using irex as the relying site irb/human research
TRANSCRIPT
USING IREX AS THE RELYING SITE IRB/HUMAN RESEARCH PROTECTION PROGRAM (HRPP) 1.0 INTRODUCTION FOR HRPP/ IRBS ................................................................................................................................................... 1
1.1 Access the IRB Reliance Exchange (IREx) ......................................................................................................................... 2
1.2 Change Your Password .................................................................................................................................................... 2
1.3 The IRB/HRPP IREx Homepage ....................................................................................................................................... 3
1.4 Listing Your Component Sites ........................................................................................................................................4
1.5 Tracking Your Institution’s Reliance Agreements ..........................................................................................................4
1.6 Tracking Your Indemnification ........................................................................................................................................ 5
1.7 Tracking External agreements ........................................................................................................................................6
2.0 SEARCHING FOR STUDIES IN IREx ................................................................................................................................................. 7
3.0 Using the “IREx Study at Your Site” Notification ......................................................................................................................... 8
4.0 REGISTRATION FOR A STUDY ......................................................................................................................................................... 9
4.1 Registration – ADDITIONAL FWA Engaged .................................................................................................................. 10
4.2 Registration – when your fwa is Not Engaged .............................................................................................................. 11
4.3 Registration – Wrong FWA Listed ................................................................................................................................. 11
4.4 Registration – Wrong PI Listed ...................................................................................................................................... 12
4.5 Registration – As A Combo Site .................................................................................................................................... 12
5.0 THE STUDY PAGE - OVERVIEW ..................................................................................................................................................... 14
6.0 GETTING STARTED CHECKLIST .................................................................................................................................................... 15
6.1 Verify Study Team Access ............................................................................................................................................. 16
6.2 Complete Agreements................................................................................................................................................... 17
6.3 Confirm your Institutional Profile ................................................................................................................................. 18
6.4 Indicate Reliance: Review and accept the study-specific reliance plan ........................................................................ 18
6.5 Complete Local Considerations ..................................................................................................................................... 21
6.5.1 Complete Local Considerations – As A Combo Site ...................................................................................................... 22
6.6 Remind PI To Complete PI Survey – Validate PI Survey ............................................................................................... 23
7.0 View Approval Documents for Your Site....................................................................................................................................... 26
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1.0 INTRODUCTION FOR HRPP/ IRBS
IREx is a freely available web-based portal supporting single IRB documentation & coordination:
IREX IS USED BY...
Single IRBs Lead Study Teams & Coordinating Centers
Participating Site HRPPs/IRBs
Participating Site Study Teams
capture information from site HRPPs & study teams
track site progress towards sIRB review & approval
document reliance & local considerations
communicate with the sIRB & retrieve sIRB
approvals
STANDARDIZE THE RELIANCE PROCESS ACROSS SIRBS Using IREx promotes a standardized single IRB review process for capturing reliance documentation and facilitating communication between the sIRB, study teams, and relying HRPPs, while allowing sIRBs to delegate sIRB coordination responsibilities to the Lead Study Team or Coordinating Center on a study-by-study basis.
HARMONIZE SIRB DATA COLLECTION sIRBs can use IREx to capture local considerations from sites. This creates consistency in (a) the data collected by sIRBs and (b) provided from sites. Two types of data are collected in IREx:
The Institutional Profile (IP): All sites complete an IP upon joining IREx. The IP captures (1) general FWA/IRB information; (2) overarching local and state laws/policies affecting all research; (3) processes and requirements when relying on an sIRB; and (4) preferences for handling the flexible elements of reliance when serving as the sIRB. Tip: The IP is completed once and can be updated as the information changes. Study-specific Local Considerations: On a study-by-study basis, participating sites must document local considerations for the sIRB. IREx can be used to capture this information, which includes consent form language and applicable state or local laws, regulations, institutional policies, standards, or other local factors, including ancillary reviews, that would affect the conduct or approval of the study at an institution.
FACILIATE SIRB COORDINATION WITH PARTICIPATING SITES sIRB review requires additional coordination to ensure all reliance documentation is captured from sites. IREx provides dashboards and tracking mechanisms the Lead Study Teams and Coordinating Centers (“Study Managers”) use to (1) communicate with sites; (2) track site readiness for sIRB review; (3) capture information for submission to the sIRB, and (4) disseminate site approvals.
