UNIVERSITY OF MICHIGAN MEDICAL SCHOOL

IRBMED Home Forms Informed Consent Templates Guidance Education About IRBMED Resources AE/ORIO/Unanticipated Problems IRBMED Members Research Participants

IRBMED
517 W. William, Argus I,
Ann Arbor , MI 48103-4943
Email: irbmed@umich.edu
Phone: (734) 763 4768
FAX (734) 763 9603

Guidance: General Guidelines

The following is a list of the most basic information needed by every investigator. Please refer to the links in the list below, the IRBMED's Standard Operating Procedures, the IRBMED Guidance Page, and the IRBMED Education Page for details and additional information.

• IRB approval is required prior to commencing research involving human subjects or private information about human subjects/patients. Click for federal definitions. Applications are found at the IRBMED Forms page.
  • Studies are approved until the end of their expiration date.  That is, a study with an expiration date of July 4 is considered "approved" until 11:59pm on July 4.  It becomes "expired" as of 12:00am on July 5.
• If your study expires, you may not conduct any work on it until appropriate approval has been re-established, except as necessary to eliminate apparent immediate hazards to research subjects. Should the latter occur, you must notify the IRB Office as soon as possible.
• The scope of IRBMED jurisdiction is set forth in the Decision Rules for Selection of a Particular IRB for Research Proposal Review established by OVPR .
• The principal investigator (PI) is responsible for the conduct of the study. This includes:
• adhering to IRBMED and Institutional policies , as well as applicable federal , and state laws
• assuring all study team members are appropriately trained and supervised
• obtaining and maintaining IRB approval
• assuring amendments (changes in the research) are not implemented prior to obtaining the approval of the IRB, including those changes perceived to reduce risk (except for changes to eliminate apparent immediate hazards to the subject which must be reported within 7 days after the action is taken).
• notifying the IRB of adverse events (AEs) and other reportable information and occurrences (ORIOs) according to posted guidance
• notifying the IRB of study completion. Allowing a study's IRBMED approval to expire does not terminate the study (although the IRB may administratively terminate a lapsed study as outline in the Standard Operation Procedures).
  • If the investigator has left the University and cannot be located, the department chair's signature (Legacy)may be substituted for the principal investigator's , but this should be explicitly noted on the application. Ask the IRB for assistance in eResearch.
  • The study ends when data-analysis using records linkable to particular subjects is completed (not when enrollment and/or subject interaction ends).
• assuring and that study activities are documented according to legal and accepted research integrity standards (see MICHR Clinical Research Regulatory Checklist and the DHHS Office of Research Integrity's Introduction to the Responsible Conduct of Research ) .
• Allow 8-10 weeks for review of new project, scheduled continuation (renewal), and amendment applications. IRBMED turnaround time is currently averaging 6-8 weeks (goal is 4 weeks), but investigators should allow more time "just in case."
• Informed consent and HIPAA authorization must be sought from subjects except in cases where the IRB explicitly grants a waiver. For details, refer to the Guidance Page under the Informed Consent heading.