complex diseases, a positive result of one individual can affect the lifestyle of the entire family. For example, adoption of healthy eating habits may be better achieved if the entire family is involved in promoting healthy living.2326 Special treatment of a child found to be at increased genetic risk may lead to feelings of ostracism, stigmatization, and inferiority.

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Personalized Medicine for Diabetes: Ethical Issues of ...

Genetic Testing: Ethical, Legal, and Religious Issues - Topic Overview

Genetic Testing: Ethical, Legal, and Religious Issues Guide

The decision to have genetic tests may involve consideration of ethical, legal, and religious issues.

If you are thinking about having genetic tests, be sure that you clearly understand the implications of all possible test results before you make your decision about testing. Genetic counseling can help you explore the implications of possible test results.

This information is produced and provided by the National Cancer Institute (NCI). The information in this topic may have changed since it was written. For the most current information, contact the National Cancer Institute via the Internet web site at http:// cancer .gov or call 1-800-4-CANCER.

WebMD Medical Reference from Healthwise

Last Updated: March 12, 2014

This information is not intended to replace the advice of a doctor. Healthwise disclaims any liability for the decisions you make based on this information.

1995-2014 Healthwise, Incorporated. Healthwise, Healthwise for every health decision, and the Healthwise logo are trademarks of Healthwise, Incorporated.

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Issues in Genetics and Health

Genomics is the study of an organism's whole hereditary information that is present in its genes (DNA) and the use of its genes. It deals with the use of genome information associated with other information to provide answers in biology and medicine.

Genomic research may greatly change the practice of health care. But genomic research alone is not enough to apply this new knowledge to improving human health. We need to carefully study the many ethical, legal and social issues raised by this research. Such study is crucial to being able to use genomic research to help patients and to preventing misuse of new genetic technologies and information.

Ethical, legal and social issues raised by genomic research include:

Controversial issues such as cloning, stem cell research and eugenics also need to be carefully studied.

Since the beginning of the Human Genome Project, the National Human Genome Research Institute (NHGRI) has understood the need to address these issues as part of advancing the science of genomic research. We have an Ethical, Legal and Social Implications (ELSI) program, which is the federal government's largest funding source for study of these issues. Within NHGRI, the Division of Policy, Communications, and Education (DPCE) examines the intersection of ELSI issues with legislative policy and provides recommendations for federal policy and legislation. NHGRI also works to increase public awareness of ELSI issues in genomic research.

To learn more about ethics and policy topics and other resources for more information, follow these links to the Policy and Ethics section of this website.

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Last Updated: October 31, 2013

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Issues in Genetics, Genomics and Health

Medical genetics is the specialty of medicine that involves the diagnosis and management of hereditary disorders. Medical genetics differs from human genetics in that human genetics is a field of scientific research that may or may not apply to medicine, but medical genetics refers to the application of genetics to medical care. For example, research on the causes and inheritance of genetic disorders would be considered within both human genetics and medical genetics, while the diagnosis, management, and counseling of individuals with genetic disorders would be considered part of medical genetics.

In contrast, the study of typically non-medical phenotypes such as the genetics of eye color would be considered part of human genetics, but not necessarily relevant to medical genetics (except in situations such as albinism). Genetic medicine is a newer term for medical genetics and incorporates areas such as gene therapy, personalized medicine, and the rapidly emerging new medical specialty, predictive medicine.

Medical genetics encompasses many different areas, including clinical practice of physicians, genetic counselors, and nutritionists, clinical diagnostic laboratory activities, and research into the causes and inheritance of genetic disorders. Examples of conditions that fall within the scope of medical genetics include birth defects and dysmorphology, mental retardation, autism, and mitochondrial disorders, skeletal dysplasia, connective tissue disorders, cancer genetics, teratogens, and prenatal diagnosis. Medical genetics is increasingly becoming relevant to many common diseases. Overlaps with other medical specialties are beginning to emerge, as recent advances in genetics are revealing etiologies for neurologic, endocrine, cardiovascular, pulmonary, ophthalmologic, renal, psychiatric, and dermatologic conditions.

In some ways, many of the individual fields within medical genetics are hybrids between clinical care and research. This is due in part to recent advances in science and technology (for example, see the Human genome project) that have enabled an unprecedented understanding of genetic disorders.

