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Articles 331 - 360 of 383

Full-Text Articles in Bioethics and Medical Ethics

Fast Cbt For Pediatric Ocd: A Multiple-Baseline Controlled Pilot Trial Of Parent Training In Exposure And Response Prevention Delivered, Lara J Farrell, Natalja A Nabinger De Diaz, Sharna Mathieu, Matthew L Mckenzie, Taka Miyamoto, Caroline L Donovan, Allison M Waters, Sonja March, Nicole Bothma, Rianca Kroon, Gabrielle Simcock, Robert S Ware, Robert R Selles, Eric A Storch, Thomas Ollendick Jan 2022

Fast Cbt For Pediatric Ocd: A Multiple-Baseline Controlled Pilot Trial Of Parent Training In Exposure And Response Prevention Delivered, Lara J Farrell, Natalja A Nabinger De Diaz, Sharna Mathieu, Matthew L Mckenzie, Taka Miyamoto, Caroline L Donovan, Allison M Waters, Sonja March, Nicole Bothma, Rianca Kroon, Gabrielle Simcock, Robert S Ware, Robert R Selles, Eric A Storch, Thomas Ollendick

Center for Medical Ethics and Health Policy Staff Publications

Objective: The current study utilized a single case series, non-concurrent multiple baseline design to examine the efficacy of training parents via telehealth videoconferencing in exposure and response prevention (ERP) for home delivery of the treatment for their children and adolescents with obsessive compulsive disorder (OCD).

Method: There were nine participants aged 8 to 14 years who had received a primary diagnosis of OCD. The design involved a series of AB replications, whereby following pre-treatment assessments participants were randomly assigned to either a 2-week (n = 4) or 3-week (n = 5) baseline condition with weekly monitoring of their …


A Mixed-Methods Protocol To Develop And Validate A Stewardship Maturity Matrix For Human Genomic Data In The Cloud, Vasiliki Rahimzadeh, Ge Peng, Mildred Cho Jan 2022

A Mixed-Methods Protocol To Develop And Validate A Stewardship Maturity Matrix For Human Genomic Data In The Cloud, Vasiliki Rahimzadeh, Ge Peng, Mildred Cho

Center for Medical Ethics and Health Policy Staff Publications

This article describes a mixed-methods protocol to develop and test the implementation of a stewardship maturity matrix (SMM) for repositories which govern access to human genomic data in the cloud. It is anticipated that the cloud will host most human genomic and related health datasets generated as part of publicly funded research in the coming years. However, repository managers lack practical tools for identifying what stewardship outcomes matter most to key stakeholders as well as how to track progress on their stewardship goals over time. In this article we describe a protocol that combines Delphi survey methods with SMM modeling …


The Ratio Method: Addressing Complex Tort Liability In The Fourth Industrial Revolution, Harrison C. Margolin, Grant H. Frazier Oct 2021

The Ratio Method: Addressing Complex Tort Liability In The Fourth Industrial Revolution, Harrison C. Margolin, Grant H. Frazier

St. Mary's Law Journal

Emerging technologies of the Fourth Industrial Revolution show fundamental promise for improving productivity and quality of life, though their misuse may also cause significant social disruption. For example, while artificial intelligence will be used to accelerate society’s processes, it may also displace millions of workers and arm cybercriminals with increasingly powerful hacking capabilities. Similarly, human gene editing shows promise for curing numerous diseases, but also raises significant concerns about adverse health consequences related to the corruption of human and pathogenic genomes.

In most instances, only specialists understand the growing intricacies of these novel technologies. As the complexity and speed of …


Decreasing Unintentional Pregnancies For Tennesseans, Paula M. Todd Oct 2021

Decreasing Unintentional Pregnancies For Tennesseans, Paula M. Todd

Electronic Theses and Dissertations

In 2018, 49% of all pregnancies in the United States were unintended, with women with a lower- income status being five times more likely to experience an unplanned pregnancy. Tennessee has a high rate of unintended pregnancies, particularly among the uninsured, low-income, and rural teen populations; some 22% of these unintended pregnancies end in abortion. Oral or transdermal contraceptives that are affordable and accessible for women of childbearing age can reduce unintentional pregnancies. The addressed gap in clinical practice was that contraceptives are not currently available over the counter in Tennessee pharmacies without a prescription, which necessitates a costly medical …


Black And White Health Disparities: Racial Bias In American Healthcare, Yasmeen Almomani Jul 2021

