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Consent Forms jhmeirb@jhmi.edu

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Consent Forms jhmeirb@jhmi.edu

  1. 1. Consent Forms [email_address]
  2. 2. Consent Forms <ul><li>Consent forms must be on the current HIPAA Combined Informed Consent/Authorization Template. </li></ul><ul><li>Download the consent form template from within the eIRB application on the Written Consent screen. </li></ul>
  3. 3. Consent Forms <ul><li>Only electronic consent forms are accepted in eIRB. </li></ul><ul><li>Paper copies of sponsor consent forms must be scanned and converted into an electronic copy in Adobe Acrobat (.pdf), MS Word (.doc), or HTML (.html) format. </li></ul><ul><li>The Office of Human Subjects Research (OHSR) has a high-speed scanner that may be used to convert paper documents into Adobe Acrobat (.pdf) files. Call 410-955-3008 or send an email to [email_address] to schedule an appointment. </li></ul><ul><li>Some Macintosh users need to add the three character PC style file-type extensions to Mac file names before uploading into eIRB. </li></ul>
  4. 4. Help Tools <ul><li>Help Tools appear beside each question. </li></ul>
  5. 5. Help Tools <ul><li>Help Tools appear beside each question. </li></ul><ul><li>Regulatory Guidelines </li></ul><ul><ul><li>Click the “?” icon to access IRB Regulatory Guidelines and Policies. </li></ul></ul><ul><ul><li>Download Forms. </li></ul></ul><ul><li>Information Technology </li></ul><ul><ul><li>Click the “i” icon to access step by step technologic instructions. </li></ul></ul>
  6. 6. Download Consent Form Template <ul><li>Click the icon. </li></ul>
  7. 7. Download Consent Form Template <ul><li>Right click the consent form template link. </li></ul><ul><li>Save the form to your local drive. </li></ul><ul><ul><ul><li>Use a simple name including the upload date. </li></ul></ul></ul><ul><ul><ul><li>Consent Sample_102008.doc </li></ul></ul></ul><ul><ul><ul><li>The IRB will modify the name you give your consent form. </li></ul></ul></ul><ul><ul><ul><li>The modified name will appear in all letters. </li></ul></ul></ul><ul><li>Complete the consent form and save it to your local drive. </li></ul>
  8. 8. Upload Consent Form <ul><li>The consent form field is a multiple upload field. </li></ul><ul><li>It displays the colored bars that indicate a multiple upload field. </li></ul><ul><li>An unlimited number of consent forms may be uploaded. </li></ul>
  9. 9. Upload Consent Form <ul><li>Click the Information Technology icon for step by step directions. </li></ul>
  10. 10. Upload Consent Form <ul><li>Click the Information Technology icon for step by step directions. </li></ul>
  11. 11. Upload Consent Form <ul><li>Click Add </li></ul><ul><li>Submit a Document Window </li></ul><ul><ul><li>Browse </li></ul></ul><ul><ul><li>Select the consent form saved to your local drive. </li></ul></ul><ul><ul><li>Leave the title field blank. eIRB will use the consent form file name for the title. </li></ul></ul><ul><ul><ul><li>Use a simple name including the upload date. </li></ul></ul></ul><ul><ul><ul><li>Consent Sample_102008.doc </li></ul></ul></ul><ul><ul><ul><li>The IRB will modify the name you give your consent form. </li></ul></ul></ul><ul><ul><ul><li>The modified name will appear in all letters. </li></ul></ul></ul><ul><ul><li>Click OK or OK and Add Another to upload consent forms. </li></ul></ul>
  12. 12. <ul><li>Save the screen. </li></ul>Upload Consent Form
  13. 13. Delete Consent Form <ul><li>Delete consent forms prior to initial submission only. </li></ul><ul><li>Select the consent form. </li></ul><ul><li>Click the Delete button. </li></ul><ul><li>Save the screen. </li></ul>
  14. 14. Revise Consent Form <ul><li>Right click the consent form name. </li></ul><ul><li>Save the consent form to your local drive. </li></ul>
  15. 15. Revised Consent – Tracked Changes <ul><li>Open the saved consent. </li></ul><ul><li>Access the track changes function of MS Word. </li></ul><ul><li>Complete the revisions. </li></ul><ul><li>Changes will be clearly displayed. </li></ul><ul><li>Save the revised consent to your local drive. </li></ul><ul><ul><li>Indicate tracked changes in the file name. </li></ul></ul><ul><ul><li>Change the upload date. </li></ul></ul><ul><ul><li>Consent Sample_tracked changes_122008.doc </li></ul></ul>
  16. 16. Upload Revised Consent Form <ul><li>Do not delete previous versions of the consent form. </li></ul><ul><li>Click [Edit] to upload the tracked changes version into the consent form field when requested by the IRB or for changes in research . </li></ul><ul><li>This replaces the previous version of the same consent. </li></ul><ul><li>Only one version of each consent form should be visible. </li></ul><ul><li>Save the screen. </li></ul>
  17. 17. Upload Revised Consent Form <ul><li>A clean version of the consent form is not needed. </li></ul><ul><li>Use [Edit] to upload new tracked changes revisions and replace previous versions when requested by the IRB or for changes in search . </li></ul><ul><li>Do not delete previous consent form versions. </li></ul><ul><li>Only one version of the consent form should be displayed. </li></ul><ul><li>Save the screen. </li></ul>
  18. 18. Consent History <ul><li>Click the small icon located beside the consent form name. </li></ul><ul><li>This opens the Consent History Window. </li></ul>
  19. 19. Consent History Window <ul><li>Select the uploaded file name to open the consent form. </li></ul>
  20. 20. Locate Approved Consent Form <ul><li>The IRB will upload a clean, approved consent directly into this application question. </li></ul><ul><li>This consent is to be used with changes in research and continuing reviews. </li></ul><ul><li>Only one version of each consent form should be visible. </li></ul>
  21. 21. Supplemental Study Documents <ul><li>You may be using other documents that require IRB approval. </li></ul><ul><li>Upload supplemental study documents that require the JHM IRB approval logo into question 1.0. </li></ul><ul><li>The IRB will upload the approved documents without a logo directly into this application question. </li></ul>
  22. 22. Supplemental Study Documents <ul><li>These documents are to be used with changes in research and continuing reviews. </li></ul><ul><li>These documents will be listed in the approval letter. </li></ul><ul><li>Do not delete previous versions. </li></ul><ul><li>Use [Edit] to upload new tracked changes revisions and replace previous versions when requested by the IRB or for changes in research. </li></ul><ul><li>Only one version of each document should be visible. </li></ul><ul><li>Save the screen. </li></ul>
  23. 23. Supplemental Study Documents <ul><li>Upload supplemental study documents that do not require the JHM IRB approval logo into question 2.0. </li></ul><ul><li>These documents will not be listed in the approval letter. </li></ul><ul><li>Only one version of each document should be visible. </li></ul><ul><li>Do not delete previous document versions. </li></ul><ul><li>Use [Edit] to upload clean, revised documents and replace previous versions. </li></ul><ul><li>Save the screen. </li></ul>
  24. 24. Locate Stamped Documents <ul><li>Application/Further Study Action Workspace application/FSA approved </li></ul><ul><li>Select the Stamped Documents tab. </li></ul><ul><li>Scroll down to the desired section. </li></ul><ul><li>Right click the documents to download. </li></ul><ul><li>Use these stamped documents with study participants. </li></ul>FSA
  25. 25. Consent Forms [email_address]

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