Clinical genetics is the practice of clinical medicine with particular attention to hereditary disorders. Referrals are made to genetics clinics for a variety of reasons, including birth defects, developmental delay, autism, epilepsy, short stature, and many others. Examples of genetic syndromes that are commonly seen in the genetics clinic include chromosomal rearrangements, Down syndrome, DiGeorge syndrome (22q11.2 Deletion Syndrome), Fragile X syndrome, Marfan syndrome, Neurofibromatosis, Turner syndrome, and Williams syndrome.

Physicians who practice clinical genetics are accredited by the American Board of Medical Genetics and Genomics (ABMGG). [1] In order to become a board-certified practitioner of Clinical Genetics, a physician must complete a minimum of 24 months of training in a program accredited by the ABMGG. Individuals seeking acceptance into clinical genetics training programs must hold an M.D. or D.O. degree (or their equivalent) and have completed a minimum of 24 months of training in an ACGME-accredited residency program in internal medicine, pediatrics, obstetrics and gynecology, or other medical specialty. [2]

Metabolic (or biochemical) genetics involves the diagnosis and management of inborn errors of metabolism in which patients have enzymatic deficiencies that perturb biochemical pathways involved in metabolism of carbohydrates, amino acids, and lipids. Examples of metabolic disorders include galactosemia, glycogen storage disease, lysosomal storage disorders, metabolic acidosis, peroxisomal disorders, phenylketonuria, and urea cycle disorders.

Cytogenetics is the study of chromosomes and chromosome abnormalities. While cytogenetics historically relied on microscopy to analyze chromosomes, new molecular technologies such as array comparative genomic hybridization are now becoming widely used. Examples of chromosome abnormalities include aneuploidy, chromosomal rearrangements, and genomic deletion/duplication disorders.

Molecular genetics involves the discovery of and laboratory testing for DNA mutations that underlie many single gene disorders. Examples of single gene disorders include achondroplasia, cystic fibrosis, Duchenne muscular dystrophy, hereditary breast cancer (BRCA1/2), Huntington disease, Marfan syndrome, Noonan syndrome, and Rett syndrome. Molecular tests are also used in the diagnosis of syndromes involving epigenetic abnormalities, such as Angelman syndrome, Beckwith-Wiedemann syndrome, Prader-willi syndrome, and uniparental disomy.

Mitochondrial genetics concerns the diagnosis and management of mitochondrial disorders, which have a molecular basis but often result in biochemical abnormalities due to deficient energy production.

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Medical genetics - Wikipedia, the free encyclopedia

Feature Learn more about human subjects research

The use of human subjects in the field of genomics raises a number of key policy considerations that are being addressed at NHGRI and elsewhere. Learn more about his important topic with a new fact sheet from the Policy and Program Analysis Branch. Read more

Informed consent is the basic and primary tool through which investigators communicate with each potential study participant and is vital to ensuring that the research purpose, any risks and possible benefits, or other implications of participation are understood. NHGRI's online Informed Consent Resource has helped thousands of researchers navigate the informed consent process since 2009. Now, the ICR has been updated to keep pace with advances in genomics over the past several years. Read more

NIH has issued a position statement on the use of public or private cloud systems for storing and analyzing controlled-access genomic data under the NIH Genomic Data Sharing (GDS) Policy. Read the Position Statement

The U.S. Food and Drug Administration (FDA) today announced steps it will take to ensure that certain tests used by health care professionals to diagnose and treat patients provide accurate, consistent and reliable results to inform patient care. These steps come at a critical time for genomic, or precision, medicine. As more and more genetic tests are developed and marketed, the public must be able to rely on the accuracy and clinical validity of these tests. Read the FDA Release Read a statement from NIH Director Francis Collins

Last Updated: May 8, 2015

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Law and Contemporary Problems: All Issues - Duke University

The Ethical, Legal, and Social Implications (ELSI) program was founded in 1990 as an integral part of the Human Genome Project. The mission of the ELSI program was to identify and address issues raised by genomic research that would affect individuals, families, and society. A percentage of the Human Genome Project budget at the National Institutes of Health and the U.S. Department of Energy was devoted to ELSI research.

The ELSI program focused on the possible consequences of genomic research in four main areas:

Privacy and fairness in the use of genetic information, including the potential for genetic discrimination in employment and insurance.