SYSTEMATIZE THE COLLECTION OF SIRB METRICS IREx captures time to approval metrics for the Lead and Relying Sites in the hopes of evaluating the success of existing national policies and informing future policy decisions. Data are captured on a site-by-site and study-by-study basis so bottlenecks can be identified and resolved.
Basic Reliance Documentation
•sIRB agreement completion•Study-specific reliance decisions
Advanced Reliance Documentation
•Study-specific local considerations from sites
•sIRB approval documents for sites
sIRB Coordination
•Communicating with sites•Tracking site readiness for sIRB
review•Faciliating site submissions to
the sIRB•Disseminating approvals to sites
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1.1 ACCESS THE IRB RELIANCE EXCHANGE (IREX) The IREx website can be accessed at www.irbexchange.org. Click the LOGIN button in the top right-hand corner of the web page, enter your email address and your password to log in.
The FIRST TIME you log in, you will need to use the temporary password emailed to you from IREx. Tip: Use the email address where you received the IREx notification as your login name.
1.2 CHANGE YOUR PASSWORD
After you first log in to IREx, please change your password using Your Profile at the top of the dashboard. Click Change Password to set a new password.
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1.3 THE IRB/HRPP IREX HOMEPAGE
The IRB/HRPP IREx Homepage is tailored to your site’s use of IREx.
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Quick Links: these are visible from any page of IREx and provide quick access to edit Your Profile, Contact Us, view Resources, return to the Homepage and log out.
2 IRB Dashboards: Use these links for quick access to a list of all the studies where you are the Reviewer or Single IRB (sIRB) and a Participant – the Participating Site IRB Dashboard includes a column that lists the PI for each study, the Local IRB number (optional on the HRP Survey) for easy sorting, and shows the date the IRB approved your site under the “To Do”. Data exports for your studies are available for sIRBs and Relying Site HRPPs. View a list of all the individuals at your site with access to IREx in the users box.
3 Use Find a Study to search for studies in IREx. Search by study title or IREx project ID (“proj=#”), found on study link.
4 Your Institution: Use these links to edit your Institutional Profile, list Components to your FWA, and track your institution’s Agreements.
5 Your Liaisons are listed on the dashboard, along with their phone number, if available. This list is also on the homepage of other users at your institution.
6 Resources: Use these links to Find other users or Find other sites. Use the Agreement Checker to view whether sites have executed agreements with an sIRB. You can also Add HRPP Staff, Request Help, Join a Training, and access additional Resources.
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1.4 LISTING YOUR COMPONENT SITES
In IREx, FWA-holding entities have liaisons assigned and have an Institutional Profile. However, FWA sites can also add their component sites, as listed on the OHRP website, to IREx if they (1) are more commonly known as the name of one of their components and/or (2) wish to more specifically delineate where research is happening for a particular study. Providing component sites can also be helpful if you have more than one study team participating in a study independent from one another. When component sites are part of studies, they are listed along with the name of the main FWA holder. For example, [FWA Holder “Short Name"] – [Component Site Name] To list component sites in IREx: 1. Login to IREx and click the blue Components
button on the homepage. 2. Enter the full name of the component, as well as a
short name. 3. Click the green plus + button and Save.
1.5 TRACKING YOUR INSTITUTION’S RELIANCE AGREEMENTS
IREx can be used to support the use of any reliance agreement on a study. While we strongly encourage use of the SMART IRB Agreement v1 and v2, IREx can also be used with Other Reliance Agreements (e.g., IAAs), for sites that are unable to join SMART IRB. In fact, the Reviewing IRB can offer multiple agreements on the same study. IREx can also be used to track whether sites have executed a Letter of Indemnification.
If multiple reliance agreements are offered:
• SMART IRB is the default, if signed. The SMART IRB status for sites will be updated in IREx based on the SMART IRB website Participating Institution list. If SMART IRB and an Other Reliance Agreement (ORA) are offered on the same study, sites in SMART IRB will default to that agreement for the study.
• If the reliance involves the NIH Intramural Research Program, both the Reviewing IRB and Relying Institutions will be required to use SMART version 2.
• Joining SMART IRB does not override prior studies where a Relying Institution used an ORA. Tracking sites that have signed your institution’s Reliance Agreement(s): 1. Click the blue Agreement button on the homepage. 2. On the Your Reliance Agreements tab, you can see a list
of sites that have executed or are indicated they will sign your institution’s Other Reliance Agreement, if listed on a study when serving as the Reviewing IRB.
