Ethics / Regulations / Guidelines

The following links provide information concerning the ethical principles, codes and federal regulations that govern the protection of human subjects in research. Please notify the Office of the IRB at irb@utsa.edu of any links that are not functioning.

Ethical Principles and Codes

The Belmont Report
Ethical Principles and Guidelines for the Protection of Human Subjects in Research
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

The Nuremberg Code
Directives for Human Experimentation
http://ohsr.od.nih.gov/guidelines/nuremberg.html

World Medical Association
Declaration of Helsinki
http://www.wma.net/e/policy/b3.htm

Federal Regulations

Department of Health and Human Services (DHHS)
DHHS Code of Federal Regulations 45 CFR 46
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

Exempt Categories
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.101

Expedited Categories
http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm

Food and Drug Administration (FDA)
Title 21 CFR 50
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50

Title 21 CFR 56
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56

Guidance

Office of Human Protections (OHRP)
OHRP Home Page
http://www.hhs.gov/ohrp/

OHRP Glossary of Terms
http://www.hhs.gov/ohrp/irb/irb_glossary.htm

HIPAA
DHHS Office of Civil Rights
http://www.hhs.gov/ocr/hipaa/

NIH HIPAA Privacy Rule: Information for Researchers
http://privacyruleandresearch.nih.gov/

Other Links of Interest

The Tuskegee Timeline
http://www.cdc.gov/nchstp/od/tuskegee/time.htm

Jesse's Intent
http://www.primr.org/resources/Jesse_s_Intent.pdf (pdf)