Internet Links

Categories

Regulatory Agencies
FDA
National Institutes of Health
HIPAA
Other Federal
Local Companies and Organizations
Professional and Medical Organizations
Institutional Review Boards
Training and Education
Employment and Recruiting
Position Papers
Other Resources

Regulatory Agencies (back to top)

Australian Therapeutic Goods Administration - www.health.gov.au/tga
Canadian Health Products and Food Branch - www.hc-sc.gc.ca/hpfb-dgpsa/inspectorate
European Agency for the Evaluation of Medicinal Products - www.emea.eu.int
International Conference on Harmonization - www.ifpma.org
Japanese Ministry of Health, Labour and Welfare - www.mhlw.go.jp
US Food and Drug Association - www.fda.gov

FDA (back to top)

Bioresearch Monitoring Information System File - www.fda.gov/cder/foi/special/bmis/index.htm
CDER Guidance Documents - www.fda.gov/cder/guidance/index.htm
CDRH Guidance Documents - www.fda.gov/cdrh/guidance.html
Clinical Investigator Disqualifications Proceedings - www.fda.gov/foi/clinicaldis
Clinical Investigator Forms - www.fda.gov/cder/about/smallbiz/Forms.htm
Clinical Investigator Inspection List - www.fda.gov/cder/regulatory/investigators/default.htm
CDRH Device Advice - www.fda.gov/cdrh/devadvice
Drug Approvals List - www.fda.gov/cder/da/da.htm
FDA Debarred Persons List - www.fda.gov/ora/compliance_ref/debar/default.htm
FDA Disqualified/Restricted/Assurance List - www.fda.gov/ora/compliance_ref/bimo/dis_res_assur
FDA Info for Clinical Investigators - www.fda.gov/cder/about/smallbiz/clinical_investigator
FDA's Information Sheets for IRB's and Clinical Investigators - www.fda.gov/oc/ohrt/irbs/default.htm
Reporting Complaints About FDA-Regulated Clinical Trials - www.fda.gov/oc/gcp/complaints.html
Requesting Information and Records from FDA - www.fda.gov/opacom/backgrounders/foiahand
Warning Letters - www.fda.gov/foi/warning.htm

National Institutes of Health (back to top)

Asthma Clinical Research Network - www.acrn.org
Center for Information Technology - www.cit.nih.gov
Center for Scientific Review - www.csr.nih.gov
National Cancer Institute - www.nci.nih.gov
National Center for Complementary and Alternative Medicine - nccam.nih.gov
National Center on Minority Health and Health Disparities - ncmhd.nih.gov
National Center for Research Resources - www.ncrr.nih.gov
National Eye Institute - www.nei.nih.gov
National Heart Lung & Blood Institute - www.nhlbi.nih.gov
National Human Genome Research Institute - www.nhgri.nih.gov
National Institute on Aging - www.nia.nih.gov
National Institutes of Alcohol Abuse & Alcoholism - www.niaaa.nih.gov
National Institutes of Allergy & Infectious Diseases - www.niaid.nih.gov
National Institutes of Arthritis & Musculoskeletal & Skin Disease - www.niams.nih.gov
National Institute of Biomedical Imaging and Bioengineering - www.nibib.nih.gov
National Institute of Child Health and Human Development - www.nichd.nih.gov
National Institute on Deafness and Other Communication Disorders - www.nidcd.nih.gov
National Institute of Dental & Craniofacial Research - www.nidr.nih.gov
National Institute of Diabetes and Digestive and Kidney Diseases - www.niddk.nih.gov
National Institutes of Drug Abuse - www.nida.nih.gov
National Institute of Environmental Health Sciences - www.niehs.nih.gov
National Institute of General Medical Sciences - www.nigms.nih.gov
National Institutes of Health - www.nih.gov
National Institutes of Mental Health - www.nimh.nih.gov
National Institutes of Neurological Disorders and Stroke - www.ninds.nih.gov
National Institute of Nursing Research - www.nih.gov/ninr
National Library of Medicine - www.nlm.nih.gov
Office of Human Subjects Research - ohsr.od.nih.gov

HIPAA (back to top)

HHS Office of Civil Rights HIPAA - www.hhs.gov/ocr/hipaa/
“Protecting the Privacy of Patients’ Health Information” (HHS fact sheet, 4/14/03)
Office of Civil Rights Summary of the Privacy Rule (4/11/03)
Frequently Asked Questions on Privacy - answers.hhs.gov
Office of Civil Rights Guidance Explaining Significant Aspects of the Privacy Rule (12/4/02)
“Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule” (NIH)
"Institutional Review Boards and the HIPAA Privacy Rule" (NIH)
Centers for Medicare & Medicaid Services Covered Entity Decision Tool
Centers for Disease Control HIPAA - www.cdc.gov/privacyrule
HIPAAdvisory (Phoenix Health Systems) - www.hipaadvisory.com
HIPAA Resource (Atlantic Information Services) - www.aishealth.com/Compliance/HIPAAResource
HIPAAcomply (Beacon Partners) - www.hipaacomply.com
Health Privacy Project - www.healthprivacy.org
IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations (FDA Guidance, 10/21/03)