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3. Click the pencil icon to update information such as, date the agreement was sent to the site, date agreement was executed, upload as signed copy of agreement, and any notes. 4. Click Save to save the information for the site. Tip: Use the Download CSV button to download an excel file of all your reliance agreement information.
1.6 TRACKING YOUR INDEMNIFICATION
Some institutions require an indemnification agreement when serving as the Reviewing IRB using the SMART IRB Agreement, which is silent on indemnification (see section 4.11 of the SMART IRB Agreement). IREx allows Reviewing IRBs to track institutions from which they require an indemnification agreement. This can be a unique agreement between the Reviewing IRB and another institution; however, only one executed indemnification agreement can be tracked per institution on a study. Tracking sites that have signed your Indemnification Agreement: 1. Click the blue Agreements button on the homepage. 2. On the Your Indemnification tab, you can see a list of
sites that have executed or are indicated they will sign your institution’s Indemnification Agreement, if listed on a study when serving as the Reviewing IRB.
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3. Click the pencil icon to update information such as, date the agreement was sent to the site, date agreement was executed, upload as signed copy of agreement, and any notes. 4. Click Save to save the information for the site. Tip: Use the Download CSV button to download an excel file of all your reliance agreement information.
1.7 TRACKING EXTERNAL AGREEMENTS
You can track which Reviewing IRBs have asked your institution to sign a reliance and indemnification agreement. Track agreements your institution has signed with Reviewing IRBs: 1. Click the blue Agreement button on the homepage. 2. On the External Agreements tab, you can see a View Only list of agreements that your institution needs to sign or
has executed. It will list the single IRB requiring the agreement, the agreement Type, Agreement Name, and Related Studies using the agreement. The date Sent, date Executed, and agreement Document will be shown if it has been logged in IREx by the Reviewing IRB.
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2.0 SEARCHING FOR STUDIES IN IREX
To find a study in IREx, use the Find a Study search at the top of the homepage. Search for specific studies by entering a full or partial name of the study, by selecting a sponsor, or by typing the IREx project ID number (“proj=#”) found at the end of the study page link (e.g., the project IRB number for: https://www.irbexchange.org/test/study?proj=150103 is “150103”).
Tip: You can view the entire IREx database of studies by leaving the name and sponsor fields blank and clicking find. If your site has not yet been alerted as a participating site on a study in IREx, you will receive a pop-up stating that you are not authorized to access this study. Please contact the Reviewing IRB Liaison or Study Manager to be given access to the study.
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3.0 USING THE “IREX STUDY AT YOUR SITE” NOTIFICATION
If you receive an email notification that your site is part of a study in IREx, the Reviewing IRB has listed your site as a Participating Site in IREx. When you receive this email, please check to see if you have a local submission or request to rely from your local PI. If not, no immediate action is required.
The email notification has a link to register for the study.
1. Click the Login to IREx link to go directly to the study registration page. 2. You can also login to IREx and search for the study by title, as shown in the previous section.
If you do not have a submission from your local investigator or a request to rely, you might consider reaching out to the site PI to confirm if your site is engaged.
1. If you learn your site is not engaged in research, you can indicate you are not engaged during the registration process and will be removed from the study and prevent any future email notifications.
2. If you are engaged, but you do not have a submission from your local investigator, you might consider letting the PI/ study team know what information you require to move forward. While waiting for your local submission, you can always login to IREx, register, and complete your Institutional Profile.
3. If you know additional FWAs are engaged for this performance site, you will be able to indicate that when you register for the study.
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4.0 REGISTRATION FOR A STUDY
Only IREx Liaisons can register their site with a study in the system. Upon registration, Liaisons are able to confirm the information listed for their site, make changes, or indicate they are not engaged.
NOTE: REGISTERING IS NOT AN INDICATION OF RELIANCE, ONLY AN INDICATION THAT YOUR SITE IS ENGAGED IN RESEARCH FOR THE STUDY. YOU INDICATE WILLINGNESS TO RELY ON THE REVIEWING IRB AFTER CONFIRMING YOU ARE ENGAGED.
The first question in the registration asks whether your investigator and FWA are listed correctly. If Yes, you will be asked to: 1. Confirm or edit the PI details, and 2. Edit the FWA or Component
engaged, which helps delineate where research is conducted.
3. The next question asks if the
investigator engages other known FWAs for this study. If not, you have completed registration and can Submit to confirm engagement and access the study.
