When relying on an external or centralized IRB of record, it is the Principal Investigator’s responsibility to adhere to policies and procedures of the IRB of record. In cases when there is an external or centralized IRB utilized, the IRB of Record policies prevail. However the Principal Investigator will also be required to continue to follow all University of Iowa institutional policies as well as state and local laws governing human subjects research. The HawkIRB application is designed to capture the majority of the information necessary to identify the Human Research Protection Program review requirements and various institutional policies.
If you are interested in pursuing human subjects research utilizing an External IRB model, please review the "Final SOP for General External IRB" for specific information on the process and contact the Human Subjects Office at firstname.lastname@example.org. We will help you determine which model may work best for your proposal (Lead IRB of record, relying IRB, commercial IRB models, etc.)
What is SMART IRB?
SMART IRB, the Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform, is designed to harmonize and streamline the IRB review process for multisite studies, while ensuring a high level of protection for research participants. Freely available for institutions and investigators, SMART IRB is an integrated, comprehensive platform that allows flexibility in the size and scope of collaboration to enable IRB reliance for multisite studies across the nation, regardless of funding status. SMART IRB is funded by the National Center for Advancing Translational Sciences (NCATS) and intended to serve as a roadmap for institutions to implement The National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board for Multisite Research.
Who can use the SMART IRB reliance platform?
The University of Iowa has signed the SMART IRB agreement allowing any investigator at the University of Iowa the ability to propose the use of SMART IRB for his/her research study. Nationally, all 64 CTSA hubs and over 235+ institutions have signed the SMART IRB agreement and the number of institutions who have signed the agreement continues to grow. View the list of current participating institutions here: https://smartirb.org/participating-institutions/
How does it work?
The Overall Principal Investigator (PI) of a multisite study works with the Points of Contact (POCs) for each participating institution involved in the study to determine an appropriate reliance arrangement. Together they will identify a Reviewing IRB and determine which institutions will rely upon that IRB for the review and oversight of the research. Additional details on these processes are available in the SMART IRB SOPs on "Establishing Reviewing IRBs and Relying Institutions" and "Initial Review Submission and Review Process." Speak with the External IRB Coordinator in the Human Subjects Office as soon as a decision is made to use the SMART IRB model! The HSO can help plan and streamline the IRB Reliance process.
What if I want to be the Overall Principal Investigator and have the University of Iowa IRB as the reviewing IRB?
If you are planning to be the Overall Principal Investigator (PI), it is important to know the expectations when engaging in a multi-site research project utilizing a single IRB. For this reason, when in the planning stages you must schedule an appointment to review the reliance process with the External IRB Coordinator here at the University of Iowa. As the Lead PI it is your responsibility to know the expectations of both the lead and relying sites, which are outlined in the SMART IRB Agreement and Standard Operating Procedures manual. A few responsibilities as an Overall PI under the SMART IRB agreement are:
- Work in collaboration with the Reviewing IRB and POC to determine and document specific roles and responsibilities for communicating and coordinating key information to Relying Institutions and the Reviewing IRB as described throughout these SOPs and summarized in the Appendix: Additional Multi-Site Research Management Roles and Responsibilities.
- Obtaining and collating information from Relying Site Study Teams and/or Relying Site Points of Contacts (depending on who is designated to provide that information at the Relying Institution) regarding local variations in study conduct, such as recruitment materials and process, consent process and language, and subject identification processes.
- Providing the Site Investigators with the IRB policies of the Reviewing Institution. This will include but is not limited to policies for reporting unanticipated problems, noncompliance, and subject complaints.
- Providing participating Relying Site Study Teams with the IRB-approved versions of all study documents (e.g., consent and authorization forms, protocol, recruitment materials).
- Assisting Relying Site Study Teams and/or POCs at the Relying Institution(s) (depending on who is designated to provide that information) in ensuring consent documents follow the Reviewing IRB’s template form and include applicable site-specific required language from each Relying Institution
- When agreed upon in coordination with the Reviewing IRB, promptly reporting to the Site Investigator (or designee on the Relying Site Study Team) any unanticipated problems involving risks to subjects or others research-related subject injuries, or significant subject complaints that are related to or may affect subjects participating in the Research (i.e., the specific study or studies ceded to the Reviewing IRB) at the Relying Institution.
