Reliance FAQs

Frequently Asked Questions (FAQs) specific to the reliance process are available below. For all available FAQs, please visit the Main FAQ page. This page includes an index with links to all specific FAQ pages.

• What is a reliance agreement?
  For multi-site, non-exempt research with engaged external sites, arrangements may be made for institutions to rely on one-another for IRB review. MSU may enter into a written agreement (IRB Authorization Agreement (IAA) or reliance agreement) to rely on an external (non-MSU) IRB or to allow an external site to rely on MSU’s IRB review. Each reliance is situation and context-dependent. The MSU Institutional Official retains final authority to determine whether MSU may enter into a reliance agreement.
• When is MSU engaged in human subject research?

  In general, MSU is considered engaged in a particular non-exempt human subject research project when MSU is the primary awardee of externally sponsored funding, even when its employees will not be involved in human subject research, OR when its employees or agents for the purposes of the research project obtain:

  • data about the subjects of the research through intervention or interaction with them;
  • identifiable private information about the subjects of the research; or
  • the informed consent of human subjects for the research

  The Office for Human Research Protection Program (OHRP) Guidance “Engagement of Institutions in Human Subjects Research (2008)” describes the types of institutional involvement that generally would or would not result in an institution being engaged in human subjects research. https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-institutions/index.html

• Who are considered “employees or agents”?

  MSU’s employees or agents refers to individuals who:

  • act on behalf of MSU
  • exercise institutional authority or responsibility
  • perform institutionally designated activities

  Employees and agents can include staff, students, contractors, and volunteers, among others, regardless of whether the individual is receiving compensation.

• I am participating in a multi-site non-exempt study that has been approved by one of the participating institution’s IRB’s. Do I need to submit anything to the MSU IRB?
  Yes, if you will be engaged in research with human subjects as an employee or agent of MSU, you will either need MSU IRB review and approval or MSU would need to agree to rely on an external IRB. The HRP-513 – Template – External IRB Request must be submitted to the MSU HRPP and the researcher must receive an acknowledgement letter before any MSU individual can engage in the human research activities.
• If MSU is the primary awardee on an HHS funded grant but all activities involving human subjects are carried out by employees of another institution, do I need MSU IRB review and approval or agreement to rely on an External IRB?
  Yes, institutions that receive an award through a grant, contract, or cooperative agreement directly from HHS for non-exempt human subjects research (i.e. awardee institutions), even where all activities involving human subjects are carried out by employees or agents of another institution, are considered engaged in research with human subjects. Therefore, while all the human subjects work is being done at an external site, MSU would still be considered engaged in that work based on its status as the awardee institution and MSU IRB review and approval or agreement to rely on an external IRB would be required.
• How do I submit a request for MSU to rely on an External IRB?
  In order to request that MSU consider relying on an external IRB, submit an external IRB request in Click. Create a new study, answer question 5 of the Basic Information SmartForm as Yes, upload the completed HRP-513 - External IRB Request into #11 of the Basic Information SmartForm along with the requested documents where indicated in the relevant section of the HRP – 513 (e.g. upload the consent form into the Consent Forms SmartForm, protocol into #11 of the Basic Information SmartForm, External IRB application into the Supporting Documents SmartForm, External IRB approval letter into the Supporting Documents SmartForm, funding materials into the Supporting Documents SmartForm, etc.). The HRP – 513 is available at: https://hrpp.msu.edu/templates/index.html.
• Once I submit an External IRB request, what happens next?
  The MSU HRPP will review to determine whether a reliance is appropriate for the project. If it is determined that the project could potentially fall under a reliance agreement with the external IRB, the MSU HRPP will work with the external IRB to execute a reliance agreement. The MSU PI will be asked to work with the external site investigators to submit a modification to the external IRB to add MSU as a site (or equivalent depending on the external IRB’s requirements to review and approve MSU’s involvement in the project and its reliance on the external IRB). The consent form will also need to be revised to include language in the confidentiality section to allow for access to research records by individuals with oversight of research responsibilities. This language is needed to allow for access to research records by MSU individuals in the event of an audit. Once the modification is approved, the MSU HRPP will release a reliance acknowledgment letter. MSU investigators may not engage in research with human subjects until a reliance acknowledgment letter is received.
• How do I submit a request for an external site to rely on an MSU IRB?

  If the request will be reviewed with a new study submission, list the external site in the External Sites (Non-MSU Institutions) SmartForm, No to External IRB Review and Yes to MSU IRB Review. List key personnel at the external site (including the external site PI) as External Team Members in the Study Team Members SmartForm, along with documentation of current human research protection training. Include a description of the external site’s involvement in the multi-site study section of the HRP-503 or HRP-508. Upload any site specific documents (e.g. recruitment materials, data collection forms, site specific consent form, etc.) into the SmartForms. The MSU HRPP will work with the external site’s IRB to execute a reliance agreement.

  
  If the request is being added to an existing study already approved by the MSU IRB, a modification will need to submitted to add the external site relying on MSU for IRB review along with key personnel at the external site and any site specific documents (e.g. recruitment materials, data collection forms, site specific consent form, etc.). Add the external site to the External Sites (Non-MSU Institutions) SmartForm, No to External IRB Review and Yes to MSU IRB Review. List the key personnel at the external site (including the external site PI) as External Team Members in the Study Team Members SmartForm, along with documentation of current human research protection training. Include a description of the external site’s involvement in the multi-site study section of the HRP-503 or HRP-508. Upload any site specific documents into the SmartForms. The MSU HRPP will work with the external site’s IRB to execute a reliance agreement.