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4.1 REGISTRATION – ADDITIONAL FWA ENGAGED If your investigator and FWA listed are engaged, but an additional FWA is also engaged: 1. Select Yes, confirm or edit PI details, and Submit. 2. Confirm your engaged FWA or component to help delineate where research is conducted. 3. Then, select Yes, search and enter the additional FWA, and click +Add Site to list the FWA. 4. Next, select the site you wish to be the Primary HRPP for the Combo Site and Submit to complete the registration and access the study.
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4.2 REGISTRATION – WHEN YOUR FWA IS NOT ENGAGED
If your investigator is no longer participating in the study, you can indicate that your FWA is not engaged on the study:
1. Select No for all fields and enter a reason that briefly describes why the FWA listed is not engaged for the study. 2. Click Submit and a notification will be sent to the Study Manager and Reviewing IRB with your provided response.
4.3 REGISTRATION – WRONG FWA LISTED
If your investigator is engaged but the wrong FWA is listed:
1. Select No when asked if the investigator engages the FWA listed.
2. Then select Yes and confirm or edit the PI details. 3. List any other sites/ FWAs that may be engaged.
Search and enter the site, click +Add Site to list the FWA.
4. The last question asks if another PI engages the FWA previously listed. If so, select Yes to confirm further details. Otherwise, select No, provide a reason, and Submit to complete the registration process and access the study page.
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4.4 REGISTRATION – WRONG PI LISTED
If your site in engaged in the study but the wrong investigator is listed (e.g., PI change):
1. Select No when asked if the investigator engages the FWA listed.
2. Select No when asked if the investigator engages another site/ FWA.
3. Select Yes when asked if another PI engages your FWA listed. Enter the PI’s email address, first name, and last name. Click Submit to complete registration and access the study page.
4. You will be asked if the PI engages other sites/ FWAs on the study. If so, you will need to identify the Primary HRPP for the Combo Site you’ve created (see section 4.1).
4.5 REGISTRATION – AS A COMBO SITE
When an investigator engages more than one FWA, in IREx, we call it a “Combo Site”. To register for a study as part of a Combo Site, confirm the investigator and FWA listed is correct:
1. Select Yes, confirm or edit PI details, and Submit.
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2. Confirm your engaged FWA or component to help delineate where research is conducted.
3. First HRPP to register must verify the Combo Site Primary HRPP.
4. You will be asked if the PI engages an additional FWA that is not listed. If not, select No and Submit. If so, select Yes, search and enter the additional site, click +Add Site to list the FWA. TIP: If this is not an FWA you oversee, the liaison for the FWA will be notified to confirm their engagement
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5.0 THE STUDY PAGE - OVERVIEW
The descriptions below correspond with numbers in the picture above.
1. General Study Information and Contacts can be found at the top of the page. Click the Study Overview button for a brief study summary, the type of study (minimal risk, greater than minimal risk) and the study sponsor.
2. The GETTING STARTED checklist appears when you first register for a study and is your guide to reaching initial IRB approval from the Reviewing IRB. The steps must be completed in order and the next step(s) is highlighted green. The GETTING STARTED Checklist will disappear after all steps are completed.
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3. The Study-wide IRB Approvals tab captures approval information (type of review and key dates) and documents for the Lead Site or Overall Study. These documents are separate from approvals for Relying Sites. View the Document Types Overview to learn more about the types of IRB approved documents uploaded to IREx. NOTE: IF THE LEAD SITE IS NOT APPROVED, A DRAFT PROTOCOL AND CONSENT FORMS MAY BE AVAILABLE FOR DOWNLOAD; HOWEVER, THEY WILL BE MARKED DRAFT AND A POP-UP WILL NOTE THE DOCUMENTS ARE DRAFT WHEN DOWNLOADED.
4. The Site-specific Approvals tab shows the approval details for your site and all participating sites. You can only view documents for your site. As the Relying Site, this tab will be your default view after you agree to cede review to the Reviewing IRB. Your site will be listed first on the Site-specific Approvals tab, followed by other participating sites, which will be listed in alphabetical order.
5. The Status Summary tab shows your site’s progress and steps completed for sIRB review. 6. The Site-Specific Info menu provides various tools to review and update your site’s information for the study. Here you
can edit information about your local review (e.g., date the local reviews were completed), update Study Team Contacts; view the Study Specific Reliance Plan (SSRP), Participating Site List, and download another copy of the Letter of Reliance that is generated after you accept the Reviewing IRB’s SSRP.