Black And White Health Disparities: Racial Bias In American Healthcare, Yasmeen Almomani

Bridges: An Undergraduate Journal of Contemporary Connections

This paper explores the historical implications of race in American society that have led to implicit racism in the healthcare system. Racial bias in healthcare against Black people is a factor in the health disparities between Black and white people in America, such as the gap in life expectancy, infant death, and maternal mortality. Black people are more likely to report racial discrimination from healthcare providers, which is a reason for the decreased quality of care received. The past justifications of slavery, the Tuskegee syphilis study, and the medical experimentations on Black women are horrifying but were considered acceptable in …


Full Issue: The International Undergraduate Journal Of Health Sciences, Volume 1, Issue 1, June 2021, Iujhs Full Issue Jun 2021

Full Issue: The International Undergraduate Journal Of Health Sciences, Volume 1, Issue 1, June 2021, Iujhs Full Issue

International Undergraduate Journal of Health Sciences

The full June 2021 issue (Volume 1, Issue 1) of the International Undergraduate Journal of Health Sciences


Corruption In Capsules: How It Is Legal For Companies To Put Harmful Ingredients In Vitamins And Dietary Supplements, Emily Leggiero Apr 2021

Corruption In Capsules: How It Is Legal For Companies To Put Harmful Ingredients In Vitamins And Dietary Supplements, Emily Leggiero

English Department: Research for Change - Wicked Problems in Our World

The vitamin and supplement industry has increased exponentially in profits as well as potential products on the market since the turn of the century. However, these products are not regulated, nor do they undergo any premarket clinical research or testing. Public health is compromised by vitamins and supplements that are available for American consumption that is disproportionately unregulated to their chemically similar counterparts. This wicked problem is facilitated through the combination of historical legislative definitions that has since been distorted for corrupt administrative gain through the allotment of corporate expenditures. Company disbursements are made to the same policymakers that create …


Implementación De Políticas De Prevención Y Control De La Obesidad Infantil En Estados Unidos Y Latinoamérica: Lecciones Para La Investigación Y La Práctica Transfronterizas, Mireya Vilar-Compte, Rafael Perez-Escamilla, Elizabeth Rhodes, Olga L. Sarmiento, Camila Corvalan, Rachel Sturke, Susan Vorkoper Jan 2021

Implementación De Políticas De Prevención Y Control De La Obesidad Infantil En Estados Unidos Y Latinoamérica: Lecciones Para La Investigación Y La Práctica Transfronterizas, Mireya Vilar-Compte, Rafael Perez-Escamilla, Elizabeth Rhodes, Olga L. Sarmiento, Camila Corvalan, Rachel Sturke, Susan Vorkoper

Department of Public Health Scholarship and Creative Works

Aunque se han hecho avances en el desarrollo y aplicación a gran escala de inter-venciones eficaces contra la obesidad infantil, los retos siguen siendo importantes. Nuestro objetivo era comprender las causas del éxito de Estados Unidos y los países latinoamericanos en la implementación de políticas y programas (PYP) contra la obe-sidad e identificar oportunidades de mejora aplicando los principios de la ciencia de la implementación. Seleccionamos tres estudios de comparación de casos: (1) el etique-tado frontal en los envases de alimentos (México y Chile), (2) los programas de calles abiertas y calles para el juego (Colombia y Estados Unidos) y …


Vaccines In Current Culture: The Hpv Vaccine Controversy, Alyssa Johnston Apr 2020

Vaccines In Current Culture: The Hpv Vaccine Controversy, Alyssa Johnston

Senior Honors Theses

The use of vaccinations has drastically decreased mortality and morbidity rates related to infectious disease and has become an intrinsic part of modern health care. However, the fear of risks related to vaccines has been partially responsible for the decisions of many parents to delay or avoid vaccinating their children. The human papilloma virus (HPV) vaccine specifically is one of the most controversial vaccines in current culture due to reports of new onset or exacerbation of autoimmune diseases, infertility, and even death following its administration. This review synthesizes information regarding the relevance and safety of the HPV vaccine, as well …


Eugenics In The 21st Century, Jessica Linn Chin Sep 2019

Eugenics In The 21st Century, Jessica Linn Chin

Dissertations, Theses, and Capstone Projects

Eugenics is the science of enhancing the human population through the management of breeding and hereditary traits. This thesis explores the history of eugenics and shows how eugenic practices continue in the 21st century with advancements in technology and positive eugenic goals that can result in adverse effects on the human body and society. When Sir Francis Galton coined the term eugenics in 1883, he intended to improve British society with the use of positive eugenics. Galton used positive eugenics to encourage people with good mental and physical qualities to produce more children. He avoided negative eugenics, which involved …


