Policies Jul 10, 2020 Statement of Practice: eResearch Cross-Reference Table IRBMED has developed the eResearch Cross-Reference Table and Guide to guide study team members, IRB staff, and IRB board members in achieving complete and consistent resolution of all IRB review contingencies. Click here for PDF version. Tags: IRBMED Statement of Practice
Guidance Jul 8, 2020 Exempt Human Subjects Research This page contains information regarding human subjects research that falls within the federal exemption categories or U-M exemption categories . Exempt human subjects research does require an application and determination in the eResearch system...
Policies Feb 12, 2020 Statement of Practice: IRBMED Finalization of Study Documents This document replaces: ‘ Approval Dates on Consent Documents and Recruitment Materials ’ Statement of Practice. Click here for PDF version. Tags: IRBMED Statement of Practice
Policies Aug 5, 2019 Statement of Practice: Ancillary Approval & Final IRBMED Approval Click here for PDF version .
Guidance Jan 16, 2019 Transition to 2018 Regulations - ARCHIVED 04/23/2021: This page has been archived. This transition is largely complete. All new applications are evaluated according to 2018 Revised Common Rule. With questions, contact your IRB staff. On January 21, 2019 most provisions of the Revised Common...
Guidance Jun 11, 2018 Adverse Event Reporting Internal adverse events are events that involve subjects or others whom the UM investigator is responsible for and/or events for which a UM IRB has direct oversight. These guidelines apply only to IRBMED reporting. They do not apply to required...
Guidance Jun 11, 2018 Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), & Other Required Reporting Investigators and research staff are responsible for reporting information concerning the approved research to the IRB in a timely fashion, understanding and adhering to the reporting guidance provided here and on the detail pages linked below, and...
Guidance May 22, 2018 UMMS Biorepository Registration Decision Tree This decision tree represents UMMS policy for registration of biorepositories funded by a UMMS Department , and/or operating in UMMS space, and/or directed by faculty with an appointment in the Medical School. For more information, see Medical...
Templates May 4, 2018 Data Office Data Request Form To request data, complete a Data Request Form, which includes IRB information (if applicable), study team information and where you will store your data. Note: You may save your work and submit at a later time Tags: Data Use
Templates Mar 13, 2018 Data Office Access Request Form Request an account for a self-serve tool through this online form through Jira. If you have issues accessing this page, please contact the Data Office at [email protected] . Tags: Data Use
Templates Mar 13, 2018 Data Office Data Set Specification To request data, complete a Data Set Specification to define your subject population (inclusion/ exclusion criteria) and the data elements needed in your data set. Note: You may save your work and submit at a later time Tags: Data Use
Guidance Feb 1, 2018 Exempt Under OHRP/FDA, but Regulated by HIPAA Applications - ARCHIVED 04/23/2021: This page has been archived. Please refer to the more comprehensive Exempt human subjects research and Federal Exemption Categories pages.
Policies Jun 15, 2017 Institutional Review Board Oversight Policy This policy is to ensure that Central Biorepository (“CBR”) operations, and research projects facilitated by the CBR, undergo appropriate ethics committee review to protect human research subjects.
Policies May 26, 2017 Statement of Practice: Sections 15 and 16 of IRB Application Click here for PDF version. What Agents/Articles must be listed in Sections 15 and 16 of the IRBMED eResearch application? Note : This document outlines IRBMED recommendations for completing the eResearch application. Other committees may make...
Guidance Feb 17, 2017 Responsibility for REP Oversight and Compliance REP application and Application Supplement Form capture several different levels and types of information about a repository's processes and intents, including: information characterizing a repository to identify useful relationships for researchers...
Guidance Aug 14, 2015 External Adverse Event (AE) Reporting This page explains the required reporting for 'external' AEs. These are events that are under the direct oversight of non -UM investigators and non -UM IRBs , events about which the UM investigator receives a report, usually from the study sponsor...
Guidance Jul 20, 2015 eResearch Regulatory Management (eRRM) eResearch Regulatory Management (eRRM) is the web-based system that centralizes the review and approval process for Human Subjects Research Applications and IBC Biosafety Registrations.
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...
Guidance Mar 12, 2012 Study-Specific AE Reporting Click to review previous steps Step 1 Step 2 Refer to the IRB - approved documents for the specific study that includes a detailed plan for AE reporting . Follow the directions in the plan for reporting to oversight bodies (e.g. DSMB , sponsor, IRB...
