Useful Links/Resources

UMB Resources

Human Research Protections Office (HRPO):  http://medschool.umaryland.edu/orags/hrpo
General Clinical Research Center (GCRC):  http://medschool.umaryland.edu/gcrc
Office of Research and Development (ORD):  http://www.ord.umaryland.edu
Office for Research and Graduate Studies (ORAGS):  http://medschool.umaryland.edu/ORAGS/
Environmental Health and Safety (EHS):   http://www.ehs.umaryland.edu/

Federal Agencies

FDA (Food and Drug Administration): http://www.fda.gov/
NIH (National Institutes for Health): http://www.nih.gov/
DHHS (Department of Health and Human Services):  www.os.dhhs.gov
OHRP (Office of Human Research Protection):  http://www.hhs.gov/ohrp/
VA (Veteran’s Administration): http://www.va.gov/
CMS (Center for Medicare and Medicaid):  http://www.cms.hhs.gov/default.asp/
OIG (Office of the Inspector General):  http://www.oig.hhs.gov
 ORI (Office of Research Integrity): http://ori.hhs.gov/html/programs/instructresource.asp
 ORO (Office of Research Oversight- Veteran’s Health Administration: http://www1.va.gov/oro/

Good Clinical Practice

ICH (International Conference on Harmonization): ICH Harmonised Tripartite Guideline (Benchmark) (Click on "Guidelines" which is located under "Publications" on the left menu.) : http://www.ich.org
ICH Guidance for Industry - E6 Good Clinical Practice: Consolidated Guidance:  http://www.fda.gov/cder/guidance/959fnl.pdf
Good Clinical Practice in FDA-Regulated Clinical Trials: http://www.fda.gov/oc/gcp/default.htm

Federal Regulations

Code of Federal Regulations: 45 CFR Part 46
Belmont Report
VA - Current ORD Policy Documents
VA Regulations - Human Subjects Protections

FDA Regulations:  21 CFR:

Part 11 - Electronic Records; Electronic Signatures
Part 50 - Protection of Human Subjects
Part 54 - Financial Disclosure by Clinical Investigators
Part 56 - Institutional Review Boards
Part 312 - Investigational New Drug Application (IND)
Part 314 - Applications for FDA Approval to Market a New Drug (NDA)
Part 600 - Biological Products
Part 812 - Investigational Device Exemptions

Research Organizations

AAHRPP (Association for the Accreditation of Human Research Protections Programs):  www.aahrpp.org
AAMC Medical Research : http://www.aamc.org/research/start.htm
PRIM&R (Public Responsibility in Medicine & Research): http://www.primr.org/
The Hastings Center: http://www.thehastingscenter.org/
ACRP (Association of Clinical Research Professionals): http://www.acrpnet.org/
SOCRA (The Society of Clinical Research Associates):  http://wwwsocra.org/
Research Practitioner:  http://wwwresearchpractice.com/

Other Resources

NIH Bioethics Resources: http://www.nih.gov/sigs/bioethics/
Clinical Trials.gov: http://clinicaltrials.gov/
Centerwatch:  http://www.centerwatch.com/
Certificates of Confidentiality: http://grants2.nih.gov/grants/policy/coc/index.htm
FDA Information Sheets: http://www.fda.gov/oc/ohrt/irbs/default.htm

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