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Policies
Jun 18, 2020

Use and Distribution of Biospecimens and Data Policy

This policy operates subject to the Medical School Governing UMMS Research Biorepositories Policy ("Research Biorepositories Policy") and applies to all Central Biorepository (CBR) resources. This policy establishes a framework for appropriate...
Tags: Data Use Biorepository Use
Templates
Nov 27, 2018

Biorepository Informed Consent Informational Sheet (editable PDF)

This illustrated biorepository informational sheet is designed to accompany the biorepository informed consent template . Below, click the button that corresponds to the type of biorepository you plan to submit to: the university's Central...
Tags: Regulatory
Guidance
Feb 26, 2021

Elements and Uses of a Repository

A research repository is defined as a collection of data/biospecimens that have been collected and stored with the intention of using the materials for future research , either by the investigator who collected them or by sharing the materials with...
Guidance
Feb 17, 2017

Repository Overview

Data and biospecimen repositories (sometimes called registries, banks , or libraries) are used to store data, with or without biospecimens, for future research use. Federal regulations and U-M policies that protect the privacy of patients 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...
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). It operates subject to the UMMS Policy Governing Tissue Sample Collection, Ownership...
Tags: Data Use Biorepository Use
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...
Templates
Dec 16, 2020

Central Biorepository Memorandum of Understanding Regarding Use of CBR Resources

The CBR plans to provide certain materials (biospecimens and/or data associated with or derived from them) (“CBR resources”) from individuals who have participated as research subjects in the CBR (“CBR participants”), for use in the research project...
Tags: Access
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
Nov 25, 2021

Specialty Informed Consent Templates

Obtaining the consent of a subject is a process that goes far beyond asking for a signature on a document. Potential participants must understand the nature of the study, the risks, discomforts, inconveniences, and potential benefits involved if...
Tags: Regulatory Study Coordinator Principal Investigator Participant Management Study Teams
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...
Informational
Dec 17, 2020

Guidance for Writing HUM Applications for Creating a Biorepository 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 creating a biospecimen collection. IRBMED may require more information...
Policies
Feb 27, 2020

Privacy and Confidentiality Protections for Individual-Level Data Policy

This policy operates subject to all applicable laws, regulations, and U-M policies regarding protection of clinical and research data. It sets standards specific to Central Biorepository (CBR) operations in accordance with sound ethical principles...
Tags: Data Use Biorepository Use
Guidance
Feb 16, 2022

Research Involving Genetic, Genomic, and/or DNA Collection or Analysis

This guidance document outlines IRB expectations for research involving genetic analysis which generates or uses human genetic information through analysis of human biospecimens and/or data. For this guidance, the relevant human genetic information...
Templates
Apr 17, 2018

Biorepository Informed Consent Template

This biorepository informed consent template is designed to be accompanied by the illustrated biorepository informational sheet . Clinical teams engaging with the patients are provided with the Biorepository Consent and Authorization template to...
Templates
Jul 9, 2018

CBR Use Proposal Form

Central Biorepository staff will use the information you provide in this form to make contact with the investigator(s) who collected the materials that might be useful to your project, begin to identify candidate samples, and assess and advise on...
Tags: Access
Guidance
Feb 15, 2019

FAQ: Repository application (REP)

Policies
Jun 15, 2017

Establishment of New Biospecimen Collections Policy

This policy operates subject to the University of Michigan Medical School ( UMMS ) Policy Governing Tissue Sample Collection, Ownership, Usage, and Disposition Within All UMMS Research Biorepositories (“UMMS Tissue Ownership Policy”) and applies to...
Tags: Data Use Biorepository Use

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