Generations Of Fertility: A Bioethical And Evolutionary Analysis, Kat Panos 19 Apr 2019

Generations Of Fertility: A Bioethical And Evolutionary Analysis, Kat Panos 19

Honor Scholar Theses

Influenced by both societal and biological factors, women play a central role in reproducing offspring for future generations. Because females play such an integral role in reproduction, it is often psychologically difficult for women to cope with infertility that can arise due to a variety of factors: ovarian factor infertility, cervical factor infertility, uterine factor infertility, and peritoneal and tubal infertility factors. As a result, technology has evolved to cater to women's infertility in procedures and treatments regarded as assisted reproductive techniques (ARTS), medical regimens than impose bioethical implications. Examples of ART include therapeutic intrauterine insemination (IUI), in-vitro-fertilization (IVF), pre-implantation …


Demystifying The Placebo Effect, Phoebe Friesen Sep 2018

Demystifying The Placebo Effect, Phoebe Friesen

Dissertations, Theses, and Capstone Projects

This dissertation offers a philosophical analysis of the placebo effect. After offering an overview of recent evidence concerning the phenomenon, I consider several prominent accounts of the placebo effect that have been put forward and argue that none of them are able to adequately account for the diverse instantiations of the phenomenon. I then offer a novel account, which suggests that we ought to think of the placebo effect as encompassing three distinct responses: conditioned placebo responses, cognitive placebo responses, and network placebo responses. Next, I consider implications of the placebo effect’s role in complementary and alternative medicine for discussions …


Designer Babies: A Paired Analysis Of The Technological Advances And Ethical Implications Of Genetic Selection, Alexandra Schmerge 18 Apr 2018

Designer Babies: A Paired Analysis Of The Technological Advances And Ethical Implications Of Genetic Selection, Alexandra Schmerge 18

Honor Scholar Theses

No abstract provided.


Biosocial Criminology Versus The Constitution, Karen E. Balter Jan 2018

Biosocial Criminology Versus The Constitution, Karen E. Balter

Regis University Student Publications (comprehensive collection)

The continually emerging field of biosocial criminology provides a basis for productively merging biology with sociological reasonings for criminal behavior. Mainstream research in criminology focuses on environmental factors as the sole reason individuals exhibit antisocial behavior patterns and may ultimately commit crimes. Criminological research has travelled in this direction for decades. The current climate within this community subscribes heavily to the notion that biology has very little to do with why people behave the way they do, and if it did, government control would be the norm. The nature of biocriminology opens a door through which constitutional issues may enter. …


Mlk Book Read 2018 (Research Materials), Holy Cross Libraries Jan 2018

Mlk Book Read 2018 (Research Materials), Holy Cross Libraries

Library Resources for Campus Events

A bibliography of resources available through the Holy Cross Libraries which provide additional information related to the MLK Winter Book Read, based on the best-seller “The Immortal LIfe of Henrietta Lacks” by Rebecca Skoot.


Germ-Line Gene Editing And Congressional Reaction In Context: Learning From Almost 50 Years Of Congressional Reactions To Biomedical Breakthroughs, Russell A. Spivak, J.D., I. Glenn Cohen, J.D., Eli Y. Adashi, M.D., M.S. Jul 2017

Germ-Line Gene Editing And Congressional Reaction In Context: Learning From Almost 50 Years Of Congressional Reactions To Biomedical Breakthroughs, Russell A. Spivak, J.D., I. Glenn Cohen, J.D., Eli Y. Adashi, M.D., M.S.

Journal of Law and Health

On December 18, 2015, President Obama signed into law a policy rider forestalling the therapeutic modification of the human germ line. The rider, motivated by the science’s potential unethical ends, is only the most recent instance in which the legislature cut short the ongoing national conversation on the acceptability of a developing science. This essay offers historical perspective on what bills were proposed and passed surrounding four other then-developing scientific breakthroughs—Recombinant DNA, in vitro fertilization, Cloning, Stem Cells—to better analyze how Congress is, and should, regulate this exciting and promising science.


