Helpful Links and Resources

Department of Health and Human Services Federal Guidelines for Basic Ethical Principles (Primary Resource for Information Related to Human Subject Research Protections):

http://www.hhs.gov/ohrp/humansubjects/

HISTORICAL DOCUMENTS RELATED TO HUMAN RESEARCH PROTECTIONS (For an Understanding of the Necessity for and Historical Development of Current Regulatory Standards Related to Human Subject Research):

  • Belmont Report:

http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html

  • Nuremberg Code:

http://www.hhs.gov/ohrp/archive/irb/irb_appendices.htm#j5

  • Kefauver-Harris Amendment:

http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/PromotingSafeandEffectiveDrugsfor100Years/default.htm

  • Declaration of Helsinki:

http://www.hhs.gov/ohrp/archive/irb/irb_appendices.htm#j6

  • Federal Policy for the Protection of Human Research Subjects: The “Common Rule”:

http://www.hhs.gov/ohrp/humansubjects/commonrule/index.html

FEDERAL GUIDELINES USED FOR PROTECTION OF HUMAN SUBJECTS: Code of Federal Regulations TITLE 45 PART 46 Subparts A-E. (TUC IRB Assesses Human Research Proposals Based on Regulations Outlined by This Document):

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

INFORMED CONSENT INFORMATION AND RESOURCES:

  • Informed Consent Checklist:

http://www.hhs.gov/ohrp/policy/consentckls.html

  • Informed Consent from Vulnerable Populations:

http://www.hhs.gov/ohrp/policy/populations/index.html

  • Video Interview w/ Potential Research Subject Outlining Informed Consent Information:

http://www.hhs.gov/ohrp/education/training/ded_video.html

Human Subject Regulations Decision Charts Used for Determination of IRB Review Exemption Status:

http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html

Human Subject Research Categories Qualifying for Expedited Review:

http://www.hhs.gov/ohrp/policy/expedited98.html

CITI Program (Collaborative Institutional Training Initiative) Online Training Course (Online Human Research Subjects Protections Training Module Recommended by the TUC IRB)

https://about.citiprogram.org/en/series/human-subjects-research-hsr/

NIH Online Training Course: Protecting Human Research Participants:

http://phrp.nihtraining.com/users/login.php

NIH Training Resource Archive (Further Resources Available for Training in Human Research Protections):

http://www.nihtraining.com/cc/ippcr/archive04f/menu.html