Common use of Retention Incentives Clause in Contracts

Retention Incentives. Any item used by the sponsor/ study team to provide incentive to a subject to remain in the study, other than compensation identified in the Payment section, will be submitted to the IRB for review prior to use. The IRB- HSR will provide the study team with a Receipt Acknowledgement for their records. Retention incentive items are such things as water bottles, small tote bags, birthday cards etc. Cash and gift cards are not allowed as retention incentives. Clinical Privileges The following procedures will be followed: • Investigators who are members of the clinical staff at the University of Virginia Medical Center must have the appropriate credentials and been granted clinical privileges to perform specific clinical procedures whether those procedures are experimental or standard. • The IRB cannot grant clinical privileges. • Performing procedures which are outside the scope of the clinical privileges that have been granted may result in denial of insurance coverage should claims of negligence or malpractice arise. • Personnel on this protocol will have the appropriate credentials and clinical privileges in place before performing any procedures required by this protocol. • Contact the Clinical Staff Office- 924-9055 or 924-8778 for further information. Sharing of Data/Specimens Data and specimens collected under an IRB approved protocol are the property of the University of Virginia. You must have “permission” to share data/ specimens outside of UVa other than for a grant application and or publication. This “permission” may come in the form of a contract with the sponsor or a material transfer agreement (MTA) with others. A contract/ MTA is needed to share the data outside of UVa even if the data includes no HIPAA identifiers and no code that could link the data back to a HIPAA identifier. • No data will be shared outside of UVa, beyond using data for a grant application and or publication, without a signed contract/MTA approved by the SOM Grants and Contracts office/ OSP or written confirmation that one is not needed. • No specimens will be shared outside of UVa without a signed contract/MTA approved by the SOM Grants and Contracts office/ OSP or written confirmation that one is not needed. Prisoners If the original protocol/ IRB application stated that no prisoners would be enrolled in this study and subsequently a subject becomes a prisoner, the study team must notify the IRB immediately. The study team and IRB will need to determine if the subject will remain in the study. If the subject will remain in the study, the protocol will have to be re-reviewed with the input of a prisoner advocate. The prisoner advocate will also have to be involved in the review of future continuations, modifications or any other reporting such as protocol violations or adverse events. Prisoner- Individuals are prisoners if they are in any kind of penal institution, such as a prison, jail, or juvenile offender facility, and their ability to leave the institution is restricted. Prisoners may be convicted felons, or may be untried persons who are detained pending judicial action, for example, arraignment or trial. For additional information see the OHRP website at xxxx://xxx.xxx.xxx/ohrp/policy/populations/index.html

Retention Incentives. Any item used by the sponsor/ study team to provide incentive to a subject to remain in the study, other than compensation identified in the Payment section, will be submitted to the IRB for review prior to use. The IRB- HSR will provide the study team with a Receipt Acknowledgement for their records. Retention incentive items are such things as water bottles, small tote bags, birthday cards etc. Cash and gift cards are not allowed as retention incentives. Clinical Privileges The following procedures will be followed: • Investigators who are members of the clinical staff at the University of Virginia Medical Center must have the appropriate credentials and been granted clinical privileges to perform specific clinical procedures whether those procedures are experimental or standard. • The IRB cannot grant clinical privileges. • Performing procedures which are outside the scope of the clinical privileges that have been granted may result in denial of insurance coverage should claims of negligence or malpractice arise. • Personnel on this protocol will have the appropriate credentials and clinical privileges in place before performing any procedures required by this protocol. • Contact the Clinical Staff Office- 924-9055 or 924-8778 for further information. Sharing of Data/Specimens Data and specimens collected under an IRB approved protocol are the property of the University of Virginia. You must have “permission” to share data/ specimens outside of UVa other than for a grant application and or publication. This “permission” may come in the form of a contract with the sponsor or a material transfer agreement (MTA) with others. A contract/ MTA is needed to share the data outside of UVa even if the data includes no HIPAA identifiers and no code that could link the data back to a HIPAA identifier. • No data will be shared outside of UVa, beyond using data for a grant application and or publication, without a signed contract/MTA approved by the SOM Grants and Contracts office/ OSP or written confirmation that one is not needed. • No specimens will be shared outside of UVa without a signed contract/MTA approved by the SOM Grants and Contracts office/ OSP or written confirmation that one is not needed. Prisoners If the original protocol/ IRB application stated that no prisoners would be enrolled in this study and subsequently a subject becomes a prisoner, the study team must notify the IRB immediately. The study team and IRB will need to determine if the subject will remain in the study. If the subject will remain in the study, the protocol will have to be re-reviewed with the input of a prisoner advocate. The prisoner advocate will also have to be involved in the review of future continuations, modifications or any other reporting such as protocol violations or adverse events. Prisoner- Individuals are prisoners if they are in any kind of penal institution, such as a prison, jail, or juvenile offender facility, and their ability to leave the institution is restricted. Prisoners may be convicted felons, or may be untried persons who are detained pending judicial action, for example, arraignment or trial. For additional information see the OHRP website at xxxx://xxx.xxx.xxx/ohrp/policy/populations/index.html.