Other Federal (back to top)

Agency for Healthcare Research and Quality - www.ahrq.gov
Clinical Trials Registry - clinicaltrials.gov
Code of Federal Regulations On-Line - www.access.gpo.gov
Department of Health and Human Service - www.hhs.gov
Federal Register - www.gpo.gov
FedWorld - www.fedworld.gov
HHS Office of Civil Rights - www.hhs.gov/ocr
HHS Office for Human Research Protections - ohrp.osophs.dhhs.gov
HHS Office of Inspector General - oig.hhs.gov
HHS Office of Research Integrity - ori.dhhs.gov
National Bioethics Advisory Commission - bioethics.georgetown.edu/nbac
National Human Research Protections Advisory Comm. - ohrp.osophs.dhhs.gov/nhrpac/nhrpac
Occupational Safety & Health Administration - www.osha.gov
PHS Investigators Subject to Administrative Action - silk.nih.gov/public/cbz1bje.@www.orilist
President's Council on Bioethics - bioethics.gov
Veterans' Administration Office of Research Compliance and Assurance - www.va.gov/orca

Local Companies and Organizations (back to top)

Advanced Respiratory - www.thevest.com
Acorn Cardiovascular - www.acorncv.com
Acumen Healthcare - www.acumenhealthcare.com
Alquest - www.alquest.com
American Medical Systems - www.americanmedicalsystems.com
Augustine Medical/Arizant - www.augustinemedical.com/arizant/index.shtml
Beckman Coulter - www.beckmancoulter.com
Birchwood Laboratories - www.birchlabs.com
Boston Scientific - www.bostonscientific.com
Centerpulse Spine-Tech - www.spinetech.com
CHF Solutions - www.chfsolutions.com
Clinical Research Institute - www.clin-research.com
CoAxia - www.coaxia.com
Comprehensive Research Group Inc. - www.crginc.org
Corporate Resources - www.corpres.com
Data Sciences International - www.datasci.com
Deltec - www.deltec.com
Diabetes Institute for Immunology and Transplantation at the University of Minnesota - www.diabetesinstitute.org
Disetronic Medical Systems - www.disetronic-usa.com
Empi Inc. - www.empi.com
First Circle Medical - www.fcmedical.com
Guidant - www.guidant.com
HealthPartners Research Foundation - www.hprf.org/docs/home.html
Hutchinson Technology Incorporated - www.htch.com
Ingenix Pharmaceutical Services - www.ingenixps.com
Integral Business Solutions - www.go-integral.com
LumiLife - www.lumilife.com
Lumina Engineering - www.luminaeng.com
Mayo Clinical Trials - www.mayo.edu/research/trials
Mayo Alliance for Clinical Trials - www.mayoclinicaltrialservices.org/mact/index.asp
Mayo Pulmonary Clinical Research Center - www.mayo.edu/research/pcrc
MedCentrus - www.medcentrus.com
MedHeads - www.medheads.com
Medical Alley - www.medicalalley.org
Medtronic - www.medtronic.com
Metropolitan Cardiology Consultants - www.metrocardiology.com
MGI Pharma - www.mgipharma.com
Microvena - www.microvena.com
Minnesota Applied Research Center - www.onthemarcresearch.com
Minneapolis Heart Institute Foundation - www.mplsheartfoundation.org
Minnesota Clinical Research - www.mngastro.com/Research/Research.htm
Minnesota Eye Consultants, P.A. - www.mn-eye.com
Minnesota Statue on Access to Health Records - www.revisor.leg.state.mn.us/stats/144/335.html
Minnetronix - www.minnetronix.com
MR Eagan - www.mreagan.com
National Bone Marrow Donor Program - www.nmdp.org
Noran Neurological Clinic - www.noranclinic.com
Northwestern Health Sciences University - www.nwhealth.edu
ONCALL Clinicians - www.oncallstaffing.com
Orphan Medical - www.orphan.com
Park Nicollet Health Services - www.parknicollet.com
Park Nicollet Institute - www.parknicolletinstitute.org
Radiant Research, Minneapolis - www.radiantresearch.com
Regulatory & Clinical Research Institute (RCRI) - www.rcri-inc.com
Ridgeview Research - www.ridgeviewmedical.org/services/ridgeview_research
SCI (Staff Connection, Inc.) - www.mm.com/sci/
St. Jude Medical - www.sjm.com
St. Paul Consulting - www.stpaulconsulting.com
Stat-Ease, Inc. - www.statease.com
SurModics - www.surmodics.com
Synovis - www.biovascular.com
3M Pharmaceuticals - www.3m.com/us/healthcare/pharma
ThreeWire - www.threewire.com
Total Renal Research (DaVita Clinical Research) - www.trri.com
TruSource (search consulting firm) - www.trusource.net
Upsher-Smith Laboratories - www.upsher-smith.com
Urologix - www.urologix.com
University of Minnesota Research Services Organization - www.ahc.umn.edu/rso
University of Minnesota  Research Subjects Protection Programs - www.research.umn.edu/subjects
Vascular Solutions - www.vascularsolutions.com
Zimmer - www.zimmer.com

