Human Research Review Board
Ethical codes
Belmont report
Ethical principles and guidelines by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. April 18, 1979.
Declaration of Helsinki
World Medical Association's recommendation for ethical principles for medical research involving humans. June 1964 - September 1989.
Nuremburg Code
Directives for human experimentation from the Trials of War Criminals before the Nuremburg Military Tribunals under Control Council Law. April 1949.
Federal agencies
DHHS (or HHS)
Department of Health and Human Services
FDA
Food and Drug Administration
CBER
Center for Biologics Evaluation and Research. Regulates biological and related products including blood, allergenics, vaccines, tissue and biological therapeutics.
CDER
Center for Drug Evaluation and Research. Regulates drugs to ensure their safety and effectiveness.
CDRH
Center for Devices and Radiological Health. Regulates medical device research to ensure their safety and effectiveness.
NIH
National Institutes of Health
CBT
Computer Based Training. Human Participant Protections: Education for Research Teams. Required tutorial for investigators conducting NIH sponsored research.
OHSR
Office of Human Subjects Research. Assist intramural research program investigators understand and comply with ethical guidelines and regulatory requirements for human research.
OCR
Office of Civil Rights (HIPAA compliance office)
OHRP
Office of Human Research Protections
ORI
Office of Research Integrity
Federal guidance and fact sheets
Clinical research and HIPAA
NIH Fact Sheet, 2/5/04 (reformatted 6/22/04) coded private info.
FAQs:
Office of Civil Rights (HHS): Research
NIH: Research
HIPAA Privacy Rule Booklet for Research
NIH Booklet, 4/14/03 (revised 7/13/04).
HIV and HIPAA
HIV/AIDS Bureau of HRSA Guidance for HIV services providers, 4/04.
Impact of HIPAA on the NIH Process
NIH Guidance, 2/5/03.
IRBs and HIPAA
NIH Fact Sheet, 8/15/03 (reformatted 7/8/04).
IRB Review of stand-alone authorization forms
FDA Guidance, 11/7/03.
Privacy boards and HIPAA
NIH Fact Sheet, 9/25/03 (reformatted 7/12/04).
Research and coded private information or biological specimens
OHRP guidance, 8/10/04.
Research repositories, databases and HIPAA
NIH Fact Sheet, 1/12/04 (reformatted 7/2/04).
HIPAA research standards
OCR Guidance, 12/3/02 (revised 4/3/03).
Research and HIPAA
NIH Web site for the research community.
Health care and HIPAA
OCR Web site for medical privacy regarding national standards.
General HIPAA FAQs
HHS answer site with regular updates.
Federal regulations for DHHS
FDA
21 CFR (Code of Federal Regulations)
Part 11 – Electronic records; electronic signatures
Part 50 – Protection of human participants
Part 54 – Financial disclosure by clinical investigators
Part 56 – Institutional Review Boards (IRB)
Part 312 – Investigational new drug application (IND)
Part 314 – Applications for FDA approval to market a drug (NDA)
Part 601 – Applications for FDA approval of a biologic license
Part 812 – Investigational device exemptions (IDE)
Part 814 – Premarket approval of medical devices (PMA)
FDA information sheets
Guidance for IRBs and clinical investigators (1998).
OCR
45 CFR
Parts 160 and 164 - HIPAA final rule
OHRP
45 CFR
Part 46 – Protection of human research participants
Frequently Asked Questions
Frequently Asked Questions
Good Clinical Practices (GCP)
FDA GCP
U.S. standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of FDA-regulated clinical trials (also see 21 CFR).
ICH GCP
International and ethical quality standard for the design, conduct, recording and reporting of research involving human participants.
Health Insurance Portability and Accountability Act (HIPAA)
Laws and regulations
Federal 'Security and Privacy' regulation
45 CFR 164
Entire federal regulation
45 CFR
160 – general administrative requirement
162 – administrative requirements
164 – security and privacy
Wisconsin statutes on privacy
Chapter 146. See 81, 815, 819, 82, 83, 836
Levels of risk
Levels of risk - Adults
Levels of risk - Children
Newsletters, publications, informational Web sites
Clinical Trials Weekly
Free e-newsletter
HRPO E-Update
Monthly updates from MCW Human Research Protection Office and archives
IRB Forum
MCWIRB promotes the discussion of ethical, regulatory and policy concerns with human subjects research. (Free)
OHRP list serve
Information regarding human participant research protection, upcoming educational workshops and other programs.
Patient Safety Monitor
Free e-newsletter
Other documents
Membership list
IRB library
FWA number
Professional organizations
ACRP
Association of Clinical Research Professionals. Non-profit educational, certification and networking resource for clinical research professionals, both sponsors and investigative sites.
ARENA
Applied Research Ethics National Association. Membership division of PRIM&R.
CCRP
Center for Clinical Research Practice. For profit educational resource.
DIA
Drug Information Association. Professional organization for pharmaceutical and related health care industries.
PRIM&R
Public Responsibility in Research & Medicine (See ARENA). Non-profit organization that promotes strong research programs and consistent application of ethics in medicine and research.
SoCRA
Society of Clinical Research Associates. Non-profit organization dedicated to the continuing education, development and certification of clinical research professionals.
Support services
Public relations
The Children's Hospital of Wisconsin Public Relations staff can help you publicize studies and recruit volunteers.
We can assist you with developing and implementing targeted communication plans that may include:
- Advertising development and placement (newspaper, TV, radio and other media).
- Complying with official public notice rules.
- News releases and media pitches to assist in launching a study, provide public updates or publicize results.
If you would like our help, please involve us early in the study planning process to avoid having to resubmit amendments for IRB approval (news releases, ads or target media). For assistance, contact Erin Hareng, senior public relations specialist.
Training
CITI training
NIH training
Biomedical research ethics:
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