April 23, 2014 - University of Maryland, Baltimore

Dear Dr. Jarrell:

The Office for Human Research Protections (OHRP) conducted an on-site evaluation of the human research protection program (HRPP) at University of Maryland Baltimore, School of Medicine (UMB) from March 18-20, 2014. The evaluation was conducted as part of our program to evaluate human subject protection programs of institutions that receive Department of Health and Human Services (HHS) support for research in compliance with 45 CFR Part 46.

The evaluation, conducted by five OHRP staff and two expert consultants, included interviews with senior HRPP officials, institutional review board (IRB) chairs and vice-chairs, forty-five IRB members, sixteen Human Research Protections Office (HRPO) staff and fifteen principal investigators who conduct HHS-supported research. The site-visit team reviewed IRB files for over 40 HHS-supported research studies, IRB meeting minutes for the past year, IRB written procedures and observed an IRB meeting.

Based on our observations, UMB officials, HRPO leadership, IRB chairs and members conveyed a sincere commitment and concern for the protection of human research subjects. We note that multiple improvements were implemented in the UMB HRPP since our previous visit in October 2011.  For example, the electronic IRB tracking system includes corresponding IRB meeting minutes for each submission reviewed by the IRB.   

A. Recommendations

Based on our observations, we make the following recommendations regarding UMB’s HRPP:

(1) There was some confusion on the part of IRB members, chairs, and staff related to Maryland State requirements for research involving children, particularly waiver of parental permission. We recommend that clarification be provided to investigators, IRB members and staff regarding these requirements, particularly how Maryland State requirements interface with the HHS regulations for the protection of human subjects.  

(2) Based on our observations, when the IRB requires modifications to research which can be reviewed by the chair to secure approval, the IRB seems to believe that the vote at the meeting is not actually for approval, and the approval occurs after the modifications are reviewed by the chair.  This is contrary to OHRP’s interpretation of when actual approval occurs in these situations. We recommend that the IRB action of “require modifications in order to secure approval” be clarified to require approval of research at a convened meeting. Please see OHRP guidance (http://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-irb-approval-of-research-with-conditions-2010/index.html) on conditional approval for more information on how to handle such actions.

(3) Based on our observations, we noted that a motion to defer a protocol may include circumstances when the IRB needs clarification about something related to the proposed research from individuals other than the investigator. We recommend that UMB expand the description in its IRB written procedures of when to defer a protocol to include circumstances when the IRB does not have sufficient time to review a study or when it needs clarification from individuals other than the investigator.

At this time, there should be no need for further involvement by our office in this matter. Please notify us if you identify new information which might alter this conclusion.

We appreciate the continued commitment of your institution to the protection of human research subjects. Please do not hesitate to contact me should you have any questions.

Sincerely,

Lisa Buchanan, MAOM
Division of Compliance Oversight
1101 Wootton Parkway, Suite 200
Rockville, Maryland 20852
Telephone: 240-453-8298
FAX: 240-453-6909
E-mail: Lisa.Buchanan@HHS.gov

cc:
Ms. Susan C. Buskirk, Assistant Vice President, Human Research Integrity & Compliance, University of Maryland Baltimore, Office of Academic Affairs
Ms. Susan E. Hines, Director, Human Research Protections Program, University of Maryland Baltimore, Office of Academic Affairs, Regulatory Compliance
Dr. Robert Edelman, Associate Director, Clinical Research/IRB Chair, University of Maryland, Baltimore, School of Medicine

Dr. Margaret Hamburg, Commissioner, Food and Drug Administration (FDA)
Dr. Joanne Less, FDA
Dr. Michelle Bulls, Director of OPERA, Office of Extramural Research, NIH
Ms. Sarah Carr, Office Science Policy, NIH