Human Subject Research Protection Resource Guide (Biomedical)
Name: Barbara Wright and Irene Lubker
Phone: (804)828-0636
Email: bawright@vcu.edu
Email: imlubker@vcu.edu
All research involving human subjects have to go through an Institutional Review Board (IRB). Office for Human Research Protection (OHRP) and Food and Drug Administration (FDA) define an IRB as an independent ethics committee or a group that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the subjects. Human Subject Research Protection involves both Biomedical as well as Social and Behavioral Research. This Resource guide is for Biomedical Research.
RESEARCH ASSISTANCE AT VCU LIBRARIES
VCU Libraries provides services and resources to assist researchers. Tompkins-McCaw Library for the Health Sciences offers a broad range of Reference Services for VCU investigators in Biomedical Research such as individual consultations by appointment to assist in the development of search strategies and the selection of appropriate databases. A fee-based literature search service is also available to VCU students, faculty, and staff.
HUMAN SUBJECT RESEARCH PROTECTION OFFICES AT VCU
The Office of Research Subjects Protection at VCU under VCU Office of Research is charged with reviewing all research protocols involving humans to ensure compliance with federal, state, and local regulations. This office also provides guidance on activities needing IRB approval.
Office of Education and Compliance Oversight under VCU Office of Research serves as an educational and ethics resource to faculty, staff, students, IRB and IACUC members and staff, and interested research participants at VCU. This office also can answer questions and concerns about possible non-compliance in research.
VCU Research Compliance Matrix
This matrix was developed to facilitate the responsible conduct of research at VCU by providing VCU investigators with a single point of access for policy information, education & training programs, forms & submission processes, and more.
VCU requires all investigators and key personnel undertaking human subject research to complete the Collaborative IRB Training Initiative (CITI) basic course in either Biomedical or Social-Behavioral research.
Here is a listing of some human subject-related publications that are available from the VCU Libraries
More books and journal articles can be found by searching the VCU Libraries Catalog or Databases that VCU subscribes to.
In designing a research project involving human subjects, consider searching PubMed using Medical Subject Headings (MeSH) such as the following:
- Bioethical Issues
- Bioethics
- Biomedical Research
- Codes of Ethics
- Confidentiality
- Conflict of Interest
- Duty to Warn
- Ethics, Professional
- Ethics, Research
- Genetic Privacy
- Helsinki Declaration
- Human Experimentation
- Informed Consent
PubMed searches can also be limited to a subset of Bioethics journals.
IRB Guidebook from the Office for Human Research Protection (OHRP) with Appendices and a complete bibliography including the Nuremberg Code, the Declaration of Helsinki and Belmont Report. For the books and articles that are not available in the VCU Libraries Catalog, please request them through Illiad.
BIOETHICS The National Library of Medicine (NLM) provides access to the published literature on the ethical, legal and public policy issues surrounding health care and biomedical research. This information is provided in conjunction with the Kennedy Institute of Ethics located at Georgetown University, Washington, DC
NIH - Bioethics on the Web - This website contains a broad collage of annotated web links, and while this list is comprehensive, it is not totally inclusive. The listed resources provide background information and various positions on issues in bioethics. Where possible, links are provided directly to those positions
Informal Listing of International Bioethics / Health Care Ethics Guidelines and Declarations
Model Ethical Protocol for Collecting DNA Samples
International Guidelines for the Review of Epidemiological Studies - issued by CIOMS (Council for International Organizations of Medical Sciences) in 1991. Document is provided by the CDC (Centers for Disease Control and Prevention).
Universal Declaration on the Human Genome and Human Rights - adopted by UNESCO (United Nations Educational, Scientific, Cultural Organization) in November, 1997.
CODEX -- the Swedish Research Council's gateway to various research ethics and professional guidelines, run in collaboration with the Centre for Bioethics at Karolinska Institute and Uppsala University.