Common use of FREQUENTLY ASKED QUESTIONS Clause in Contracts

FREQUENTLY ASKED QUESTIONS. What is the main difference between an Individual Investigator Agreement (IIA) and an IRB Authorization Agreement (IAA)? IIAs are used for engaged study collaborators who are either i) not affiliated with any institution or ii) affiliated with an institution that does not possess an IRB or FWA (e.g., a private practice, Walgreens, a church, etc.). IAAs, on the other hand, are used for engaged study collaborators whose institutions do possess an FWA (i.e., they have or routinely use an IRB with an FWA). Why do I have to submit everything approved and/or reviewed by the reviewing IRB to the UTHSC IRB, which sometimes recommends changes? Haven’t we ceded review to the other IRB? While another institution is the IRB of record for this study, the UTHSC IRB retains the responsibility to ensure that the performance of the study at this site complies with determinations and the terms of the UTHSC Federalwide Assurance. Further, UTHSC has responsibilities under the reliance agreement that have to be fulfilled throughout the life of the study. As the UTHSC PI, do I still have responsibilities when UTHSC is relying on another IRB? • Yes, you must provide to the UTHSC IRB, an initial registration form (via the Form 1: Study/Project Application) in iMedRIS with all of the documents that have been reviewed and approved by the reviewing IRB. • You must also submit via a Documents from Reviewing IRB form in iMedRIS, copies of any documents and the reviewing IRB’s determination letters on any future actions that it takes with respect to this study (such as review of revisions, continuations, unanticipated problems, protocol deviations, any suspension of subject enrollment or of the study itself, etc.). How can I streamline the process and reduce the number of recommendations the UTHSC IRB and/or other relying institution IRBs provide post-IRB approval? • Communication is KEY! The generation of new applications and amendments should be a collaborative process involving study teams at all engaged sites. • Be aware that each institution tends to have unique local requirements that not only continually need to be met throughout the life of the study but are also subject to change. • A lack of collaboration has typically led to unnecessary multiple amendments being submitted to the IRB of record. o In these cases, UTHSC’s required consent form language was either not initially incorporated or was incorrectly modified due to a communication breakdown between study teams at both sites. I would like to administer a survey at another institution, but I will not be doing it in conjunction with anyone there. Do I need a reliance agreement? • If you will not collaborate with any faculty, staff, students, residents, or fellows from the institution at which the survey will be administered, a reliance agreement will not be needed. However, you must obtain written permission from the appropriate official(s) at that institution in order to conduct your research there. Documentation of the site’s permission must be submitted to the UTHSC IRB before any activities may commence. You will want to verify this by contacting the IRB. I would like to add a site to my research study that was approved by the UTHSC IRB. The site will be sending us de-identified data collected from chart reviews. Do I need to do anything? • Although sharing of de-identified data may not trigger the human subjects research definition, a Form 2 still needs to be submitted in order to add the site to your study since the overall study meets the definition of human subjects research. • When you submit the Form 2: Change Request and Amendments, enter the site information in section (1200) of your application and also upload a spreadsheet containing all data points that will be sent to you. o Note: If the data points you will receive are an exact match to what has already been approved (e.g., other sites are already sending you the same data points), you can state this in the Form 2 in lieu of providing the spreadsheet. • The investigators at the other site must contact the appropriate officials at their institution in order to set up the data transfer. This may require IRB review and/or the execution of a Data Use Agreement (DUA). The institution providing the data to UTHSC will draft the DUA. Incoming and outgoing DUAs are processed by the UTHSC Office of Sponsored Programs; please contact them for the appropriate steps to take or additional guidance. What is the difference between a reliance agreement and a data use agreement (DUA)? Do I need to have both? • In a nutshell, reliance agreements cover investigators while data use agreements cover the physical or electronic transfer of data between unaffiliated institutions. Below are a few examples: • You can have a reliance agreement without a DUA: o Investigators at two or more institutions are engaged in the same human subjects research study, but all data is collected and stored at the investigators’ respective institutions. Investigators only access the data at the other sites through that site’s VPN but no data physically or electronically leaves the site at which it’s stored (meaning no data is downloaded or recorded at the external site). • You can have a DUA without a reliance agreement: o Investigators at UTHSC will receive a Limited Data Set (LDS), which does not contain any of the 16 direct HIPAA identifiers, and UTHSC’s IRB grants a Not Human Subjects Research (NHSR) determination indicating that IRB oversight is not required. However, the site providing the LDS to UTHSC may still require a DUA to cover the physical or electronic transfer of the data. • You can have both a reliance agreement and a DUA:

FREQUENTLY ASKED QUESTIONS. What is the main difference between an Individual Investigator Agreement (IIA) and an IRB Authorization Agreement (IAA)? IIAs are used for engaged study collaborators who are either i) not affiliated with any institution or ii) affiliated with an institution that does not possess an IRB or FWA (e.g., a private practice, Walgreens, a church, etc.). IAAs, on the other hand, are used for engaged study collaborators whose institutions do possess an FWA (i.e., they have or routinely use an IRB with an FWA). Why do I have to submit everything approved and/or reviewed by the reviewing IRB to the UTHSC IRB, which sometimes recommends changes? Haven’t we ceded review to the other IRB? While another institution is the IRB of record for this study, the UTHSC IRB retains the responsibility to ensure that the performance of the study at this site complies with determinations and the terms of the UTHSC Federalwide Assurance. Further, UTHSC has responsibilities under the reliance agreement that have to be fulfilled throughout the life of the study. As the UTHSC PI, do I still have responsibilities when UTHSC is relying on another IRB? • Yes, you must provide to the UTHSC IRB, an initial registration form (via the Form 1: Study/Project Application) in iMedRIS with all of the documents that have been reviewed and approved by the reviewing IRB. • You must also submit via a Documents from Reviewing IRB form in iMedRIS, copies of any documents and the reviewing IRB’s determination letters on any future actions that it takes with respect to this study (such as review of revisions, continuations, unanticipated problems, protocol deviations, any suspension of subject enrollment or of the study itself, etc.). How can I streamline the process and reduce the number of recommendations the UTHSC IRB and/or other relying institution IRBs provide post-IRB approval? • Communication is KEY! The generation of new applications and amendments should be a collaborative process involving study teams at all engaged sites. • Be aware that each institution tends to have unique local requirements that not only continually need to be met throughout the life of the study but are also subject to change. • A lack of collaboration has typically led to unnecessary multiple amendments being submitted to the IRB of record. o In these cases, UTHSC’s required consent form language was either not initially incorporated or was incorrectly modified due to a communication breakdown between study teams at both sites. I would like to administer a survey at another institution, but I will not be doing it in conjunction with anyone there. Do I need a reliance agreement? • If you will not collaborate with any faculty, staff, students, residents, or fellows from the institution at which the survey will be administered, a reliance agreement will not be needed. However, you must obtain written permission from the appropriate official(s) at that institution in order to conduct your research there. Documentation of the site’s permission must be submitted to the UTHSC IRB before any activities may commence. You will want to verify this by contacting the IRB. I would like to add a site to my research study that was approved by the UTHSC IRB. The site will be sending us de-identified data collected from chart reviews. Do I need to do anything? • Although sharing of de-identified data may not trigger the human subjects research definition, a Form 2 still needs to be submitted in order to add the site to your study since the overall study meets the definition of human subjects research. • When you submit the Form 2: Change Request and Amendments, enter the site information in section (1200) of your application and also upload a spreadsheet containing all data points that will be sent to you. o Note: If the data points you will receive are an exact match to what has already been approved (e.g., other sites are already sending you the same data points), you can state this in the Form 2 in lieu of providing the spreadsheet. • The investigators at the other site must contact the appropriate officials at their institution in order to set up the data transfer. This may require IRB review and/or the execution of a Data Use Agreement (DUA). The institution providing the data to UTHSC will draft the DUA. Incoming and outgoing DUAs are processed by the UTHSC Office of Sponsored Programs; please contact them for the appropriate steps to take or additional guidance. What is the difference between a reliance agreement and a data use agreement (DUA)? Do I need to have both? • In a nutshell, reliance agreements cover investigators while data use agreements cover the physical or electronic transfer of data between unaffiliated institutions. Below are a few examples: • You can have a reliance agreement without a DUA: o Investigators at two or more institutions are engaged in the same human subjects research study, but all data is collected and stored at the investigators’ respective institutions. Investigators only access the data at the other sites through that site’s VPN but no data physically or electronically leaves the site at which it’s stored (meaning no data is downloaded or recorded at the external site). • You can have a DUA without a reliance agreement: o Investigators at UTHSC will receive a Limited Data Set (LDS), which does not contain any of the 16 direct HIPAA identifiers, and UTHSC’s IRB grants a Not Human Subjects Research (NHSR) determination indicating that IRB oversight is not required. However, the site providing the LDS to UTHSC may still require a DUA to cover the physical or electronic transfer of the data. • You can have both a reliance agreement and a DUA:: Investigators at UTHSC will provide a data set containing HIPAA identifiers to their study collaborators at another institution. Before providing the identifiable data set to their collaborators, the UTHSC study team works with the UTHSC Office of Sponsored Programs to execute a DUA with the other institution. At the same time, because both institutions are engaged in the conduct of the same human subjects research protocol, a reliance agreement is established between the two institutions such that both study teams report to a single IRB (i.e., the IRB of record).

