Research with Children’s Healthcare of Atlanta IRB Webinar March 9, 2017

Objectives Identify which IRB to submit your studies to based on study staff and type of project. Know what to do with projects that fall outside the Emory/Children’s Agreement. Understand what the Children’s requirements are when your project is approved through the Emory IRB.

Terminology IRB Authorization Agreement (IAA) Collaborative Research

Emory + Children’s Emory and Children’s have an IAA that dictates how we will handle collaborative research. The IAA does not cover: Research that includes institutions or personnel beyond Emory and Children’s. Non-Human Subjects Research

When does a study go to CHOA? PI is solely employed by CHOA Study is limited to the review of CHOA medical records

When does a study go to Emory? Everything else

What happens if the study goes to CHOA? No additional Emory actions are required

What happens if the study goes to Emory? Use the Emory/CHOA Consent Template Consider Ancillary Approvals/Routing Office of Sponsored Programs Departmental Approval Nursing Research Board Approval Credentialing Submit the IAA Acknowledgement Form

Scenarios An Emory investigator is conducting a retrospective chart review of Children’s records? What if it’s a CHOA investigator?

Scenarios An Emory investigator is conducting a retrospective chart review of Children’s records? What if it’s a CHOA investigator? An Emory PI conducting a chart review that is limited to Children’s medical records should submit to the Children’s IRB. Whether the PI is Emory or Children’s if the project is limited to the review of Children’s medical records the project should be submitted to the Children’s IRB.

Scenarios A CHOA investigator is conducting a prospective chart review of Children’s records? What if it’s an Emory investigator?

Scenarios A CHOA investigator is conducting a prospective chart review of Children’s records? What if it’s an Emory investigator? Whether it’s a Children’s or Emory PI conducting a prospective chart review that is limited to Children’s medical records, the study should be submitted to the Children’s IRB.

Scenarios A Georgia Tech student is the PI on a study that includes an Emory Co-Investigator and is conducted at Children’s?

Scenarios A Georgia Tech student is the PI on a study that includes an Emory Co-Investigator and is conducted at Children’s? If an institution beyond Children’s or Emory is involved, you should contact either the Emory or Children’s IRB so they can work together to determine which IRB should review the study.

Scenarios A CHOA investigator is doing a case report on 6 patients? What if it’s an Emory investigator?

Scenarios A CHOA investigator is doing a case report on 6 patients? What if it’s an Emory investigator? At Children’s, a case report with 6 subjects could be considered research, but not necessarily. You should contact the IRB for guidance. If this is an Emory PI and there are more than 5 subjects, you should submit to the Emory IRB as the project would be considered research. For Case Reports that are collaborative, it is a good idea to contact at least one IRB in advance of submission for guidance.

Scenarios A CHOA investigator is conducting a clinical trial? What if it’s an Emory investigator?

Scenarios A CHOA investigator is conducting a clinical trial? What if it’s an Emory investigator? If the PI is solely employed by Children’s and is conducting a clinical trial, the study should be submitted to the Children’s IRB. If the PI is Emory and the study is a clinical trial, the study should be submitted to the Emory IRB.

Scenarios An Emory physician needs to treat a CHOA patient with an Emergency Use drug, and the Emory physician holds (or not) the IND for the use?

Scenarios An Emory physician needs to treat a CHOA patient with an Emergency Use drug, and the Emory physician holds (or not) the IND for the use? If the patient receives the drug at Children’s, the request should come through the Children’s IRB. For Emergency Use cases that are not research, the request for use of the drug or device should come to the IRB where the patient will receive the drug or device. It is a good idea to reach out to one of the IRBs early in the process so we can help you submit the to correct IRB, use the appropriate forms and help move the submission through the process as quickly as possible.

Questions

CHOA IRB Contact Info General: irb@choa.org Sarah Marie Huban: sarahmarie.huban@choa.org 404-785-7477