The integration of new genetic technologies, such as genetic testing, into the practice of clinical medicine.

Ethical issues surrounding the design and conduct of genetic research with people, including the process of informed consent.

The education of healthcare professionals, policy makers, students, and the public about genetics and the complex issues that result from genomic research.

Information about the ELSI program at the National Institutes of Health, including program goals and activities, is available in the fact sheet Ethical, Legal and Social Implications (ELSI) Research Program from the National Human Genome Research Institute. The ELSI Planning and Evaluation History web page provides a more detailed discussion of the program.

More discussion about ethical issues in human genetics, including genetic discrimination, the cloning of organisms, and the patenting of genes is available from the Centre for Genetics Education.

The World Health Organization provides further discussion of the ELSI implications of human genomic research.

Next: Genomic Research

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Human Genome Project - Genetics Home Reference

Genetic Discrimination

Many Americans fear that participating in research or undergoing genetic testing will lead to them being discriminated against based on their genetics. Such fears may dissuade patients from volunteering to participate in the research necessary for the development of new tests, therapies and cures, or refusing genomics-based clinical tests. To address this, in 2008 the Genetic Information Nondiscrimination Act was passed into law, prohibiting discrimination in the workplace and by health insurance issuers. In addition, there are other legal protections against genetic discrimination by employers, issuers of health insurance, and others.

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GINA protects Americans from discrimination based on their genetic information in both health insurance (Title I) and employment (Title II). Title I amends the Employee Retirement Income Security Act of 1974 (ERISA), the Public Health Service Act (PHSA), and the Internal Revenue Code (IRC), through the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as the Social Security Act, to prohibit health insurers from engaging in genetic discrimination.

GINA prohibits issuers of health insurance from discrimination on the basis of the genetic information of enrollees. Specifically, health insurance issuers may not use genetic information to make eligibility, coverage, underwriting or premium-setting decisions. Furthermore, issuers may not request or require individuals or their family members to undergo genetic testing or to provide genetic information. As defined in the law, genetic information includes family medical history and information regarding individuals' and family members' genetic tests.

The regulations governing implementation of GINA in health insurance[hhs.gov]took effect on December 7, 2009 and are implemented by the Internal Revenue Service, Department of Labor, and Department of Health and Human Services. GINA amends HIPAA to clarify that genetic information is health information and provides a finalized rule [hhs.gov] that went into effect March 26, 2013.

GINA prevents employers from using genetic information in employment decisions such as hiring, firing, promotions, pay, and job assignments. Furthermore, GINA prohibits employers or other covered entities (employment agencies, labor organizations, joint labor-management training programs, and apprenticeship programs) from requiring or requesting genetic information and/or genetic tests as a condition of employment. Theregulations [gpo.gov] governing implementation of GINA in employment took effect on January 10, 2011 and are implemented by the Equal Employment Opportunity Commission (EEOC).

GINA has implications for individuals participating in research studies. The Office of Human Research Protections (OHRP) within the Department of Health and Human Services has issuedguidance on integrating GINA into clinical research, including information on GINA's research exemption, considerations for Institutional Review Boards, and integrating information on GINA into informed consents.

Informed Consent Forms To comply with GINA, informed consent forms should include information on any risks associated with participation in the research project and a statement describing how the confidentiality of records will be maintained. NHGRI has developed guidance for informed consent forms for participants in genomics research.

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Genetic Discrimination - Genome.gov

The proposed new platform for the Republican Party of Iowa touches on abortion, agriculture, budgeting, business, criminal justice, education, elections, energy, environment, family values, foreign policy, government, gun rights, health care, homeland security, human services, immigration, marriage, religious freedom, the Republican Party, right to work, taxation and transportation.

Iowa Gov. Terry Branstad said most people dont read the platform, which is controlled by the most ardent activists. The candidates stances are more important, he said.

At the end of the day, the platform is a grassroots a document as developed by the delegates, Branstad told the Des Moines Register Tuesday. But whats more important, in my mind, is the candidates that really articulate their stand on the issues. Thats really the important thing and thats what goes to the voters. Most people dont read the party platforms and you can take either party platform and you find that parties tend to be controlled by the more ardent left or right and that doesnt really reflect where the candidates are going to come down.

