July 14, 2016 - Northwestern University

Joseph Walsh Jr., Ph.D. 
Vice President for Research 
Northwestern University 
Office of Research 
633 Clark St, Rm 2-232 
Evanston, IL 60208-1108 

Human Research Subject Protections under Federalwide Assurance (FWA) -1549


Dear Dr. Walsh: 
The Office for Human Research Protections (OHRP) conducted an on-site not-for-cause evaluation of the human research protection program (HRPP) at Northwestern University in Chicago, Illinois on April 20 through 22, 2016.  The site visit is part of our program to routinely evaluate human subjects protection programs of institutions that receive Department of Health and Human Services (HHS) support for research to assess compliance with 45 CFR Part 46. 
This site evaluation included interviews with the Institutional Official, the Associate Vice-President for Research, IRB Executive Director, senior HRPP officials, institutional review board (IRB) Chairs and vice-chairs, IRB members, IRB staff, and investigators who conduct HHS-supported research.  The site-visit team reviewed IRB files for over 50 HHS-supported research studies, IRB meeting minutes for the past six months, IRB written standard operating procedures, and attended one of your IRB meetings. 
We are pleased to note that we observed a robust human research protection program.  Based on our observations, Northwestern officials, IRB chairpersons, staff, and researchers conveyed a sincere commitment to and concern for the protection of human research subjects.  We would like to highlight the essential role your IRB analysts play in successfully carrying out the daily operations of your program.  Your IRB analysts seem to work as a very knowledgeable, collegial, and capable team.  We also note that in the last couple of years, Northwestern’ s HRPP has gone through changes in leadership, policies, and procedures, and has implemented a new IRB electronic protocol submission, review, and approval system.  
Northwestern officials shared some recent improvements to the institution’s HRPP operations, as well as some proposed improvements they intend to implement.  These include the revision and expansion of the institution’s Standard Operating Procedures and Worksheets to assure that the regulatory mandates of 45 CFR Part 46 are included and easily followed.  We understand that these changes are intended to assist in making  determinations that an activity does not involve research with human subjects, exemption determinations, initial determinations, changes to determinations, and to distinguish between “approval with conditions” and “deferred” decisions.  Northwestern officials and staff are working with the software developer to ensure that the IRB electronic system can provide their staff the flexibility to capture and retain more details of protocol reviews and of discussions during IRB meetings.  In line with these revisions, program staff, IRB members, as well as IRB Chairs and Vice-Chairs, will go through the appropriate re-training. 
While we found no significant violations or evidence of systemic noncompliance with 45 CFR part 46, we agree with the institution that these recent changes and proposed actions will further improve Northwestern’s HRPP operations.  At this time, there should be no need for further involvement by our office in this matter.  We appreciate your institution’s continued commitment to the protection of human research subjects. 
Alfredo R. Sancho, Ph.D., MPH 
Commander, U.S. Public Health Services 
Division of Compliance Oversight 
Office for Human Research Protections 
1101 Wootton Parkway, Suite 200 
The Tower Building 
Rockville, MD 20852 
Phone: (240) 453-8297 
Fax: (240) 453-6909 
Ms. Ann K. Adams, J.D., Assistant Vice-President of Research 
Ms. Denise A. Roe, MSM, RAC, CHRC, CCCRP, CIP, IRB Executive Director 
Dr. Christina Marciniak, MD, Chairperson, IRB Panel A 
Dr. Thomas Holly, MD, Chairperson, IRB Panel B 
Dr. Jonathon Goldman, MD, Chairperson, IRB Panel C 
Dr. Frank Palella, MD, Chairperson, IRB Panel D 
Dr. Michael Roloff, Ph.D., Chairperson, IRB Panel E 
Ms. Maureen Moran, MPH, Chairperson, IRB Panel Q 
Dr. Joanne Less, Food and Drug Administration 
Ms. Sarah Carr, Office Science Policy, National Institutes of Health 
Dr. Michelle Bulls, Director of OPERA, Office of Extramural Research, National Institutes of Health 
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