Agreements and Human Subjects Research

What is ancillary review?

In addition to the usual requirement for a FSU proponent office's primary review of a research agreement (such as for example review by the FSU Sponsored Research Administration of a sponsored research or subaward agreement or FSU Research Legal Counsel review of a data use or material transfer agreement), secondary or "ancillary" review by another FSU office may be required if a research agreement implicates a legal, regulatory or policy requirement that is under the purview of the other FSU office. Under these circumstances, the FSU proponent office may request that another office conduct an ancillary review of a research agreement to determine if the legal, regulatory or policy requirement under that office's purview have been satisfied. The ancillary review may be more or less perfunctory or substantive, depending upon the type of agreement and what the proponent office may determine is a legal, regulatory or policy matter.

Ancillary reviews and Human Studies

Ancillary review may be required for research agreements that may be associated with research that involves human subjects (aka study participants) (see footnote 1 therein). Under these circumstances, an FSU proponent office's request for ancillary review may be directed to OHSP to determine if and whether any IRB requirements have been satisfied. For example, the Sponsored Research Administration may request OHSP ancillary review for sponsored research or subaward agreements that may support human study activities, or the Research Legal Counsel office may request OHSP ancillary review for data use agreements that provide for the sharing of individuals' study data.

Unless an underlying human study has already been accepted or cleared by the OHSP/IRB or, if already accepted or cleared is consistent with the associated research agreement, an ancillary review made of the OHSP with regard to the agreement will NOT be completed or approved. Therefore, researchers should make certain that: (1) for any research agreement that may be associated with a human study, that the underlying study has been submitted to the FSU IRB using FSU's RAMP IRB system; (2) the underlying study's scope, activities and other parameters are consistent with the research agreement's terms and conditions and any applicable scope of work; and (3) any OHSP request for clarification made of the researcher is timely and thoroughly provided to the OHSP's satisfaction so that the ancillary review may be completed as expeditiously as possible.

To assist the research community, the OHSP provides below more specific human research-related agreement information, guidance and instructions.

Reliance agreements (officially called IRB Authorization Agreements but sometimes referred to as reciprocity agreements) are some of the most common human subjects-related agreements that are handled by OHSP. This is because reliance agreements are used specifically to allow an institution like FSU to rely upon, or to be relied upon by, another institution to conduct IRB review. Since federal law on human subjects protection requires that IRB reliance arrangements be officially documented among the relying institutions, the OHSP is handles these agreements under delegation by the FSU Vice President for Research.

IRB reliance is generally sought under the following circumstances:

• Two or more institutions are collaborating on a human research study;
• An institution engaged in human research does not have its own IRB;
• An institution's IRB does not have the specific expertise to review a particular study; and/or,
• Federal law or policy or a study sponsor* requires that for a multisite or cooperative research study, that the collaborating institutions rely upon one of the collaborating institution's IRB (referred to as "single IRB" or sIRB review) (see Resources below).

There may be other circumstances under which reliance may be sought.

*Federal law and policy also require that certain collaborative or multi-site studies be reviewed by a single IRB (sIRB). Study sponsors may also require reliance upon certain IRBs. Be sure to check your funding opportunity announcement or contact your study sponsor for these requirements.

WHAT TO DO (if your study may involve reliance upon or by the FSU IRB):

