SMART IRB - Collaborative Research Portal
Revised Human Subjects Regulations (Common Rule) Wednesday, June 20th 2018
The regulations that human subjects researchers must adhere to (referred to as the Common Rule Regulations) were established in 1991. In 2011, federal agencies began the long-awaited process to revise these regulations and, on January 18, 2017, the final revisions to the Common Rule (Final Rule) were posted in the federal register. The effective and implementation dates have recently changed. As posted in the federal register on June 18, 2018, the revised final Common Rule is both effective and to be implemented on January 21, 2019 with the option of implementing 3 burden-reducing provisions before January 21, 2019.
CSU researchers work collaboratively with many researchers at other institutions. These collaborations come in various shapes and sizes. The following two (3) scenarios are the most common. If you have questions on your steps, give us a call.
I am a CSU investigator and Dr. XYZ at ABC University would like to collaborate with me on my study. We have discussed that this investigator will recruit participants at her site, conduct the protocol, and send me data collected. She has a local IRB that she can contact for an IRB approval, but I already have an IRB approval.
What can I do?
My protocol, in essence, is being amended to include another research site. I can create an amendment to include that other research site and include the new investigator. I will want to outline what the scope of work with be with this other investigator. Parallel to this process, I can start the SMART IRB Reliance process [link to page or portal] so that both institutions are able to communicate with each other on whether a reliance would be feasible while my amendment is being reviewed by CSU IRB. SMART IRB is a platform that over 400 research institutions have become members to aid in establishing reliance agreements to reduce investigator burden.
I am have a subcontract with Dr. XYZ at ABC University in that I will aid in the analysis of coded specimens collected under Dr. XYZ’s IRB approved protocol. I am not interacting or intervening with participants, but I am receiving coded specimens to analyze and share the data back to the principal investigator.
What can I do?
Dr. XYZ, as principal investigator, should include an amendment that includes my activity for analysis. In addition, as principal investigator, she can initiate the SMART IRB Reliance process [link to page or portal]. Primary institution’s Point of Contact (POC) will have first right of accepting being the IRB of record for my activity on the study. CSU will review and determine agreement to the terms of the reliance via SMART IRB. Once finalized, the agreement is housed in SMART IRB, no further action unless CSU requests minutes, IRB records, etc.
I am collaborating on a COMIRB approved protocol at UCDenver. I have been added to the protocol and they have are requesting CSU IRB to rely on COMIRB.
What can I do?
COMIRB and CSU have some steps in place to bring some efficiencies between our institutions. My COMIRB lead investigator will identify CSU in Attachment A of the COMIRB application form with a Relying Site Details form included as an attachment that will list me, as a CSU faculty/student, and will identify my role in the study.
In parallel to that, I can initiate an eProtocol IRB submission [link to eProtocol] via the reliance agreement process identified in eProtocol Unified form and submit to the IRB. CSU IRB Point of Contacts will have access to the InfoEd submission of the COMIRB protocol to view and process the reliance agreement. CSU IRB Point of Contact will review the request and issue a reliance agreement directly from InfoEd. Once COMIRB has issued the final executed in InfoEd, this will be maintained for both the COMIRB lead investigator and in eProtocol for me and I will be notified by CSU IRB of this action.
NOTE: Establishing a reliance agreement does not establish a data use agreement for federally funded activities. That is a separate process that is done via OSP based on contracts.
What if the other institution is not a member of SMART IRB?
Create a protocol in eProtocol that fully discloses the research activities of all the investigators, including the collaborating institutions. If you are the principal investigator, you should be able to work with CSU IRB and other IRBs to establish a reliance agreement that will accurately reflect the activities.
Why do I need to submit eProtocol?
Consider eProtocol a home for the agreement and the outlined activities. Your reliance agreement may not require an IRB approval, but it does require an “audit trail” or a “paper trail” and eProtocol is a sufficient place to maintain the communications, determinations, and reliance agreement.
As a Principal Investigator of a multisite study or collaborative research study, it is your responsibility to adhere to the policies and procedures of the IRB of Record. In cases when there is an external or centralized IRB used, the IRB of Record policies prevail. It is, also, your responsibility to continue to adhere to all Colorado State University’s institutional policies as well as state and local laws governing human subjects research.
Using an external IRB as the IRB of Record for your study does not replace all other CSU institutional policies that you need to follow.
Who Can Use the Smart IRB?
Colorado State University has signed the SMART IRB agreement allowing any investigator at Colorado State University collaborating with other institutions to streamline the reliance process by using the SMART IRB platform to initiate and monitor reliance agreements between institutions.
How to Initiate the Process?
You can start by going to https://smartirb.org/reliance/ and requesting investigator access! There are many resources available on this web page to guide you through initiating the reliance process in SMART IRB. There are primarily 4 basic steps identified in the video: Investigator submits a request [2:44].
Should you have any questions, please contact your point of contact for CSU.