7. The VERSIONS box organizes the study approvals with the most recent approval at the top and previous versions collapsed below. The box lets you view sIRB approvals sorted by Reviewing IRB, Relying Sites, and sites who are Registered/In Progress. Sites will not show in the Versions box if they have not yet registered or ceded review.
6.0 GETTING STARTED CHECKLIST
After registering for a study, Relying Site HRPPs use the GETTING STARTED Checklist on the left to lead you through the steps to reaching initial approval from the Reviewing IRB in IREx. These steps may include the following, which are described in detail below:
1. Verify Study Team Access 2. Complete Agreements 3. Confirm Institutional Profile [If the Reviewing IRB is capturing local considerations in IREx, you will also see steps 5-6.] 4. Indicate Reliance 5. Complete HRP Survey 6. Remind PI To Complete PI Survey / Validate PI Survey 7. Awaiting Reviewing IRB Approval 8. View Status Summary
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6.1 VERIFY STUDY TEAM ACCESS Click on Verify Study Team Access on the GETTING STARTED Checklist to open the site contacts pop-up. Site contacts listed by the Study Manager will auto-fill in the pop-up dialog. Confirm the existing study contact(s), add other contacts by entering the contact information, or remove contacts as needed. NOTE: STUDY TEAM MEMBERS CAN ADD OTHER STUDY TEAM CONTACTS TO IREX SO YOU DO NOT NEED TO ADD ALL STUDY TEAM MEMBERS. WE RECOMMEND ADDING A COORDINATOR. Select the Type of contact you wish
to add (PI or Coordinator) and enter their email address to search the database for existing investigators.
For new contacts, enter the email, first and last name. This will create an account for the user so they can log in to IREx. Press continue to move to through the additional screens requesting optional information. NOTE: THE STUDY TEAM CONTACTS LISTED HERE WILL RECEIVE AN EMAIL NOTIFICATION GIVING THEM ACCESS TO THE STUDY IN IREX. THEY WILL ALSO RECEIVE EMAIL NOTIFICATIONS OF ANY NEW APPROVALS THE REVIEWING IRB UPLOADS FOR YOUR SITE.
OTHER OPTIONAL INFORMATION Study Information • Role: your institution will default to
the Relying Site for this study. • IRB Number: enter the number used
at your institution to track the study, if applicable.
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Key Local Review Dates These dates are optional; however, they are helpful to collect and inform the evaluation of the SIRB process. • Submitted for Local Review: when was the study first submitted to your HRPP/IRB for local review? • Local Review Conducted: when did your HRPP start the local review for the study? • Local Review Completed: when did your HRPP complete/conclude the local review?
Review & Submit Review your study information and click Save. If any sections are missing required information, the section and field will be highlighted RED.
After saving this information, you will be taken back to complete the next steps on the GETTING STARTED Checklist.
6.2 COMPLETE AGREEMENTS
Click Complete Agreements to see what agreements are required for the study (e.g., SMART IRB and f Indemnification). IREx will send an email notification to you, the Relying HRPP when the sIRB indicates all the required agreements have been executed. This email lets the Relying HRPP know they can indicate reliance. If your agreements are complete, this section will be grayed out with a checkmark.
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6.3 CONFIRM YOUR INSTITUTIONAL PROFILE
The Institutional Profile includes institutional-level information about your site. It is frequently completed by the site IRB team when they initially gain access to IREx so it may already be complete for your site.
Click on Confirm Institutional Profile on the GETTING STARTED Checklist to open the form. Tip: You can confirm your Institutional Profile or indicate reliance first. If the Institutional Profile has previously been completed, you have the option to “Confirm” or “Edit” the information on your Institutional Profile Tip: Be sure to move through each page using the navigation buttons at the bottom of each page and click Submit on the last page when finished with edits.
If the Institutional Profile has not been previously completed, it will open in edit mode on the page that was last completed. You can take this opportunity to fill in your institution’s details on this screen—using the navigation buttons at the bottom of each page and clicking Submit on the last page when finished. Then you can Confirm the profile.