1. If your study may involve Tallahassee Memorial HealthCare (TMH), first visit this Studies involving TMH web page for important information and instructions before proceeding below. TMH and FSU have put into place special arrangements for such studies, which may or may not include the steps below. Save time and plan ahead!
2. Using the FSU's RAMP system, navigate to RAMP IRB (top row, "IRB" tab) and create and submit your study (OR study modification, if your previously IRB approved or cleared study did provide for a reliance arrangement) for IRB review (navigate to the left panel, click "Create" and select "IRB", or to modify an existing study, navigate to the second row and select the "Active" tab and click on the Name of the study to modify, then under Next Steps click the Create Modification/CR button). For additional instructions, refer to our video tutorials for creating and submitting a study or study modification in RAMP IRB. For additional information about requesting an IRB reliance arrangement, carefully review our sIRB web page and refer to the "Requesting sIRB Review for Your Study" panel. 
3. Using the FSU's RAMP system, navigate to RAMP IRB (top row, "IRB" tab) and create and submit your study for IRB review (navigate to the left panel, click "Create" and select "IRB"). Be sure to check out our video tutorials page to learn more about creating and submitting a study in RAMP IRB.
   • Once you have created your RAMP IRB submission for your study, you may indicate on the Basic Study Information page that your study may involve an external IRB or the FSU IRB to act as the IRB of record. Doing so will put OSHP on notice that an IRB reliance arrangement may be required, including alerting you to complete item 3 below.
   • When you have submitted your study, the OHSP will perform pre-review, including review of any reliance arrangement; the OHSP may then instruct you as indicated in item 3 below. For most studies, our office cannot finalize a reliance agreement unless the underlying study has been submitted for review and IRB approval.
4. If a reliance arrangement for your study is required, you must, using FSU's RAMP Agreements system, create and submit a reliance agreement. For instructions on how to submit an IRB reliance agreement in the RAMP Agreements system, please refer to how-to-guide, RAMP AGM How To Guide REL (A How To Guide and Helpful Tips for Creating a Reliance Agreement), available in RAMP under the Agreements and Help Center tabs. Refer also to our video tutorials ("Multisite or Cooperative Studies; Overview: Reliance on Single or external IRBs). Note that the RAMP Agreements system is a different module from RAMP IRB. 
5. As part of its pre-review of your RAMP IRB submission, OHSP will provide you with the IRB reliance agreement draft template for your upload, and/or other instructions to process and finalize a reliance agreement, including obtaining the necessary signatures. Be sure to request the template if you don't receive one. Also, be sure that the agreement references your study's RAMP IRB identification (i.e., STUDY0000xxxx) to make cross-referencing between the agreement, ancillary review and IRB study accurate and quicker.

Unless an underlying human study has already been accepted or cleared by the OHSP/IRB or, if already accepted or cleared is consistent with the associated reliance agreement, processing of the agreement will NOT be completed or approved. Therefore, researchers should make certain that: (1) for any reliance agreement that may be associated with a human study, that the underlying study has been submitted to the FSU IRB using FSU's RAMP IRB system; (2) the underlying study's scope, activities and other parameters (including relying institutions and external study team members) are consistent with the reliance agreement; and (3) any OHSP request for clarification made of the researcher is timely and thoroughly provided to the OHSP's satisfaction so that the reliance agreement may be routed for signature and executed as expeditiously as possible.

Resources:

• sIRB: for more detailed instructions about IRB reliance and sIRB requirements, including how to submit your request for a sIRB reliance agreement in the RAMP Agreements system, see our Single IRB Review web page.
• SmartIRB: FSU is member of the SMART IRB, a national organization sponsored by the NIH. SMARTIRB provides a streamlined process sIRB review among collaborating institutions. If the sIRB uses the SMART IRB process for a reliance arrangement with FSU, then the sIRB will generate a formal SMART IRB Letter of Acknowledgment; the PI should upload this letter in RAMP Agreements.

Individual investigator agreements (a type of reliance agreement) are also handled by OHSP. These agreements are generally used in the following circumstances at FSU:

1. An individual researcher or group of researchers are not employed by FSU;
2. The non-FSU researcher is from an institution or organization that does not have (i.e., is not covered by) an official agreement with a U.S. federal agency (specifically called an Assurance agreement*) to conduct federally funded human research, or the non-FSU researcher is independent or self-employed;
   • many local government agencies, non-for-profit and charitable organizations, as well as foreign institutions, agencies or organizations, do not have an Assurance to conduct federally funded human research (an Assurance is required by federal laws for the protection of human subjects, of institutions that receive federal support to conduct human research);
3. When the non-FSU researcher is collaborating on a human study at FSU (whether or not federally funded) that will be reviewed by the FSU IRB; and,
4. When the non-FSU researcher will (1) obtain study participants’ consent, (2) obtain (directly or indirectly) study participants’ identifiable private information, or (3) intervene or interact with study participants for a research purpose.

An individual investigator agreement allows FSU to extend its federal Assurance over non-FSU researchers so that these non-FSU researchers may conduct federally funded human research in compliance with applicable federal laws.

