May 2005

The Organization requires research team members described in each protocol to be qualified to perform the research procedures that they have agreed to perform.  The PI is responsible for assembling a team that has the proper qualifications.  The Organization has policies that govern what procedures individuals are credentialed to perform.  The OHSR works closely with the credentialing offices of the Organization to assure that these policies are followed in the conduct of research.  The Organization has a policy regarding involvement of Fellows in clinical research, and this policy was developed in close consultation with the credentialing offices of the Organization.  The Kennedy Krieger Institute has credentialing procedures that apply in addition to credentialing requirements on the part of the Hospitals and University.  OHSR and JHM IRB questions regarding credentials will be referred to the appropriate offices for response. 

The Organization is cognizant of the responsibility to assure that collaborative institutions have performed required IRB/Ethics Committee reviews and have on file with OHRP appropriate assurance documents.  Investigators are required to submit approvals from off site IRBs/Ethics Committees, as well as any required Organizational administrative approval for conduct of research at non-Hopkins facilities.  The JHM IRBs may grant conditional approval for a project that requires this type of additional documentation.  OHSR staff is responsible for communicating with investigators to assure that documentation is provided before a project may be initiated.

When the investigator plans to conduct research at any site not under the control of the Organization (e.g. school, nursing home, health care facility, private practice, etc.), the following information must be provided on the application form:

• Name of site
• Name of contact at the site
• Contact information (phone or email)
• Has the site provided permission to conduct the research at that site?
• Does site have an IRB?
• Has the site’s IRB approved the research?
• Does the site plan to rely on the JHU SOM IRBs?

IRB staff will check this information on the application.

In order to grant final approval, IRB staff will ensure that:

• All sites have provided permission to conduct the research at the site
• If the site has an IRB, the IRB has either approved the research, or the site has deferred approval to the JHM IRBs.

If a site has not granted permission, the IRB staff will contact the investigators to indicate that final approval will be withheld until the site has provided permission. Future information regarding the site’s permission will be documented in writing and maintained in the protocol file.

If a site has an IRB and does not plan to rely on the JHM IRBs, the IRB staff will inform the investigators that final approval will be withheld until the site’s IRB has approved the research. Future information regarding approval by the site’s IRB will be documented in writing and maintained in the protocol file.

If a site does not have an IRB or plans to rely on the JHM IRBs, the JHM IRBs will serve as the IRB of record.

If any problems arise with external sites, IRB staff will communicate with the contact person named on the application.