Federal Regulations and Guidelines | Texas Tech Health El Paso

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Department of Health and Human Services (DHHS)

OHRP - Office for Human Research Protections, DHHS
45 CFR 46 - DHHS regulations for the protection of human subjects
45 CFR Parts 160, 162 and 164 - Health Insurance Reform: Security Standards; Final Rule
Exempt Guidelines - Categories of research that may be reviewed by the IRB through an exempt review procedure
Expedited Guidelines - Categories of research that may be reviewed by the IRB through an expedited review procedure

Food and Drug Administration (FDA)

OHRP - Office for Human Research Protections, DHHS
45 CFR 46 - DHHS regulations for the protection of human subjects
45 CFR Parts 160, 162 and 164 - Health Insurance Reform: Security Standards; Final Rule
Exempt Guidelines - Categories of research that may be reviewed by the IRB through an exempt review procedure
Expedited Guidelines - Categories of research that may be reviewed by the IRB through an expedited review procedure

Good Clinical Practice (GCP)

Good Clinical Practice: Consolidated Guidance - guidance for investigators, sponsors and IRBs
Good Clinical Practice in FDA-Regulated Clinical Trials - FDA web site for investigators conducting clinical trials

Ethical Codes

Belmont Report - Ethical principles and guidelines for the protection of human subjects of research
Declaration of Helsinki - Recommendations guiding medical doctors in biomedical research involving human subjects
Nuremberg Code - Directives for human experimentation