WHAT TO DO (if your study may involve non-FSU researchers that need to be covered by the FSU federal Assurance):

• For instructions on how to submit an IIA in RAMP Agreements, please refer to how-to-guide, RAMP AGM How To Guide REL (A How To Guide and Helpful Tips for Creating a Reliance Agreement), available in RAMP under the Agreements and Help Center tabs. OHSP will provide you with the agreement draft for your upload. Refer also to our video tutorials ("Multisite or Cooperative Studies; Overview: Reliance on Single or external IRBs). Note that the RAMP Agreements system is a different module from RAMP IRB. 
• Complete and submit an Individual Investigator Agreement (IIA) in RAMP Agreements for each non-FSU study team member (see 4 above); due to these individual's study-related activities, these non-FSU individuals must be covered under FSU's Federalwide Assurance agreement with the federal government, which is accomplished through an IAA.
• Each individual will be required to sign the agreement; the individuals must also complete the required CITI training and provide documentation of training completion certificates as requested in the RAMP Agreements SmartForm (see our CITI Training Requirements web page for detailed instructions).
• As part of its pre-review of your IRB submission, OHSP will provide you with the IRB reliance agreement draft template for your upload, and/or other instructions to process and finalize a reliance agreement, including obtaining the necessary signatures. Be sure to request the template if you do not receive one. Also, be sure that the agreement references your study's RAMP IRB identification (i.e., STUDY0000xxxx) to make cross-referencing between the agreement, ancillary review and IRB study accurate and quicker.

Unless an underlying human study has already been accepted or cleared by the OHSP/IRB or, if already accepted or cleared is consistent with the associated individual investigator agreement, processing of the agreement will NOT be completed or approved. Therefore, researchers should make certain that: (1) for any individual investigator agreement that may be associated with a human study, that the underlying study has been submitted to the FSU IRB using FSU's RAMP IRB system; (2) the underlying study's scope, activities and other parameters (including external study team members) are consistent with the individual investigator agreement; and (3) any OHSP request for clarification made of the researcher is timely and thoroughly provided to the OHSP's satisfaction so that the individual investigator agreement may be routed for signature and executed as expeditiously as possible.

*If you or your non-FSU study team member are not sure about whether the non-FSU study team member's institution or organization is covered by a federal Assurance, visit this federal Assurance site to search for the institution's Assurance status (or https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/irb-and-fwa-status/index.html), or contact OHSP. If your non-FSU study team member IS covered by their institution's federal Assurance, then an IRB reliance agreement, not an IIA, will suffice.

A Data Use Agreement (DUA) is an agreement under which a data provider agrees to provide another (which may be referred to as a data recipient) with proprietary or confidential data for a specified research purpose. Under a DUA, all parties may agree to exchange data. A DUA may be necessary to share data to or from FSU, without regard to whether the data are considered confidential. DUAs are generally arrangements between an FSU study team and others, not within an FSU study team.

While a DUA is intended to ensure that data confidentiality is suitably protected, the DUA may permit publication and sharing of research results in accordance with the FSU IRB-approved study, FSU policies, applicable laws and regulations, and federal requirements. DUAs are similar to confidentiality agreements in that both restrict the use and disclosure of data.

A DUA will generally specify the purpose for which the data is to be used; the scope of data (e.g., elements, variables, data set(s)); how data may be transmitted, stored, shared, and retained; data access requirements; deidentification procedures; and non-disclosure obligations. The DUA may also include terms or conditions related to human subjects (see footnote 1 therein) protection and IRB approval.

Note that OHSP and IRB have no signature authority for data use agreements, but may be asked to perform an ancillary review of an agreement to determine whether any terms and conditions related to human subjects protection requirements and IRB approval have been satisfied.

