How to get started

When you log in to ORahs, either click on the "Create New Protocol" button on the left side of the page or select the “Create New Protocol” button on the main menu screen. You will then be asked two questions confirming whether your project is “research involving human subjects”.

  • You will be asked if you would like to see if your project may be exempt (see HSC SOP 15 Exemption Review for exempt definition/categories)
  • If your project is determined to be exempt, you will be asked to complete the exempt application
  • If you know your protocol is NOT exempt, you can answer "no" and skip this part
  • If it's not exempt, you will be asked whether you would like to base the protocol on an existing protocol or template, or create a new protocol

Hints:

  • Ensure your browser is up to date and pop-ups are enabled
  • If it is your first time logging in, you will have to pick your challenge question first
  • Go through the exemption decision tree, it is possible your project could be exempt
  • Fill out every section out completely
  • Click “Save” after completing every section within each tab (this will save what you've done in your "work in progress" queue)
  • You can click around the protocol with the tabs on top, but make sure you save before you change tabs
  • When you are finished answering all the required questions in a given tab, click “Save & Continue”, the tab will turn green and advance you to the next page if there are no missing fields. Red tabs indicate there is missing or incomplete information
  • The application will indicate which fields need to be completed before you can submit the protocol for review by
  • Submit your protocol from the “End: Submit” tab

How to complete the Human Subjects training module

  • Faculty/Researchers can find the training faculty key code by going to "MyInfo" and clicking on “User Information” in ORahs; this code can be given to anyone who needs to complete the module. All students and those who need UCSB Faculty sponsorship to conduct research should get this number from their Faculty Advisor
  • Go to the Training Module
  • Click on “Login”
  • Enter your (or your faculty advisor's) key code that is in the form XXXX-XX-XX-###
  • Enter your last and first name as how it appears in the Campus Directory; this will ensure your training records are associated with the correct account
  • Owner: last name of key code owner (i.e. faculty advisor’s key code)
  • Complete the training module; only use the module navigation, do NOT use the back button or anything else in the web browser
  • When completed, you'll get an e-mail confirmation

How to add an Associate Account (for “Researcher” role)

  • Log in to ORahs
  • If this is the first time logging in, you'll have to pick your challenge question first
  • Click on “MyInfo” and “User Information” at the top right hand portion of the page
  • If you are unsure whether an individual should be assigned as an associate or proxy click on “Not sure which role to add? Click here” for guidance.
  • Click on "Search and add Associate Investigator"
  • Enter first and last name of the person who needs the account as it appears in the Campus Directory and search
  • Find the person you want and click “Select" on the left side of page
  • They now have an account and they can create a protocol of their own

How to add a Proxy account (for “Researcher” role)

  • Log in to ORahs
  • If this is the first time logging in, you'll have to pick your challenge question first
  • Click on “MyInfo” and “User Information” at the top of the page
  • If you are unsure whether an individual should be assigned as an associate or proxy click on “Not sure which role to add? Click here for guidance.
  • Click on "Search and add Proxy Personnel"
  • Enter first and last name of person who needs the account and search
  • Find the person you want and click "Select" on the left side of page
  • They now have an account

How to change or add personnel to a protocol (for Exempt Studies)

  • Log in to ORahs
  • Make sure the personnel have been added to your account first; follow the instructions above for adding an individual to your account
  • Locate your approved protocol in your "Exempt" queue (the most current approved version); do not click on it
  • On the left side of the page, there are several commands (mod, renew w/mods, renew no changes, personnel change, etc.)
  • Click on "Personnel Change"
  • Make the changes in the One tab of the protocol
  • In the "Correspondence Box", note the personnel change
  • Submit the personnel change via the “End: Submit” tab

How to change or add personnel to a protocol

  • Log in to ORahs
  • Make sure the personnel have been added to your account first; follow the instructions above for adding an individual to your account
  • Locate your approved protocol in your "Approved" queue (the most current approved version); do not click on it
  • On the left side of the page, there are several commands (mod, renew w/mods, renew no changes, personnel change, etc.)
  • Click on "Personnel Change"
  • Make the changes in the One tab of the protocol
  • In the Progress tab, note the personnel change
  • Submit the personnel change via the “End: Submit” tab

How to add an ORBiT record number

  • Log in to ORahs
  • Locate your approved protocol from the "Approved" or "Exempt" queue without selecting
  • Click on the "Add Title/Orbit Rec No." command under Actions in the Queue
  • Locate the appropriate grant on the ORBiT record drop down list and select it
  • Click on "Add ORBiT record"
  • Confirm the ORBiT grant is congruent with the protocol by checking “yes”; If it is not congruent with the protocol, submit a modification to the protocol first
  • For non-exempt protocols, click on “Confirm ORBiT title”
  • You have successfully added the grant to the corresponding human subjects protocol

How to modify a protocol (for Expedited or Full Board Protocols)

