Office for Human Research Protections (OHRP)
OHRP educational videos were developed by OHRP's 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 provided below represent OHRP's current thinking on the topics presented, and should be veiwed as recommendations unless specific requirements are cited.
OHRP: Research Use of Human Biological Specimens and Other Private Information
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: Reviewing and Reporting Unanticipated Problems and Adverse Events
Dr. Michael Carome, former Office for Human Research Protections (OHRP) Associate Director of Regulatory Affairs, is interviewed and discusses the criteria for determining if, in the context of human subjects research, an experience, incident, or outcome is an unanticipated problem involving risk to subjects or others, as described in the HHS regulations at 45 CFR part 46. He discusses the differences between adverse events and unanticipated problems and appropriate responses for investigators, IRBs, and institutions when encountering an unanticipated problem. He also discusses prompt reporting requirements and the difference between external and internal unanticipated problems, what to do in the case of multi-center research, and what information that should be reported to OHRP.
OHRP: General Informed Consent Requirements
In this Office for Human Research Protections (OHRP) video, all of the characters are fictional. This presentation takes part in two scenes. In the first scene an investigator meets with an expert to go over some issues for obtaining legally effective informed consent from potential subjects with schizophrenia before submitting her protocol to the IRB. These issues include determining capacity to consent, using a legally authorized representative, and meeting the regulatory requirements for the process of informed consent. In the second scene, Dr. Presley obtains appropriate informed consent from a potential subject, Mr. Smith, who has the capacity to consent.
OHRP: Research Involving Vulnerable Populations
In this Office for Human Research Protections (OHRP) video, all of the characters are fictional. This video presentation on the additional protections for certain vulnerable subjects, including pregnant women, children, and prisoners starts out at the end of a panel presentation on the additional protections afforded to vulnerable populations described in the subparts B, C, and D or the HHS regulations at 45 CFR part 46.
When the video starts, you will see a fictional OHRP presenter summarizing the key points of the just completed presentation to the audience. She then invites questions from the audience, where she and her colleague (also a fictional OHRP presenter) respond to some rather complex and interesting questions regarding vulnerable populations.
OHRP: IRB Membership
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.