Navigating Human Subjects and Animal Protocols

The Bloomberg School of Public Health has a large number of faculty who rely on Human Subjects and Animal testing for their projects. ORA checks for Human Subjects and Animals at the proposal stage and again at the award stage. If a protocol has not been approved by the time the award is being processed for account setup, it is put on hold, which means a delay in accessing the award funding. Here are a few helpful tips for getting protocol approval in a timely manner:

If ORA cannot locate an active protocol in the PHIRST and Sirius systems based on the PIs name, project title, or COEUS IP number, the Sponsored Project Specialist will email the Department Administrator or Analyst (with a copy to the PI) requesting the protocol number and expiration date. She will contact you three times by email. If she do not get a response or the protocol is still in development, it will be the department’s responsibility to contact her. If the award has a protocol that was reviewed by the Western Institutional Review Board (WIRB), ORA will need a copy of the protocol certificate, as we do not have access to that system.

If the Human Subjects protocol will take a long time to be processed, due to components involving foreign countries or other issues that would cause a delay, you are encouraged to apply for a Planning Phase approval.   They are generally approved in a few days time.

Don’t forget to keep track of your protocol’s expiration date! We cannot process any award without a current protocol, even something as basic as a no cost extension.

Please plan ahead for your Animal Use protocol! The Animal Care and Use Committee only meets once a month. The is no “planning phase” protocol for animals so planning is especially important.

If you have any questions regarding the use of Human Subjects or Animals, please contact the following offices:

Animals: Animal Care and Use Committee (IACUC) http://web.jhu.edu/animalcare

Human Subjects: Institutional Review Board (IRB):  http://www.jhsph.edu/irb

You can also, as always, contact your Contracts or Grants Associate for guidance.