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Opening Remarks by David Schteingart 00:00:00 Introduction of Daniel Federman 00:01:34 Talk by Daniel Federman 00:03:20 Individual Participant / Participant Perspective 00:04:41 Responsible Research - Protect Every Research Participant 00:09:53 - What is an HRPPP? 00:11:17 - highest ethical standard 00:16:03 - accountability etc. 00:17:52 - necessary conditions 00:19:51 - Refocus protocol review 00:20:53 - Informed consent 00:25:41 - Risk appropriate monitoring 00:29:03 - Compensation for injury and costs 00:30:51 Panel Discussion led by Gilbert Omenn 00:33:12 The Role of Academic Medical Centers 00:33:25 The Societal Compact 00:33:55 Clinical Research Trends - Favorable Factors 00:35:17 Research America 00:35:47 The U.S. should remain a leader in medical research 00:35:56 Value of clinical research 00:36:13 Good Hospitals Conduct Medical Research and Train Medical Students 00:36:22 How likely would you be to participate in a clinical research study? 00:36:40 Introduction to Dorene Markel 00:37:07 U of M Improvements and Initiatives 00:37:30 University Initiative 00:39:16 MPRIME Functional Overview 00:40:14 Medical School Initiative 00:40:47 Panel Discussion - Edward Goldman 00:42:19 Case presentation #1 00:43:12 Case presentation #2 00:44:25 Case presentation #3 00:45:39 Case presentation #4 00:47:30 Case Presentation Summaries - Vernon Sondak 00:50:21 Human Subjects Protection Compliance with regulations is not enough 00:50:41 Human Subjects Protection Compliance with regulations is not enough 00:51:40 Human Subjects Protection How are our IRBs doing? 00:54:32 Human Subjects Protection The Therapeutic Misconception 00:55:27 Human Subjects Protections Are we worried about the right things? 00:56:50 Closing Remarks by Gilbert Omenn 00:57:46 Closing Remarks by Daniel Federman 00:59:14