WHAT TO DO (if your study requires a Data Use Agreement (DUA)):

Follow the instructions below for submitting a Data Use Agreement for the FSU Research Legal Counsel office review (note that the Research Legal Counsel office, not the FSU OHSP/IRB, exercises signature authority over the DUA's content and execution):

• If (a) FSU will require that as a condition of sharing FSU information with a member of your study team or with a non-FSU colleague or other non-FSU data recipient that you enter into a DUA, and/or (b) if a non-FSU organization will require that you and/or members of your study team enter into a DUA in order to receive the non-FSU organization’s information, then FSU will require that you use the separate RAMP Agreements module (not the RAMP IRB module) to route the actual DUA for FSU signature by the Office of Research legal counsel.
• For detailed instructions about submitting a DUA in RAMP Agreements, log in to the RAMP system and select the Agreements tab in the top row. Once there, under the Help Center and then under the Quick Reference tabs, refer to both the “RAMP AGM PI Quick Reference” and the “RAMP AGM How to Guide DUA” documents, and follow the instructions therein. Your data source, the FSU Research Legal Counsel office, or your non-FSU data recipient may require use of specific DUA templates or DUA language/content, so be sure to ask for the required DUA template or about other DUA requirements. Be sure that the agreement references your study's RAMP IRB identification (i.e., STUDY0000xxxx) to make cross-referencing between the agreement, ancillary review and IRB study accurate and quicker. Note that the Office of Research may have other requirements of you or pertaining to the DUA before extending approval or signature.
• Once you submit the DUA in the RAMP Agreements module, the OHSP/IRB may be asked by the FSU Research Legal Counsel office to serve as one of the ancillary review offices to document that, in support of the DUA, that the IRB has approved of or cleared your study. If as part of OHSP ancillary review there is no underlying FSU IRB-approved study, OHSP will not approve of the ancillary review; see the further instruction below about creating and submitting a study so that OHSP may complete an ancillary review request for your DUA:
  • Using the FSU's RAMP system, navigate to RAMP IRB (top row, "IRB" tab) and create and submit your study (OR study modification, if your previously IRB approved or cleared study did not describe arrangements for using or disclosing study data as provided in a DUA) for IRB review (navigate to the left panel, click "Create" and select "IRB", or to modify an existing study, navigate to the second row and select the "Active" tab and click on the Name of the study to modify, then under Next Steps click the Create Modification/CR button). For additional instructions, refer to our video tutorials for creating and submitting a study or study modification in RAMP IRB.
  • Be certain to follow any requirements for use and disclosure of study data, including describing in sections 7 and 17 and 19 of the HRP-503 protocol templates (and sections II and IV.26 of the HRP-503d form) how study data will be obtained, shared and secured, and any plans for putting into place a data use or other agreement for those purposes.
  • When you have submitted your study, the OHSP will conduct pre-review of any DUA-related arrangement and may if necessary refer your study for further IRB review and approval. Both OHSP and the IRB will scrutinize the underlying study's scope, activities and other parameters to ensure that those are consistent with the research agreement's terms and conditions and any applicable scope of work.
  • Once your study conforms to the above and is subsequently cleared or approved, the OHSP will be prepared to complete any DUA-related ancillary review request.

Unless an underlying human study has already been accepted or cleared by the OHSP/IRB or, if already accepted or cleared is consistent with the associated data use agreement, an ancillary review made of the OHSP with regard to the agreement will NOT be completed or approved. Therefore, researchers should make certain that: (1) for any data use agreement that may be associated with a human study, that the underlying study has been submitted to the FSU IRB using FSU's RAMP IRB system; (2) the underlying study's scope, activities and other parameters are consistent with the data use agreement's terms and conditions and any applicable scope of work (e.g., data source and data recipient; data set and extracted variables; data confidentiality, management and security; etc.); and (3) any OHSP request for clarification made of the researcher is timely and thoroughly provided to the OHSP's satisfaction so that the ancillary review of the planned data use agreement may be completed as expeditiously as possible.

Resources:

• Visit this FSU Research Compliance office web page for information and instructions related to other, non-financial research.
• Visit our Confidentiality, Privacy and Information Security web page to learn more about how human research data are protected.
• See our NIH Data Management and Sharing web page to see how NIH-funded researchers are subject to that agency's policies for both protecting and sharing scientific data.

A sponsored research agreement is a negotiated agreement under which, in part, a study sponsor may agree to provide an institution such as FSU with funding or other tangible support for a research project, often with the requirement that FSU in turn provide reports about the study's progress and specified project deliverables. Sponsored research agreements, as well as contracts and grants that require no negotiation, are usually processed in the University's RAMP Grants rather than Agreements module.