  • Log in to ORahs
  • Locate the approved protocol from the "Approved" queue (the most current approved version); do not click on it
  • On the left side of the page, there are several commands (mod, renew w/mods, renew no changes, personnel change etc.)
  • Click on "Mod"
  • Make the changes in the body of the protocol for each tab you wish to modify and be sure to date the modification for each section within the tab you have modified and click on “Save”
  • On the "Progress" tab, date the modification, indicate which tabs have been updated, and provide a summary of the changes
  • Submit the modification via the "End: Submit" tab

How to modify a protocol (for Exempt Protocols)

  • Log in to ORahs
  • Locate the approved protocol from the "Exempt" queue (the most current approved version); do not click on it
  • On the left side of the page, there are several commands (mod, personnel change, add title/Orbit record no., etc.)
  • Click on "Mod"
  • Make the changes in the body of the protocol for each section you wish to modify and be sure to date the modification for each section within the section you have modified and click on “Save”
  • In the "Correspondence Box" at the top of the page, date the modification, indicate which sections have been updated, and provide a summary of the changes
  • Submit the modification via the "End: Submit" tab
  • Note the HSC Staff will review the request for modification to ensure it does not change the exemption status of the protocol

How to renew a protocol

  • Log in to ORahs
  • Click on the "Expired/Due to" queue; you may also access the protocol via the “Approved” queue
  • Locate the protocol you would like to renew (the most current approved version); do not click on it
  • On the left side of the page, there are several commands (mod, renew w/mods, renew no changes, personnel change, etc.)
  • Click on the appropriate "Renew" choice
  • If the protocol was originally created in ORahs 1.0, all protocol text, consent forms, and attachments will be copied over to the protocol in ORahs 2.0; however there will be several new fields that will need to be completed in ORahs 2.0 and you will need to complete these fields in order to submit the renewal
  • Add a progress report on the "Progress" tab
  • Go to the “End:Submit” tab and submit the protocol to your faculty advisor if you have an associate investigator or proxy role or submit the protocol to the HSC if you have a researcher role

Hints

  • The completion of new fields in ORahs 2.0 will only happen one time when you initially renew a protocol

How to switch a Blanket “In Concept” protocol to a regular ORahs Protocol

  • Log in to ORahs
  • Locate the approved protocol from the "Approved" queue (the most current approved version); do not click on it
  • On the left side of the page, there are several commands (mod, renew w/mods, renew no changes, personnel change etc.)
  • Click on "Renew w/Mods"
  • Make the changes in the body of the protocol for each tab you wish to modify and click on “Save”.
    • Remove references throughout the protocol to the blanket submission (e.g. ‘to be determined’), add study materials (recruitment, instruments, consent forms, etc.) 
  • On the "Progress" tab, indicate that the blanket protocol should be switched to a regular protocol, date the requested changes, indicate which tabs have been updated, and provide a summary of the changes.
  • Submit the renewal with mods via the "End: Submit" tab. 
    • Once submitted, the HS staff will administratively change the “in concept” to a regular ORahs protocol application.

How to submit a protocol on your Faculty Advisor Queue (for “Researcher” role)

  • Log in to ORahs
  • Click on the "Faculty Advisor/Investigator" queue
  • Locate the protocol and select it
  • Read through the submission
  • If there are no changes required to the protocol, click on the "End: Submit" tab and select "Submit to HSC"
  • If the protocol requires revisions before submitting the project to the HSC, type them in the boxes (they will appear as ‘track changes’) on the corresponding tabs and click on "Send to Proxy/Associate" on the "End:Submit" tab

How to change your Faculty Advisor (for “Associate” investigator role)

  • First, your new Faculty Advisor will need to log in to ORahs
  • Your new Faculty Advisor will need to follow the directions for adding an associate investigator
  • Once you have been added to the account, you will need to create a new protocol under the Faculty Advisor's key code
  • Log in to ORahs, click on the "Create" button and once you get to the Create Submission screen, be sure to select your new Faculty Advisor's key code
  • You can base the new protocol off the most currently approved version of the protocol under your previous advisor
  • Include an explanation in the "Correspondence Box" on the One tab
  • After you have finished making the changes, submit the changes via the “End: Submit” tab

How to print a copy of the approved protocol

  • Log in to ORahs
  • Click on the "Approved" queue
  • Locate the approved protocol you wish to print
  • On the left side navigation of the page, there are several commands (mod, renew w/mods, renew no changes, personnel change etc.)
  • Click “Print Protocol”
  • Select the items you wish to print from the menu, then click on “Print Selected Documents”
  • This will open up the approved protocol materials in a new tab
  • Choose either the printer icon or the download icon in the upper right hand corner of the webpage to print the protocol

Hints:

  • There are several ways in which you can print the approved protocol
  • You can also print a copy of the approved protocol by locating the protocol you wish to print on the “Approved” queue
  • Click on the protocol to open it
  • On the left side navigation, there are several commands (Create New Protocol, Search, Protocol, Print, etc.)
  • You can either click on “Print” and then select “Full Protocol” from the report list and enter the protocol number you wish to print OR click on “Full Protocol” from the left side navigation and then select the items you wish to print from the menu, then click on “Print Selected Documents”

