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Education & Outreach Archived Materials

OHRP maintains in our archives versions of educational materials that have been available in the past. Please note that some of the information in these archived materials may be out of date. We recommend that you refer to our current materials for the most updated and accurate information. 
 
Archived materials include:
 
The U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies announced proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. A Notice of Proposed Rulemaking (NPRM) was published in the Federal Register on September 8, 2015.
 
In order to help the public better understand the goals and impact of the new proposals, OHRP developed six webinars covering key aspects of the NPRM. The webinars aim to explain the NPRM proposals that are most relevant to each topic. As such, there is a fair amount of overlap in content and material covered in the webinars.
 
It is important to remind the audience that information provided in these webinars is necessarily simplified. For a complete and fully accurate description of the proposed changes, the audience is advised to refer to the full NPRM document (PDF 1063 KB).
 
6 key topics covered by the webinars:
  1. Overview of the NPRM (approx. 34 mins.), Jerry Menikoff, Director, OHRP
    Watch: Overview of the NPRM
     
  2. Exclusions and Exemptions (approx. 30 mins.), Jerry Menikoff, Director, OHRP
    Watch: Exclusions and Exemptions
     
  3. Informed Consent (approx. 28 mins.), Jerry Menikoff, Director, OHRP
    Watch: Informed Consent
     
  4. IRB Review and Operations (approx. 18 mins.), Julia Gorey, Policy Analyst, Division of Policy and Assurances, OHRP
    Watch: IRB Review and Operations
     
  5. Research with Biospecimens (approx. 22 mins.), Julie Kaneshiro, Deputy Director, OHRP
    Watch: Research with Biospecimens
     
  6. Secondary Research Use of Data (approx. 21 mins.), Ivor Pritchard, Senior Advisor to the Director, OHRP
    Watch: Secondary Research Use of Data
 

This collection includes early online training modules developed by OHRP that cover foundational information about the HHS regulations for the protection of human subjects in research.

If "Not in Archive" message appears, then there is a link error in the archive. Please click on the "live web" link to access the live site.

 

Description: The 1993 Guidebook was designed to assist IRB members, researchers, and institutional administrators in fulfilling their responsibilities to protect the rights and welfare of human subjects as defined in the HHS regulations (45 CFR 46). The Guidebook is not designed to tell IRBs whether or not specific protocols should be approved, however, it does point out issues to which IRBs should pay attention and, wherever possible, presents areas where ethicists and others concerned with these issues have arrived at a consensus on the ethical acceptability of a particular activity or method. The Guidebook includes regulations and policies, relevant institutional documents, text dealing with specific topics, a glossary of terms, and a bibliography. 

Note: The IRB Guidebook was last updated in 1993. Developments over the intervening years have made portions of the Guidebook information obsolete, while portions of the information remain valid. There is no errata document to indicate which information has been superseded. OHRP cautions users to verify the current validity of any Guidebook information before relying on the information in a program of human subjects protection.

 
Content created by Office for Human Research Protections (OHRP)
Content last reviewed on March 5, 2016