A sponsored research agreement may include, for example, among the following content:

• Scope of Work
• Budget
• Reporting or deliverables
• Intellectual property
• Confidential of study data
• Export controls

The sponsored research agreement may also stipulate IRB-related and other applicable regulatory requirements.

Somewhat similarly, a subaward agreement (sometimes referred to as a sub-grant/subcontract) is an agreement under which FSU and/or other third-party agree to provide or perform some defined services or products under a prime award or agreement to which FSU and/or other third-party is a recipient or awardee. The terms of a subaward may be subsumed under the terms of the prime award or agreement and may include some or all content to that listed above. Generally, a prime awardee will carefully monitor a sub-awardees' performance under the subaward agreement.

Note that OHSP and IRB have no signature authority for sponsored research agreements, including subaward agreements, but may be asked to perform an ancillary review of an agreement to determine whether any terms and conditions related to human subjects protection requirements and IRB approval have been satisfied.

WHAT TO DO (if your study involves a sponsored research agreement):

• As soon as you become aware that your study may be subject to a sponsored research agreement, contact your Central Office grants officer or department grants management specialist for information and instructions, including information and instructions about how and by whom a sponsored research agreement may be created, submitted and processed in the RAMP Grants system. Be sure that the agreement references your study's RAMP IRB identification (i.e., STUDY0000xxxx).
• Once the sponsored research agreement is submitted in RAMP and if the sponsored research agreement includes any term or condition related to human subjects (see footnote 1 therein) protection and IRB approval, the OHSP may be asked to perform an ancillary review of the agreement to determine whether those terms and conditions have been satisfied. Therefore, be certain that (a) your study has been submitted and cleared or approved by the IRB so that the ancillary review may be completed and (b) that the agreement references your study's RAMP IRB identification (i.e., STUDY0000xxxx) to make cross-referencing between the agreement, ancillary review and IRB study accurate and quicker.
• If as part of ancillary review, the OHSP finds that there is no underlying FSU IRB-approved study, OHSP will not approve of the ancillary review; see the further instruction below about creating and submitting a study for IRB review so that OHSP may complete an ancillary review request for your sponsored research agreement:
  • Using the FSU's RAMP system, navigate to RAMP IRB (top row, "IRB" tab) and create and submit your study (OR study modification, if your previously IRB approved or cleared study did not describe human subjects-related activities covered in a sponsored research agreement) for IRB review (navigate to the left panel, click "Create" and select "IRB", or to modify an existing study, navigate to the second row and select the "Active" tab and click on the Name of the study to modify, then under Next Steps click the Create Modification/CR button). For additional instructions, refer to our video tutorials for creating and submitting a study or study modification in RAMP IRB.
  • Be certain to follow any RAMP IRB and protocol requirements for providing information, documents and materials that are involved in any human research activity for which the sponsored research agreement may require IRB review or for which the agreement provides funding or support, including providing information about other study sites or institutions that may be involved in the study pursuant to the sponsored research agreement.
  • When you have submitted your study, the OHSP will conduct pre-review of any sponsored research agreement-related arrangement and may if necessary refer your study for further IRB review and approval. Both OHSP and the IRB will scrutinize the underlying study's scope, activities and other parameters to ensure that those are consistent with the research agreement's terms and conditions and any applicable scope of work.
  • Once your study conforms to the above and is subsequently cleared or approved, the OHSP will be prepared to complete any sponsored research agreement-related ancillary review request.

Unless an underlying human study has already been accepted or cleared by the OHSP/IRB or, if already accepted or cleared is consistent with the associated sponsored research agreement, an ancillary review made of the OHSP with regard to the agreement will NOT be completed or approved. Therefore, researchers should make certain that: (1) for any sponsored research agreement that may be associated with a human study, that the underlying study AND the underlying funding award have been submitted to the FSU IRB using FSU's RAMP IRB system; (2) the underlying study's scope, activities and other parameters are consistent with the sponsored research agreement's terms and conditions and any applicable scope of work; and (3) any OHSP request for clarification made of the researcher (including, e.g., adding the funding application and award in RAMP IRB to ensure congruence between the application/award and the study) is timely and thoroughly provided to the OHSP's satisfaction so that the ancillary review of the planned sponsored research agreement may be completed as expeditiously as possible.