Heres the proposed 2012 platform, which delegates will vote on Saturday during the state convention in downtown Des Moines:

Preamble: We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable rights, that among these are life, liberty, and the pursuit of happiness. That to secure these rights, governments are instituted among men, deriving their just powers from the consent of the governed. That whenever any form of government becomes destructive of these ends, it is the right of the people to alter or to abolish it, and to institute new government, laying its foundation on such principles and organizing its powers in such form, as to them shall seem most likely to effect their safety and happiness.

As Republicans, we seek a world of liberty; a world in which all individuals are sovereign over their own lives and are never deprived of property or forced to sacrifice ones values for the benefit of others. We believe that respect for individual rights is the essential precondition for a free and prosperous world, and that only through freedom can peace and prosperity be realized. Consequently, we defend each persons right to engage in any activity that is peaceful and honest, and welcome the diversity that freedom brings. We defend the right of each individual to be free and to follow their own dreams in their own ways, unless the exercise of their freedoms infringes upon the valid rights of others.

In the following pages we have set forth our basic principles and enumerated various policies derived from those principles. Let it be clear that these specific policies are not our end goal. Our goal is nothing more nor less than a world set free, and it is to this end that we stand together.

Where two planks might seem to be contradictory, the platform should be interpreted as favoring the goal of the plan providing the least government while protecting basic rights and responsibilities of individuals. Some planks may appear redundant or in conflict, but upon closer evaluation you should see that sufficient nuance exists to include each plank. Any redundancy from one section of this Platform to another was deliberately adopted for emphasis and because government actions often impact more than one area of life. All planks should be read and understood in the context of related issues, events, and circumstances.

Other planks are supported as possible steps toward the goal of limited, responsible, Constitutional, Republican Government. It has taken many years to move away from Constitutional Government and it is unlikely that we will be able to return to the vision of our illustrious Founding Fathers overnight.

A Right to Life 1.1 We believe in the sacred gift of life from conception to natural death. On day one a babys genetic code and DNA are formed. That is the beginning of life. We affirm that the unborn child is a living human being, with rights separate from those of its mother regardless of gestational age or dependency. 1.2 We oppose infanticide, euthanasia, and assisted suicide. 1.3 We advocate the appointment of judges who respect the sanctity of life and who understand their limited role in government. 1.4 We disagree with Roe vs. Wade and Doe vs. Bolton as settled law. Under the Tenth amendment, these Supreme Court decisions have no authority over the states. 1.5 We support a personhood amendment to the US Constitution that states, Personhood and life begins at Conception and that no person shall be deprived of life, liberty, and property, according to the 14th amendment with-out due Process of Law and shall hold all officials accountable to enforce it. 1.6 We oppose the use of public revenues for abortion, and call for elimination of government funding for all organizations, such as Planned Parenthood, which advocate or support abortion. 1.7 We support a ban of RU-486 (morning after pill) and all abortion-inducing drugs. 1.8 We support legislation requiring a parent or legal guardians consent before an abortion or any reproductive surgery is performed on a minor child. 1.9 We believe in conscience-clause legislation so that no physician, pharmacist, or other health care provider can be penalized for refusing to prescribe, dispense, or participate in the procurement of abortion or anything contrary to the conscience of the health care provider. 1.10 We support an Iowa Womans Right to Know Law requiring informed consent including a three day waiting period with a mandatory ultrasound before any elective abortion services may be provided. Informed Consent means that abortionists must offer to the pregnant woman, prior to the abortion, complete factual information about the complications of abortion, the biological development of the unborn, fetal pain, and the availability of alternatives to abortion. 1.11 We call for confidential statistical reporting of abortion procedures to the State Health Department by all doctors and health facilities performing abortions. 1.12 Facilities performing abortions should be subject to the same health and safety standards as hospitals. 1.13 We call for the end of tele-med abortions. 1.14 We support legislation that would prohibit organizations, such as Planned Parenthood, from entering public school facilities for the purpose of promoting abortion. 1.15 We call for banning partial birth abortions. 1.16 We support agencies that do not refer for or perform abortions and encourage Positive Alternatives, for pregnancy counseling. We support adoption and aid to unwed mothers during pregnancy. All funding must come from the private sector. 1.17 We support the use of non-embryonic stem cells to advance modern medical research. We oppose somatic cell nuclear transfer (human cloning), embryonic stem cell research, human fetal-tissue research from induced abortions, and the commercial use or sale of fetal parts. 1.18 We oppose the selling, brokering, or marketing of fetal and aborted tissue. We oppose the use of aborted fetal tissue in vaccines. This should be illegal.

