Applying to Use the CRUs

All investigators must submit an application to a Johns Hopkins Institutional Review Board (IRB) before beginning their ICTR Clinical Research Units (CRUs) application.

There are two ways to submit an application to the ICTR Clinical Research Units (CRUs)– one method applies if you are using the School of Medicine eIRB system, while the second applies if you have submitted to another Johns Hopkins IRB. Please read through the materials below.

First method: For investigators who apply to the School of Medicine IRB through eIRB.

  1. Begin by submitting an IRB application via the eIRB. When completing your application, you MUST answer “Yes” to Section 9, question #9- “Will you apply to the Bayview CRU or JHH CRU (includes NBRU) for funding or use of facilities? You must also complete Section 10- (Study Location), indicating ALL ICTR-CRU sites you plan to use.
  2. After you have submitted your eIRB application, please wait until you receive an eIRB confirmation that the request has been processed.
  3. Once you have received eIRB notification, please log on to CRUOnline. You will find your new application under the “My Protocols” menu option. Please upload ALL the necessary IRB documents and then follow the instructions online to complete and submit your CRU application. NOTE: If your CRU application is not listed under the “My Protocols” menu, please recheck your eIRB application to be sure Section 8 has been completed.

Second Method: For investigators who submit applications to other Johns Hopkins IRBs (Bloomberg School of Public Health, for example).

  1. Complete your IRB submission; many of the same documents you use for this process will be needed for your CRU application.
  2. Log on to CRUOnline. Choose the menu option “My Protocols”, and click on the “Add a New Application” button.
  3. Follow the instructions online to complete your application, and upload your supporting documentation.
    • You may save your work at any time as your work on your application.
    • The people you designate as Co-Investigators or Study Coordinators on your application will also have access to your draft application. That way, members of your study team can also work on your application.
    • Finally, you may have a Co-Investigator or Study Coordinator fill out a CRU Application on your behalf through CRUOnline.
  4. When you’ve completed the application, the system will allow you to submit it to the CRU and begin the review process.

Once your application is submitted, it will be pre-reviewed. You will be sent an e-mail detailing the changes necessary and/or questions to be addressed so that your study can be forwarded to the full protocol review committee to begin the Protocol Review Process.

How to Access CRUOnline

If you have any questions regarding the CRU application process, please feel free to contact us at 410-550-7033 or by email at crus@jhmi.edu.

The ICTR Clinical Research Units (CRUs) are required by NIH to have a Protocol Review Committee that must review and approve all research protocols before they use CRU funds. There are three Protocol Review Committees: the Adult Protocol Review Committee, the Pediatric Protocol Review Committee, and the NeuroBehavioral Research Unit Protocol Review Committee.

These committees do the in-depth reviews, communicate with investigators, and give final approval.  Protocols conducted primarily in the pedicatric population are reviewed by the Pediatric Protocol Review Committee, chaired by Beth Laube, Ph.D.  Protocols conducted primarily in the adult population are reviewed by the Adult Protocol Review Committee, co-chaired by Suzanne Jan de Beur, M.D. and Wendy Post, M.D., MS, FAAC.  Protocols requiring the expertise of the Neuro Behavioral Research Unit at the Kennedy Krieger Institute are reviewed by the Neuro Behavioral Research Unit Protocol Review Committee, chaired by Dr. Michael Johnston, M.D.

The Review Process:

  1. Application is submitted to the CRU prior to the deadline and assigned to the appropriate committee.
  2. Application is placed on the agenda for the next committee meeting and primary, secondary, biostatistical, and human subjects reviewers are assigned.
  3. Application is discussed at the committee meeting, culminating in a vote.
  4. Committee chair sends letter to the investigator informing of the committee’s decision, and including any relevent comments.

Possible Outcomes

Approved: The protocol is fully approved by the committee to proceed with the use of CRU resources.

Scientifically Deferred: The protocol may have a safety issue, concern regarding the study design, lack of an analytic plan, or significant human subjects’ issues.  A deferral letter including comments and concerns will be sent to the investigator and the application will be reconsidered once those issues have been addressed.  If the committee is not satisfied with the response and votes to defer again, the PI is usually invited to attend the next committee meeting.

Administratively Deferred:  The protocol requires relatively minor clarifications or responses, but does not need to be re-reviewed by the full committee.   This may include a lack of IRB approval, conflicts between consent form and study protocol, lack of acceptable Inclusion Children statement, or an unsettled budget issue.   A deferral letter including comments and concerns will be sent to the investigator.  Once a satisfactory response is received, full approval is granted.

Disapproved: The protocol has a serious design flaw or insufficient material to judge it fairly.  These applications are not reconsidered by the committee unless they are resubmitted with major revisions.

Once a study is fully approved a letter from the committee will be forwarded to the principal investigator.  To check on the approval status, contact: crus@jhmi.edu