Online Resources

ONLINE RESOURCES

DUKE LINKS

• Duke University School of Medicine

• ClinicalTrials.gov Registration -- this is a link on the Duke University School of Medicine web site

• HIPAA at Duke:  HIPAA Resources, Policies, and Contacts 

• Trent Center for Bioethics, Humanities & History of Medicine

• Duke Office of Clinical Research (DOCR - formerly the CRSO)

• Research Grants and Contracts

• Office of Corporate Research and Collaboration (OCRC)

• Institutional BioSafety Committee (IBC)

• Duke Radiation Safety Committee

• Duke Center for Hyperbaric Medicine and Environmental Physiology

• Duke Clinical Research Unit (DCRU)

• Office of Research Administration (ORA)

• Duke University School of Medicine Research Integrity Office - (Conflict of Interest Program)

• Duke University School of Medicine Compliance Office 

• Duke Biobank

LINKS BEYOND DUKE

• NIH: On-line Tutorial for Clinical Researchers

• NIH: National Library of Medicine

• NIH: Certificates of Confidentiality Kiosk

• NIH: National Human Genome Research Institute (NHGRI)

• OHRP: Human Subject Protections

• FDA: Guidance for IRBs, Clinical Investigators, and Sponsors

• FDA: Good Clinical Practice

• FDA: Center for Drug Evaluation and Research (CDER) Drug Information

• FDA: MEDWATCH Safety Information and Adverse Event Reporting Program

• CDC: Centers for Disease Control

• EPO: Epidemiology Program Office at the CDC

• Harvard School of Public Health: Global Research Ethics Map (links to human subjects laws, guidelines, procedures in foreign countries)

• International Compilation of Human Research Standards (2013 edition) - prepared by OHRP and lists laws, regulations, and guidelines on human subject protections in more than 100 countries

• NIH: Office of Behavioral and Social Sciences Research

• The Belmont Report

• Glossary of Terms

• ClinicalTrials.gov - ClinicalTrials.gov is a registry and results database of federally and privately supported clinical trials conducted in the US and around the world.

GENE TRANSFER RESOURCES

• NIH Brochure - Deciding Whether to Enroll in Gene Transfer Research:  Information for Study Participants

• NIH Guidance on Informed Consent for Gene Transfer Research (contains sample ICF language)

• FAQs About the NIH (RAC) Review Process