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 Please note that some of the information in these archived materials may be out of date.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

This Assurance Training is outdated and archived. It should only be used as a historical reference. 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.

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.

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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 There is no errata document to indicate which information has been superseded.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.

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?

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 (1063 KB - PDF).
 
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

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.

Biobanking: When Issues with Tissues Come a’Knockin’

Presenters: Carol J. Weil, Program Director for Ethical and Regulatory Affairs, National Cancer Institute and Samantha Smith, OHRP Carol's talk focuses broadly on current ethical and regulatory controversies involved with the collection, storage and research use of biospecimens. Issues covered include informed consent frameworks, privacy concerns, the identifiability of genomic data, different models of data sharing, and the return of research results.

Learn more about the Office for Human Rights Protections (OHRP) at http://www.hhs.gov/ohrp.

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 Assurance Comes A Knockin': OHRP's FWA and IRB Registration Processes

This webinar will feature Dr. Irene Stith-Coleman, Dr. Hal Blatt, and Ms. Jean Makle with the Division of Policy and Assurances, OHRP. They will discuss the requirements and processes involved in registering Institutional Review Boards (IRBs) and obtaining Federalwide Assurances (FWAs) under the HHS regulations at 45 CFR part 46.

This webinar is a basic offering well-suited for those new to the field of human subjects' protection and those not-so-new seeking to refresh and reinforce their understanding of these requirements.

Learn more about the Office for Human Rights Protections (OHRP) at http://www.hhs.gov/ohrp.

This video is outdated and has been archived.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

When PIs Come a'Knockin': Everything Investigators Want to Know but are Afraid to Ask

This webinar from the Office for Human Research Protections (OHRP) features Michelle Feige, MSW, Public Health Analyst with the Division of Education and Development, OHRP. Michelle discusses investigator obligations under the HHS regulations at 45 CFR part 46 when conducting research with human subjects.

This webinar is a basic offering well-suited for those new to the field of human subjects' protection and those not-so-new seeking to refresh and reinforce their understanding of the regulatory requirements.

Learn more about the Office for Human Rights Protections (OHRP) at http://www.hhs.gov/ohrp.

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

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.

When the Feds come a'Knockin': How to Prepare for an OHRP Compliance Evaluation of your Program

Former Director of OHRP's Division of Compliance Oversight, Kristina Borror, discussed how to respond to allegations of noncompliance and how to prepare for an investigation.

Note: This video was created before the 2018 revisions of the Common Rule and may include information that is not up to date.

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

IRB Records, Part I

In this Office for Human Research Protections (OHRP) video, all of the characters are fictional. This video provides information regarding the IRB records requirements described at 45 CFR part 46. The institution portrayed in the video hired a consultant to evaluate its human subjects protections program. The consultant made a number of observations and findings regarding the institution's compliance with the requirements of the regulations.

In this video the institutional official, Dr. Westerberg, meets with the consultant, Ms. Williams, to discuss a plan of action related to some of the findings made by Ms. Williams.

OHRP Educational Videos-Additional Information

OHRP educational videos were developed by the OHRP Division of Education and Development and are intended to provide information regarding the requirements of the Department of Health and Human Services (HHS) regulations for the protection of human subjects at 45 CFR part 46. The videos represent OHRP's current thinking on these topics and should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word must in OHRP guidance means that something is required under HHS regulations at 45 CFR part 46. The use of the word should in OHRP guidance means that something is recommended or suggested, but not required. An institution may use an alternative approach if the approach satisfies the requirements of the HHS regulations at 45 CFR part 46. OHRP is available to discuss alternative approaches at 240-453-6900 or 866-447-4777.

Learn more about the Office for Human Rights Protections (OHRP) at http://www.hhs.gov/ohrp.

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

IRB Records, Part II

In this Office for Human Research Protections (OHRP) video, all of the characters are fictional. This video provides information regarding the IRB records requirements described at 45 CFR part 46. The institution portrayed in the video hired a consultant to evaluate its human subjects protections program. The consultant made a number of observations and findings regarding the institution's compliance with the requirements of the regulations.

