Biomedical Research Law and Policy Guide
Hyla Bondareff, bondareh at wustl dot edu, Washington University School of Law Library
This guide is written to assist students of Professor Dresser's Biomedical Research Law and Policy Seminar. It is intended to facilitate your retrieval of relevant documents and exploration of new or related topics for your seminar paper. If you cannot find the information you seek, please come see me or another librarian for more assistance.
Because your research in this area will extend beyond the boundaries of traditional legal research resources, you may want to start out looking for secondary source materials. One place to start is the online catalog at http://libcat.wustl.edu or http://catalog.wustl.edu. From the first site you can type in your research topic and retrieve relevant books, electronic resources, journals and other periodicals and websites. It is a one box search which you can then refine buy clicking on any number of limiting facets.
If this doesn't work, or if you prefer to start with a book in hand, you might try BioLaw: A Legal and Ethical Reporter on Medicine, Health Care, and Bioengineering, KF3821.A6 B58. This looseleaf set is a great way to get an overview on many topics. Each year older topics are updated and news topics are added.
Other print and electronic resources organized around general topics are:
Bioethics Topics (University of Washington School of Medicine [http://depts.washington.edu/bioethx/topics/index.html]
"Each topic begins with an overview and a series of commonly asked questions, and followed by case-based scenarios and useful links."
Bioethics Research Library at Georgetown University
This library has all sorts of great information on bioethics research topics. From the front page, there are individual topic pages with links to infomation on particular subjects. Be sure to click on the Bioethics Resources tab.
University of Minnesota's Center for Bioethics
Has ‘summaries and overviews’ on numerous topics and in depth overviews of End of Life Care; Distributing Limited Healthcare Resources; Ethics of Organ Transplantation; Human Stem Cells; New Frontiers in Genetic Testing & Screening; Research Ethics; and Resuscitation Decisions. Also has links to bioethics topics in the news; Bioethics in the News; internet sources for Law and Bioethics; and other bioethics resources.
Encyclopedia of Bioethics [Olin Level 1 Reference QH332 .E52 2004]
5-volume set with comprehensive coverage of bioethics topics
Use the links in the following chart to search online catalogs for relevant books or journal titles. You can try keyword searches using specific words for your issues or you can do subject searches using some of the subject headings listed below. For materials found using WorldCat that are not available at Washington University, you will need to request the item via Interlibrary Loan using the Law School Illiad link. If you have any questions or are unable to do a successful search, please ask a Reference Librarian for help.
|Catalog||Contents & Comments|
|Washington University Libraries Catalog||Materials available on (from) the Hilltop campus.
|Washington University's Medical Library||Try using legal or ethical and your topic (e.g., fetal tissue) as a keyword search.|
|MOBIUS||A union catalog of academic libraries in Missouri--includes all libraries in the University of Missouri system and Saint Louis University. Make sure you choose the Law Library as the delivery site. Great source but due dates are short.|
|WorldCat (over 40 million items) change to worldcat, not first search||Use this source for materials located in libraries other than Washington University. Materials may be requested via Interlibrary Loan (ILL) using Law School ILLIAD. You can also register through the WorldCat interface as described below.
|LOCATORplus||National Library of Medicine's catalog of books, journal titles (not articles), and audiovisuals and access points to other medical research tools.|
Government Web Sites
Timeline of Laws Related to the Protection of Human Subjects, great guide from NIH with links to many of the important documents.
Office for Human Research Protections (OHRP), The Office for Human Research Protections (OHRP) is the division of the United States Department of Health and Human Services responsible for ensuring that human subject research complies with appropriate regulations. The OHRP Web site publishes a range of policy guidance, including federal regulations, compliance procedures and other advice-giving materials, for organizations engaged in research involving human subjects. There is also a selection of educational materials, including online tutorials, presentations and guidebooks. All documentation is available to download as Adobe Acrobat PDF files. Additionally, the site offers a search facility, site map and a page devoted to latest news in the field of human research.
Office of Human Subjects Research. The Department within NIH that "protects the rights and promotes the welfare of human subjects."
NIH's Bioethics Resources on the Web The NIH's guide--the specific topics guide (left side of page) should prove to be especially handy. Includes a list of links for Stem Cell Research information.
Ethical Issues in Research Involving Human Participants An NIH bibliography with over 4500 citations listed. A table of contents is given at the beginning, with links to topical sections within the guide. Very extensive, however, nothing more recent than 1999.
Biothics.gov, The President's Council on Bioethics The Department of Health and Human Services Commission is an advisory panel of the nation’s leaders in medicine, science, ethics, religion, law, and engineering. The Commission advises the President on bioethical issues arising from advances in biomedicine and related areas of science and technology. The Commission seeks to identify and promote policies and practices that ensure scientific research, health care delivery, and technological innovation are conducted in a socially and ethically responsible manner. Click on "Studies" for links to lots of federal commission reports on research topics.
National Human Genome Research Institute, National Institutes of Health [http://www.genome.gov]. Originally set up to map the human genome, the National Human Genome Research Institute (NHGRI) (previously known as the National Center for Human Genome Research), is now one of 27 institutions and centers that make up the NIH. It applies genome technologies to the study of specific diseases. The web site provides information about NHGRI's research projects and its grant. The "Policy & Ethics" section includes a searchable "Legislative Database" of federal and state laws and policy related to genetics (stem cell research, cloning, employment/insurance discrimination, etc.).
Other Web Sites
The web site provides links to bioethics news for the week and the American Journal of Bioethics (full-text available via Med School subscription .. off campus access available via VPN connection ). You can enter your email to receive weekly news updates. There are also links to debates, articles, reports on featured topics: cloning, genetics, and NBC's ER.