Gadgets And Grieving: A Chronological Analysis On The Ways In Which Advancements In Medical Technologies Have Altered The Grieving Process, Grace Mcnair Jun 2017

Gadgets And Grieving: A Chronological Analysis On The Ways In Which Advancements In Medical Technologies Have Altered The Grieving Process, Grace Mcnair

Dialogue & Nexus

Since the 1940s, both end-of-life care and advancements in medical technologies have expanded exponentially. This article explores the advancements in medical technologies and how these have altered the way that Western society grieves death. With the capabilities to prolong life, the family, the patient, and the medical team, all grieve the end of life in different ways. This article provides a chronological analysis of palliative care, hospice care, and various medical advancements. These changes in medicine are then paralleled with alterations in the bereavement process. This article explores historical narratives of Western society’s transformation of grief through the lens of …


Ethical Concerns For Assisted Reproductive Technologies, Olga Najera May 2017

Ethical Concerns For Assisted Reproductive Technologies, Olga Najera

Dialogue & Nexus

The development of assisted reproductive technologies has provided new options for infertile couples in their pursuit of parenthood. As a result of the successful implementation of in vitro fertilization (IVF), gestational surrogacy is now an alternative. Other technology, such as genetic enhancement, could potentially become available for human beings soon; however, numerous ethical concerns have been raised by the fact that it requires germline engineering. The concerns brought about by these new reproductive technologies will be addressed in light of the teachings of the Roman Catholic Church and of the following ethical theories: Kantian, evolutionary, utilitarian, and virtue ethics.


Genomic Contraindications For Heart Transplantation., Danton S. Char, Gabriel Lázaro-Muñoz, Aliessa Barnes, David Magnus, Michael J. Deem, John Lantos Apr 2017

Genomic Contraindications For Heart Transplantation., Danton S. Char, Gabriel Lázaro-Muñoz, Aliessa Barnes, David Magnus, Michael J. Deem, John Lantos

Manuscripts, Articles, Book Chapters and Other Papers

Genome sequencing raises new ethical challenges. Decoding the genome produces new forms of diagnostic and prognostic information; however, the information is often difficult to interpret. The connection between most genetic variants and their phenotypic manifestations is not understood. This scenario is particularly true for disorders that are not associated with an autosomal genetic variant. The analytic uncertainty is compounded by moral uncertainty about how, exactly, the results of genomic testing should influence clinical decisions. In this Ethics Rounds, we present a case in which genomic findings seemed to play a role in deciding whether a patient was to be listed …


Newborn Sequencing In Genomic Medicine And Public Health., Jonathan S. Berg, Pankaj B. Agrawal, Donald B. Bailey, Alan H. Beggs, Steven E. Brenner, Amy M. Brower, Julie A. Cakici, Ozge Ceyhan-Birsoy, Kee Chan, Flavia Chen, Robert J. Currier, Dmitry Dukhovny, Robert C. Green, Julie Harris-Wai, Ingrid A. Holm, Brenda Iglesias, Galen Joseph, Stephen F. Kingsmore, Barbara A. Koenig, Pui-Yan Kwok, John Lantos, J Steven Leeder, Megan A. Lewis, Amy L. Mcguire, Laura V. Milko, Sean D. Mooney, Richard B. Parad, Stacey Pereira, Josh E. Petrikin, Bradford C. Powell, Cynthia M. Powell, Jennifer M. Puck, Heidi L. Rehm, Neil Risch, Myra Roche, Joseph T. Shieh, Narayanan Veeraraghavan, Michael S. Watson, Laurel K. Willig, Timothy W. Yu, Tiina Urv, Anastasia L. Wise Feb 2017

Newborn Sequencing In Genomic Medicine And Public Health., Jonathan S. Berg, Pankaj B. Agrawal, Donald B. Bailey, Alan H. Beggs, Steven E. Brenner, Amy M. Brower, Julie A. Cakici, Ozge Ceyhan-Birsoy, Kee Chan, Flavia Chen, Robert J. Currier, Dmitry Dukhovny, Robert C. Green, Julie Harris-Wai, Ingrid A. Holm, Brenda Iglesias, Galen Joseph, Stephen F. Kingsmore, Barbara A. Koenig, Pui-Yan Kwok, John Lantos, J Steven Leeder, Megan A. Lewis, Amy L. Mcguire, Laura V. Milko, Sean D. Mooney, Richard B. Parad, Stacey Pereira, Josh E. Petrikin, Bradford C. Powell, Cynthia M. Powell, Jennifer M. Puck, Heidi L. Rehm, Neil Risch, Myra Roche, Joseph T. Shieh, Narayanan Veeraraghavan, Michael S. Watson, Laurel K. Willig, Timothy W. Yu, Tiina Urv, Anastasia L. Wise

