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CONTENTS OF THIS PAGE:

Home Pages of Relevant Web Sites
Key Documents
Adverse Events (AE) Reporting
Audits/Inspections
Biological Sampling
Certificates of Confidentiality
Clinical Trials Information
Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
Confidentiality
Conduct Of Human Subject Research
Conflict of Interest
Data And Safety Monitoring Plans (e.g., DSMPs)
Data And Safety Monitoring Committees or Boards (DSMCs or DSMBs)
HIPAA
Informed Consent
Investigational Drugs
IRBs
Presentations
Regulatory Information
Study Populations
Training

HOME PAGES OF RELEVANT WEB SITES:

Association of American Medical Colleges (AAMC): http://www.aamc.org/

The Food and Drug Administration (FDA): http://www.fda.gov/

National Bioethics Advisory Commission: http://bioethics.georgetown.edu/nbac/

National Cancer Institute: http://www.nci.nih.gov/
National Center for Research Resources (NCRR): http://www.ncrr.nih.gov/
National Institutes of Health: http://www.nih.gov/
Office of Research Integrity: http://ori.dhhs.gov/

Office for Human Research Protections (OHRP): http://www.hhs.gov/

Public Responsibility in Medicine & Research (PRIMR/ARENA): http://www.primr.org/

RSA web site: http://www.srsa.us

KEY DOCUMENTS:

Belmont Report: http://www.fda.gov/oc/ohrt/IRBS/belmont.html
Declaration of Helsinki (World Medical Association): http://www.wma.net/e/policy/17-c_e.html

45 CFR 46 (The Common Rule):

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

Searching the CFRs: http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=200045

ADVERSE EVENTS (AE) REPORTING:

Expedited Safety Reporting Requirements for Human Drug and
Biological Products: http://www.fda.gov/cder/aers/fr07oc97.htm
NIH guidance for reporting AEs for multi-site clinical trials with a DSMB (June 11, 1999): http://grants.nih.gov/grants/guide/notice-files/not99-107.html

AUDITS/INSPECTIONS:

FDA inspections of IRBs and clinical investigators: http://www.fda.gov/oc/ohrt/irbs/operations.html

BIOLOGICAL SAMPLING:

NCI sample consent form for use of tissue for research: http://www-cdp.ims.nci.nih.gov/infcondocs991.html
National Bioethics Advisory Commission Publications: http://bioethics.georgetown.edu/nbac/pubs.html

CLINICAL TRIALS INFORMATION:

NIH/FDA/NLM joint effort to provide clinical trial information to the public: http://clinicaltrials.gov
CenterWatch (focuses on industry supported trials): http://centerwatch.com

Common Terminology Criteria for Adverse Events v3.0 (CTCAE):

NCI Common Terminology Criteria for Adverse Events v3.0 (CTCAE 3): http://ctep.cancer.gov/reporting/CTCAE v3 (PDF File) or http://ctep.cancer.gov/reporting/ctc.html

CONFIDENTIALITY:

NIH web site about Certificates of Confidentiality: http://grants2.nih.gov/grants/policy/coc/index.htm

or http://grants1.nih.gov/grants/policy/coc/index.htm

Model confidential disclosure: http://ctep.cancer.gov/forms/index.html

CONFLICT OF INTEREST:

Institutional responsibility regarding conflicting interests of investigators: http://grants.nih.gov/grants/compliance/42_CFR_50_Subpart_F.htm

CONDUCT OF HUMAN SUBJECT RESEARCH:

Guidelines for the conduct of research involving human subjects at the NIH: http://ohsr.od.nih.gov/guidelines.php3

DATA AND SAFETY MONITORING (e.g., DSMPs):

NIH policy for data and safety monitoring (June 10, 1998): http://grants.nih.gov/grants/guide/notice-files/not98-084.html
Further guidance on data and safety monitoring for Phase I and Phase II trials (June 5, 2000): http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html
NCI DSMP (essential elements): http://www.cancer.gov/clinical_trials/doc_header.aspx?viewid=a7fbcf28-458e-4f1b-a8e4-5d9c4a9171d5&docid=be7739e5-129b-404e-8efe-f9ce199518ca
Guidelines for data and safety monitoring: http://ohsr.od.nih.gov/info/rinfo_18.php3
Template of a DSMP by Duke GCRC: http://igg1.mc.duke.edu/gaveston/app_g.htm

DATA & SAFETY MONITORING COMMITTEES (DSMCs or DSMBs):

On the Establishment and Operation of Clinical Trial Data Monitoring Committees (draft guidance document) FDA DSMB (DMC) criteria: http://www.fda.gov/cber/gdlns/clindatmon.htm#2
Guidelines for data and safety monitoring: http://ohsr.od.nih.gov/info/rinfo_18.php3

HIPAA:

Office of the Secretary; Standards for Privacy of Individually Identifiable Health Information; Proposed Rule [HIPAA; 45 CFR Parts 160 and 164]: http://www.hhs.gov/ocr/hipaa/

INFORMED CONSENT:

MedicineNet.com (good source for description of medical terminology): http://www.medicinenet.com/Script/Main/hp.asp

INVESTIGATIONAL DRUGS:

Investigational new drug application: http://www.fda.gov/cder/guidance/index.htm
Conducting investigational drug trials (FDA brochures for clinical investigators): http://www.fda.gov/cder/about/smallbiz/clinical_investigator.htm

IRBs:

OHRP guidance on written IRB procedures: http://www.hhs.gov/ohrp/humansubjects/guidance/wirbproc.pdf
IRB Guidebook-Human Subject Protections - IRB Index Page (OHRP): http://www.hhs.gov/ohrp/irb/irb_guidebook.htm

PRESENTATIONS:

NIH-based videocasts on bioethical issues: http://www.videocast.nih.gov/PastEvents.asp?c=22&s=11
NIH-based video-casts on bioethical issues: http://www.videocast.nih.gov/PastEvents.asp?c=22&s=11

REGULATORY INFORMATION:

Regulatory Affairs Professional Society (RAPS) http://www.raps.org
Regsource http://www.regsource.com/

STUDY POPULATIONS:

NIH guidelines on inclusion of women and minorities as subjects in clinical research (August 2, 2000): http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html

TRAINING:

Investigator 101 CD-Rom available through OHRP: http://www.hhs.gov/ohrp/references/cdrom.pdf

Human participant protections education for research teams: http://cme.nci.nih.gov/intro2.htm

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Page Updated: 12/21/2008

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