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Iowa governor downplays GOP party platform; here's the whole document

Ethical, Clinical and Commercial Issues to be Navigated before Full Potential of Stem Cell Therapies can be Unleashed

LONDON, June 13, 2012 /PRNewswire-Asia/ -- Stem cells offer exciting potential in regenerative medicine, and are likely to be widely used by mid-2017. Pharmaceutical, biotech and medical device companies are showing increased interest in stem cell research.

New analysis from Frost & Sullivan (http://www.pharma.frost.com), Analysis of the Stem Cell Markets-Unlocking the New Era in Therapeutics, finds that the market will be driven by stem cell applications in drug discovery platforms and by successful academia commercial company partnership models.

"The high attrition rates of potential drug candidates has piqued the interest of pharmaceutical and biotech industries in stem cell use during the drug discovery phase," notes Frost & Sullivan Consulting Analyst Vinod Jyothikumar. "Previously, animal cell lines, tumours, or genetic transformation have been the traditional platform for testing drug candidates; however, these 'abnormal' cells have significantly contributed to a lack of translation into clinical studies."

Many academic institutes and research centres are collaborating with biotechnology and pharmaceutical companies in stem cell research. This will provide impetus to the emergence of novel cell-based therapies.

Key challenges to market development relate to reimbursement, ethics and the complexity of clinical trials.

Securing reimbursement for stem cell therapeutic products is expected to be critical for commercial success. However, stem cell therapies are likely to be expensive. Insurers, therefore, may be unwilling to pay for the treatment. At the same time, patients are unlikely to be able to afford these treatments.

"The use of embryonic stem cells raises a host of thorny ethical, legal, and social issues," adds Jyothikumar. "As a result, market prices for various products may be affected."

Moreover, many research institutes are adopting policies promoting the ethical use of human embryonic tissues. Such policies are hindering the overall research process for several companies working in collaboration with these institutes.

"In addition to apprehensions about how many products will actually make it through human-based clinical trials, companies are also worried about which financial model can be applied to stem cell therapies," cautions Jyothikumar. "Possibly low return on investment (ROI) is also resulting in pharmaceutical companies adopting a cautious approach to stem cell therapeutics."

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New Applications in Drug Discovery Platforms to Fuel Advance of Stem Cells, Says Frost & Sullivan

(Reuters) - A U.S. appeals court on Friday reinstated a lawsuit that challenges an Obama administration policy for federal funding of some human embryonic stem cell research.

The unusual suit against the National Institutes of Health, backed by some Christian groups opposed to embryo research, argued that the NIH policy takes funds from researchers seeking to work with adult stem cells.

It also argues that new Obama administration guidelines on stem cell research are illegal.

The three-judge federal appeals panel did not rule on the merits of the lawsuit itself, but said two of the doctors involved had legal standing to file it.

A federal district court had earlier rejected the lawsuit, saying the challengers had no standing.

Stem cells are the body's master cells. There are several kinds, including those taken from days-old human embryos, which can give rise to all the cells and tissues in the body.

Some people oppose working with human embryonic stem cells, but President Barack Obama's administration reversed a policy that severely limited federal funding of such work.

The NIH will now pay for research using the cells, although it will not pay for the actual process of making the cells, which does involve human embryos. The use of federal funds to pay for the destruction of human embryos is forbidden by law.

The NIH also funds work with so-called adult stem cells, immature cells found throughout the body.

Dr. James Sherley, a biological engineer at Boston Biomedical Research Institute who opposes the use of embryonic stem cells, had argued that the guidelines violated the law by permitting research on stem cells derived from human embryos and would harm their work by increasing competition for limited federal funding.

Sherley and Theresa Deisher of Washington-based AVM Biotechnology were joined in their challenge by the Christian Medical Association, which opposes federal funding of embryonic stem cell research, and an adoption agency called Nightlight Christian Adoptions, which had argued that the guidelines reduced the number of embryos available for use in adoption.