In this video a consultant, Ms. Williams, meets with Mr. Cash, the new Director of the institution's IRB office, to review in detail the deficiencies she observed and requirements related to the IRB meeting minutes and other IRB records.

OHRP Educational Videos-Additional Information

OHRP educational videos were developed by the OHRP Division of Education and Development and are intended to provide information regarding the requirements of the Department of Health and Human Services (HHS) regulations for the protection of human subjects at 45 CFR part 46. The videos represent OHRP's current thinking on these topics and should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word must in OHRP guidance means that something is required under HHS regulations at 45 CFR part 46. The use of the word should in OHRP guidance means that something is recommended or suggested, but not required. An institution may use an alternative approach if the approach satisfies the requirements of the HHS regulations at 45 CFR part 46. OHRP is available to discuss alternative approaches at 240-453-6900 or 866-447-4777.

Learn more about the Office for Human Rights Protections (OHRP) at http://www.hhs.gov/ohrp.

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

Institutional Review Board (IRB) Membership

Note: This video was created before the 2018 revisions of the Common Rule and may include information that is not up to date.

In this Office for Human Research Protections (OHRP) video, all of the characters are fictional. A Signatory Official, Dr. Quinn, meets with her staff members to discuss establishing an effective and efficient IRB for their institution. Ms. Hobbs, the future Human Subjects Protections Administrator, provides guidance regarding IRB membership, IRB guidance, quorum requirements, conflicts of interest, alternate members, the difference between recusals and abstentions, appointment of IRB members, written procedures, training, incentives and other relevant information for establishing and maintaining an IRB. As a dedicated investigator, Dr. Reznor provides relevant input and support to the discussion.

OHRP educational videos were developed by the OHRP Division of Education and Development and are intended to provide information regarding the requirements of the Department of Health and Human Services (HHS) regulations for the protection of human subjects at 45 CFR part 46. The videos represent OHRP's current thinking on these topics and should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word must in OHRP guidance means that something is required under HHS regulations at 45 CFR part 46. The use of the word should in OHRP guidance means that something is recommended or suggested, but not required. An institution may use an alternative approach if the approach satisfies the requirements of the HHS regulations at 45 CFR part 46. OHRP is available to discuss alternative approaches at 240-453-6900 or 866-447-4777.

Learn more about the Office for Human Rights Protections (OHRP) at http://www.hhs.gov/ohrp.

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

Research Use of Human Biological Specimens and Other Private Information

Note: This video was created before the 2018 revisions of the Common Rule and may include information that is not up to date.

Ms. Julie Kaneshiro, Office for Human Research Protections (OHRP) Policy Team Leader, is interviewed and discusses the challenges and complexities of the application of the HHS regulations at 45 CFR part 46 to activities involving biological specimens and other private information. Ms. Kaneshiro discusses how to assess whether an activity constitutes non-exempt human subjects research. She clarifies when the HHS regulations do and do not apply to an activity and when an institution is engaged in human subjects research. This is an advanced topic video and is best suited to viewing by individuals already possessing a basic understanding of the HHS regulations for the protection of human subjects.

OHRP educational videos were developed by the OHRP Division of Education and Development and are intended to provide information regarding the requirements of the Department of Health and Human Services (HHS) regulations for the protection of human subjects at 45 CFR part 46. The videos represent OHRP's current thinking on these topics and should be viewed as recommendations unless specific regulatory requirements are cited. The use of the word must in OHRP guidance means that something is required under HHS regulations at 45 CFR part 46. The use of the word should in OHRP guidance means that something is recommended or suggested, but not required. An institution may use an alternative approach if the approach satisfies the requirements of the HHS regulations at 45 CFR part 46. OHRP is available to discuss alternative approaches at 240-453-6900 or 866-447-4777.

Learn more about the Office for Human Rights Protections (OHRP) at http://www.hhs.gov/ohrp.

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.

Content created by Office for Human Research Protections (OHRP)
Content last reviewed