Guidance Apr 16, 2015 Unanticipated Problems Involving Risks to Subjects or Others For information about other types of required reporting, see the Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), and Other Required Reporting page. Also see the University of Michigan Human Research Protection Program...
Policies Feb 18, 2015 Statement of Practice: External Adverse Event Reports & Unanticipated Problems Click here for PDF version. UM investigators participating in multi-site trials and those using sponsored agents routinely receive reports of external adverse events . Office of Human Research Protections (OHRP) guidance indicates that individual...
Templates Jan 13, 2014 Assent Template (Recommended for ages 10 to 14-years-old as well as 14 to 17-year-olds when the study involves drug or pregnancy testing and/or birth control.) Return to I nformed Consent Templates page.
Guidance Mar 8, 2013 Electronic Records and Electronic Signatures (21 CFR Part 11) - ARCHIVED 11/8/2021: This page has been archived. UMMS Regulatory Affairs maintains documentation regarding FDA Part 11 compliance at Data Integrity and Sharing (level-2 login required). The regulations in 21 CFR Part 11 set forth the criteria under which FDA...
Guidance Apr 18, 2012 Who May Consent for Participation in Research Studies (Michigan) Participant = Minor Participant = Incapacitated / Incompetent Adult Outpatient Psychotherapy Minor age 14 or over if seeking limited confidential outpatient psychotherapy services under M.C.L. §330.1707 Parent(s)* with legal custody or guardian† See...
Guidance Apr 17, 2012 Federal Regulations - ARCHIVED 04/23/2021: This page has been archived. IRBMED Guidance pages throughout Research A-Z link to relevant federal websites Regulations enforced by the Food and Drug Administration (FDA) 21 CFR 50 -- Protection of Human Subjects 21 CFR 56 --...
Guidance Jun 17, 2011 AHRQ: Mandatory Use of Data Safety and Monitoring Plans The Agency for Healthcare Research and Quality ( AHRQ ) has issued notice requiring Data Safety and Monitoring Plans (DSMPs) for certain AHRQ-conducted or -supported projects. As of May 6, 2011, the inclusion of DSMPs will be considered pa of...
Guidance Jul 24, 2007 Guidelines For Using Magnitude Of Harm In Categorizing Risk Level The probability* and magnitude of harm or discomfort anticipated in the research and not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or...
