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Web Resources: UGA Regulatory Affairs Masters Program

Web Resources

General Resource

Below are lists of useful web links for course work and professional needs.

If you find a site that you believe would be useful to other Regulatory Affairs Professionals, please email that url to regaffairs[@]rx.uga.edu. Let us also know if you find an outdated or broken link so we may replace it. Thank you.

Glossary of Terms

Federal Clinical Trials Programs

  • Clinical Trials at the National Institutes of Health - NIH Clinical Center in Bethesda, Maryland is the research hospital of the National Institutes of Health (NIH). There, through clinical research, scientific discoveries in the laboratory are translated into new and better medical treatments and therapies for people. www.cc.nih.gov, guides potential participants, their families and physicians about participating in clinical trials in Bethesda, Maryland.
    • The National Cancer Institute (NCI) is the U.S. government's focal point for clinical trials on cancer. Most U.S. government agencies that conduct cancer research, such as DOD or VA, do so in partnership with NCI: www.cancer.gov/
  • The Veterans Administration (VA) and NCI provide information on their interagency partnership agreement in clinical trials for cancer:
    www.va.gov/cancer
  • U.S. Department of Health and Human Services provides information on HIV/AIDS Treatment, Prevention, and Research: www.aidsinfo.nih.gov
  • National Eye Institute (NEI) provides a clinical studies database, vision research information, and resources: www.nei.nih.gov/resources
  • National Institute of Mental Health (NIMH) supports FAQs for potential participants in mental health research; read "A Participant's Guide to Mental Health Clinical Research":
    www.nimh.nih.gov/health/trials/index.shtml

Information on Bioethics

  • NIH Office of Extramural Research (OER) and the NIH Inter-Institute Bioethics Interest Group provide information on policies and regulations, Institutional Review Board resources, guidance for clinical investigators, research resources, courses and tutorials on bioethical issues in human studies:
    www.nih.gov/sigs/bioethics
  • The National Library of Medicine (NLM) compiled a comprehensive bibliography from 1989 through November 1998, "Ethical Issues in Research Involving Human Participants," compiled by the National Library of Medicine:
    www.nlm.nih.gov/archive//20061214/pubs/cbm/hum_exp.html
  • HHS Office of Human Research Protection (OHRP) provides a guide and training materials on regulations and procedures governing research with human subjects; includes a guidance document on financial relationships in clinical research:
    www.hhs.gov/ohrp
  • Medicare Coverage for Clinical Trials
    Centers for Medicare and Medicaid Services (CMS) provides information on the September 19, 2000 final national coverage decision regarding Medicare payments for routine costs and reasonable and necessary items in clinical trials. Read "Medicare Coverage Policy ~ Clinical Trials," based upon the authority found in §1862(a)(1)(E) of the Social Security Act. www.cms.hhs.gov/ClinicalTrialPolicies/Downloads/finalnationalcoverage.pdf

US Government-related Links

 

Life Science and University Research Links

 

Scientific Journal Links

 

International Links

 

Professional Association and Societies Links

 

Additional Reference Sites

Bioethics

Below are lists of useful web links for course work and professional needs.

If you find a site that you believe would be useful to other Clinical Trials or Regulatory Affairs Professionals, please email that URL to clinical[@]rx.uga.edu. Also, let us know if you find an outdated or broken link so we may replace it.

Agencies and Institutions

Journals and Periodicals

  • BioEdge: Weekly newsletter aims to promote ethics in medicine and to provide information and commentary on bioethics. www.bioedge.org
  • Bioethics.com: Global information source on bioethics news and issues. www.bioethicsnews.com
  • Bioethics Wire:A service of The Hastings Center, provides commentary on issues in bioethics - patient care, health policy, medical science and research, biotechnology, the beginnings and endings of life, and environment and health. It aims to broaden and deepen the social debates about bioethical issues: www.thehastingscenter.org/BioethicsWire/Default.aspx
  • Bioethics.net: Provides links to daily news articles and weekly commentary on issues in bioethics, from the American Journal of Bioethics, www.bioethics.net/news
    Bioethics News: The news service sponsored by the biotechnology industry.
  • CNN's ethicsmatters: This site archives CNN columns by Dr. Jeffrey Kahn, University of Minnesota Center for Bioethics.  The most recent information is from 2002 and organized by topic. cnn.com/HEALTH/bioethics/archive.index.html.
  • IRB Forum: This site provides news and information about upcoming events concerning ethical, regulatory, policy concerns about research with humans. www.irbforum.org.
  • MSNBC "Breaking Bioethics": News columns on topical issues by Dr. Arthur Caplan for the University of Pennsylvania, msnbc.msn.com/id/3035344.
  • News in Bioethics and Biotechnology: This site links to journals, books and news, www.eubios.info/NBB.htm.
  • Science and Development Network: News stories about health in the developing world. Search for bioethics. www.scidev.net/dossiers/index.cfm?fuseaction=dossierItem&Dossier=5;
    SciDev.Net: Distributes news and science and technology aimed toward the developing world. updated weekly and has a section on ethics of research. www.scidev.net/index.cfm?fuseaction=aboutus

Cell Therapy and Biologics

Below are lists of useful web links for course work and professional needs.

If you find a site that you believe would be useful to other Clinical Trials or Regulatory Affairs Professionals, please email that URL to clinical[@]rx.uga.edu. Also, let us know if you find an outdated or broken link so we may replace it.