Your SlideShare is downloading. ×
Consent Forms jhmeirb@jhmi.edu
Upcoming SlideShare
Loading in...5
×

Thanks for flagging this SlideShare!

Oops! An error has occurred.

×

Saving this for later?

Get the SlideShare app to save on your phone or tablet. Read anywhere, anytime - even offline.

Text the download link to your phone

Standard text messaging rates apply

Consent Forms jhmeirb@jhmi.edu

376
views

Published on

Published in: Technology

0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
376
On Slideshare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
9
Comments
0
Likes
0
Embeds 0
No embeds

Report content
Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
No notes for slide

Transcript

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