Policies
Aug 28, 2018

Statement of Practice: Interpretation of Expedited Category (8)

Expedited Category (8) pertains to the continuing review of research, regardless of its previously determined risk level. The IRB member performing expedited review under category 8 must determine that the ongoing and future research activity...
Policies
Aug 28, 2018

Statement of Practice: Interpretation of Expedited Category (5)

Expedited Category (5) pertains to research involving data/materials that have been collected previously for research or non-research purposes and/or will be collected solely for non-research purposes, provided that certain criteria are met. Click...
Templates
Jul 20, 2018

Foreign Language Short Forms

Investigators are responsible for understanding and following the IRBMED Guidance for non-English speaking subjects before using the forms below. Please note, the instructions on this page are for filling out the form, NOT the guidance for using a...
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

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...
Guidance
May 30, 2018

Blood Draw Guidelines

The whole blood volume is used as a general guide in estimating reasonable volumes of blood that can be removed safely. The table below shows values for mean blood volume in children , men and women (Geigy Scientific Tables, 7th Ed; 1971): Whole...
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 University of...
Guidance
May 9, 2018

Payment to Research Subjects

The IRBMED reviewers look at each project individually in order to assess the risks and benefits involved. There is no set guideline regarding the total amount of payment investigators may give to study participants. Payments to subjects are not...
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 UM-Expanded-Access-Request@med.umich.edu 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

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

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
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...

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