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AAOS Registry Program Legal Frequently Asked Questions

 

  1. Which agreements are required to join the AAOS Registry Program?

There is one master agreement with four parts that must be reviewed and signed in order to participate in our registries.

The first section is a Business Associate Agreement which includes a Data Use Agreement (BAA/DUA). The BAA/DUA outlines our joint responsibilities as business associates. This includes elements such as indemnification, breach notification, and specified use of data under the Health Information Portability and Accountability Act of 1996 (HIPAA).

The second section is a Participation Agreement. The participation agreement outlines the terms and conditions of participating in the Registry Program. This includes how and when data should be submitted, term and termination, fees, ownership and confidentiality of data, and other policies and procedures for participation.

The third part of the agreement consists of appendices for the registries you are interested in participating in.

The last section has exhibits for each Registry that grant your surgeons access to the Registry Program’s Surgeon Dashboards to view their individual data.

 

  1. I’m already participating in an AAOS Registry Program Registry. How do I add on another one?

Your site will only need to sign a brief addendum to add on another Registry. Contact RegistryEngagement@aaos.org to get started.

 

  1. My site’s surgeons do not have access to the Surgeon Dashboards. How can I give them access?

Your site will need to sign a brief addendum to add Surgeon Dashboards to your account. Once this is in place, we can provide them access and issue individual logins and passwords. Contact RegistryEngagement@aaos.org to get started.

 

  1. Will each site’s Institutional Review Board (IRB) need to review this project and/or obtain informed consent from patients?

All AAOS registries are considered quality improvement registries and are exempt from IRB review. If a site requires an IRB review given the PROM collection, AAOS maintains a centralized IRB protocol through Western IRB (WIRB) which confirms a waiver of patient consent. This documentation can be provided to sites and to their local IRBs as needed. The protocol and approval will be provided to all contracted sites and staff can support any questions that local IRBs and coordinators have.

IRB questions can be directed to RegistryEngagement@aaos.org.