Guidance Sep 21, 2020 Waiver or Alteration of HIPAA Authorization To use and/or disclose Protected Health Information (PHI) for research purposes , the HIPAA Privacy Rule in general requires that researchers obtain signed authorization from the individual. An IRB can grant a Waiver of HIPAA Authorization to permit...
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
Informational Nov 22, 2017 Handling Patient Data General Security Guidelines To minimize the risk of unauthorized disclosure of patient data and other sensitive information, data security must be a top priority for all. Research performed at the University of Michigan is governed by related institutional policies.
Templates Apr 17, 2018 Eligibility Screening Informed Consent Template This template should be used when creating an Eligibility Screening Informed Consent document. This template may be used only for eligibility screening and only if screening procedures pose no more than minimal risk to subjects. You may not use this...
Templates Apr 17, 2018 One-Time Blood or Tissue Sample (Minimal Risk) Informed Consent Template This template should be used when creating a One-Time Blood or Specimen Sample ( Minimal Risk ) informed consent document. You may not use this template if you plan to conduct genetic analysis on subjects’ samples you plan to submit subjects’...
Informational Dec 17, 2020 Guidance for Writing HUM Applications for Access to Biospecimens Stored at the CBR This page provides guidance on policies and practices related to CBR activities. It is not an exhaustive set of instructions on how you should complete your HUM application for secondary use of biospecimens. IRBMED may require more information from...
Templates Apr 15, 2024 Standard Informed Consent Template New IRBMED studies should most often use the latest Standard Informed Consent template available on this webpage. Specialty Consent Templates may be appropriate for low-risk studies with simpler study methodologies.
Guidance Aug 31, 2020 Certification Preparatory to Research Review of data and/or biospecimens preparatory to research are not regulated under the Common Rule if any data obtained is not used for future research. However, if you or any member of the study team will be accessing Protected Health Information (...
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...
Guidance Oct 17, 2011 Non-Regulated under FDA/OHRP, but Regulated under HIPAA Applications - ARCHIVED 04/23/2021: This page has been archived. Please refer to the more comprehensive pages: Certification Preparatory to Research Decedents De-identified Limited Data Sets
Guidance Feb 17, 2017 Tips on the REP Application and Supplement Form An REP application must include an Application Supplement Form, uploaded in Section 08 . The Application Supplement Form, in combination with the eResearch Repository application (REP), to provides a comprehensive overview of the repository's...
Policies Dec 14, 2023 Required Use of Clinical Research Coordinator Career Ladder This policy outlines the required use of the Clinical Research Coordinator (CRC) career ladder. Tags: Study Coordinator
Policies Apr 1, 2023 Establishment of Biospecimen Collections Within the Central Biorepository The UMMS Central Biorepository (CBR) is a repository of human biospecimens that serves as central storage facility, point of research access, and administrative hub for research using these biospecimens and data associated with, or derived from them... Tags: Data Use Biorepository Use
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 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...
Policies May 1, 2015 Statement of Practice: Flexibility Initiative: Exemption 7 - ARCHIVED This flexibility initiative was active May 1, 2015 - June 10, 2018. It is obsolete as of June 11, 2018. Note : IRB applications granted Exemption 7 may not be used to support proposals or future awards involving federal funding. Note : Exemption 7...
Guidance Jul 8, 2020 Federal Exemption Categories Federal regulations governing human subjects protection specify categories of “human subjects research” that are “exempt from this policy.” [ 45 CFR 46.104 ]. See also OHRP's Human Subject Regulations Decision Charts: 2018 Requirements The federal...
Guidance Oct 27, 2023 Other Reportable Information or Occurrence (ORIO) Investigators sometimes receive information that has a direct impact on a research study. This information is reportable to the IRBMED . Frequently this information falls within the Adverse Event Reporting context, or it is reported to IRBMED in...
Templates Jun 1, 2018 Data & Biospecimen Sharing Checklist This checklist is to be used when individual-level patient/participant data or biospecimens are to be transferred to an external for-profit organization. Tags: Data Use Biorepository Use Access