• If an external site agrees to rely on an MSU IRB, does anything need to be submitted to the external site’s IRB?
  Many institutions have a process to review requests for reliance on an external IRB. The external site investigators should follow-up with their IRB to determine what is required by their institution.
• If MSU is relying on an External IRB, do I need to submit a continuing review to the MSU IRB?
  No, a continuing review would not need to be submitted to the MSU IRB. The external IRB would conduct the continuing review, which would include MSU’s involvement. Only the external IRB’s continuing review approval letter needs to be provided to MSU via email or as an Update in Click.
• Does MSU rely on an External IRB for exempt research?
  No, MSU does not enter into reliance agreements for exempt research. MSU will need to make its own exempt determination. A new study submission will need to be created in Click.
• If MSU has an institutional reliance agreement with an institution, do I still need to submit something to both institutions?
  Yes, if a non-exempt project will involve an institution with which MSU has an institutional reliance agreement both institutions must agree that the project would fall under the institutional reliance agreement and both institutions must agree with the proposed reliance arrangement (i.e. which institution will serve as the reviewing IRB and which institution will serve as the relying IRB). Typically, a submission to both IRB’s would be required (i.e. an external IRB request to the relying IRB and a new study submission to the reviewing IRB).
• Is the question above different if the project is exempt or not research with human subjects?
  Yes, a determination that a project does not meet the definition of research with human subjects and exempt research do not fall under an institutional reliance agreement. MSU will need to make its own exempt determination (and determination of human subject research as applicable). Investigators are encouraged to follow-up directly with their own institution’s IRB to confirm whether any permissions/approvals are required before becoming involved in projects that do not meet the definition of research with human subjects or are determined exempt by MSU.
• I have an NIH JIT for a multi-site study in which MSU is relying on an External IRB. Will I receive an IRB approval letter from MSU for my NIH JIT?
  No, if MSU will be relying on an external IRB, a reliance acknowledgment letter will be issued, not an IRB approval letter. We recommend following-up with your program officer to confirm whether they would accept the IRB approval letter of the external IRB for the NIH JIT.
• How do I close a project in which MSU is relying on an External IRB?
  If MSU is relying on an external IRB, the project will either need to be closed with the external IRB or a modification to remove MSU as a site indicating MSU’s involvement in the project has ended would need to be approved by the external IRB. The closure letter or modification approval letter would then need to be provided to MSU before the reliance project may be closed at MSU.
• If I have a project that was determined exempt or not research with human subjects by one of the participating institution’s IRB’s should I answer #5 of the Basic Information SmartForm in Click as Yes (will an external IRB act as IRB of record)?
  No, question 5 should only be answered ‘Yes’ if you are requesting MSU consider relying on an external IRB for review of a non-exempt project. MSU does not enter into reliance agreements for projects that are determined not to meet the definition of research with human subjects or for exempt research. MSU will need to make its own exempt determination (and determination of human subject research as applicable).
• What is the SMART IRB?
  SMART IRB is not an IRB but is a master IRB reliance agreement. MSU is a participating institution in SMART IRB. Information about SMART IRB is available at: https://smartirb.org/. Note that use of SMART IRB vs an IRB Authorization Agreement (IAA) will be decided by the reviewing and relying IRB’s.
• I am trying to request a reliance agreement between MSU and an external site in the SMART IRB online system and I am unable to find Michigan State University in the SMART IRB platform. What should I do?
  MSU prefers not to utilize the SMART IRB online reliance system and instead document the reliance arrangement outside the system via a SMART IRB Letter of Acknowledgement. However, if use of the SMART IRB online reliance system is a requirement of the external IRB, the system may be used. The external site (IRB or PI as appropriate) would need to initiate the request in the online system.
• What do I submit to request a Single IRB Designation?
  When an MSU IRB will be identified as the sIRB or when an external IRB will be identified as the sIRB in an NIH proposal, the MSU HRPP must agree upon the selection. Create a new study submission in Click, answer question 5 of the Basic Information SmartForm as Yes if an external IRB will be the sIRB or No if requesting MSU serve as the sIRB. Upload a completed HRP-562 - Use of a Single IRB into #11 of the Basic Information SmartForm. No other templates are needed at the time of the sIRB submission. The MSU HRPP will request the MSU PI confirm with the other participating sites that they agree with the sIRB designation. The HRP-562 is available at: https://hrpp.msu.edu/templates/index.html.
• If MSU is relying on an External IRB, what are the MSU PI’s reporting responsibilities?

  In addition to reporting obligations with the external IRB, there is still an ongoing obligation to report the following immediately to the MSU HRPP:

  • Any audit (e.g. NIH or FDA)
  • Potential unanticipated problem involving risks to subjects or others (UPIRSO)
  • Potential subject complaint
  • Potential serious or continuing noncompliance with the federal regulations or the requirements or determinations of the IRB
  • Suspension or termination of IRB approval
  • Change in MSU principal investigator
  • Additional affiliate site(s)
  • Enrollment of prisoners
  • Potential conflicts of interest
  • Amendments to the executed contract, when appropriate
  • Changes to consent form language previously requested by MSU
• If an external site relies on an MSU IRB, what are the MSU PI’s responsibilities?
  The MSU PI is responsible for the IRB review/oversight/reporting of research activities conducted at MSU as well as IRB review and reporting for the institution relying on MSU for IRB review. Note that information about research activities at the external site will need to be provided to the MSU PI and reported to the MSU IRB per MSU HRPP policies. This includes providing enrollment numbers for MSU as well as relying sites at the time of continuing review and reporting reportable events for MSU as well as relying sites according to MSU HRPP policies.
• Does MSU conduct site visits for studies that are relying upon an External IRB?
  Yes, the MSU HRPP Compliance office still conducts site visits on studies that are relying upon an External IRB. Each institution is still responsible for safeguarding the rights and welfare of human subjects and for complying with the human subject protection requirements. The HRPP Compliance office also still does TEACH visits for studies relying upon an External IRB.