Retention Incentives. Any item used by the sponsor/ study team to provide incentive to a subject to remain in the study, other than compensation identified in the Payment section, will be submitted to the IRB for review prior to use. The IRB- IRB-HSR will provide the study team with a Receipt Acknowledgement for their records. Retention incentive items are such things as water bottles, small tote bags, birthday cards etc. Cash and gift cards are not allowed as retention incentives. Clinical Privileges The following procedures will be followed: • Investigators who are members of the clinical staff at the University of Virginia Medical Center must have the appropriate credentials and been granted clinical privileges to perform specific clinical procedures whether those procedures are experimental or standard. • The IRB cannot grant clinical privileges. • Performing procedures which are outside the scope of the clinical privileges that have been granted may result in denial of insurance coverage should claims of negligence or malpractice arise. • Personnel on this protocol will have the appropriate credentials and clinical privileges in place before performing any procedures required by this protocol. • Contact the Clinical Staff Office- 924-9055 or 924-8778 for further information. Sharing of Data/Specimens Data and specimens collected under an IRB approved protocol are the property of the University of Virginia. You must have “permission” to share data/ specimens outside of UVa other than for a grant application and or publication. This “permission” may come in the form of a contract with the sponsor or a material transfer agreement (MTA) with others. A contract/ MTA is needed to share the data outside of UVa even if the data includes no HIPAA identifiers and no code that could link the data back to a HIPAA identifier. • No data will be shared outside of UVa, beyond using data for a grant application and or publication, without a signed contract/MTA approved by the SOM Grants and Contracts office/ OSP or written confirmation that one is not needed. • No specimens will be shared outside of UVa without a signed contract/MTA approved by the SOM Grants and Contracts office/ OSP or written confirmation that one is not needed. Prisoners If the original protocol/ IRB application stated that no prisoners would be enrolled in this study and subsequently a subject becomes a prisoner, the study team must notify the IRB immediately. The study team and IRB will need to determine if the subject will remain in the study. If the subject will remain in the study, the protocol will have to be re-reviewed with the input of a prisoner advocate. The prisoner advocate will also have to be involved in the review of future continuations, modifications or any other reporting such as protocol violations or adverse events. Prisoner- Individuals are prisoners if they are in any kind of penal institution, such as a prison, jail, or juvenile offender facility, and their ability to leave the institution is restricted. Prisoners may be convicted felons, or may be untried persons who are detained pending judicial action, for example, arraignment or trial. For additional information see the OHRP website at xxxx://xxx.xxx.xxx/ohrp/policy/populations/index.htmlxxxx://xxx.xxx.xxx/ohrp/policy/populations/index.html Compensation in Case of Injury If a subject requests compensation for an injury, the study team should notify the IRB-HSR (924- 9634/2439847) the UVa Health System Patient Relations Department (924-8315). As a proactive courtesy, the study team may also notify UVa Health System Patient Safety and Risk Management (924-5595). On request, the study team should provide the Risk Management Office with the following information/documents: • Subject Name and Medical Record Number • Research medical records • Research consent form • Adverse event report to IRB • Any letter from IRB to OHRP Subject Complaints During a research study, the study team may receive complaints from a subject. If the study team is uncertain how to respond to a complaint, or is unable to resolve it with the subject, the study team may contact the IRB-HSR (000-0000/000-0000), the UVa Health System Patient Relations Department (924-8315).