Manuscripts, Articles, Book Chapters and Other Papers

The rapid development of genomic sequencing technologies has decreased the cost of genetic analysis to the extent that it seems plausible that genome-scale sequencing could have widespread availability in pediatric care. Genomic sequencing provides a powerful diagnostic modality for patients who manifest symptoms of monogenic disease and an opportunity to detect health conditions before their development. However, many technical, clinical, ethical, and societal challenges should be addressed before such technology is widely deployed in pediatric practice. This article provides an overview of the Newborn Sequencing in Genomic Medicine and Public Health Consortium, which is investigating the application of genome-scale sequencing …


Surrogate Pregnancy After Prenatal Diagnosis Of Spina Bifida., Lynnette J. Mazur, Mary Kay Kisthardt, Helen H. Kim, Laura M. Rosas, John Lantos Feb 2017

Surrogate Pregnancy After Prenatal Diagnosis Of Spina Bifida., Lynnette J. Mazur, Mary Kay Kisthardt, Helen H. Kim, Laura M. Rosas, John Lantos

Manuscripts, Articles, Book Chapters and Other Papers

Some pregnancies today involve infertile individuals or couples who contract with a fertile woman to carry a pregnancy for them. The woman who carries the pregnancy is referred to as a "gestational carrier." The use of such arrangements is increasing. Most of the time, these arrangements play out as planned; sometimes, however, problems arise. This article discusses a case in which a fetal diagnosis of spina bifida led the infertile couple to request that the gestational carrier terminate the pregnancy, and the gestational carrier did not wish to do so. Experts in the medical and legal issues surrounding surrogacy discuss …


Carotid Ultrasound Is Not Helpful In Simple Syncope, Nicholus Yee M.D., Shilin Patel M.D., Raymond Gong May 2016

Carotid Ultrasound Is Not Helpful In Simple Syncope, Nicholus Yee M.D., Shilin Patel M.D., Raymond Gong

Clinical Research in Practice: The Journal of Team Hippocrates

A critical appraisal and clinical application of Scott JW, Schwartz AL, Gates JD, Gerhard-Herman M, Havens JM. Choosing wisely for syncope: low-value carotid ultrasound use. J Am Heart Assoc. 2014 Aug 13;3(4). pii: e001063. doi: 10.1161/JAHA.114.001063


Choosing An Allograft Or Autograft In Orthopedic Surgeries For Athletes, Cassandra M. Izzo Jan 2016

Choosing An Allograft Or Autograft In Orthopedic Surgeries For Athletes, Cassandra M. Izzo

Honors Theses and Capstones

Athletes and their doctors have the choice of using an allograft or autograft in reconstruction surgeries. The purpose of this study is to see if there is a difference in the healing mechanism and surgical outcome in using an allograft or autograft during orthopedic surgical procedures, as well as to analyze graft rejection and disease transmission through donor tissue.

Doctors and athletic trainers were interviewed in order to learn about the healing mechanisms and advantages and disadvantages of allografts and autografts in order to conclude if one was better than the other. College level athletes on different sports teams were …


Introduction To Bioethics Special Supplement V: Ethical Issues In Genomic Testing Of Children., John D. Lantos Jan 2016

Introduction To Bioethics Special Supplement V: Ethical Issues In Genomic Testing Of Children., John D. Lantos

Manuscripts, Articles, Book Chapters and Other Papers

Next-generation genome sequencing of children is one of the most promising and most challenging new technologies in pediatrics. On the one hand, it offers the hope that we will be able to diagnose rare conditions that were previously impossible to diagnose, which, in turn, might lead to new treatments. On the other hand, the technology for sequencing presents daunting problems of interpretation. It is problematic to conduct the research necessary to characterize the pathogenicity of those variants at the same time that we are using them to guide the clinical care of children who have complex medical problems. It is …


Whole-Genome Sequencing And Disability In The Nicu: Exploring Practical And Ethical Challenges., Michael J. Deem Jan 2016

Whole-Genome Sequencing And Disability In The Nicu: Exploring Practical And Ethical Challenges., Michael J. Deem

