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OHRP On-line Tutorial Introduction

Assurance Training Online

Welcome.

When applying for an assurance, the Institutional Official and others may consider taking OHRP's assurance on-line training.

Introduction

Any institution engaged in federally conducted or supported human subjects research must commit itself in writing to the protection of those subjects.

This written commitment is called an Assurance of Compliance.

For human subjects research conducted or supported by the Department of Health and Human Services (HHS), the Office for Human Research Protections (OHRP) must approve an institution's Assurance before the funds can be awarded and human subjects research can begin. 

The Institutional Official who signs the FWA, the Chair of the Institutional Review Board (IRB), and the Human Protections Administrator or primary contact for human subjects protections at the institution must understand the responsibilities involved in an institutional program of human subjects protections.

The purpose of this tutorial is to explain these responsibilities, as well as the informed consent process. 

The tutorial consists of three modules:

  1. HHS Regulations & Institutional Responsibilities
  2. Investigator Responsibilities & Informed Consent
  3. Human Research Protections Program

Click on any module name to go to the first page of that module.

These modules are not designed to satisfy the investigator education requirements of the National Institutes of Health (NIH) grant recipients. For NIH investigator training, please see the following URL:  http://phrp.nihtraining.com/users/login.php

Note: The second module, "Investigator Responsibilities & Informed Consent" includes on page 28 of 29 four links that are outdated and will not work.  The modules exist on another organization's system, and OHRP has been unable to update those links.  The incorrect links, and the substitutes to use in their place are:

Informed Consent Checklist
http://www.hhs.gov/ohrp/humansubjects/assurance/consentckls.htm - DOES NOT WORK

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

Informed Consent, Legally Effective and Prospectively Obtained
http://www.hhs.gov/ohrp/humansubjects/guidance/hsdc93-03.htm - DOES NOT WORK

Use: http://www.hhs.gov/ohrp/policy/hsdc93-03.html

Informed Consent, Non-English Speakers
http://www.hhs.gov/ohrp/humansubjects/guidance/ic-non-e.htm - DOES NOT WORK

Use: http://www.hhs.gov/ohrp/policy/ic-non-e.html

Certificates of Confidentiality
http://www.hhs.gov/ohrp/humansubjects/guidance/certconf.htm - DOES NOT WORK

Use: http://www.hhs.gov/ohrp/policy/certconf.html

 Similarly, in Module 3 "Human Research Protection Program", on page 23 of 25:

See OHRP Guidance at: http://www.hhs.gov/ohrp/humansubjects/guidance/contrev0107.htm. - DOES NOT WORK

Use: http://www.hhs.gov/ohrp/policy/continuingreview2010.html