Retention Incentives. Any item used by the sponsor/ study team to provide incentive to a subject to remain in the study, other than compensation identified in the Payment section, will be submitted to the IRB for review prior to use. The IRB- HSR will provide the study team with a Receipt Acknowledgement for their records. Retention incentive items are such things as water bottles, small tote bags, birthday cards etc. Cash and gift cards are not allowed as retention incentives. Clinical Privileges The following procedures will be followed: •  Investigators who are members of the clinical staff at the University of Virginia Medical Center must have the appropriate credentials and been granted clinical privileges to perform specific clinical procedures whether those procedures are experimental or standard. •  The IRB cannot grant clinical privileges. •  Performing procedures which are outside the scope of the clinical privileges that have been granted may result in denial of insurance coverage should claims of negligence or malpractice arise. •  Personnel on this protocol will have the appropriate credentials and clinical privileges in place before performing any procedures required by this protocol. •  Contact the Clinical Staff Office- 924-9055 or 924-8778 for further information. Sharing of Data/Specimens Data and specimens collected under an IRB approved protocol are the property of the University of Virginia. You must have “permission” to share data/ specimens outside of UVa other than for a grant application and or publication. This “permission” may come in the form of a contract with the sponsor or a material transfer agreement (MTA) with others. A contract/ MTA is needed to share the data outside of UVa even if the data includes no HIPAA identifiers and no code that could link the data back to a HIPAA identifier. •  No data will be shared outside of UVa, beyond using data for a grant application and or publication, without a signed contract/MTA approved by the SOM Grants and Contracts office/ OSP or written confirmation that one is not needed. •  No specimens will be shared outside of UVa without a signed contract/MTA approved by the SOM Grants and Contracts office/ OSP or written confirmation that one is not needed. Prisoners If the original protocol/ IRB application stated that no prisoners would be enrolled in this study and subsequently a subject becomes a prisoner, the study team must notify the IRB immediately. The study team and IRB will need to determine if the subject will remain in the study. If the subject will remain in the study, the protocol will have to be re-reviewed with the input of a prisoner advocate. The prisoner advocate will also have to be involved in the review of future continuations, modifications or any other reporting such as protocol violations or adverse events. Prisoner- Individuals are prisoners if they are in any kind of penal institution, such as a prison, jail, or juvenile offender facility, and their ability to leave the institution is restricted. Prisoners may be convicted felons, or may be untried persons who are detained pending judicial action, for example, arraignment or trial. For additional information see the OHRP website at xxxx://xxx.xxx.xxx/ohrp/policy/populations/index.htmlxxxx://xxx.xxx.xxx/ohrp/policy/populations/index.html Compensation in Case of Injury If a subject requests compensation for an injury, the study team should notify the IRB-HSR (924- 9634/2439847) the UVa Health System Patient Relations Department (924-8315). As a proactive courtesy, the study team may also notify UVa Health System Patient Safety and Risk Management (924-5595). On request, the study team should provide the Risk Management Office with the following information/documents:  Subject Name and Medical Record Number  Research medical records  Research consent form  Adverse event report to IRB  Any letter from IRB to OHRP Subject Complaints During a research study, the study team may receive complaints from a subject. If the study team is uncertain how to respond to a complaint, or is unable to resolve it with the subject, the study team may contact the IRB- HSR (000-0000/000-0000), the UVa Health System Patient Relations Department (924-8315).

Retention Incentives. Any item used by the sponsor/ study team to provide incentive to a subject to remain in the study, other than compensation identified in the Payment section, will be submitted to the IRB for review prior to use. The IRB- IRB-HSR will provide the study team with a Receipt Acknowledgement for their records. Retention incentive items are such things as water bottles, small tote bags, birthday cards etc. Cash and gift cards are not allowed as retention incentives. Clinical Privileges The following procedures will be followed: • Investigators who are members of the clinical staff at the University of Virginia Medical Center must have the appropriate credentials and been granted clinical privileges to perform specific clinical procedures whether those procedures are experimental or standard. • The IRB cannot grant clinical privileges. • Performing procedures which are outside the scope of the clinical privileges that have been granted may result in denial of insurance coverage should claims of negligence or malpractice arise. • Personnel on this protocol will have the appropriate credentials and clinical privileges in place before performing any procedures required by this protocol. • Contact the Clinical Staff Office- 924-9055 or 924-8778 for further information. Sharing of Data/Specimens Data and specimens collected under an IRB approved protocol are the property of the University of Virginia. You must have “permission” to share data/ specimens outside of UVa other than for a grant application and or publication. This “permission” may come in the form of a contract with the sponsor or a material