Guidance May 7, 2018 Expedited Review The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) regulations for the protection of human subjects recognize that not all research warrants review by the full IRB at a convened meeting. Accordingly, DHHS...
Guidance May 7, 2018 Deception and Concealment Deception in human subjects research means deliberately misleading subjects about the nature of a study. Concealment means deliberately withholding certain information. Studies involving deception or concealment must meet all criteria for a waiver...
Guidance May 7, 2018 FDA Expanded Access Program at the University of Michigan For assistance in obtaining approval to use an Expanded Access investigational product, contact MICHR IND / IDE Investigator Assistance Program (MIAP) by emailing [email protected] The FDA Expanded Access program allows a...
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
Informational Apr 30, 2018 Post-Award Information “Post-Award” comprises everything that happens to administer a research project, following the official award being received. The following pages contain resources, tools and guidance that is available to assist our Research Administrators with...
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’...
Templates Apr 17, 2018 Survey Research Informed Consent Template This template should be used when creating a Survey Research informed consent document. This template may be used only for studies that involve a survey and no other procedures pose minimal risk to subjects
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...
Guidance Apr 10, 2018 Clinical Research Billing Guidance (CRB) The Clinical Research Billing (CRB) process insures that services provided as part of a clinical study are billed properly to the sponsor or third-party payor. Many organizations (on campus and off) are involved, and compliance is required at... Tags: CRAO
Policies Mar 23, 2018 Indirect Cost Recovery The Medical School's expectations regarding the recovery of indirect costs from Federal, Industry/For-Profit, and Non-Profit sponsor s.
Policies Mar 19, 2018 Consent and HIPAA Privacy Rule Authorization Policy This policy aims to ensure that donor preferences are given due respect in the conduct of research projects that are facilitated by the Central Biorepository (CBR). This policy operates subject to the University of Michigan Medical School Policy for... Tags: Data Use Biorepository 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.
Guidance Jan 3, 2018 NIH Genomic Data Sharing Policy All U-M IRBs ( IRBMED , IRB-HSBS , IRB-Dearborn, IRB-Flint) follow the same policy for genomic data sharing. Before submitting your application to conduct research involving genomic data sharing, please review U-M's policy page and the guidance...
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.
Policies Jun 17, 2017 University of Michigan Medical School Central Biorepository Policy Acknowledgment and Authorship It is important to recognize the University of Michigan Medical School (UMMS) Central Biorepository (CBR) and the Principal Investigators who collect research materials for the contributions they make to scientific advancement of projects utilizing...
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.
Guidance Jun 5, 2017 Telephonic Consent - ARCHIVED 12/15/2021: This page has been archived. See Electronic Informed Consent and Waivers under OHRP, FDA and HIPAA pages for up-to-date information on similar topics. In most cases, a potential research subject (or subject's representative) must be...
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...
