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.

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.

In most cases, a potential research subject (or subject's representative) must be given an explanation of the protocol , including its risks , benefits , and alternatives. The subject's voluntary and un-coerced choice to participate must usually be...

This policy addresses requests for reduced overhead recovery through the Indirect Cost Waiver mechanism.

This template should be used when creating an FDA Expanded Access informed consent document. This template is designed for use in all Expanded Access uses, which include both Compassionate Use and Emergency Use. For more information on specific...

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...

This guidance describes the circumstances regarding Expanded Access Emergency Use ( Emergency Use ) of an investigational product (drug, biologic , or device) and the procedures to be followed before or immediately following the emergency use of an...

This policy describes the process and conditions for Medical School units seeking a reduction of indirect costs on pass-through expenses related to clinical trial patient payments on federal projects. Please review the School’s companion policy on...