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

Forms

• New Projects
• Previously Approved Projects
• Waivers for Informed consent and HIPAA (not required if using eResearch)
• eResearch Header/Footer for Miscellaneous Documents
• eResearch Package Cover Sheet
• Recruitment Advertising Flyer Templates
• Ward of State Advocate Checklist (also see Wards of State Guidance)
• Other Information

New Projects

• New Project Application
  Use the new project application in eResearch for both standard applications and exemption requests.
  1. Click on the New Project Application link which will take you to the eResearch homepage.
  2. Review the "How to" instructions found in the link in the left column.
  3. Return to the eResearch home page.
  4. To start an application click on the "Log-in" button in the left column.
  5. On the next screen, click the "New Study" button in the left column under the Create header.
  6. An application opens. Complete the questions on each page. Click the "Continue" button to both save input information and advance forward in the application. This button appears on both the top and bottom of the right side of the screen.
  7. Using the "continue" button will invoke 'smart form' logic which will route you to only those sections of the applications you are required to complete.
  8. If you 'jump' to different sections of the application your information will be saved but you risk completing sections that are not required.
  9. When the application is complete the principal investigator must hit the 'submit' button in the homespace of the application.
• Emergency Use Report
  Use the new project application in eResearch (see instructions in "New Project" above), indicating in section 1.12 whether the report is for use of an investigational drug or device. IRBMED recommends both calling and emailing the office as soon as the decision to use an investigational agent for clinical purposes is made. After hours and on weekends, in addition to emailing the office, ask the UMHS operator (734-936-4000) to page the IRBMED chair on-call.
• Humanitarian Use Device Application
  Use the new project application in eResearch (see instructions in "New Project" above), indicating in section 1.12 the application type.

Previously Approved Projects

Note: When submitting the renewal application it is helpful to check if the informed consent template has been changed in a manner that impacts your study. See the What's New: Informed Consent Templates page. REMINDER--Update to the new IRBMED Informed Consent Document Template required on new studies, a subset of renewals (eResearch studies must update via an amendment application) and informed consent amendments submitted after 11/1/2007

Projects Approved in the Legacy (paper-based) system

• Previously Approved Application
  Projects approved in the legacy system must use legacy to report adverse events, ORIOs, amendments, scheduled-continuation review (SCR), and termination until notified that the study has been converted to eResearch.

  Note that when submitting the SCR it is helpful to check if the informed consent template has been changed in a manner that impacts your study. See the What's New: Informed Consent Templates page.

Projects Approved in eResearch

• eResearch
  
  1. Click on the eResearch link which will take you to the eResearch homepage.
  2. Click on the "Log-in" button in the left column.
  3. On the next screen, click the "Approved Studies" tab in the center of the page.
  4. Click on the link (i.e. the title) of the particular study you need to amend, renew, terminate, or for which you need to submit an adverse event or ORIO (other reportable information or occurences).
  5. Click on the needed function tab in the left lower column of the study's home space (as seen in the illustration below).
  6. Use "New Continuing Review" to renew or terminate the study, as appropriate.
     

Informed Consent and HIPAA Authorization Waiver Requests

Use these forms only if amending a project previously approved in the legacy (paper-based) system. These forms are not required in eResearch.

Use these forms only when an amendment to the protocol is proposed and the project has previously received an IRBMED waiver or alteration of informed consent or waiver of documentation of informed consent.

• Complete Waiver
  Examples: studies involving record review where subjects permission will not be sought; requests to search Careweb for potential subjects; some tissue studies.
  
  
• Alteration of the Consent Form or Process
  Examples: studies involving deception where the informed consent document cannot reveal all aspects of the study prior to the research procedure.
  
  
• Documentation Waiver
  This is used when there will be consent process but the subject's signature will not be required. Examples: studies where the informed consent document itself poses the greatest risk to the subject; survey studies where the only interaction with subjects is completion of a survey by mail or internet.

Additional Waiver Information

• Waiver of Informed Consent under OHRP, FDA & HIPAA

eResearch

• eResearch Package Cover Sheet
  Use this cover sheet when submitting three-dimensional objects to the IRB Office that are associated with a particular eResearch submission. For example, complete the cover sheet when submitting a DVD with a movie for subjects that was too large to upload into the on-line form. Sample: http://www.med.umich.edu/irbmed/forms/sample.pdf

 

• eResearch Header/Footer for Miscellaneous Documents

Recruitment Advertising Flyer Templates

Researchers are NOT required to use these templates. They are offered as an example of the type of flyer typically approved. You may change the fonts, colors, add logos, artwork, etc. Do not make monetary compensation a larger font than the expected risks.

These templates include the header for 'watermarking' in eResearch. The flyer must be saved and uploaded into eResearch as a .DOC to enable the watermarking function.

• 8-1/2 x 11 Flyer
• 11 x 8-1/2 Flyer

Other Information

• Instructions for Signatures on Applications to the IRBMED
• What's New on Applications & Forms