FREQUENTLY ASKED QUESTIONS. What is the main difference between Replica Studios Digital Voice Replica Agreement? The Replica Studios Agreement is an Individual Investigator innovative, groundbreaking pair of contracts governing the development and use/licensing of digital voice replicas created by Replica Studios. Although we are currently in negotiations with other companies and anticipate that these terms will become the standard going forward, this agreement only relates to Replica Studios. The agreement is made up of two parts — a “development” agreement, which sets terms for the initial creation of digital voice replicas and Replica Studios’ own internal use of the replicas (such as for development and demonstration purposes); and a “licensing and external use” agreement that governs how Replica Studios and its clients can use the replicas in the creation of video games. We have created a simple summary of the key terms or you can review the full Agreement. Who bargained and approved the Replica Studios Agreement? The Replica Studios Agreement was bargained and unanimously approved by the Interactive Media Negotiating Committee, the SAG-AFTRA committee with oversight of this contract area. It is made up of actors who regularly work in the video game industry. The committee members were involved throughout the negotiation process, including in setting the minimum terms for negotiations. They also had the opportunity to meet with Replica Studios to ask questions and provide feedback directly to its founder and CEO. Following the committee’s approval, the Replica Agreement was unanimously approved by SAG-AFTRA’s Executive Committee. How does the Replica Studios Digital Voice Replica Agreement relate to the Interactive Media Agreement? This is not part of any other agreement — it is its own, standalone agreement. We continue to be in negotiations with the major video game companies to achieve the protections we need in the Interactive Media Agreement, including AI protections, and the strike authorization we have already secured remains a tool to be deployed in that negotiation if needed. That said, the terms in the Replica Studios Agreement are in alignment with and support the Interactive Media Agreement negotiations as a concrete act of compliance with the transparency, consent, and compensation we are bargaining for in the IMA . Why wasn’t there a member referendum on the Replica Studios Digital Voice Replica Agreement? Unlike the recently-approved AMPTP contract, which is a national contract setting terms for a multi-employer bargaining unit, the Replica Studios agreement only sets terms for a single company. Pursuant to the SAG-AFTRA Constitution, single employer agreements are approved by the Executive Committee (IIAor National Board) and an IRB Authorization are not sent out to membership referendum. Why are you announcing the Replica Studios Agreement (IAA)now? IIAs are used for engaged study collaborators Member viewpoints on AI vary greatly, from those who would like to ban it to those who are either i) excited about the opportunities it presents. The Replica Studios Agreement is a forward-looking agreement that provides important protections for performers in a rapidly-developing area. Entering into a contract like this now, as use of AI technology in the video game industry is still developing, allows us to help guide the industry toward fair compensation and working conditions for professional performers. The “experimental” one-year term means we can quickly negotiate adjustments with Replica Studios should new circumstances come to light that warrant a change in terms. Why are you saying the Replica Studios Agreement is “groundbreaking”? All the terms and agreements we are negotiating around AI technology are breaking new ground. There are new and novel considerations related to digital recreation and use of a performer’s voice that are not affiliated present in connection with work performed live, all of which must be considered and addressed. In addition, the agreement expands coverage to include “scratch tracks” which have traditionally not been done by professional performers under union contracts. This is just one example of the expansion of work opportunities made possible under this agreement. Why agree to allow the creation of Digital Voice Replicas at all? While we understand and respect that some members strongly oppose any institution or ii) affiliated use of AI in entertainment, there are other members who are eager to embrace new income streams, and there are also members who would engage with an institution new technologies under the right circumstances. The reality is that does not possess an IRB or FWA (e.g.this area is already developing, a private practicewith foreign and non-union companies setting terms and conditions that, Walgreens, a church, etc.). IAAs, on the other handat best, are used for engaged study collaborators whose institutions do possess below what our members expect or, at worst, are highly exploitative. The Replica Studios Agreement is an FWA (i.e., they have or routinely use an IRB with an FWA)important step toward setting fair terms that will protect our members in this new space into the future. Why do I have to submit everything approved and/or reviewed by the reviewing IRB to the UTHSC IRB, which sometimes recommends changes? Haven’t we ceded review to the other IRB? While another institution is the IRB of record for this study, the UTHSC IRB retains the responsibility to ensure that the performance of the study at this site complies with determinations and What are the terms of the UTHSC Federalwide Assurance. Further, UTHSC has responsibilities under Replica Studios Digital Voice Replica Agreement? The Replica Agreement covers only the reliance agreement that creation of digital voice replicas for development purposes and for use in and in connection with video games.We have to be fulfilled throughout the life created a simple summary of the study. As the UTHSC PI, do I still have responsibilities when UTHSC is relying on another IRB? • Yes, you must provide to the UTHSC IRB, an initial registration form (via the Form 1: Study/Project Application) in iMedRIS with all key terms of the documents Agreement, and you can also review the full agreement. In addition to setting minimum rates for the creation of a performer’s digital voice replica and for the use of their digital voice replica in