Professional and Medical Organizations (back to top)

Advanced Medical Technology Association - www.advamed.org
American Academy of Pharmaceutical Physicians - www.aapp.org
American Association of Pharmaceutical Scientists - www.aaps.org
American Cancer Society - www.cancer.org
American Diabetes Association - www.diabetes.org
American Lung Association - www.lungusa.org
American Medical Association - www.ama-assn.org
American Medical Writers Association - www.amwa.org
American Nurses Association - www.nursingworld.org
American Society for Clinical Pharmacology and Therapeutics - www.ascpt.org
Applied Research Ethics National Association - www.primr.org/arena
Association for the Accreditation of Human Research Protection Programs - www.aahrpp.org
Association for the Advancement of Medical Instrumentation - www.aami.org
Association of Clinical Research Professionals - www.acrpnet.org
Biotechnology Industry Organization - www.bio.org
Clinical Data Interchange Standards Consortium, Inc. (CDISC) - www.cdisc.org
Council for International Organizations of Medical Sciences - www.cioms.ch
Drug Information Association - www.diahome.org
International Organization for Standardization (ISO) - www.iso.ch/iso
International Society for Pharmaceutical Engineering - www.ispe.org
Joint Commission on Accreditation of Healthcare Organizations - www.jcaho.org
Medical Device Manufacturers Association - www.medicaldevices.org
National Committee for Quality Assurance - www.ncqa.org
Pharmaceutical Research and Manufacturers of America - www.phrma.org
Regulatory Affairs Professional Society - www.raps.org
Society of Clinical Research Associates - www.socra.org
Society for Clinical Trials - www.sctweb.org
World Health Organization - www.who.int
World Medical Association - www.wma.net

Institutional Review Boards (back to top)

BRANY - www.brany.com
Chesapeake Research Review - www.chesapeakeirb.com
Coast IRB - www.coastirb.com
Copernicus Group IRB -  www.copernicusgroup.com
Independent Review Consulting - www.irb-irc.com
Internet IRB - www.internetirb.com
IRB Forum - www.irbforum.com
New England IRB - www.neirb.com
Quorum IRB - www.quorum-irb.com
Schulman Associates IRB - www.sairb.com
Western IRB - www.wirb.com

Training and Education (back to top)

Barnett International - www.barnettinternational.com
Center for Business Intelligence - www.cbinet.com
Center for Clinical Research Practice - www.ccrp.com
Center for Professional Advancement - www.cfpa.com
Center for Professional Innovation & Education - www.cfpie.com
Drug Information Association - www.diahome.org/docs/Education
ePharmaLearning - www.epharmalearning.com
Food and Drug Law Institute - www.fdli.org
Institute of Clinical Research - www.instituteofclinicalresearch.org
Institute for International Research - iir-ny.com
MedCentrus - www.medcentrus.com
MedTrials - www.medtrial.com
Pharmaceutical Education and Research Institute - www.peri.org
Pharmaceutical Training Institute - www.pti-international.com
Research Dynamics Consulting Group - www.resdyncg.com
Validation Associates - www.validassoc.com
Walter B. Morley Research Foundation - www.morleyfoundation.org

Employment and Recruiting (back to top)

