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 Please note that some of the information in these archived materials may be out of date.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:
 

This Assurance Training is outdated and only reflects the pre-2018 Common Rule. For a comprehensive foundational training on protecting human subjects in HHS-funded research, please refer to OHRP’s Human Research Protection Training first launched in November 2020.

Reporting to OHRP 1: What's Necessary, What's Not

OHRP staff member Lisa Buchanan explains what constitutes unanticipated problems, adverse events, serious non-compliance, and continuing non-compliance, in addition to discussing IRB suspensions and terminations. She also explains requirements for written procedures for reporting to OHRP.

This video is outdated and has been archived. If you wish to access this content please contact ohrp-edu@hhs.gov for assistance.


Reporting to OHRP 2

OHRP staff member Lisa Buchanan discusses what investigators should do when a reportable incident occurs, actions that IRBs need to take, when to report an incident to OHRP, and how OHRP will process incident reports.

This video is outdated and has been archived. If you wish to access this content please contact ohrp-edu@hhs.gov for assistance.

Relevant OHRP guidance: Guidance on Reporting Incidents to OHRP

Back to Basics: Does My Project Fall within the Scope of Regulations?

OHRP's Misti Ault Anderson provides an overview of OHRP, the Common Rule, and how the HHS regulations on human research protections are applied. This video is for investigators or IRB professionals seeking basic training or a refresher on the HHS regulations for the protection of human subjects.

This video is outdated and has been archived. If you wish to access this content please contact ohrp-edu@hhs.gov for assistance.

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, Jerry Menikoff, Director, OHRP
    This video is outdated and has been archived. If you wish to access this content please contact ohrp-edu@hhs.gov for assistance.
  2. Exclusions and Exemptions, Jerry Menikoff, Director, OHRP
    This video is outdated and has been archived. If you wish to access this content please contact ohrp-edu@hhs.gov for assistance.
  3. Informed Consent, Jerry Menikoff, Director, OHRP
    This video is outdated and has been archived. If you wish to access this content please contact ohrp-edu@hhs.gov for assistance.
  4. IRB Review and Operations, Julia Gorey, Policy Analyst, Division of Policy and Assurances, OHRP
    This video is outdated and has been archived. If you wish to access this content please contact ohrp-edu@hhs.gov for assistance.
  5. Research with Biospecimens, Julie Kaneshiro, Deputy Director, OHRP
    This video is outdated and has been archived. If you wish to access this content please contact ohrp-edu@hhs.gov for assistance.
  6. Secondary Research Use of Data, Ivor Pritchard, Senior Advisor to the Director, OHRP
    This video is outdated and has been archived. If you wish to access this content please contact ohrp-edu@hhs.gov for assistance.
 
Guidance on Reporting Incidents to OHRP

OHRP’s Kristina Borror addresses the HHS regulatory requirements that apply to reporting incidents and strategies for managing regulatory considerations. Topics include: the regulatory background, what needs to be reported and when, common areas of noncompliance, and institutional considerations.

CE: 1:00 CIP Unit (OHRP doesn't provide documentation but viewers can provide the date, time, title, and URL on the CIP recertification application.)

This video is outdated and has been archived. If you wish to access this content please contact ohrp-edu@hhs.gov for assistance.

When the Regs Come a' Knockin': Nuts and Bolts of 45 CFR part 46

Former OHRP staff, Elyse Summers, discusses the history and requirements of the HHS regulations for the protection of human subjects in research. (1:05:35)

This video is outdated and has been archived. If you wish to access this content please contact ohrp-edu@hhs.gov for assistance.

Reviewing and Reporting Unanticipated Problems and Adverse Events

Michael Carome, formerly of OHRP, discusses the criteria for determining if an incident or outcome is an unanticipated problem involving risk to subjects or others (according to the HHS regulations), the differences between adverse events and unanticipated problems, and how to respond. (25:18)

This video is outdated and has been archived. If you wish to access this content please contact ohrp-edu@hhs.gov for assistance.

Learning about the HHS regulations and policies for the protection of human subjects in research can be challenging. To help you get started, OHRP has compiled educational resources tailored for the different roles in human subjects research. Also, consider attending an OHRP in-person educational event and joining OHRP’s mailing list for our monthly newsletter.

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 May 4, 2021