video games, the contract sets several key protective terms that have been reviewed at the heart of our efforts to create guardrails around AI.. These protective terms include, among others: transparency around the content a digital replica will be used to create; performer consent for use of their replica in any new project; limitations on the amount of time a performer’s replica can be made available without further payment and approved consent; limits on confidentiality / non-disclosure agreements (“NDAs”); and data security protections, including for the digital voice replica. What are the compensation terms in the Replica Studios Agreement? Compensation is based on the provisions of our Interactive Media Agreement (“IMA”) which covers professional performers working on video games. For work performed to create the digital replica, compensation is based on the IMA session rates currently in effect ($956.75 for a 4-hour session). Use of digital replicas as a principal character in a video game is based on the IMA’s “limited integration” terms. Replica, or its clients, are required to pay a 4-hour session fee per 300 lines of dialogue (or 3,000 words). Performers are also entitled to the same secondary “additional compensation payments” required by the reviewing IRBIMA when their digital replica is used in a video game. • You must also submit via a Documents from Reviewing IRB form in iMedRIS“Atmospheric voices” — those ancillary voices that do not advance the story, copies of any documents and the reviewing IRB’s determination letters on any future actions that it takes with respect to this study (such as review the townsperson NPC yelling a greeting as the player character passes by — are permitted upon payment of revisionsa session fee and compliance with additional conditions, continuations, unanticipated problems, protocol deviations, any suspension of subject enrollment or of the study itself, etc.). How can I streamline the process including minimum hiring requirements and reduce the number of recommendations the UTHSC IRB and/or other relying institution IRBs provide post-IRB approval? • Communication is KEY! The generation of new applications and amendments should be a collaborative process involving study teams at all engaged sites. • Be aware that each institution tends to have unique local requirements that not only continually need to be met throughout the life of the study but are also subject to change. • A lack of collaboration has typically led to unnecessary multiple amendments being submitted to the IRB of record. o In these cases, UTHSC’s required consent form language was either not initially incorporated or was incorrectly modified due to a communication breakdown between study teams at both sites. I would like to administer a survey at another institution, but I will not be doing it in conjunction with anyone there. Do I need a reliance agreement? • If you will not collaborate with any faculty, staff, students, residents, or fellows from the institution at which the survey will be administered, a reliance agreement will not be needed. However, you must obtain written permission from the appropriate official(s) at that institution in order to conduct your research there. Documentation of the site’s permission must be submitted to the UTHSC IRB before any activities may commence. You will want to verify this by contacting the IRB. I would like to add a site to my research study that was approved by the UTHSC IRBadditional notice requirements. The site will be sending us deagreement also sets compensation terms for “pre-identified data collected from chart reviewsproduction” uses, often referred to as “scratch tracks.” This is work that is often done internally during a game’s development and for which our members are rarely employed. Do I need Replica or its clients can use a performer’s digital voice replica in connection with a game’s development for up to do anything? • Although sharing of de-identified data may not trigger the human subjects research definition, a Form 2 still needs to be submitted in order to add the site to your study since the overall study meets the definition of human subjects research. • When you submit the Form 2: Change Request and Amendments, enter the site information in section (1200) of your application and also upload a spreadsheet containing all data points that will be sent to you. o Note: If the data points you will receive are an exact match to what has already been approved (e.g., other sites are already sending you the same data points), you can state this in the Form 2 in lieu of providing the spreadsheet. • The investigators at the other site must contact the appropriate officials at their institution in order to set up the data transfer. This may require IRB review and/or the execution two years upon payment of a Data Use Agreement (DUA)minimum of two-times the 4-hour session fee rate. The institution providing the data to UTHSC will draft the DUA. Incoming and outgoing DUAs are processed by the UTHSC Office It can be extended on an annual basis for payment of Sponsored Programs; please contact them for the appropriate steps to take or additional guidance. What is the difference between a reliance agreement and a data use agreement (DUA)? Do I need to have both? • In a nutshell, reliance agreements cover investigators while data use agreements cover the physical or electronic transfer of data between unaffiliated institutions. Below are a few examples: • You can have a reliance agreement without a DUA: o Investigators at two or more institutions are engaged in the same human subjects research study, but all data is collected and stored at the investigators’ respective institutions. Investigators only access the data at the other sites through that site’s VPN but no data physically or electronically leaves the site at which it’s stored (meaning no data is downloaded or recorded at the external site). • You can have a DUA without a reliance agreement: o Investigators at UTHSC will receive a Limited Data Set (LDS), which does not contain any of the 16 direct HIPAA identifiers, and UTHSC’s IRB grants a Not Human Subjects Research (NHSR) determination indicating that IRB oversight is not required. However, the site providing the LDS to UTHSC may still require a DUA to cover the physical or electronic transfer of the data. • You can have both a reliance agreement and a DUA:another session fee.