- If a Relying Site Study Team does not provide the Lead Study Team (or designee) with the required information before the continuing review application is submitted to the Reviewing IRB, reporting the absence of this information as part of the continuing review and notifying affected Relying Site Study Team of lapse in approval for their site and any applicable corrective action plans.
- Following all requirements of the Relying Institution with regard to ceded review, such as ensuring administrative requirements for documenting ceded review have been met before study activation occurs at a Relying Institution.
For more information, please review the “Overall Principal Investigator/Lead Study Team Checklist” and the Site Delegation Log.
What if I want to be a relying site PI and have the University of Iowa to be a relying IRB?
If you are planning to be the PI at a relying site, you have responsibilities to both the UI IRB and Reviewing IRB. The UI IRB is responsible for conducting the Human Research Protections Program review. This means you will submit application materials to the UI IRB for the initial review and for any modifications, continuing reviews or reportable events for the duration of the study. However, the IRB of Record is responsible for providing the regulatory oversight for the research protocol. The Reviewing IRB will provide the IRB review for the initial review, and any modifications, continuing reviews, or reportable events for the duration of the study. A few responsibilities as a relying site PI under the SMART IRB agreement are:
- Following all requirements of their home institution with regard to ceded review, such as ensuring other reviews or sign-offs required by the institution have been completed before a study is activated.
- Working with the Lead Study Team and the POC from their home institution, as applicable, to incorporate site-specific required language into the consent template to be used at their institution.
- Providing the POC from their home institution with information regarding local Site Investigator or other Relying Site Study Team personnel changes.
- Reporting to their home institution POC any changes in conflict of interest (COI) disclosures and resulting changes in COI management plans related to the Research (i.e., the specific study or studies ceded to the Reviewing IRB).
- Reporting to the Lead Study Team (or designee) any changes (including funding changes and personnel changes), reportable events, and continuing review progress reports, for submission to the Reviewing IRB in accordance with the Reviewing IRB’s policies and procedures for timing and content of such submissions.
- Promptly reporting to the Overall PI via the Lead Study Team (or designee) any unanticipated problems involving risks to subjects or others, subject injuries related to the research, or significant complaints that could impact the conduct of the Research (i.e., the specific study or studies ceded to the Reviewing IRB) in accordance with the Reviewing IRB’s policies and procedures for timing and content of such submissions. Significant complaints are defined as those that cannot be resolved by the study team and a) suggest an increased or unexpected new risk or harm or b) change the risk/benefit ratio of the Research. Other complaints should be reported in accordance with the Reviewing IRB’s policies and procedures.
- Promptly reporting to the Overall PI via the Lead Study Team (or designee) any potential noncompliance that occurs in relation to the Research (i.e., the specific study or studies ceded to the Reviewing IRB) in accordance with the Reviewing IRB’s policies and procedures for timing of submission and content of such submissions.
For more information, please review the “Relying Institution Principal Investigator Checklist”.
How do I get started?
Determinations to serve either as the Reviewing IRB or Relying IRB are made on a case-by-case basis. If you are interested in utilizing the SMART IRB for a multisite project, you will need to speak with the External IRB Coordinator in the Human Subjects Office as soon as a decision is made to use the SMART IRB model!
- If you are planning to have the University of Iowa serve as a relying site, complete an External IRB Reliance application in HawkIRB.
- In question I.1 select “Other”
- In the open text field for I.1.a type “SMART IRB: [name of Reviewing IRB]”
- If you are planning to have the University of Iowa serve as the Reviewing IRB, complete a regular 01 or 02 application.
- In VIIA.1 listed the proposed participating sites
- In VII.A.2 select “Yes”
- In VII.A.3 select University of Iowa as a “Clinical/Participating site”, “Coordinating Center”, and “Other”. For “Other”, please write “SMART IRB”.
SMART IRB Resources
Who to Contact?
Mail: 105 HLHS, Human Subjects Office
600 Newton Rd, University of Iowa, Iowa City, IA 52242