BioethicsWeb (United Kingdom) [http://bioethicsweb.ac.uk/]
"BioethicsWeb offers free access to a searchable catalogue of Internet sites and resources covering biomedical ethics." Descriptions of each web site are available. The webpage is, however, no longer updated.
Genethics.ca Topics [http://genethics.ca]
The web site provides list of agencies/organizations and literature on topics including genetic testing, patenting, DNA banking, gene therapy & engineering, stem cells, etc. Also contains list of related journals.
Ethics Updates [http://ethics.sandiego.edu]
It is intended to provide resources and updates on current literature, both popular and professional, that relate to ethics. From the University of San Diego.
International Society for Stem Cell Research (ISSCR) [http://www.isscr.org/]
"[A]n independent, nonprofit organization formed in 2002 to foster the exchange of information on stem cell research." The web site provides general information about the society. It also includes the full text of the monthly "ISSCR Newsletter" (2002- ) which collects worldwide news on stem cell research as well as highlights of recent literature on the topic.
Georgetown Research Guide a great research guide on bioethics. Very thorough.
Journal articles are also likely to be a great source of information. The chart below lists general legal and non-legal databases as well as some specific to bioethics and /or medicine. Once you find an article you want, check the online catalog to see if we have the Journal title. The Law Library's current journals are kept on Reserve (Circulation Desk); the older journals are bound and shelved on the 5th floor, in alphabetical order. Each has slightly different coverage. The non-law journal titles will need to be searched in the catalog to determine location. If the title isn't held on campus, the library can obtain it via Interlibrary Loan. Just fill out the online form, and we'll do the rest.
Source, Coverage, Content and Comments
LegalTrac, 1980 -, A database of legal newspapers and journals, including law reviews.
Index to Legal Periodicals and Retrospective, 1903 -, Another database of law reviews.
Index to Foreign Legal Periodicals, 1985 -, Great source if you're studying the international/foreign/comparative aspects of the topic.
PubMed, 1965 -, A service of the National Library of Medicine providing access to over 12 million MEDLINE citations and additional life science journals. Includes links to sites providing full text articles (e.g. PubMed Central) and other related resources. If you find one good article, click on “See all related articles” to pull up other relevant materials.
JSTOR is a non-profit organization with a dual mission to create and maintain a trusted archive of important scholarly journals, and to provide access to these journals as widely as possible. Content spans many disciplines, primarily in the humanities and social sciences.
HeinOnline, searchable database containing full-text pdf copies of many law journals.
Philosopher's Index, 1940 -, Useful for material on ethical considerations.
Academic Search Premier, 1975 -, Scholarly, multi-disciplinary database containing full text for more than 4,650 publications, including more than 3,600 peer-reviewed publications
Web of Science, 1988 -, A multidisciplinary database, with searchable author abstracts, covering the journal literature of the sciences. A great source for the scientists viewpoint on your topic.
BNA Medical Research Law and Policy Report. A bi-weekly publication that documents, reports on, and analyzes developments in the area of health law, including coverage of activity in the courts, Congress and state legislatures, state and federal regulatory agencies, and the private sector. On Westlaw (BNA-MRLP) or the law library’s BNA page
Finding Primary Source Materials
Administrative Rules and Regulations
Federal and state administrative agencies promulgate rules and regulations to carry out statutory mandates. Notices of federal rules and regulations are first published in the Federal Register. Once a rule becomes final, it is codified into the Code of Federal Regulations.Lexis and Westlaw provide access to the CFR and the Federal Register. FDSys, an excellent source for federal government laws and regulations, is another source. To avoid the laborious updating with the List of Sections Affected, use CFR on Westlaw, Lexis or the E-CFR on GPO Access.
Selected regulations and documents:
- 45 CFR 46
The Federal Government regulations regarding Protection of Human Subjects.
- 34 CFR 97
More federal regulations--these apply specifically to educational institutions.
- 42 CFR 121
Federal Regulations regarding organ transplants.
- 21 CFR 50
FDA regulations Protection Of Human Subjects.
- National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research on the Fetus: Report and Recommendations (Washington, D.C.) 1975. Reprinted at 40 Fed. Reg. 33,526 (1975).
- “HEW Support of Human In Vitro Fertilization and Embryo Transfer: Report of the Ethics Advisory Board,” 44 Fed. Reg. 35,033 (June 18, 1979) at 35,055-35,058.
Biolaw: A Legal and Ethical Reporter on Medicine, Health Care, and Bioengineering [KF 3821.A6 B58] first may well be the best course of action. It is a looseleaf with cases and commentary covering most of the topics for this class.
If you find one good case, you can use Westlaw’s Key Number System to find other cases assigned the same topic and key number. You can also Shepardize and/or KeyCite the case to find other primary and secondary materials that cite your case.
The official source for federal codified law is the United States Code (U.S.C.), but the commercially published United States Code Annotated (U.S.C.A.) and United States Code Service (U.S.C.S.) are often more useful for research. They are updated more frequently and include annotations. Copies of all are in the Reading Room, and USC and USCA are also on the Fifth Floor in the Federal Materials section. The annotated codes are also available full text online: the U.S.C.S. is on Lexis and the U.S.C.A. is on Westlaw (Westlaw Database: USCA). Once you find a relevant code section, it will have links to cases, regulations, law review articles and other relevant secondary sources.
Current state statutes are available on Lexis and Westlaw. The library also has paper copies: Missouri in the Reading Room, and other states on the first floor. If you want to do a state-by-state comparison of a statutory issue, try Westlaw’s 50 State Surveys (SURVEYS) database.