NIH Office of Biotechnology Activities (OBA) – This NIH Office monitors scientific progress in human genetics research in order to anticipate future developments, including ethical, legal, and social concerns, in basic and clinical research involving Recombinant DNA and gene transfer. The site links to NIH Guidelines for Research Involving Recombinant DNA Molecules the Genetic Modification Clinical Research Information System (GeMCRIS), the National Science Advisory Board for Bio-security, the Secretary's Advisory Committee on Genetics, Health and Society, and the Secretary's Advisory Committee on Xenotransplantation.
Report and Recommendations of the Panel to Assess the NIH Investment in Research on Gene Therapy (1995) – A report commissioned by the Director, NIH to advise the NIH on research on gene therapy.
Recombinant DNA and Gene Transfer – The NIH Office of Biotechnology Activities links to news, guidelines, database information, documents and frequently asked questions.
NIH Guidance on Informed Consent for Gene Transfer Research (2003) – This site discusses gene transfer experiments and addresses informed consent issues that merit attention. The site links to appended material that focuses on points to consider in design of clinical gene transfer experiments. It also links to FDA and DHHS regulatory requirements and to OHRP
guidance. Bibliographic information can be accessed from this site.
genome.gov | Ethical Boundaries Workshop (2002) – This summary report explores scientific and ethical boundaries of reproductive technologies, germline gene transfer and genetic enhancement. The site links to background papers on each of the main agenda topics.
genome.gov | Germline Gene Transfer (2004) – A brief report that addresses scientific and ethical issues. The majority of trials involve the treatment of cancer, infectious diseases and vascular disease. Human gene transfer raises ethical issues, in particular the potential use of genetic therapies for genetic enhancement and the potential impact of germline gene transfer on future generations.
Genome.gov - Genetic Enhancement (2006) – An Exploration of the scientific and ethical issues involved in the transfer of genetic material intended to modify nonpathological human traits.
GenEthx – A database at the Kennedy Institute of Ethics at Georgetown University on ethics and genetics. Search for “ethics and gene therapy.”
Gene Therapy and Genetic Engineering – This site is maintained by Bryn Williams-Jones from the University of Montreal. It provides links to other sites, literature and case studies.
What next for human gene therapy?.(2003) – An article that addresses the scientific promise, potential for abuse, and ethical issues raised by gene therapy and transfer. The article advocates involvement in shaping social policy for gene therapy.
Limitations of Informed Consent for in Utero Gene Transfer Research: Implications for Investigators and Institutional Review Boards (2000) – Federal guidelines for fetal research rely on minimizing risk and informed consent to protect the "rights and welfare" of both the fetus and pregnant woman This article posits that prenatal gene transfer poses special challenges to informed consent because the dire condition of the fetus may cloud parental comprehension and voluntariness. Therefore, IRBs should place more weight on benefit/harm assessment than on consent to adequately protect the fetus from research risks.
Kennedy Institute of Ethics Journal, Volume 15, 2005 – A special issue of the journal on justice and genetic enhancement. The issue includes three main articles that challenge one or more of the standard arguments against germline genetic enhancement.
Genetic Alteration – A Howard Hughes Medical Institute site that explores the ethical issues related to genetic alteration. The site links to a video and to a bibliography. It includes discussion questions.
HUGO Ethics Committee Statement on Gene Therapy (2001) - This statement from the Human Genome Organization defines gene therapy, summarizes its developing trends, and addresses risks, benefits and ethical safeguards. The statement includes recommendations.
Operational Procedures for the Gene Therapy Advisory Committee in its Role as the National Ethics Committee for Gene Therapy Clinical Trials (2004) - This document gives guidance on the procedures that should be followed in the United Kingdom (UK) when proposals are made to conduct gene therapy research on human subjects. The site links to news and to related policy papers.
Wellcome Trust: The Human Genome – This page includes news related to advances in genetics research and clinical trials. This site summarizes the report of the UK Gene Therapy Advisory Committee. It links to other information and to public comments.
European Society of Gene and Cell Therapy – The site posts the society’s position papers, including one on social, ethical and public awareness issues in gene and cell therapy and another on future strategies for gene and cell therapy. It also lilnks to clinical trials.
