Statement to Faculty and Staff re OHRP New Procedures

TO FACULTY AND STAFF:

On Sunday, July 22, the Office for Human Research Protections (OHRP) accepted the Johns Hopkins corrective action plan and reinstated the Multiple Project Assurance (MPA) for our institutions, recognizing the extraordinary efforts of the Hopkins faculty and staff in developing the plan. 

 

 Although the MPA has been reinstated, there are many conditions on the reinstatement.  If you are involved in any human research protocols, please carefully note the following procedures:

 

 1.  Subjects Already Enrolled in Ongoing Studies

 

 Principal investigators (PIs) may continue research protocols involving human subjects if they believe it is in the "best interests" of their subjects.  The PI should send a concise statement explaining the protocol and the justification for continuation of the study (include PI name and study RPN#) by e-mail to the JCCI/JHBMC IRB that originally approved the protocol.  JCCI/JHBMC IRB faculty will review the request.  Investigators may continue the protocol unless the investigator is notified by the IRB.   (If you already have sent an e-mail advising of a "best interest" protocol, there is no need to send a new e-mail.)

 

 2.  Enrollment of New Subjects in Ongoing Therapeutic Studies

 

 If the PI wishes to enroll new subjects in an ongoing therapeutic study, the PI must provide the relevant IRB office with the items listed below.  (This is a revised requirement and therefore even if you have sent an e-mail requesting approval for a new enrollment, it is necessary to send a new e-mail.)

 

(i)  Provide protocol # and title.
(ii)  Detail the research intervention offered.
(iii) Define the disease in question.
(iv) Detail the standard of care options if the patient does not join this study.  Compare the
 standard of care to the research study and describe the advantages of the research  study.
(v) Detail why, in your judgment, the subject must enter the study.
(vi)  Describe the time frame for the commencement of treatment of this patient.

 

 All requests for enrollment of new subjects will be reviewed by the applicable IRB and those determined to be appropriate will be forwarded to OHRP for its prior approval.

 

 Please note that when the protocol has been re-reviewed by the IRB, you will be notified by the IRB and this requirement for new enrollment will no longer be applicable.

 

3. Studies Qualifying for Expedited Review

 

  If you are the PI for a protocol for which an expedited review was issued, your protocol is reinstated.

 

 4. OHRP Requirement to Re-Review All Ongoing Protocols Not Qualifying for Expeditied Review

 

 The OHRP has required that all ongoing protocols not qualifying for expedited review be re-reviewed as expeditiously as possible.  This will mean that some delay will occur in the review of new protocols. 

 

 5. Human Subjects Research Qualifying for an Exemption from IRB Review

 

  If the IRB has previously confirmed in writing that a protocol does not require IRB review, the exemption remains valid and no additional review is required.

 

 6. Review of New Protocols

 

 All new protocols not qualifying for exemption from IRB review must be reviewed by the IRB under the corrective action plan procedures.  As noted in 4 above, there may be some delay in reviewing new protocols because all ongoing protocols must be re-reviewed under the corrective action plan procedures.

 

For Further Information:

 

 If you have questions regarding the interpretation or implementation of any of these procedures, please contact the chair of the relevant IRB or Barbara Starklauf or Michael Amey, in the School of Medicine Administration.