How to print your consent forms

  • Log in to ORahs
  • Locate the approved protocol from the "Approved" queue
  • Click on the protocol you wish to print from
  • Click on "Consent forms" tab
  • Click on "Print" for each consent form
  • This will open up the approved consent form in a new tab
  • Choose either the printer icon or the download icon in the upper right hand corner of the webpage to print the consent form
  • Now you can print the consent form (it will print with the expiration date of the protocol on top)

Hints:

  • There are several ways in which you can print the approved consent form
  • You can also follow the instructions described above for printing a copy of consent forms
  • Select “consent forms” for items to be printed

How to print a copy of your approval letter

  • Log in to ORahs
  • Click on the "Approved" queue
  • Click on the protocol you wish to print from
  • On the left side navigation of the page, there are several commands (Create New Protocol, Search, Print, etc.)
  • Click on “Approval Letter”
  • This will open up the approval letter in a new tab
  • Choose either the printer icon or the download icon in the upper right hand corner of the webpage to print the protocol

Hints:

  • There are several ways in which you can print the approved protocol
  • You can also print a copy of the approval letter by locating the protocol you wish to print on the “Approved” queue
  • Click on the protocol to open it
  • Go to the “Status” tab of the protocol
  • Click on “Print Approval Letter”

How to print a copy of your training certification (for "Researcher" role)

  • Log in to ORahs
  • On the left side navigation of the page, there are several commands (Create New Protocol, Search, Print, etc.)
  • Click on “Training Certifications” under the “Print” command
  • Enter first and last name of person whose training certification you wish to print and click on “Search”
  • Select “Print” to print the certification
  • This will open up the training certification in a new tab
  • Choose either the printer icon or the download icon on the upper right hand corner of the webpage to print the training certification

How to print a copy of your training certification (for "Associate" role)

  • Log in to ORahs
  • Click on “MyInfo” and “User Information” at the top right hand portion of the page
  • Click on "Print Certification Letter"
  • This will open up the training certification in a new tab
  • Choose either the printer icon or the download icon on the upper right hand corner of the webpage to print the training certification

How to create a template

  • Log in to ORahs
  • On the home page, select “Create New Protocol”
  • Fill out the application
  • On the “End:Submit” tab click on “Save as Template” and give the template a name and click “Save”
  • Now you can base future protocols off a template

Hints:

  • Templates can also be created from an existing protocol
  • Click on the “Approved” queue and locate the protocol you wish to save as a template
  • Click on the protocol to open it
  • Go to the “End:Submit” tab and click on “Save as Template”
  • Now you can base future protocols off a template

How to base a new protocol off an existing protocol or template

  • Log in to ORahs
  • On the home page, select “Create New Protocol”
  • Answer the questions for confirming if your project is “research involving human subjects”
  • You will be asked if you would like to base your protocol off an existing protocol or template
  • Select either “Existing Protocol” or “Template”
  • If you select “Existing Protocol” you will be given the option of which existing protocol you would like to base your new protocol on; click on “Select” on the right side of the screen of the protocol you wish to use
  • If you select “Template” you will be provided with a list of templates that were previously created; click on “Select” on the right side of the screen of the protocol you wish to use

How to close a protocol

  • Log in to ORahs
  • Click on the "Expired/Due to" queue; you may also access the protocol via the “Approved” queue
  • Locate the protocol you would like to close; do not click on it
  • On the left side of the page, there are several commands (mod, renew w/mods, renew no changes, personnel change, etc.)
  • Click on “Close Project”
  • Complete the status report and click on “Submit” at the bottom of the page

How to print a copy of your voluntary closure confirmation and report

  • Log into ORahs
  • On the left side navigation of the page, there are several commands (Create New Protocol, Search, Print, etc.)
  • Click on “Search”; type in the closed protocol number you would like to print and click on “Search”
  • Click on the protocol number
  • On the left side navigation of the page, click on “Closure Letter” or “Closure Report”, depending on if you would like to print a copy of the closure letter or the closure report
  • This will open up the document in a new tab
  • Choose either the printer icon or the download icon on the upper right hand corner of the webpage to print the document

How to Create a Blanket “In Concept” for Funding 

  • NOTE: “Blanket” protocols CANNOT be used to conduct any human subjects research and a subsequent non-blanket submission will need to be reviewed by the IRB prior to commencing any research involving human subjects. For more information on when to submit a Blanket “In Concept” submission review the information on the For Researchers webpage.
  • Log in to ORahs
  • Click on “Create New Protocol”
  • Answer “Yes” to the questions pertaining to research and human subjects
  • Answer “No” to the question “Would you like to see if your project is exempt?”
  • On the following page, select “Yes - In Concept” to the question “Is this a Blanket Submission?”
  • Complete the ORahs protocol application. List “[procedures etc.] have not been fully developed and a modification will be submitted once we have developed this portion of the research. No human subjects activities will occur until IRB approval has been obtained”  in all Tabs of the protocol, except the Purpose section. 
  • Do Not create consent documents or upload any instruments (e.g., recruitment, survey, interview materials, etc.)
  • Go to the “End:Submit” tab and submit the protocol to the HSC