6.4 INDICATE RELIANCE: REVIEW AND ACCEPT THE STUDY-SPECIFIC RELIANCE PLAN
The next step is to cede review to the Reviewing IRB by accepting the Study-Specific Reliance Plan (SSRP). The SSRP is used to document how flexible elements of the reliance agreement will be handled (e.g., auditing, SOPs, insurance, etc.). The Reviewing IRB initiates this process by establishing the SSRP for the study. The Reviewing IRB also has the final say on the SSRP for each study. In order to rely on the Reviewing IRB, you and the Reviewing IRB must agree on an SSRP. However, if you disagree with the terms of the SSRP initially, you can request changes that the Reviewing IRB can consider, as described below.
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Click on Indicate Reliance on the GETTING STARTED Checklist. The SSRP window will open showing the Reviewing IRB’s proposed Study-Specific Reliance Plan. Review the SSRP details to determine whether you wish to “Accept” or “Request changes”.
Click Accept SSRP if you agree with the proposed SSRP.
You (and the Reviewing IRB) will receive an email noting your acceptance. This email will also include your official documentation of reliance or Letter of Reliance.
Tip: If another reliance agreement (e.g., IAA, MOU) is offered by the SIRB, Relying Institutions that execute that agreement and indicate reliance will see the name of the SIRB’s reliance agreement in the email and attached PDF.
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Relying Institutions can also download the Letter/ Notification of Reliance and site-specific SSRP PDFs from the Site-specific Info menu on the study page. If you wish to make changes to the Reviewing IRB’s purposed SSRP, click Request changes to show the contact information (phone and email) for the Reviewing IRB Liaisons. You must contact them to discuss the desired changes.
If the Reviewing IRB agrees to make the changes you have discussed, you will receive an email notification when the Reviewing IRB has modified the SSRP for your site. Use the link in the email to login to IREx and review the revised SSRP.
To review the revised SSRP click Indicate Reliance on the GETTING STARTED Checklist. If you agree with the edits, click Accept SSRP and a notification of reliance will get sent to the Reviewing IRB and Study Manager for the study. NOTE: ONCE YOU ACCEPT THE SSRP, YOUR SITE NAME WILL APPEAR UNDER RELYING SITES IN THE VERSIONS BOX ON THE LEFT OF THE PROJECT PAGE.
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Requesting changes to the SSRP AFTER it has been accepted: Changes can be made to your SSRP with the Reviewing after you have accepted the SSRP using the steps outlined below:
1. Contact the Reviewing IRB outside of IREx (via email or phone) to request changes. 2. Once the Reviewing IRB makes changes to the SSRP in IREx, your will be notified by email and the changes will be
detailed in the email. 3. Next, log in to IREx, presses Indicate Reliance on the GETTING STARTED checklist, and accept the revised SSRP. 4. After the revised SSRP is accepted, IREx sends an email, “Relying HRPP Accepted Revised SSRP,” to
the Reviewing IRB and Relying Institution with a PDF of the revised SSRP. NOTE: THE ORIGINAL DATE OF RELIANCE IS NOT RESET IN THIS INSTANCE. THE DATE THE REVISED SSRP WAS ACCEPTED WILL BE NOTED AS AN “UPDATED” RELIANCE DECISION ON THE STATUS SUMMARY TAB.
6.5 COMPLETE LOCAL CONSIDERATIONS
One of the biggest challenges to relying on a single IRB (sIRB) is ensuring the Participating Site’s Human Research Protection Program (HRPP) is aware of the study, has completed the appropriate institutional reviews, and communicates all relevant local considerations to the sIRB. If the Reviewing IRB is using IREx to capture local considerations for the study on which you are relying, your site has three components to complete:
1. Site-specific Information: each HRPP completes an Institutional Profile (IP), one time. The IP captures information about the FWA, legal components, and over-arching state laws or institutional policies that affect all research at the site.
2. Study-specific Information from the HRPP: For each study, the participating institution’s HRPP must complete the HRP Survey, communicating any applicable state or local laws, regulations, institutional policies, standards, relevant consent language, or other local factors, including local ancillary reviews, relevant to the study being reviewed.
3. Study-specific Information from the PI: For each study, site PIs are asked to complete a PI Survey where they provide information about the conduct of the study and any procedures that differ from the protocol. This information is available to and verified by the participating site’s HRPP.
