活動期間: 2014 Jun 01~Sep 30
時間: 請來電預約02-22648982或線上填寫報名表; 每次諮詢時間1.5小時
對象: 1. 剛加入臨床試驗領域一年內，
The following educational videos were developed by the 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.
OHRP anticipates the release of additional training videos in the future. We welcome any feedback or suggestions on content, format, or any other aspect of the training videos. Please send your comments to OHRP@hhs.gov.
These videos are also listed on the OHRP YouTube Playlist.
Mrs. Julie Kaneshiro, 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. Mrs. 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. This video is also available in RealPlayer format at http://videocast.nih.gov/ram/ohrp_kaneshiro.ram
Reviewing and Reporting Unanticipated Problems and Adverse Events
Dr. Michael Carome, former 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. This video is also available in RealPlayer format athttp://videocast.nih.gov/ram/ohrp_carome.ram
General Informed Consent Requirements
In this video, all of the characters are fictional. This presentation takes part in two scenes. In the first scene an investigator meets with the IRB Chair 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.
Institutional Review Board (IRB) Membership
In this 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.
Complex Issues with Research Involving Vulnerable Populations
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.
This video provides information regarding the IRB records requirements described at 45 CFR part 46. All of the characters are fictional. 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 the first scene, the institutional official, Dr. Westerberg, is meeting with the consultant, Ms. Williams, to discuss a plan of action related to some of the findings made by Ms. Williams.
IRB Records II: In the second scene, Ms. Williams is meeting 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.
To view the videos in RealPlayer format, you must have the Real® Media player installed on your computer to view the training modules. Click the following link to Download the free Real® Media player: http://www.real.com/realplayer. The RealPlayer format videos are hosted on the NIH website. If you have technical difficulties with viewing the videos, please see: http://videocast.nih.gov/faq/#topic4