ACRP Career Center - www.vv-vv.com/acrp
Advanced Clinical Services - www.advancedclinical.com
Aerotek Scientific - www.aerotek.com
AllStarJobs (Healthcare) - www.allstarjobs.com/Career_Specific/Healthcare
ASG, Inc. - www.asg-inc.com
ClinForce Staffing - www.clinforce.com
Clinical Staffing Associates (CSA) - www.clinicalstaffing.com
Clinical Research Associate Registry - www.craregistry.com
Corporate Resources - www.corpres.com
De Angelis Group - www.thedeangelisgroup.com
Eagle Research - www.eagleresearch.net
Happy Career Nursing Jobs - www.happycareer.com
HealthCare Recruiters International - www.hcrnetwork.com
HireHealth.com - www.hirehealth.com
Jasneek Medical Staffing - www.jasneek.com
Manpower Scientific - www.manpowerprofessional.com/Services
Med Exec International - www.medexecintl.com
MedFocus - www.medfocus.com/medfocus
MedHeads - www.medheads.com
Medical Alley Job Board - www.medicalalley.org/jobboard/index.htm
Medical Staffing Network (formerly Health Search International) - www.msnhealth.com
Metropolitan Research Associates, LLC - www.metropolitanresearch.com
MR Eagan - www.mreagan.com
Nursing School - www.thenursingschool.com
ONCALL Clinicians - www.oncallstaffing.com
Radian Executive Search - www.radiansearch.com
Research Careers - researchcareers.com
SCI (Staff Connection, Inc.) - www.scistaffing.com
SRG Woolf Group - www.srgwoolf.com
temPharma - www.tempharma.com
TRIAD Group - www.triadgroup.com
TruSource (search consulting firm) - www.trusource.net
Winnertech Consulting - www.winnertech.com

Position Papers (back to top)

Advisory Committee on Human Radiation Experiments Final Report (1994)
Belmont Report (1979, National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research)
Clinical Trial Web Sites: A Promising Tool to Foster Informed Consent (2002, HHS Office of Inspector General)
Cloning Human Beings (1997, National Bioethics Advisory Commission)
Comment on Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products (2001, National Human Research Protections Advisory Committee)
Declaration of Helsinki (2000, World Medical Association)
Ethical Issues in Human Stem Cell Research (1999, National Bioethics Advisory Commission)
Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries (2001, National Bioethics Advisory Commission)
Ethical and Policy Issues in Research Involving Human Participants (2000, National Bioethics Advisory Commission)
Use of Expedited Review Procedures for IRBs (2003, OHRP Guidance)
FDA Oversight of Clinical Investigators (2000, HHS Office of Inspector General)
Guidelines for Academic Medical Centers on Security and Privacy (2001, Academic Medical Centers)
HHS Guidance on the Privacy Rule (2002, HHS)
Institutional Review Boards: A Time for Reform (1998, HHS Office of Inspector General)
Institutional Review Boards: Promising Approaches (1998, HHS Office of Inspector General)
Institutional Review Boards: The Emergence of Independent Boards (1998, HHS Office of Inspector General)
Institutional Review Boards: Their Role in Reviewing Approved Research (1998, HHS Office of Inspector General)
International Ethical Guidelines for Biomedical Research Involving Human Subjects (1993, Council for International Organizations of Medical Sciences)
International Ethical Guidelines for Biomedical Research Involving Human Subjects Revised 2002 (2002, Council for International Organizations of Medical Sciences)
Low-Volume Institutional Review Boards (1998, HHS Office of Inspector General)
NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects (1998, National Institutes of Health)
NIH Roadmap: Re-Engineering the Clinical Research Enterprise (2003)
Nuremberg Code (1947, Trials of War Criminals before the Nuremberg Military Tribunals)
Preserving Public Trust: Accreditation and Human Research Participant Protection Programs
(2001, Committee on Assessing the System for Protecting Human Research Subjects, Institute of Medicine)
Protecting Human Research Subjects: Status of Recommendations (2000, HHS Office of Inspector General)
Recommendations on HHS's draft Interim Guidance on Financial Relationships in Clinical Research (2001, National Human Research Protections Advisory Committee)
Recruiting Human Subjects: Pressures in Industry-Sponsored Clinical Research (2001, HHS Office of Inspector General)
Recruiting Human Subjects: Sample Guidelines for Practice (2001, HHS Office of Inspector General)
Research Involving Human Biological Materials: Ethical Issues and Policy Guidance (1999, National Bioethics Advisory Commission)
Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity (1998, National Bioethics Advisory Commission)
The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects (2001, HHS Office of Inspector General)
VA Human Research Protection Accreditation Program Standards (2001, National Committee for Quality Assurance)

Other Resources (back to top)

21 CFR Part 11 - www.21cfrpart11.com
AIDSinfo - aidsinfo.nih.gov
Applied Clinical Trials - www.actmagazine.com/appliedclinicaltrials
CenterWatch - www.centerwatch.com
Clinical Researcher - www.clinical-researcher.com
Clinical Trials Advisor - www.clinicaltrialsadvisor.com
Drug Study Central - www.drugstudycentral.com
FDA News - www.fdanews.com
FindLaw - www.findlaw.com
InPharm - www.inpharm.com
Medical DeviceLink - www.devicelink.com
PharmacoEthics.com - www.pharmacoethics.com
PharmaLive - www.medadnews.com
Pharmaportal - www.pharmaportal.com
PubMed (Medline) - www.ncbi.nlm.nih.gov/entrez
RegSource - www.regsource.com
Tufts Center for the Study of Drug Development - www.tufts.edu/med/csdd
Underwriters Laboratories - www.ul.com