Tip: You cannot complete the HRP Survey until you have completed your Institutional Profile. When completing the HRP Survey, the first few items are automatically filled in from information previously entered information (e.g., Study Title, Local Site Name, Local Site PI First name, Local Site PI Last Name, and Local Site PI Email). NOTE: YOU HAVE THE OPTION TO SAVE & RETURN LATER. YOU WILL RECEIVE A POP-UP WARNING THAT YOUR INFORMATION HAS BEEN SAVED, BUT IT’S NOT COMPLETE. Once all the information has been filled in, you will need to sign & attest to the information entered by clicking Add signature at the bottom of the page. Use your mouse to sign, then click Save Signature. You are now ready to click Submit to complete your HRP Survey.
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6.5.1 COMPLETE LOCAL CONSIDERATIONS – AS A COMBO SITE
The IREx Combo Site feature was created to help streamline reliance documentation when an investigator engages multiple sites/ FWAs. This chart shows the HRPP requirements from FWAs that are listed as a Combo Site:
FWA #1 – PRIMARY HRPP FWA #2 – NON-PRIMARY HRPP
Cede Decision Required Required
Institutional Profile Required Required HRP Survey Required Complete new or default to Primary
HRPP’s survey PI Survey PI complete one survey
Validate PI Survey Required View only Approval documents from sIRB Access to one set of approval documents
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After registering for the study, the Primary HRPP & Non-primary HRPP completes the steps on the GETTING STARTED checklist as described in the previous section. When the Non-primary HRPP completes the HRP Survey, a pop-up will give an option to complete the HRP survey from scratch OR copy & edit responses from the Primary HRPP. To streamline documentation, select Copy & edit responses from the Primary HRPP. If the Primary HRPP has not yet completed their HRP Survey, you will have the option to go back and complete the HRP Survey from scratch OR wait for the Primary HRPP to complete the survey. If you decided to wait, you will receive an email notification when the Primary HRPP completes the HRP Survey. This is your greenlight to login into IREx, copy and edit the response, and submit to complete the HRP Survey.
6.6 REMIND PI TO COMPLETE PI SURVEY – VALIDATE PI SURVEY The next step on the GETTING STARTED Checklist has to do with the PI Survey. If the principal investigator has not completed their survey, you have the option to click on Remind PI To Complete PI Survey to send a reminder to the investigator.
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A pop-up box will appear with a generic email you can edit to include additional information or add your contact details. Click Send Reminder to send the PI a reminder to complete the PI Survey. NOTE: YOU HAVE THE OPTION TO EDIT THE EMAIL BUT DON’T REMOVE THE HYPERLINKED FIELDS.
Once the investigator completes the PI Survey you will receive an email notification from IREx asking you to validate the answers provided. When you login to IREx, you will see Validate PI Survey on the GETTING STARTED Checklist. This is also what you will see if, by the time you reach this step, the PI has already completed the PI Survey. Click Validate PI Survey to view the responses.
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As the Relying Site Liaison, you will have the option to Edit or Confirm the PI Survey responses.
If you make edits to the survey, the PI will receive a notification outlining the changes you made. The PI cannot make additional changes.
NOTE: NON-PRIMARY HRPPS PART OF A COMBO SITE ARE NOT REQUIRED TO VALIDATE THE PI SURVEY AND HAVE VIEW ONLY ACCESS TO THE PI SURVEY. YOU WILL SEE “AWAITING PI SURVEY” ON YOUR CHECKLIST.
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7.0 VIEW APPROVAL DOCUMENTS FOR YOUR SITE Once the Reviewing IRB uploads an approval for your site, all HRPP IREx Liaisons and your study team contacts will be notified by email. The notification email includes guidance for the PIs and study teams on how to access the approved study documents for your site. Tip: After receiving sIRB approval, Relying HRPPs should communicate any local submission requirements to the PI and study team if required by your institution. Your site-specific approval documents can be found on the Site-specific IRB Approvals page, where you can access and download the documents. NOTE: THE STUDY DOCUMENTS CAN BE DOWNLOADED INDIVIDUALLY BY CLICKING ON THE FILE NAME OR ALL TOGETHER IN A ZIP FILE BY CLICKING THE DOWNLOAD ALL BUTTON.
When you login to view your approval, the current approval is always listed at the top and marked “Current”.
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As the study progresses, you may see several Versions available in the Versions box on the left. You will be notified of all new approvals from the Reviewing IRB. Archived versions are also available. New versions numbers (e.g., Version 3 vs Version 2) are an indication that the protocol was changed. If you see “Rev. #” beside a version, it means a study modification was made, but the protocol version number did not.