Resources:

• Visit the FSU Sponsored Research Administration home page for resources and FAQs related to sponsored studies.

Below are some other common agreement types that may, depending upon any underlying study activities, be associated with research that involves human subjects (aka study participants) (see footnote 1 therein). The list is not exhaustive, and FSU researchers should always inquire and/or confirm if any research agreements may be required and plan as well as comply accordingly. 

WHAT TO DO (if your study involves any research agreement listed in the above table, or if your study involves a research agreement that is not listed above and has not previously been addressed (i.e., see the reliance, individual investigator, data use or sponsored research agreements panels on this page):

• As soon as you become aware that your study may be subject to an other research agreement, contact the Research Legal Counsel office (and/or your Central Office grants officer, or department grants management specialist if the agreement involves funding to support your study) (see Resources links at the bottom of this page) for information and instructions, including information and instructions about how and by whom the other reseach agreement may be created, submitted and processed in the RAMP. Be sure that the other research agreement references your study's RAMP IRB identification (i.e., STUDY0000xxxx).
• Once the other research agreement is submitted in RAMP and if the agreement includes any term or condition related to human subjects (see footnote 1 therein) protection and IRB approval, the OHSP may be asked to perform an ancillary review of the agreement to determine whether those terms and conditions have been satisfied. Therefore, be certain that (a) your study has been submitted and cleared or approved by the IRB so that the ancillary review may be completed and (b) that the agreement references your study's RAMP IRB identification (i.e., STUDY0000xxxx) to make cross-referencing between the agreement, ancillary review and IRB study accurate and quicker.
• If as part of ancillary review, the OHSP finds that there is no underlying FSU IRB-approved study, OHSP will not approve of the ancillary review; see the further instruction below about creating and submitting a study for IRB review so that OHSP may complete an ancillary review request for your other research agreement:
  • Using the FSU's RAMP system, navigate to RAMP IRB (top row, "IRB" tab) and create and submit your study (OR study modification, if your previously IRB approved or cleared study did not describe human subjects-related activities covered in the research agreement) for IRB review (navigate to the left panel, click "Create" and select "IRB", or to modify an existing study, navigate to the second row and select the "Active" tab and click on the Name of the study to modify, then under Next Steps click the Create Modification/CR button). For additional instructions, refer to our video tutorials for creating and submitting a study or study modification in RAMP IRB.
  • Be certain to follow any RAMP IRB and protocol requirements for providing information and documentation about any human research activity for which the research agreement may require IRB review or for which the agreement provides funding, support, data or materials, including providing information about other study sites or institutions that may be involved in the study pursuant to the research agreement.
  • When you have submitted your study, the OHSP will conduct pre-review of any research agreement-related arrangement and may if necessary refer your study for further IRB review and approval. Both OHSP and the IRB will scrutinize the underlying study's scope, activities and other parameters to ensure that those are consistent with the research agreement's terms and conditions and any applicable scope of work.
  • Once your study conforms to the above and is subsequently cleared or approved, the OHSP will be prepared to complete any research agreement-related ancillary review request.

Note that for any other type of research agreement, whether or not listed above, unless an underlying human study has already been accepted or cleared by the OHSP/IRB or, if already accepted or cleared is consistent with the associated other research agreement, an ancillary review made of the OHSP with regard to the agreement will NOT be completed or approved. Therefore, researchers should make certain that: (1) for any other research agreement that may be associated with a human study, that the underlying study has been submitted to the FSU IRB using FSU's RAMP IRB system; (2) the underlying study's scope, activities and other parameters are consistent with the other research agreement's terms and conditions and any applicable scope of work; and (3) any OHSP request for clarification made of the researcher (including, e.g., revising the study by adding or updating study-related materials and documents in RAMP IRB to ensure congruence between the other research agreement and the study) is timely and thoroughly provided to the OHSP's satisfaction so that the ancillary review of the planned other research agreement may be completed as expeditiously as possible.

Resources:

• Visit the FSU Sponsored Research Administration home page for resources and FAQs related to sponsored studies.
• Visit this FSU Research Compliance office web page for information and instructions related to other, non-financial research agreements.