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 of 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. She and her colleague (also a fictional OHRP presenter) respond to some rather complex and interesting questions regarding vulnerable populations.
HHS/OHRP 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) by clicking here.
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 should be reported to OHRP.