Human Specimens and Data in Research: Ethical, Legal, and Policy Issues -
The NIH Office of Clinical Research Policy Analysis and Coordination (CRPac) is working to promote consistent policies across the NIH for NIH funded research with human specimens and data; and across the DHSS, through an inter-agency taskforce. This site includes links to laws and policies promulgated by DHHS, the FDA, the NIH and the OHRP related to research with human tissue/specimens and related data.
Guidance for Research Involving Coded Private Information or Biological Specimens (8/2004) - The OHRP Guidance addresses whether research with coded specimens is defined as research with human subjects.
Research on Human Specimens: Are You Conducting Research Using Human Subjects? -- Brochure from the National Cancer Institute.
Frequently Asked Questions about Research Using Human Specimens, Cell Lines or Data - A series of questions and answers that addresses whether research with specimens falls under the definition of human subjects research. Site offers examples of situations in which such research is considered to involve human subjects and when it does not (under NIH rules)
Research on Human Specimens- An online user-friendly brochure to help investigators understand how human subjects regulations (45CFR46) apply to their research.
Legal and Ethical Challenges for Human Specimen Repositories (2006) - Presents NIH CRPaC approach to harmonize differing policies and to develop policies for research with specimens.
CR Directory - Human Tissue and Organ Resource Cooperative Agreement - Supports a procurement network developed by the National Disease Research Interchange (NDRI), a nonprofit organization that procures and distributes normal and diseased human tissues for laboratory research studies to investigators in academia, government, and industry.
Procurement and Use of Human Biological Materials for Research - Information sheet posted by the NIH Office of Human Subjects Research. Includes recommendations of the Tissue Research Committee concerning authorization and tracking of tissue use at NIH (for NIH intramural investigators and NIH IRBs).
Summary of Federal Provisions Pertaining to the Use of Human Fetal Tissue - Federal policy (2000) in addition to Federal Regulations governing fetal tissue use by NIH investigators.
Approval Process for the Use of Human Pluripotent Stem Cells in NIH-Supported Research (2001) - NIH procedures for the approval of the use of human pluripotent stem cells in NIH-supported
research. The NIH published the National Institutes of Health Guidelines for Research Using Human Pluripotent Stem Cells in the Federal Register on August 25, 2000 http://stemcells.nih.gov/news/newsArchives/fr25au00-136.asp and http://stemcells.nih.gov/news/newsArchives/fr21no00-104.asp.
Body of Research - Ownership and Use of Human Tissue (2006) - A NEJM article by Alta Charo explores ownership of tissue and treating it as property.
Human Tissue Samples and Ethics: Attitudes of the General public in Sweden to Biobank Research (2006) - Tore Nilsten of Lund University queried members of the Swedish public about attitudes toward use of tissue. The results are analyzed in relation to ethical principles. The article links to related publications.
Ownership and Use of Tissue Specimens for Research – 2004 JAMA article by R. Hakimian and D. Korn notes increased demand for human tissue. In the past, ownership has been undefined and use of tissue relatively unregulated. Recent examination of these issues by a US federal court resulted in a ruling that individuals do not retain rights of ownership or control of biological materials contributed for research, regardless of whether commercial benefit accrues. This article examines the legal, regulatory, and ethical framework within which human tissue research is currently conducted.
Ethical and legal issues in research involving human subjects: Do you want a piece of me? (2006) - Marshall Kapp writes about the handling of human tissue specimens that may be used for present, or stored for future, research purposes. This article examines the ethical and legal ramifications of obtaining and storing tissue samples for research purposes, with special attention to the issues of informed consent and confidentiality.
Report and recommendations of the panel to assess the NIH investment in research on gene therapy - A 1995 NIH report prepared at the request of the.NIH Director.
Research Involving Human Biological Materials: Ethical Issues and Policy Guidance- Volume I: Report and Recommendations of the National Bioethics Advisory Commission.
National Heart, Lung and Blood Institute Human Tissue Repository Guidelines (April 14, 2000) - Deals with operation and implementation principles such as use of tissue (limited research versus unlimited research uses), consent guidelines, tissue coding and oversight by IRB).
The Use of Human Biological Specimens for Research: A Comparison of the Laws in the United States and Europe - The product of a US, NCI and European Working Group that looked at advances in sciences, new uses for tissues, and the legal and ethical issues they incur. Different laws are compared and the need for collaboration and harmonization is acknowledged.
Ethical Aspects of Human Tissue Banking- Opinion of the European Group on Ethics in Science and New Technologies to the European Commission (July 1998). An overview of ethical issues.
Policy and Guidance on the Use of Human Tissue, Medical Research Council, UK
Guidance on the Use of Human Tissue for Future Unspecified Research Purposes (2005) - A discussion document prepared for the New Zealand Ministry of Health. This document provides background to the issue, and explores the kinds of developments in research that are creating the need for tissue collections without a specific research purpose. The document also reviews the current regulatory framework in New Zealand with respect to informed consent for the donation and use of human tissue, outlines some of the current international thinking on the issue, and discusses the ethical issues associated with this type of tissue use.
Proposed guidelines have been developed to inform researchers of New Zealand’s approach to the use of human tissue for future unspecified research purposes, and to ensure consistency in the way these types of research applications are considered by health and disability ethics committees.
The response to the document by the Royal Society of NZ.
Use of Human Tissue in Research and Teaching - Policies from University of Monash, Australia and ethical guidelines. The Australian Government National Statement on Ethics of Research Involving Humans Part 15 – Use of Tissue focuses on ethical conduct for such research.
Association of Medical Research Charities, UK on Use of Human Tissue in Research (2006) - The site includes a postion statement and references to ethical guidance as well as regulatory and legal documents.
Human Tissue: Ethical Legal Issues (1995) - Report of a working group set up to examine the ethical and associated legal questions raised by the medical and scientific uses of human tissue. It considers ethical uses of tissue, appropriate safeguards for donors, commercialization of tissue and ways to ensure safety of human tissue used for medical purposes.
Human Tissue Banking White Paper (2007) – This paper was developed by the PRIM&R Human Tissue/Specimen Banking Working Group and Partners HealthCare Systems Inc. with support from NIH Clinical Research Policy Analysis and Coordination Program and the NCI Cancer Diagnosis Program. The purpose of the Working Group was to identify current barriers to the collection, storage, distribution, and use of human specimens and data in research and strategies for overcoming those barriers while protecting subjects. The Working Group reflected the full range of stakeholders involved in specimen banking (IRB members, lawyers, ethicists, researchers, repository managers, patient advocates, and representatives from industry, academia and government. The White Paper is organized into two parts. The first includes a discussion of the challenges and recommendations to the Federal regulatory and funding agencies. The second part provides tools for IRBs, repository managers and researchers. The link is to the first part of the report. You also can download the Toolkit excerpt.