Navigation Links
Debate over safety of gene therapy trials focuses on issue of informed consent

New Rochelle, NY, January 22, 2008Can a patient who agrees to participate in a safety study of a gene therapy protocol give truly informed consent and understand the risks involved when the consent forms are highly technical and the physician or institution seeking their consent has a stake in the study and its outcome? The continuing debate over informed consent and the acknowledgement of risk and responsibility in gene therapy trials are the focus of a series of probing and provocative commentaries published in the January 2008 issue (Volume 19, Number 1) of Human Gene Therapy, a peer-reviewed journal published by Mary Ann Liebert, Inc. The commentaries are available free online.

In the Editorial, James M. Wilson, MD, PhD, Editor-in-Chief and Head of the Gene Therapy Program, Department of Pathology and Laboratory Medicine, at the University of Pennsylvania School of Medicine, in Philadelphia, calls on the gene therapy, regulatory, and research communities to re-explore the issue of informed consent as it relates to the safety of viral vector-based gene transfer therapies and the appropriateness of having physicians and others with an interest in the trials and their outcomes recruit patients and obtain the necessary informed consent.

I encourage the professional gene therapy societies and various related foundations to work together in the new year to undertake a critical review of the conduct of our clinical behooves us to get ahead of this issue and put in place more effective ways to assure that research subjects who courageously give of themselves can do so with a full and unbiased understanding of the risks and benefits of their participation, writes Dr. Wilson.

This issue of the Journal also includes five stimulating commentaries that discuss the key controversies related to patient recruitment and trial management. They explore the question of whether patients are able to comprehend the lengthy and often highly technical study descriptions and consent forms to the extent needed to make an informed decision about enrolling in a trial. The authors also present suggestions and innovative strategies for improving the recruitment and informed consent process.

Dr. Arthur Caplan, Professor of Bioethics, Chair of the Department of Medical Ethics, and Director of the Center for Bioethics at the University of Pennsylvania, authored a commentary entitled, If It Is Broken Shouldnt it Be Fixed? Informed Consent and Initial Clinical Trials of Gene Therapy. Another, entitled, Case of Leukaemia Associated with X-Linked Severe Combined Immunodeficiency Gene Therapy Trial in London, was prepared by the Board of the European Society of Gene and Cell Therapy, Executive Committee of the Clinigene Network of Excellence, and Executive of the Consort Integrated Project. Dr. Jeffrey Kahn, Director and Professor, Center for Bioethics, at the University of Minnesota Medical School, presents his perspectives in, Informed Consent in Human Gene Transfer Clinical Trials. Also contributing a commentary is Dr. Tomas Jose Silber, Chair of the Institutional Review Board and Director of the Office of Ethics at Childrens National Medical Center, in Washington, D.C. It is entitled, Human Gene Therapy, Consent, and the Realities of Clinical Research: Is It Time for a Research Subject Advocate? Ms. Suzanne Pattee, Vice President of Regulatory and Patient Affairs for the Cystic Fibrosis Foundation authored, Protections for Participants in Gene Therapy Trials: A Patients Perspective.


Contact: Vicki Cohn
Mary Ann Liebert, Inc./Genetic Engineering News

Related medicine news :

1. Health Insurance Industry Contributions to Politicians Block Regulation, Affordability in Health Care Debate, Says FTCR
2. Cincinnati Adoption Agency Invited to Participate in Values Voter Presidential Debate
3. Docs Debate Drugs vs. Surgery for Angina
4. Doctors Debate Drugs vs. Surgery for Angina
5. New study likely to fuel debate over annual physical exams
6. Post-Debate Statement From AARP Spokesperson Drew Nannis
7. Study fuels debate over whether exercise and body size influence ovarian cancer risk
8. Post-Debate Statement from AARP Board Member Joyce Payne
9. Long Term Care Leader Applauds Clinton for Bringing Critical Issue of Senior Care into the Presidential Debate
10. Mayo Clinic Proceedings provides forum for debate about capital punishment
11. Engaging 2008 Debate, Key Long Term Care Advocacy Groups Offer New Plan to Strengthen Nations Long Term and Post-Acute Care Delivery System
Post Your Comments:
(Date:11/27/2015)... , ... November 27, 2015 , ... ... the toilets were," said an inventor from Hillside, N.J. "Many people catch diseases ... cover so that individuals will always be protected from germs." , He developed ...
(Date:11/27/2015)... Aliso Viejo, CA (PRWEB) , ... November 27, 2015 , ... ... exclusively for use in Final Cut Pro X. With ProSidebar: Fasion, video editors ... banners, or use ProSidebar as a minimalist title opener. Utilize presets featuring self-animating ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... well-respected Microsoft Dynamics SL User Group (MSDSLUG). Recognized as Microsoft’s official group for ... of Microsoft Dynamics SL software users, partners, industry experts and representatives. Intellitec Solutions’ ...
(Date:11/27/2015)... ... 27, 2015 , ... Keeping in mind challenges faced by ... wellness consultation, has collaborated with a leading web-based marketplace for extra-curricular activities for ... parents and bring advice from parenting experts within their reach. As a part ...
(Date:11/27/2015)... ... ... Dr. Thomas Dunlap and Dr. Patrick Coleman , cardiologist ... Medicine at St., Joseph Health System’s Santa Rosa Memorial Hospital , co-hosted the ... ways and require time-critical intervention to avoid large area heart damage and progressive infections ...
Breaking Medicine News(10 mins):
(Date:11/29/2015)... , Nov. 29, 2015  At this year,s ... to experience the most complete mobile C-arm portfolio with ... is Ziehm Vision RFD 3D, the world,s only 3D ... edge length per scan volume. In addition, Ziehm Imaging ... motorized mobile C-arm in four axes which is ideally ...
(Date:11/29/2015)... Iowa , Nov. 29, 2015 ... ultrasound guidance technology at the Radiological Society of ... in Chicago November 29 ... system is designed to offer customers unrivaled versatility, ... --> ...
(Date:11/27/2015)... UTRECHT , Pays-Bas, November 27, 2015 /PRNewswire/ ... combiner l,immunothérapie au traitement photodynamique au Bremachlorin contre ... Une nouvelle approche consistant à combiner l,immunothérapie au ...    --> Une nouvelle ... au Bremachlorin contre le cancer avancé.    ...
Breaking Medicine Technology: