If your project involves human subjects or their data, the best practice is to check with the IRB to confirm if IRB oversight is required, even if you think your project is Quality Improvement or Quality Assurance. You would still create a new study in the eIRB system, but instead of uploading a Protocol, you would upload the Request for Determination Form. The IRB would review the form to determine if your project requires IRB oversight, which would then require a full study submission, or if your project can proceed as described without oversight. See the Quality Improvement or Research (Quick Guide) for more information.

When IRB oversight is required, your eIRB submission must be reviewed and approved before you start your project. For more information about what the IRB must review and how the review process works, see the Investigator Manual on the IRB Policies and Forms page.

A case report of 3 subjects or less is generally not considered “research” and therefore does not need IRB oversight, however there are HIPAA implications (assuming the case report involves protected health information).

We suggest submitting a Request for Determination (RFD) – a regular eIRB submission using the Request for Determination Form rather than a protocol.  The last page of the RFD form has instructions on dealing with the HIPAA aspect of the case report, and a link to the authorization form that the patients may need to sign.

The IRB will process the RFD submission in eIRB and issue a memo saying ‘not research’, that could be helpful if the journal has any questions.

The documents needed for an initial submission can vary widely depending on what's going on in that particular study. The Initial Submission Guide (Quick Guide) covers the basics of what documents we generally expect to see for initial submissions. While we strongly encourage that initial submissions be as complete as possible upon submitting for IRB Review, it is understood that submissions usually aren't perfect from the start. Prepare what you believe is needed, and the reviewing IRB Coordinator will let you know of any changes or additional documents that are needed during the review of your submission.

All of our Protocol Templates are available on the IRB Policies and Forms page under the Submission Forms and Information section. The templates are listed below and what kinds of studies they are used for. If you are uncertain which protocol to use, pick the one you think most appropriate, and the reviewing IRB Coordinator will let you know if transferring to another template is needed once they start reviewing your submission.

• Protocol Template & Protocol Template - No Instructions: For all studies, especially clinical trials, above minimal risk.
• Protocol Template - Minimal Risk Studies & Protocol Template - Minimal Risk Studies - No Instructions: For minimal risk studies.
• Knight Cancer Clinical Research Protocol Templates: For studies involving cancer.
• Request for Determination: If you don't know if your project requires IRB oversight or not, submit this instead of a protocol.
• Future Human Subjects Research: For research projects that may involve human subjects in the future and further protocol development is needed, but you need proof of IRB Review in order to release your grant funds. This form is uploaded instead of a protocol. See the Future Human Subjects and Grants (Quick Guide) for more information about this type of submission.
• Protocol Checklist - Security and Confidentiality: This is not necessarily a protocol template by itself, but details what items should be addressed in your protocol to met institutional requirements for data security and confidentiality. See the Information Privacy and Security (IPS) Office site for more information.

All of our consent form templates, boilerplate language, and guidance documents are available on the IRB Policies and Forms page under the Consent Forms section.  The Consent and Authorization Forms Instructions document describes the available templates and when they are used. Please note that studies involving cancer should use the Knight Cancer Clinical Research Consent Form Template, which has instructions on their Bridge Site. If you are thinking about using a waiver or alteration of consent, see Consent - Waiver or Alterations (Help Sheet). For questions about translating consent forms or using the provided Short Forms, see Consent - Limited English Proficiency (Quick Guide) for more information.

As with Protocol Templates, select the template you believe is appropriate, and the reviewing IRB Coordinator will let you know if something different is needed once they start their review.

If your project involves human subjects or their data, the best practice is to check with the IRB to confirm if IRB oversight is required. If you are not sure whether your project requires IRB oversight, you can submit a Request for Determination Form. You would still create a new study in the eIRB system, but instead of uploading a Protocol, you would upload the Request for Determination Form. The IRB would review the form to determine if your project requires IRB oversight, which would then require a full study submission, or if your project can proceed as described without oversight. 

The person listed as the Principal Investigator (PI) must meet PI Eligibility Criteria. For student projects the PI is usually the mentor.

In the past, the IRB used to require Data Use Agreements (DUAs) to be uploaded in the eIRB submission. This is no longer required, and DUAs are handled by the DUA team. For all questions about DUAs or Business Associates Agreements (BAAs) for research whether funded or unfunded, please email duainbox@ohsu.edu. You will be put in touch with the correct office based on your questions.

You will need to create a new study in the eIRB and submit a Request for Determination (RFD). On the Basic Study Information page (Q3), please provide a brief explanation of the compiling recruitment list or arrangements needed to prepare your protocol. You do not need to further describe the potential research that will or may be done. The last page of the RFD form includes instructions pertaining to HIPAA requirements, where the HIPAA - Prep to Research Form is linked for you to additionally fill out and include with this submission. Note that this would not be a full study submission.

The IRB will process this information and issue a determination memo stating 'not research.' When your protocol is ready, please submit a new study submission for IRB review and approval.

1. Use Track Changes: Make all revisions using the Track Changes feature to clearly show what changes have been made and allow for easy review.
2. Consistency: Ensure that any changes made are consistent with the protocol and other relevant documents to maintain coherence throughout.
3. Avoid Deleting Entire Sections: Refrain from deleting entire risk tables or sections and pasting new ones from the sponsor template. Instead, revise the previously approved sections.
4. Include Relevant Risk Sources: If the sponsor ICF template is the primary source of risk information, include it in the revisions. Otherwise, include the tables and pages used, in the Investigator's Brochure (IB) or other risk source, to derive risks.
5. Update Document Stack: When updating a document, use the "Update" function next to the document instead of "Add," to avoid duplication and confusion.

Following these best practices will help with the IRB review process.

You must register in the eIRB in order to have an account. If you are an OHSU employee, you can register using your OHSU login credentials.

If you are a student or non-OHSU researcher, you must request an OHSU employee ID number first. Once you have one, you can register for an account at the link above.

If you are a student or non-OHSU researcher, please see the Non-OHSU Research Collaborators page for more information on how to gain access to the eIRB and other steps that may be necessary.

It takes a few days for new HR information to make it to the eIRB system. If you just received your confirmation email from HR with your employee ID number, please wait a few days for the systems to sync.

Please double-check all the information you have entered. It is also important that you enter your first and last name exactly as they appear in the OHSU HR records. There is a chance that your names may have been entered incorrectly in the HR database. You can email HR Records if you discover your name has been entered in the HR database incorrectly.

Another possibility is that your account was already created, which will be the case if your error says your employee ID number is already in use. In this case please contact Research Integrity in order to obtain your eIRB username and password.

Users cannot directly change their account information, except for their password. The IRB can only change your contact email, eIRB username, and access roles in the eIRB system. Please email Research Integrity with any requests for those types of changes.

If your name, department or other HR information is incorrect in the eIRB, please email HR Records to correct your name in the HR database, Oracle. Oracle is connected to the eIRB system and will automatically import the corrected information overnight.

You must register in order to have an account in the eIRB system, as it isn't automatically created for OHSU employees.

If you already have an account, it may have been disabled due to too many incorrect login attempts or due to inactivity. eIRB accounts are never deleted. If you can't remember your password, or you think your account was disabled, please contact Research Integrity. We can reactivate your account or help you with your username and password.

Yes, we have an Initial Submission Guide (Step-by-Step Guide) and a Modifications and Continuing Reviews (Step-by-Step Guide) on the IRB Policies and Forms page.

In addition, we have our Introduction to the IRB online training which covers the basics of the eIRB system and IRB submissions. See the Education and Resources page for more information.

After logging into the eIRB, there will be a blue "Create New Study" button on the left side. This button is available on most pages in the eIRB except when you are on the main page of an existing submission. For information on what to include in your Initial Submission, see the Initial Submission Guide (Quick Guide). The Initial Submission Guide (Step-by-Step Guide) gives instructions on how to fill out your electronic submission in the eIRB for new studies.

No matter what you are searching for (a study number, person's name, funding source, External IRB, etc.), using a "wildcard" can be helpful in any search field in the eIRB system. To search using a wildcard, first type the percent sign, "%", into the search field immediately followed (no space) by the word (or portion of the word) you are searching for. The system will then pull up a list of all entries that contain what is entered after the percent sign (whether it is at the beginning, middle, or end of the entry name). The following examples demonstrate how to use a wildcard and other search tips specific to that type of entry.

Searching for an eIRB submission

When searching for an eIRB submission, the best ways to do so are by ID (the eIRB number), PI Last Name, or Study Title. Note that when searching for eIRB submissions, you will only be able to see the submissions you have access to. This means you will only be able to see the studies (and their follow-on submissions) that you are listed as the PI or a study team member on.

• Searching by ID:
  • ID search field: "%1546"
  • This will list any studies (beginning with "IRB" or "STUDY") and follow-on submissions (MOD, MODCR, RNI, CR) that you have access to see which contain the series of numbers "1546" anywhere in their ID.
• Searching by PI Last Name:
  • PI Last Name search field: "%smith"
  • This will list any submissions with a PI Last Name containing "smith" anywhere in that name.
  • Tip: Searching by PI Last Name is best accomplished by typing in their exact last name rather than using a wildcard.
• Searching by Study Title:
  • Name search field: "%multiple sclerosis"
  • This will list any submissions that contain "multiple sclerosis" anywhere in the Long Study Title (not the Short Title).
  • Tip: Searching by Study Title works best when a unique word or phrase can be searched on with a wildcard. Otherwise, this is more of a "last ditch effort" to identify a study when no other conclusive information is known.

Searching for a funding source

When searching for a funding source, using the wildcard with a unique word or phrase is the best option. OPAM manages the funding source entries directly (not the IRB), so you may not always know the exact name they have registered for a particular funding source. Please note that each funding source has a specific "Type" listed, such as Foundation, Industry, Federal, etc. Some funding sources have more that one Type, so multiple entries of different types can be listed for the same funding source name.

• Funding Organization search field: "%cancer"
• This will list any funding sources with "cancer" contained anywhere in the name.
• Tips:
  • Name search fields usually only show a drop-down list, which may not have enough space to show all search results. So, being too general in your wildcard search term, such as "DHHS", "HHS", or "NIH" probably won't help you much.
  • If you suspect the drop-down list isn't showing all results, click on the grey "..." button immediately to the right of the search field. This will open a new search window with the option to click through pages of all the search results. You can look through the entire list, or use the wildcard to narrow it down.
  • If you've searched many different ways for the funding source and you still can't find it, contact OPAM at awards@ohsu.edu for assistance.

Searching for a new PI/study team member name

When searching for people, entering their first and last name in the search field is usually gives the most accurate result. Otherwise, using a wildcard with the last name or a portion of it may help. The most important thing to know is that the eIRB account first name and last name must exactly match a person's HR record. This name may be different than the name they normally go by or even their name in Outlook. If you can't find the person in the search, it may be worth asking the person exactly what their eIRB account name is, as it may be different than what you think.

• Study Team Member (name) search field: "%smith"
• This will list any eIRB accounts with "smith" contained anywhere in the first or last name.
• Tips:
  • Name search fields usually only show a drop-down list, which may not have enough space to show all search results. So, being too general in your wildcard search term might not help you.
  • If you suspect the drop-down list isn't showing all results, click on the grey "..." button immediately to the right of the search field. This will open a new search window with the option to click through pages of all the search results. You can look through the entire list, or use the wildcard to narrow it down.
  • If you've searched many different ways for the person and you still can't find them, it's likely that they haven't registered in the eIRB yet.

Searching for an external IRB

When searching for an external IRB, using the wildcard with a unique word or partial word is the best option. The IRB manages the external IRB entries directly, so you may not always know the exact name registered for a particular external IRB. Please note that these entries don't necessarily follow a consistent naming convention. For example, some external IRBs may have University spelled out fully, while others have "Univ." Additionally, some external IRB names may include their acronym, or may only be listed as their "acronym IRB".

• External IRB search field: "%oregon"
• This will list any external IRBs with "oregon" contained anywhere in the name.
• Tips:
  • If a state or location is included in the name, this word or a partial spelling can be a good combination with a wildcard.
  • Name search fields usually only show a drop-down list, which may not have enough space to show all search results. So, being too general in your wildcard search term, such as "University" or "Univ", probably won't help you much.
  • If you suspect the drop-down list isn't showing all results, click on the grey "..." button immediately to the right of the search field. This will open a new search window with the option to click through pages of all the search results. You can look through the entire list, or use the wildcard to narrow it down.
  • If you've searched many different ways for the external IRB and you still can't find it, contact the IRB for assistance.

eIRB errors most commonly occur when a required question has not been answered. Please be sure to answer all required questions, usually indicated by a red asterisk, on each page before clicking OK or Continue. You might also be able to see a list of the errors for more information by clicking on "Hide/Show Errors" at the top of the IRQ page.

On the Basic Information page of the IRQ, say "No" to question #6 asking if you would like to waive oversight to another institution. The External IRB page will then be removed from your submission.

Once you have filled out the IRQ and uploaded any necessary documents, there will be a button on the left side of the submission workspace page (the page with the study title and flow chart near the top) that says "submit". Only the listed PI of the submission can submit, and is the only one that can see the "submit" button. When they click on that button, they will be asked to enter their eIRB login credentials to confirm submission.

Other study team members can let the PI know the submission is ready to be submitted by clicking on the "Notify PI" button on the left side of the submission workspace page.

Note: While inside the IRQ, the "Finish" button at the end does NOT submit the submission for you, it just takes you back to the submission workspace page.

This error means that you must click the "Create or Update eCRIS Study" button on the left side of the main study page. Once you click this button to create the eCRIS study, you should then be able to submit the study for review (assuming there are no other outstanding errors).

The requirement to create an eCRIS study for your eIRB submission is triggered when you check the "OHSU Signed Consent" box on the Study Details page or the "Cancer" box on the Ancillary Reviews and Notifications page.

If you cannot see the Notify PI button, then you are probably listed as the Primary Contact, but you did not list yourself on the Study Team Members page of the IRQ. The only way to see that button is by being listed on the Study Team Member page.

Note: Listing yourself as the Primary Contact does NOT automatically add you to the Study Team Member page.

Once the PI has navigated to the IRQ/MODCR/MOD workspace page (the submission number is at the top of the page with a flowchart beneath), they can review the changes made to the submission by clicking on the "Edit Study" or "Edit MOD/MODCR" button near the top left corner of the page. In order to submit these changes, they should click the button with "submit" in the title on the left side of the submission workspace page, such as "Resubmit Clarifications." A pop-up window will open to allow comments. Once the PI clicks the OK button, they will be prompted to enter the eIRB login credentials.

In the eIRB, there is a "My Inbox" tab in the horizontal green bar at the top of the page. Your "My Inbox" page may have several different views based on role. On the left side of the My Inbox page, a "My Inboxes" section will list these difference views. All users should have at least the following two views listed below.

• The My IRB Inbox view will only have a single tab, "My Inbox", that shows all of your submissions (initials, MODs, CRs, MODCRs, and RNIs).
• The Study Team Inbox view will have three tabs.
  • The default tab is "Action Required" and will show any submissions that are in a state that requires you to do something, such as items need to be submitted or submissions that the IRB has required clarifications for.
  • The "All My Studies" tab is a list of all the studies you have been listed as the PI or a Study Team Member on. This tab is different from the "My Inbox" tab of the My IRB Inbox view above, as it will only list studies, not any follow-on submissions.
  • The third tab is "Pending CRQ", which will list any studies that will expire within the next 90 days if a MODCR is not submitted and approved before then.

Approved study documents are located under the "Documents" tab on the main study workspace page (the page with the flowchart and study number). The final version of approved documents, such as consent forms with stamps, are in the right column, titled "Final", in this tab. The left column is the Draft version, which would be used for any document revisions you would submit in a Modification.

Do NOT consent subjects using consent forms from the Draft column as they are not the approved version.

When documents are no longer in use, such as consent forms after permanently closing enrollment, they can be archived. Documents can be archived by hovering over the document in the IRQ, and clicking on the X that appears to the right of the document name. You are essentially removing the document from the IRQ, but it will still be accessible within earlier dated "Snapshots". These "Snapshots" can be viewed on the main study workspace page under the Snapshot tab.

When you are on the main workspace page of a submission, there will be a flowchart under the study title but near the top of the page. This flowchart indicates where the submission is in the review process.

The Pre-submission bubble will be red if the it hasn't been submitted yet. Any bubble after Pre-submission that is in the top row indicates the submission is under review by the IRB and any other necessary research administration groups. These bubbles will be green if the submission is in that state.

The bottom row of bubbles "Clarification Requested" or "Modification Requested" indicate that the submission has been sent back to the study team for changes. Any necessary changes should be made, and the PI must resubmit to send it back for review.

Near the top of the workspace page for the submission, there will be a name or Panel listed for the IRB Coordinator. If a name is listed, that particular IRB Specialist is responsible for reviewing this submission. If a Panel is listed, then any of the IRB Specialists assigned to that Panel number could be responsible for this submission.

Use the ‘Contact IRB Team – Ancillaries – Study Team’ activity in the eIRB to contact the IRB Specialist or any of the Ancillary committees working on your study to ask study-specific questions.  This activity allows you to easily contact the assigned IRB Coordinator, the PI/Primary Contact, Ancillary Reviewers, CoIR/Training assistance, and/or the entire Study Team by clicking the appropriate corresponding boxes. By default, IRB Coordinator (i.e., IRB Specialist) box is checked.  If the IRB Coordinator doesn’t need to receive a message, you may uncheck that selection manually.  To contact other specific individuals, add them in section #4 via the drop down menu.

This is the recommended way to contact the IRB Coordinator. If you don't have an assigned IRB Coordinator yet, but still check the box for IRB Coordinator, the message will go to all of the IRB Coordinators and someone will reach out to assist you.

If you have any questions or need assistance, contact irb@ohsu.edu.

The "Ancillary Review Notification" button sends a notification email to any Ancillaries that are listed on this submission, simply stating that the Ancillary has been assigned to this submission.

It typically isn't necessary for the PI or Study Team members to click on this button, as submitting or resubmitting will notify any assigned Ancillaries, as will the IRB Coordinator if needed.

You are not listed on the Study Team Member page. You were able to see the study and make changes to it since you were listed as the Primary Contact, but when you were removed as the Primary Contact your access to see the study was removed.

If you need to be able to see this study in the eIRB because you are participating in the research, you should have also been listed on the Study Team Member page in addition to the Primary Contact. A Modification will need to be submitted to add you to the Study Team Member page, and allow you to access the study.

The person who initially creates the study will automatically be the primary contact. Others who need to become the primary contact afterwards must be listed on the “Study Team Members” page of the study. Any study team member can be made the primary contact using the “My Current Actions” left-hand bar link titled “Assign Primary Contact.” 

A "Modification and Continuing Review" (MODCR) must be submitted and approved in order to close a study, as they do NOT close automatically. See the Modifications and Continuing Reviews (Step-by-Step Guide) for instructions on how to close a study.

Submissions in the eIRB system cannot be discarded by the PI or study team. On the eIRB workspace page (the page with the flowchart and submission number) for the submission you wish discarded, there will be an "Add Comment" activity on the left side of the screen. Make sure to check the box for IRB Coordinator, and state your request to discard the submission.

Only the Principal Investigator (PI) and Primary Contact automatically receive eIRB notifications. It is important to keep user information up-to-date for this reason.

Additional study team members can opt in to eIRB notifications using the “Manage Notification Group Membership” activity listed near the bottom of the left sidebar of the workspace. Within this activity, use the drop down menu categories to choose which auto-notifications you want which study team member(s) to receive.

Note that, for some personnel-only modifications, you may only receive an email notification but no approval memo. Please verify these modifications' approval statuses via the eIRB study page.

The eIRB system does not allow more than one submission of the same type to exist for the same study in order to prevent trying to merge discrepant information for the same question from different submissions.

For MODs and MODCRs, there are 2 options for "Modification Scope" when recreating this submission, "Study Team Member Information" and "Other Parts of the Study", which dictate what you can change in the submission. By default both boxes are checked, and we recommend you keep it this way. If you only leave the "Study Team Member Information" box checked, you will only be able to make edits to the Study Team Member page and no other IRQ pages. If this MOD has not been approved yet and you try to create a second MOD or a MODCR, the only Modification Scope option left is "Other Parts of the Study". As a result in the 2nd MOD, you will be able to make changes to documents or all other IRQ pages except the Study Team Member page. Since the "Study Team Member Option" was already in use by the first MOD, this option was unavailable for the second MOD by default.

If you create a MOD that has both Modification Scope options checked, then you will not be able to create a second MOD or a MODCR at all (as both Modification Scope options are already in use).
Note: This does NOT apply to RNI submissions, as multiple RNI submissions can be open for a single study.

Continuing Reviews are submitted by creating, filling out, and submitting a "Modification and Continuing Review" (MODCR) submission. We require MODCRs to be submitted about two months before the study expiration date to allow enough time for IRB review and any changes that may be required of the study team.

If you only need to do a Continuing Review without making any changes to the study (meaning the Modification part isn't needed), you will still need to create a MODCR submission. On the Modification Information page, you can simply state that no changes were made in the Modification Summary section.

In order to renew IRB oversight for another year (or 3 years in the case of Exempt studies), you must create and submit a "Modification and Continuing Review" (MODCR). MODCRs should be submitted about 2 months BEFORE the Study Expiration date listed near the top left corner of the main study workspace page. Do NOT wait until the Study Expiration date to submit your MODCR, as the study will very likely enter lapse state.

This means that IRB oversight for your study has expired. Reminders to submit a MODCR are sent out automatically by the eIRB 90 days, 60 days, and 30 days prior to the study expiration date. If your study is lapsed for over 60 days, your study is at risk of Administrative Closure and being charged the $550 Administrative Closure Fee. If you have not already done so, please submit a MODCR immediately to request continuing approval or study closure. You can submit a continuing review by navigating to the study through the link above and clicking Create Modification/CR.

All research activities must stop while the study is lapsed. This includes recruitment, advertising, screening, enrollment, consent, interventions, interactions, and collection or analysis of private identifiable information. Advertisements currently running in the media must be pulled. Data collected during a lapse in IRB approval cannot be included in publications nor submitted to the FDA in support of a marketing application. Continuation of research activities without prior and ongoing IRB review and approval is a violation of federal regulations.

If you believe that current subjects are at risk of harm by stopping research procedures:

• Prepare a written list of subjects who will be harmed.
• Identify the research procedures that need to continue.
• Describe the reasons that these procedures need to continue.
• Immediately provide the IRB Office with this information.

An IRB member (if needed, in consultation with others) will decide whether there is an over-riding safety concern or ethical issue involved such that it is in the best interest of the individual subjects to have research procedures continued.

Studies should be closed when all research activities are complete. We recommend keeping a study open until after journal manuscripts have been submitted and accepted, just in case further data analysis is required.

The best practice for this situation is to use the "Add Comment" function for this study and check the box for the IRB Coordinator. You can explain what you are trying to do, and if you need IRB oversight to perform such data analysis. The IRB Coordinator will then let you know if it is okay or not.
In general the answer is probably no. If the data is not already completely de-identified, meaning all HIPAA Identifiers have been removed and/or you have absolutely no access to the code to reidentify the data, then you will need to submit a new study (you can reuse documents from the original study as appropriate) and receive IRB approval before performing further data analysis.

Submissions that have been determined to be Not Human Research cannot be edited or altered to account for changes. A new study submission with your revised documents will need to be submitted for IRB review to determine if these changes now require the project to have IRB oversight.

Study Team members can be added or removed on the Study Team Member page either during the initial submission or in a Modification submission if the study already received initial IRB approval.

• To add a new study team member, click on the "Add" button for question #1.
• You can also update current member information and roles by clicking the "Update" button next to their name.
• To remove a study team member, question #1 will list all the current study team members. You can remove them from the study by hovering over their name and clicking the X to the right of their name.
  • Note: They will still be listed under question #3, as this is a running list of study team members with their start and end dates for the lifetime of the study.

If you are new to OHSU or just new to human research at OHSU, specific onboarding steps must be completed before you can be listed as a study team member on a human subject study in the eIRB system. In addition to any institution or department required trainings you must complete, federal regulations require the study staff of human research protocols to complete certain research training, depending on the type of study, and to complete an annual Conflict of Interest (CoI) in Research Disclosure form.

See the Onboarding instructions specific to your affiliation with OHSU:

• New human researchers:
  • OHSU employees
• Non-OHSU researcher collaborators:
  • OHSU affiliated non-employees (e.g., OHSU students, volunteers, etc.)
  • Portland VA (VAPORHCS) affiliates (e.g., VAPORHCS employees, PVARF employees, or VA WOCs)
    • See FAQ #7 under PI and Study Team Management for training requirements
  • External Collaborators (non-affiliates) intending to complete OHSU training or CoI disclosures
• Onboarding External Collaborator FAQ (#8 under PI and Study Team Management):
  • External Collaborators (non-OHSU, non-Portland VA/PVARF affiliates) that already have up-to-date Research Training and CoI completed through their home institution

If there is a red bar across the study workspace page with your name in it, then you are missing a required research training (RCR, HSR or GCP) or your Conflict of Interest in Research (CoIR) disclosure. More specifically, the red outlines around a box indicate each requirement that is out of compliance.

RCR, HSR, and GCP (either the FDA Focus or Social-Behavioral versions) are required based on the type of study, and must be renewed every 3 years. See our CITI Program page for more information about these courses and when they are required.

Your CoIR disclosure form must be filled out every year. See the CoI page for more information on disclosures and when they are required.

If you know that you are up-to-date on your research trainings and your CoIR disclosure, there may be a feed issue with your compliance data into the eIRB. If you think this is the case, contact RATE@ohsu.edu for assistance.

One of the many benefits of OHSU transitioning research compliance training to the CITI Program is that courses completed elsewhere have the chance of transferring partial or full credit to other institutions that also use CITI. Each course on CITI is composed of a number of modules. When the individual modules from a course at one institution have the exact same Module ID number as that from another institution’s course, completion credit for that specific module will transfer to the new institution. Since the OHSU training renewal period is every 3 years, matching modules must have been completed within the last 3 years in order to transfer credit.

It is possible that the entire module list for a course will transfer credit, and you will show as completed for that course at OHSU. For example, the Portland VA              Human Subjects Research (HSR) Basic Course and the Refreshers completed in the latter half of 2017 and onwards should match exactly to the corresponding OHSU course. However, each institution has the option to select the individual modules that compose their courses, so all the modules in a course may not match. If you receive credit for only some of the modules, you must complete any remaining modules to receive full credit for that course at OHSU.

To see if your modules will transfer credit to your OHSU CITI account, please follow the steps below.

• Step 1: Affiliate your existing CITI account with your OHSU CITI account in one of two ways.
  • Log in to your CITI account.
    • You will be directed to your "Courses" page. The first section titled "Institutional Courses" will have a button that says "Add Affiliation".
    • Once logged in, most pages will have a blue "Welcome" banner near the top of the page. The left side of this banner has an "Add Institutional Affiliation" link.
  • If you have not logged in to your OHSU CITI account before, you can affiliate any existing CITI accounts during your OHSU CITI account registration. We have different CITI registration instructions for researchers with OHSU login credentials and for External Collaborators.
• Step 2: Add the corresponding OHSU CITI course to see which modules transfer.
  • A corresponding course must be added to your OHSU CITI account in order for previously completed modules to transfer. This can be done by clicking the “Add a Course” link at the bottom of the "Courses" page when OHSU is selected as your institution.
  • Start by selecting the OHSU course with the name most closely corresponding to the course you completed at another institution. For most courses, there are multiple versions, such as the Basic Course and different Refresher Courses. If you look at the list of modules you’ve completed, sometimes the module titles will include “Refresher” or “Basic” in parenthesis to help you identify what version of the course these modules are likely to transfer to. You can use “Add a Course” as necessary to change the version of your course until you find the one that offers the most transfer credit for a particular course.

If you have any questions about OHSU CITI Training, please contact RATE@ohsu.edu.

OHSU employees, including Principal Investigators, must complete OHSU CITI research training and submit their annual Conflict of Interest in Research (CoIR) disclosure form in the eCoI system. The New Human Researchers page has more information about onboarding requirements.

However, if you have completed CITI training through another institution, there is a chance that some or all of your module credits will transfer for OHSU credit. See FAQ #4 under PI and Study Team Management for more information about affiliating non-OHSU CITI accounts.

See the CITI Program page for more information about our required research training, including registration instructions for OHSU CITI accounts.

Normally, OHSU students, volunteers or others affiliated with OHSU do not require a reliance agreement, as they are covered under our Federal-wide Assurance (FWA). This would also include Visiting Scientists, as they are physically at OHSU working on a study, despite their home institution not being OHSU. See the Collaborations - Non-OHSU Researcher Decision Tree (Quick Guide) for more information on when reliance agreements are needed.

Both OHSU students and volunteers are required to complete research training and the Conflict of Interest in Research (CoIR) disclosure form through OHSU, just as with OHSU employees. Those with different affiliations, such as Visiting Scientists, have the opportunity to complete OHSU research training and CoIR through OHSU, but might also be allowed to use documentation of research training and CoIR from their home institution, as with standard External Collaborators.

• The Non-OHSU Research Collaborators page has onboarding instructions for those that need to complete OHSU research training and CoIR.
  • If you are required to complete research training and CoIR through OHSU, but you've already completed CITI training elsewhere and want to transfer it to OHSU for credit, see FAQ #4 under PI and Study Team Management for instructions on transferring credit in CITI.
• If you are not required to complete OHSU research training and CoIR and you already completed them at your home institution, see FAQ #8 under PI and Study Team Management for instructions on uploading training documentation.

If you are either a paid VAPORHCS employee or a paid PVARF employee, VA CITI training can be used instead if the study is NOT funded by PHS or an entity following PHS Conflict of Interest (CoI) regulations (42 CFR Part 50 Subpart F and 45 CFR Part 94). When being added to the Study Team Member page, under question #2 "Roles in Research", the role for "VA or PVARF employee" should be checked.

If the study is PHS funded, then RCR training (especially the Conflict of Interest module within this course) will be required, which is not provided by the Portland VA. In this case, the OHSU RCR course must be completed, along with an OHSU CoI disclosure form. The "VA or PVARF employee" role will still need to be checked for you, but checking box #2C on the Ancillary Reviews and Notifications page to indicate PHS funding will have the eIRB system checking OHSU records for your training and CoI. The OHSU HSR and GCP courses most likely will not need to be completed as well if you already completed them through your VA CITI account. In order to have your existing VA CITI training feed into OHSU systems and ultimately the eIRB system, your VA CITI account must be affiliated with your OHSU CITI account (see FAQ #4 under PI and Study Team Management).

If your affiliation with VAPORHCS is as a VA "without compensation" appointment (VA WOC), then OHSU CITI training and a CoI disclosure will be required. Everyone performing research at the VA must have a research appointment with them; however, the difference is if you are actually being paid by the VA or PVARF.

You cannot be both a VA WOC and a VA/PVARF employee: you are one or the other. Therefore both of those roles should NOT be checked for a single person. If you are NOT being paid by the VA or PVARF, then "VA WOC" should be checked under question #2 of "Roles in Research" when being added to the study. Otherwise, if you are being paid by the VA or PVARF, you fall into the "VA or PVARF employee" role discussed above.

External Collaborators (non-OHSU, non-VA/PVARF affiliated) have a couple options when it comes to onboarding. But, they will need some kind of reliance agreement to cover their participation in research at OHSU. If they are affiliated to an external institution that requires them to complete research training (RCR, HSR, and/or GCP) and a Conflict of Interest in Research (CoIR) Disclosure form, they most likely don't need to also complete those through OHSU as well. It is the responsibility of the OHSU study team to work with the External Collaborator to find out if required training and CoI were already completed at their home institution. If they didn't complete either research training or a CoI disclosure at their home institution, they can complete them through OHSU. Examples of different COI compliance pathways can be found here.

When adding the External Collaborator to the study, you must also make sure to assign their Roles in Research properly to indicate if training or CoI were completed elsewhere (and upload copies of the training certificates), or indicate that this person must complete training or CoI through OHSU. The Help Text available when adding new study team members in the eIRB contains details on appropriately assigning Roles in Research. See the sections below for step-by-step instructions on how to properly onboard a non-OHSU researcher.

Research training and/or CoI completed through home institution:

• Request an OHSU employee ID number.
• If you completed all training the study requires (RCR, HSR, and/or GCP) at your home institution, provide the OHSU study team with PDF completion certificates for each required training.
• If your home institution is compliant with PHS regulations 42 CFR Part 50 Subpart F and 45 CFR Part 94 and you completed your CoIR disclosure through them, no documentation is needed.
• Register in the eIRB system.
• OHSU Study Team adds you to Study Team Member page.
  • In the pop-up window to add people, question #2 "Roles in Research" needs two External Collaborator roles checked (in addition to any other applicable roles):
    • "COI Option 1: From Institution with CoI policy compliant with PHS regulations 42 CFR Part 50 Subpart F and 45 CFR Part 94"
    • "RCR/HSR Option 1: With RCR and human subjects training outside OHSU (such as CITI, upload documentation)"
  • Mark "Yes" for question #3 to indicate the person is an External Collaborator.
  • Upload all training certificates in question #2 of the Study Team Member Information page.
  • Upload the reliance agreement on the Supporting Documents page.

Need to complete research training and/or CoI through OHSU:

• Follow all onboarding steps on the Non-OHSU Research Collaborators page.
• OHSU study team adds you to Study Team Member page.
  • In the pop-up window to add people, question #2 "Roles in Research" needs two External Collaborator roles checked (in addition to any other applicable roles):
    • "COI Option 2: Not from institution with CoI policy compliant with PHS regulations (Complete OHSU CoI disclosure in the eCoI System)"
    • "RCR/HSR Option 2: No prior RCR or human subjects protection training (You will need to complete OHSU research training in Compass)"
  • Mark "Yes" for question #3 to indicate the person is an External Collaborator.
  • Upload the reliance agreement on the Supporting Documents page.

A common misconception is that only investigators who will be accessing the eIRB need to be listed on the electronic IRQ. This is not true. All study staff members who are reasonably engaged in the design, conduct or analysis of the study should be listed on the electronic IRQ. The OHSU IRB utilizes the HHS Engagement of Institutions in Human Subjects Research guidance to help determine who is "engaged" in research and thus needs to be listed on the study.

Study staff must be registered with the eIRB before the system will allow them to be listed. Anyone listed on the study is required to complete applicable research training and a Conflict of Interest Disclosure either through OHSU or their home institution (if external collaborators), or their role in research is limited such that they are exempt from these requirements. When adding study staff, how you assign their Roles in Research determines how the eIRB assesses compliance with these requirements. For information on how to properly assign roles when adding study staff, please see the eIRB Help Text for question #1 in the pop-up window when adding people to the study on the Study Team Member IRQ page.

No. It is not an IRB or regulatory requirement to list the entire study staff on the consent form. At minimum, the PI must be listed on the consent form. Beyond that, we suggest no more than 5 of the people the subject is most likely to encounter during the conduct of the study.

The same applies for Co-Investigators: they can be listed but are not required to be on the consent form. The IRB will accept as many names as you choose to put on the consent, or as many as your sponsor requires. Some industry sponsors prefer that only investigators who have filed the FDA Form 1572 be listed on the consent form. This is acceptable.

Before the PI leaves OHSU, all studies they are the Principal Investigator for must be either closed or transferred to another OHSU employee that meets OHSU PI Eligibility Criteria. For guidance on how to close a study or change the PI, see the Modifications and Continuing Reviews (Step-by-Step Guide).

If the person still wants to be involved with the study, they can as a Study Team Member (not the PI). The PI will need to be changed and this person can be listed on the Study Team Member page as an External Collaborator. See FAQ #8 under PI and Study Team Management for instructions on listing External Collaborators in the eIRB. Additionally, any other studies in which they are listed as a Study Team Member, including Co-Investigator, will need to update their information on the Study Team Member page to list them as an External Collaborator.

Please consider that in addition to any departmental responsibilities to resolve prior to their departure, any grants or funding contracts will also need to be addressed as well. Contact OPAM for questions about grants, and CTO for questions about contracts.

Temporary absences where no eIRB submissions are anticipated may either fully change the PI in the eIRB or use the following process:

Step 1: Prior to the PI being absent from research duties (ex. vacation, planned absence), identify who will cover all study duties including who will be responsible for any eIRB submissions.

• Covering investigator must be qualified to cover the duties as well as eligible to be a PI. (PI Eligibility Criteria)
• Covering investigator must already be a study team member in the eIRB. Members can be added by submitting a modification.
• Covering investigator must be willing to hold full responsibility for the study’s research during the PI’s absence.

Step 2: Notify the IRB via “Add Comment” including the dates of PI coverage and the name of the covering investigator.

• In the comment, upload documentation of agreement (email exchange is sufficient) between the current PI and the covering investigator. Do not upload this documentation in the study documents.
• Select the “IRB Coordinator” checkbox in order to send email notification to the IRB.

Step 3: If an unexpected eIRB submission is needed (ex. modification, RNI submission) during the dates of PI coverage, once the submission is created, notify the IRB via “Add Comment” that a covering investigator needs to make a submission.

• Select the “IRB Coordinator” checkbox in order to send email notification to the IRB.
• IRB staff will assign the covering investigator as PI proxy to allow the eIRB submission for that item only.

Note: If multiple eIRB submissions are anticipated during longer absences, the PI name would need to be changed in the IRQ prior to the PI absence. However, modifications to study documents are not required.

• Central IRB and Single IRB: These terms tend to be used interchangeably, and generally refer to the IRB of Record (or Reviewing IRB) for a multi-site study to which all the participating sites waive IRB oversight.
• Reviewing IRB: The IRB providing regulatory oversight (IRB of Record) for any participating sites that have waived oversight to this IRB.
• External IRB: This term comes from the OHSU eIRB electronic submission form (IRQ). When OHSU is waiving oversight to another IRB, this Reviewing IRB will be listed on the "External IRB" page of the submission form. For this reason, External IRB can be used interchangeably with Reviewing IRB, Central IRB, or Single IRB.
• Relying IRB: The IRB of a participating site that has waived regulatory oversight to another IRB (the Reviewing IRB).

OHSU generally will NOT agree to be the Reviewing/Single/Central IRB particularly for multi-site studies. There are very few circumstances in which we would agree to be the Reviewing IRB for small collaborations, typically involving regional partners. See the OHSU as the Reviewing IRB section for descriptions of such situations.

No, even if IRB review is waived to another IRB, OHSU will not waive Institutional Biosafety Committee (IBC) review.  The OHSU IBC must review the study. 

No, the OHSU IRB cannot waive oversight to the Portland VA IRB, or any other VA IRBs.

No, the OHSU IRB will not agree to rely on the review of an IRB outside the United States.

In order to add an External Collaborator (non-OHSU researcher) to a study in the eIRB, they must first be properly onboarded, meaning they must gain access to certain OHSU systems and meet compliance requirements. Some type of Reliance Agreement will be needed if they are not affiliated with OHSU. Finally, if the initial study has already been approved, a Modification will need to be submitted and approved to officially add this person to your study.

For more detailed information, see FAQ #8 under PI and Study Team Management. For VA affiliates see FAQ #7 under PI and Study Team Management for onboarding information.

If a waived study is industry-sponsored or industry-funded, the OHSU IRB will charge IRB fees. See the "Central IRB Review Fees - Effective for studies submitted AFTER October 1, 2017" fee schedule for more information. For waived studies, any OHSU IRB Fees that are charged (or not charged) are in addition to any IRB fees that may be charged by the Central IRB. Any questions about IRB Fees charged by Central IRBs should be addressed to the Central IRB contact for your particular study.

Even though ethical and regulatory oversight is being waived to an External IRB, OHSU still has institutional requirements that must be met.

As stated in the question above, OHSU has institutional requirements that must be met despite waiving oversight. This includes specific language and elements that must be included in any consent or assent forms used at OHSU. If the consent or assent form is submitted and approved by the Reviewing IRB before we see it, there is a chance that some required language or element will be missing. Since local OHSU IRB approval is needed before the study can start at the OHSU site, we will still see the approved consent form, and will then required any missing language to be added in. This means that a Modification or Amendment to the Reviewing IRB is needed, Where as if we had seen the draft version before it was submitted to the Reviewing IRB, that extra Modification could have been avoided. See the OHSU Local Compliance Review Requirements for Waived Studies for details on consent form requirements.

If your study does not have any form of consent or assent form, including information sheets, permission sheets, etc., then they don't need to be uploaded. When consent forms aren't used for a study a HIPAA form may be needed, such as a Waiver or Alternation of HIPAA Authorization (WoA) or a Prep to Research Form. The WoA or Prep to Research form should be submitted with your study. See the Consent - Waiver or Alterations (Help Sheet) for more information.

Some External IRBs require study teams to fill out surveys, or information about the study site to be entered into an electronic database, while other IRBs require fewer steps. What the OHSU study team must do, and how it needs to be done will change with the IRB.

Each reliance mechanism has its own steps to follow, and some must be completed in a certain order. The SMART IRB Online Reliance System and the IREx system have different steps to request reliance to be setup in that system for a study. One major difference is that the Online Reliance System requires the Lead PI (usually) to submit a reliance request for the study and list all the participating sites. However, in IREx, the Central IRB ultimately sets up the reliance request in the system.

As a SMART IRB Participating Institution, OHSU can waive oversight under the SMART IRB Agreement to any other Participating Institution that has also signed this agreement. There are three different "mechanisms" through which a study can waive oversight under the SMART IRB Agreement, which are explained on the SMART IRB Agreement page.

The only way to utilize the SMART IRB Agreement when OHSU is the Reviewing IRB, is to use the Letter of Acknowledgement. The OHSU IRB will not be the Reviewing IRB for study documenting reliance through either the IREx or SMART IRB Online Reliance System.

The LOA is the only SMART IRB Agreement mechanism through which OHSU will provide oversight. If the collaborator's home institution has also successfully signed onto the SMART IRB Agreement, then it is possible to use the LOA, as long as that is an agreeable alternative for that institution.

There are 3 different ways to organize reliance under the SMART IRB Agreement, and each vary in complexity. If the sponsor or Reviewing IRB want to document reliance in an online system, they may decide to use either the SMART IRB Online Reliance System or the IREx system. Setting up reliance, who does what, and what each system can do are all different between the two systems. The final way to organize reliance under SMART IRB is by using the Letter of Acknowledgement. The process for this is very simple in comparison, and similar to using an IAA.

While both systems document reliance under the same agreement, they do that in different ways and can do different things. The table below summarizes some major differences and similarities between the two systems.

No, only TIN studies are required to be assigned to either Johns Hopkins, Vanderbilt, or University of Utah. For all other reliance requests, theoretically, any institution in the IREx system that has indicated in their Institutional Profile that they'd be willing to be a Reviewing IRB could potentially act as a Reviewing IRB.

If you want to know if OHSU already has an MOU in place with a specific entity, ask IRB Reliance.

We typically have standing MOUs with specific institutions we frequently collaborate with, such as Portland State University, Oregon State University, University of Oregon, Kaiser Pacific Northwest, and VAPORHCS. If you want to know if we already have an established MOU with an institution, contact us at IRBReliance@ohsu.edu.

Given the extensive amount of work that goes into organizing and executing an MOU, the development of new MOUs is determined by the needs of the institution, rather than by request from investigators.

If your funding source is not available on the Funding Sources page, please email awards@ohsu.edu. They will either add the funding source or help you find the correct source to select.

Try using the search “%DHHS” or another specific keyword from the organization to find your specific funding source. Searching “%NIH” under Funding Organization will only provide a common fund account that is rarely used.

If you still cannot locate your funding source, please contact awards@ohsu.edu to have it added. It may take up to two days for new funding sources to be activated in the eIRB.  

The Proposed Project Questionnaire (PPQ) is the “paper” version of a form that was previously needed for all Unfunded or Industry-funded/sponsored studies.  The paper PPQ is no longer required for Unfunded or Industry-funded eIRB submissions.  

The ePPQ is the electronic version of this form that is filled out in InfoEd. Federally-funded or grant-funded studies should continue to enter PPQ number(s) on the “Funding Source” page of their eIRB submission.

These forms are necessary to generate a “PPQ number” for a particular funding source attributed to a study. The PPQ number is an internal number that allows various OHSU Research Administration groups to identify a study’s funding source. 

The eIRB system will automatically require the creation of an eCRIS study for your submission (the Create or Update eCRIS Study button) if the "OHSU Signed Consent" box on the Study Details page or the "Cancer" box on the Ancillary Reviews and Notifications page is checked. Budgeting, invoicing for billable clinical services, and Contracts are also handled through the eCRIS system. See the Studies Required to Use eCRIS Flowchart for more information on when it is required or not.

For more information on why a Clinical Trial Management System like eCRIS is used at OHSU, see Why is a CTMS necessary at OHSU. Check the eCRIS FAQ page or email eCRIS Support with any eCRIS questions.

If you believe IRB Fees were incorrectly charged to your study, please contact the IRB Manager, Dave Holmgren.

Official information about the level of Research Operations, OHSU policies on restrictions on research, applications for exceptions/appeals and the COVID-19 research registry can all be found on the OHSU O2 COVID-19 Research page.

Researchers must review all their research protocols and determine what research may continue, what research must be revised, and what research must be discontinued to be in compliance with the policy for the current level of OHSU Research Modified Operations.  See the OHSU O2 COVID-19 Research page for the policy on Modified Operations.

Modifications for essential research should include changing any research visit that does not have to be conducted on-site to a remote visit. These changes will likely require an eIRB submission.

In addition to modifications to research protocols, study teams should be modifying their tasks to be working remotely for all tasks:

• Sponsor monitoring visits
• Site selection/initiation visits
• Non-visit study activities (Data analysis, manuscript preparation, grant writing, protocol preparation and submission)

If there is not time to submit a modification for approval and changes are made to prevent exposing subject or others, that is considered a 'change made to prevent immediate harm' allowable under the regulations. 

If the unapproved deviation had the potential for risk to the subject, the research team must evaluate whether it is possible serious noncompliance and if so, submit the deviation as an RNI in eIRB. If there was no potential for risk to the subject for the revised procedures, it may be summarized with the next continuing Review as a non-reportable protocol deviation. 
 

Whenever possible, research visits should be conducted remotely during the pandemic to protect the subject, the research team and prevent further spread of Coronavirus-19 in our community.  However, this may present challenges in obtaining consent and require modification of your protocol to accommodate this.  You have several options and should consider what is appropriate for your study:

Minimal risk studies

• Modify your protocol documents to have a phone or video conference consent process.
• Mail, fax, email consent to the subject or explore a legally valid electronic consent process (see OCTRI presentation posted here).
• Have subject sign and return consent by mail, fax or email or complete the electronic consent process

Depending on the study, it may be appropriate to change the consent process to one with a consent discussion and provision of an Information Sheet but with a waiver of documentation of consent.  This can be appropriate for very simple studies.  The Information Sheet has all the information in a regular consent form, but does not have the signature lines.  A good process would include the research team documenting in a note the consent discussion and the subject’s agreement to participate.  If you anticipate a difficult time receiving consent documents back from subjects, talk with your IRB Specialist about whether this is an appropriate model for your study.  You may also need to request a waiver of the signature for the HIPAA authorization, which is part of the consent and authorization form.

Above minimal risks studies 

Written, signed consent and authorization is required for above minimal studies and the COVID-19 pandemic is presenting new challenges to balance infection control practices with this requirement.  The FDA has issued Guidance on Conduct of Clinical Trials during the COVID-19 Pandemic including guidance in the FAQs at the end on obtaining consent.  In this guidance, the FDA outlines acceptable methods for obtaining consent, and documenting consent for patients in isolation that provide you options as you plan how to consent subjects:

Obtaining consent

• In the room consent
• Phone consent, which may need to include an impartial witness (someone separate from the study team) on the line (see below).

Documentation of consent

• Set up a legally valid electronic consent
• Subject signs the consent form and gives to researcher FOLLOWING ALL HOSPITAL INFECTION CONTROL PROCEDURES.  Subject must also receive a signed copy.
• Subject signs the consent form and keeps it, and the researcher is given a picture of the signed consent, considering Information, Privacy and Security issues in how that picture is obtained and transmitted
• An impartial witness who has participated in a telephone or video consent with the investigator and the subject. Subject signs the consent form and keeps it.  The witness and investigator each sign a separate clean consent form and attest (e.g., through a note in the chart) that the subject agreed to participate and that the subject signed the consent form.

The IRB has determined that these activities are not considered a ‘change to the research’ and therefore do not need to be submitted as modifications to research protocols:

• General communications with subjects about COVID-19.  These are not study-specific communications, but rather are providing information that is publicly available, e.g., on the OHSU website or CDC recommendations.
• Screening procedures for COVID-19 infection consistent with OHSU health system procedures.  These are not study-specific procedures.
• Logistics related to study visits.
• Logistic changes in protocol operations that do not contradict approved study documents.