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 It is obsolete as of June 11, 2018.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...

Click to review previous steps Step 1 Step 2 Refer to the IRB - approved documents for the specific study that includes a detailed plan for AE reporting . Follow the directions in the plan for reporting to oversight bodies (e.g. DSMB , sponsor, IRB...

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...

The regulations in 21 CFR Part 11 set forth the criteria under which FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper...

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...

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...

The probability* and magnitude of harm or discomfort anticipated in the research and not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or...

The term “ test article ” is found in the FDA regulations on Protection of Human Subjects ( 21 CFR 50.3, Definitions (j)). The term includes drugs (including botanicals, biologicals , and gene therapy, and genetically derived products that meet the...