Manuscripts, Articles, Book Chapters and Other Papers

Clinical whole-genome sequencing (WGS) promises to deliver faster diagnoses and lead to better management of care in the NICU. However,several disability rights advocates have expressed concern that clinical use of genetic technologies may reinforce and perpetuate stigmatization of and discrimination against disabled persons in medical and social contexts. There is growing need, then, for clinicians and bioethicists to consider how the clinical use of WGS in the newborn period might exacerbate such harms to persons with disabilities. This article explores ways to extend these concerns to clinical WGS in neonatal care. By considering these perspectives during the early phases of …


Compassionate Use Of Experimental Therapies: Who Should Decide?, Patricia J. Zettler Jul 2015

Compassionate Use Of Experimental Therapies: Who Should Decide?, Patricia J. Zettler

Faculty Publications By Year

In addition to being an example of unsubstantiated hype about regenerative medicine, the controversy around the Italy-based Stamina Foundation's unproven stem cell therapy represents another chapter in a continuing debate about how to balance patients' requests for early access to experimental medicines with requirements for demonstrating safety and effectiveness. Compassionate use of the Stamina therapy arguably should not have been permitted under Italy's laws, but public pressure was intense and judges ultimately granted access. One lesson from these events is that expert regulatory agencies may be the institutions most competent to make compassionate use decisions and that policies should include …


The Skinny On Eating Attitudes, Body Image, And The Thin-Ideal In College Women, Lyndsay N. Greene May 2015

The Skinny On Eating Attitudes, Body Image, And The Thin-Ideal In College Women, Lyndsay N. Greene

Undergraduate Theses and Capstone Projects

There is evidence of a link between body image and disordered eating among females, and some research that suggests exposure to the media exacerbates both body dissatisfaction and eating pathology. Despite these claims, little research has been done on the effects that exposure to photo-shopped images specifically has on body dissatisfaction and eating pathology. The present study sought to further understand the relationship between cognitive distortions of body image and eating attitudes and to examine the effects that exposure to the thin-ideal found in the media has on body dissatisfaction among college aged women. Eighty female college students answered questions …


Statins And Kidney Failure, Rebekah Pemberton Apr 2015

Statins And Kidney Failure, Rebekah Pemberton

Senior Honors Theses

Use of the HMG-CoA Reductase Inhibitors, also known as statins, in patients with renal dysfunction is laden with controversy. Studies on statin use in renal patients have given varying reports. Some research has indicated that these medications may exacerbate existing renal dysfunction and induce further progression of renal disease. Furthermore, some researchers have suggested statins may actually cause some cases of renal dysfunction through the effects of rhabdomyolysis, acute interstitial nephritis, or necrotizing immune-mediated myopathy, while other researchers have asserted that the statins can have nephroprotective effects. The use of statins is believed to be ineffective in patients who are …


Nudging The Fda, W. Nicholson Price Ii, I. Glenn Cohen Jan 2014

Nudging The Fda, W. Nicholson Price Ii, I. Glenn Cohen

Law Faculty Scholarship

[Excerpt] "The FDA’s regulation of drugs is frequently the subject of policy debate, with arguments falling into two camps. On the one hand, a libertarian view of patients and the health care system holds high the value of consumer choice. Patients should get all the information and the drugs they want; the FDA should do what it can to enforce some basic standards but should otherwise get out of the way. On the other hand, a paternalist view values the FDA’s role as an expert agency standing between patients and a set of potentially dangerous drugs and potentially unscrupulous or …


Future Oversight Of Recombinant Dna Research: Recommendations Of An Institute Of Medicine Committee, Lawrence O. Gostin, Bruce M. Altevogt, Andrew M. Pope Jan 2014

Future Oversight Of Recombinant Dna Research: Recommendations Of An Institute Of Medicine Committee, Lawrence O. Gostin, Bruce M. Altevogt, Andrew M. Pope

Georgetown Law Faculty Publications and Other Works

The National Institutes of Health (NIH) established the Recombinant DNA Advisory Committee (RAC) in 1974 in response to public concerns about the safety of manipulating genetic material through recombinant DNA. The accumulation of 40 years of experience with gene transfer research has led to a better understanding of the risks. Yet, as gene transfer research has matured, the complexity of the overall regulatory environment has remained. Gene transfer research continues to be subjected to multiple layers of review: the Food and Drug Administration (FDA), institutional review boards, institutional biosafety committees, and the RAC. It is within the context of overlapping …