transfer agreement (MTA) with others. A contract/ MTA is needed to share the data outside of UVa even if the data includes no HIPAA identifiers and no code that could link the data back to a HIPAA identifier. • No data will be shared outside of UVa, beyond using data for a grant application and or publication, without a signed contract/MTA approved by the SOM Grants and Contracts office/ OSP or written confirmation that one is not needed. • No specimens will be shared outside of UVa without a signed contract/MTA approved by the SOM Grants and Contracts office/ OSP or written confirmation that one is not needed. Prisoners If the original protocol/ IRB application stated that no prisoners would be enrolled in this study and subsequently a subject becomes a prisoner, the study team must notify the IRB immediately. The study team and IRB will need to determine if the subject will remain in the study. If the subject will remain in the study, the protocol will have to be re-reviewed with the input of a prisoner advocate. The prisoner advocate will also have to be involved in the review of future continuations, modifications or any other reporting such as protocol violations or adverse events. Prisoner- Individuals are prisoners if they are in any kind of penal institution, such as a prison, jail, or juvenile offender facility, and their ability to leave the institution is restricted. Prisoners may be convicted felons, or may be untried persons who are detained pending judicial action, for example, arraignment or trial. For additional information see the OHRP website at xxxx://xxx.xxx.xxx/ohrp/policy/populations/index.html

Retention Incentives. Any item used by the sponsor/ study team to provide incentive to a subject to remain in the study, other than compensation identified in the Payment section, will be submitted to the IRB for review prior to use. The IRB- HSR will provide the study team with a Receipt Acknowledgement for their records. Retention incentive items are such things as water bottles, small tote bags, birthday cards etc. Cash and gift cards are not allowed as retention incentives. Clinical Privileges The following procedures will be followed: • Investigators who are members of the clinical staff at the University of Virginia Medical Center must have the appropriate credentials and been granted clinical privileges to perform specific clinical procedures whether those procedures are experimental or standard. • The IRB cannot grant clinical privileges. • Performing procedures which are outside the scope of the clinical privileges that have been granted may result in denial of insurance coverage should claims of negligence or malpractice arise. • Personnel on this protocol will have the appropriate credentials and clinical privileges in place before performing any procedures required by this protocol. • Contact the Clinical Staff Office- 924-9055 or 924-8778 for further information. Sharing of Data/Specimens Data and specimens collected under an IRB approved protocol are the property of the University of Virginia. You must have “permission” to share data/ specimens outside of UVa other than for a grant application and or publication. This “permission” may come in the form of a contract with the sponsor or a material transfer agreement (MTA) with others. A contract/ MTA is needed to share the data outside of UVa even if the data includes no HIPAA identifiers and no code that could link the data back to a HIPAA identifier. • No data will be shared outside of UVa, beyond using data for a grant application and or publication, without a signed contract/MTA approved by the SOM Grants and Contracts office/ OSP or written confirmation that one is not needed. • No specimens will be shared outside of UVa without a signed contract/MTA approved by the SOM Grants and Contracts office/ OSP or written confirmation that one is not needed. Prisoners If the original protocol/ IRB application stated that no prisoners would be enrolled in this study and subsequently a subject becomes a prisoner, the study team must notify the IRB immediately. The study team and IRB will need to determine if the subject will remain in the study. If the subject will remain in the study, the protocol will have to be re-reviewed with the input of a prisoner advocate. The prisoner advocate will also have to be involved in the review of future continuations, modifications or any other reporting such as protocol violations or adverse events. Prisoner- Individuals are prisoners if they are in any kind of penal institution, such as a prison, jail, or juvenile offender facility, and their ability to leave the institution is restricted. Prisoners may be convicted felons, or may be untried persons who are detained pending judicial action, for example, arraignment or trial. For additional information see the OHRP website at xxxx://xxx.xxx.xxx/ohrp/policy/populations/index.htmlxxxx://xxx.xxx.xxx/ohrp/policy/populations/index.html Compensation in Case of Injury If a subject requests compensation for an injury, the study team should notify the IRB-HSR (924- 9634/2439847) the UVa Health System Patient Relations Department (924-8315). As a proactive courtesy, the study team may also notify UVa Health System Patient Safety and Risk Management (924-5595). On request, the study team should provide the Risk Management Office with the following information/documents: • Subject Name and Medical Record Number • Research medical records • Research consent form • Adverse event report to IRB • Any letter from IRB to OHRP Subject Complaints During a research study, the study team may receive complaints from a subject. If the study team is uncertain how to respond to a complaint, or is unable to resolve it with the subject, the study team may contact the IRB- HSR (000-0000/000-0000), the UVa Health System Patient Relations Department (924-8315).