SMART IRB Guidance: Inserng “Local Context” Language in Informed Consent Documents Reviewing IRB Approves an informed consent template, idenfying specific areas that can be revised to include appropriate local context informaon* Works with the Reviewing IRB to ensure relying site study teams are aware of the process to provide local context informaon for the consent form Distributes informed consent template** Overall Principal Invesgator (or designee) Relying Site Study Team Relying Site SMART IRB Point of Contact (POC) Works with the Overall Principal Invesgator (or designee) to: • Obtain a copy of the appropriate consent form template • Ensure they understand the secons that can be revised to reflect local context language • Confirm the process through which the local context language for that site should be provided to the Reviewing IRB, once approved by the relying site’s SMART IRB POC If addional areas of the consent form must be updated to reflect state law or instuonal requirements, contacts Reviewing IRB to discuss inclusion Works with their relying site study team to: • Ensure the appropriate instuonal language is included in that site’s consent form based on the template provided by the Reviewing IRB • Provide documentaon that the local language included in the draﬅ consent document(s) is acceptable Works with their local SMART IRB Point of Contact (POC) to: • Confirm the appropriate instuonal language that can be included in the template consent form • Obtain sign off on the consent forms to provide to the Reviewing IRB with documentation, through the agreed upon process, that the language was accepted *Template areas that can be changed are usually limited to: • Contact informaon for local study team • Costs that differ for the relying site • Relying site’s language regarding the availability of and compensaon for research-related injury **The Reviewing IRB can distribute the template to the Overall Principal Invesgator (or designee) AND/OR the Relying Site SMART IRB POC. Version date: December 14, 2017 Funded by the NIH Naonal Center for Advancing Translaonal Sciences through its Clinical and Translaonal Science Awards Program, grant number UL1TR001102-04S1. www.smarrb.org

SMART IRB Guidance: Inserting “Local Context” Language … · SMART IRB. Guidance: Inserting “Local Context” Language in Informed Consent Documents. Reviewing IRB. Approves

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Page 1: SMART IRB Guidance: Inserting “Local Context” Language … · SMART IRB. Guidance: Inserting “Local Context” Language in Informed Consent Documents. Reviewing IRB. Approves

SMART IRB Guidance: Inserting “Local Context” Language in Informed Consent Documents

Reviewing IRB

Approves an informed consent template, identifying specific

areas that can be revised to include appropriate local

context information*

Works with the Reviewing IRB to ensure relying site study teams are aware of the process to provide local context

information for the consent form

Distributes informed consent template**

Overall PrincipalInvestigator

(or designee)

Relying Site Study Team

Relying SiteSMART IRB

Point ofContact (POC)

Works with the Overall Principal Investigator (or designee) to:• Obtain a copy of the appropriate consent form template• Ensure they understand the sections that can be revised

to reflect local context language• Confirm the process through which the local context

language for that site should be provided to the ReviewingIRB, once approved by the relying site’s SMART IRB POC

If additional areas of the consent form must be updated to

reflect state law or institutional requirements, contacts

Reviewing IRB to discuss inclusion

Works with their relying site study team to:• Ensure the appropriate institutional language is included

in that site’s consent form based on the templateprovided by the Reviewing IRB

• Provide documentation that the local language includedin the draft consent document(s) is acceptable

Works with their local SMART IRB Point of Contact (POC) to:• Confirm the appropriate institutional language that can

be included in the template consent form• Obtain sign off on the consent forms to provide to the

Reviewing IRB with documentation, through the agreed upon process, that the language was accepted

* Template areas that can be changed are usually limited to: • Contact information for local study team • Costs that differ for the relying site • Relying site’s language regarding the availability of and compensation for research-related injury

** The Reviewing IRB can distribute the template to the Overall Principal Investigator (or designee) AND/OR the Relying Site SMART IRB POC.

Version date: December 14, 2017

Funded by the NIH National Center for Advancing Translational Sciences through its Clinical and Translational Science Awards Program, grant number UL1TR001102-04S1.www.smartirb.org