NEW! OHRP Webinar Series on the Common Rule NPRM
6 Key Topics Covered – Watch Now!
- Overview of the NPRM (approx. 34 mins.), Jerry Menikoff, Director, OHRP
- Exclusions and Exemptions (approx. 30 mins.), Jerry Menikoff, Director, OHRP
- Informed Consent (approx. 28 mins.), Jerry Menikoff, Director, OHRP
- IRB Review and Operations (approx. 18 mins.), Julia Gorey, Policy Analyst, Division of Policy and Assurances, OHRP
- Research with Biospecimens (approx. 22 mins.), Julie Kaneshiro, Deputy Director, OHRP
- Secondary Research Use of Data (approx. 21 mins.), Ivor Pritchard, Senior Advisor to the Director, OHRP
See more information about the NPRM.
Training Videos and Webinars
OHRP is pleased to announce the availability on the HHS YouTube channel of educational videos developed by the Division of Education and Development. These videos provide information on a variety of topics regarding the Department of Health and Human Services (HHS) regulations for the protection of human subjects of research described at 45 CFR part 46. Each video is approximately 20-25 minutes in length. An institution may reproduce or share these materials for educational purposes and may wish to consider incorporating the materials in their training programs.
OHRP also has a webinar series.Webinars vary in length but are generally one hour.
Videotape Series: "Protecting Human Subjects"
Description: The Office for Protection from Research Risks produced a videotape series entitled "PROTECTING HUMAN SUBJECTS," that consists of three instructional videotapes, as follows:
- "EVOLVING CONCERN: Protection for Human Subjects" traces the development of today's comprehensive program to protect human subjects of research out of earlier ethical codes and societal concerns. This film selected historic events in behavioral and biomedical research to show why protection is needed and how it came about.
- "BALANCING SOCIETY'S MANDATES: Criteria for Protocol Review" depicts an Institutional Review Board (IRB) in action. Dr. Edmund Pellegrino, Director of the Kennedy Institute of Ethics, explains the basis for the criteria that an IRB follows in reviewing research. In commenting on IRB deliberations he points out why the IRB seeks clarification and information from the researcher.
- "THE BELMONT REPORT: Basic Ethical Principles and Their Application" describes the basic ethical principles that underlie research involving human subjects; respect for persons, beneficence, and justice. This film illustrates their application in case studies of biomedical and behavioral research and shows the principles at work in the resolution of ethical conflicts.
Suggested Audiences: Researchers, institutional officials, reviewers, students, investigators, IRB members, and staff may also find the material useful.
Ordering Information: The video is provided free of charge. Please send your request to OHRP-EDU@hhs.gov or call (240) 453-8142 or (240) 453-6900.
You can also access a digitalized version of this videotape series online at the HHS HRSA website
OHRP/PRIM&R “INVESTIGATOR 101” CD ROM
CME credits: PRIM&R will produce a certificate of completion for individuals who have viewed the training video and completed the post-training test which achieves a score of 70 percent or higher (test must be returned to PRIM&R for scoring). The certificate of completion may then be used to apply for Category 2 CME credit. (For more information about CME credits, please see: Center for Continuing Medical Education FAQs, at http://www.mecme.org/Page.aspx?pid=15.)
On-Line Training Modules
OHRP offers an on-line tutorial that includes three modules related to roles, requirements, and procedures in conducting research involving human subjects. This tutorial consists of three modules:
Click on any module title to be taken to the tutorial log-in page.
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 orgaization'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
URL = http://www.hhs.gov/ohrp/humansubjects/assurance/consentckls.htm - DOES NOT WORK
Informed Consent, Legally Effective and Prospectively Obtained
URL = http://www.hhs.gov/ohrp/humansubjects/guidance/hsdc93-03.htm - DOES NOT WORK
Informed Consent, Non-English Speakers
URL = http://www.hhs.gov/ohrp/humansubjects/guidance/ic-non-e.htm - DOES NOT WORK
Certificates of Confidentiality
URL = http://www.hhs.gov/ohrp/humansubjects/guidance/certconf.htm - DOES NOT WORK
Similarly, in Module 3 "Human Research Protection Program", on page 23 of 25:
Institutional Review Board Guidebook
Description: The 1993 Guidebook is designed to assist institutional review board (IRB) members, research, and institutional administrators in fulfilling their responsibilities for protecting the rights and welfare of human subjects as defined in the HHS regulations (45 CFR 46) entitled, "Protection of Human Subjects," revised June 18, 1991. 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 presents, wherever possible, areas where ethicists and others concerned with these issues have arrived at a consensus on the ethical acceptability of a particular activity or method. Constructed in a loose leaf format, this book holds the regulations and policies, relevant institutional documents, text dealing with specific topics, a glossary of terms, and a bibliography.
Suggested Audience: The Guidebook is also intended to be a resource that will serve as the focal point of IRB administrators and IRB members involved in human subjects work.
The Guidebook is available Online at this website.
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.