February 5, 2019 - Columbia University Medical Center

Dear Dr. Shea:

Thank you for your April 11, 2017 report in response to the Office for Human Research Protections (OHRP) letter dated February 28, 2017 requesting that Columbia University (Columbia) evaluate allegations of noncompliance with Department of Health and Human Services (HHS) regulations for the protection of human research subjects (45 CFR part 46) regarding the above studies.

Based on our review of the documents you provided in your report, including the institutional review board (IRB) records and other pertinent information, we make the following determinations regarding the above-referenced research studies:

A complainant alleged that Columbia sent subjects enrolled in the IRB-AAAP5958 study an email to ask them to participate in a new study (IRB-AAAP1258).  The carbon copy (cc) section of the email contained 145 email addresses for the subjects in the current study (some of whom were recognized by the complainant).

Based on Columbia’s response, the principal investigator for these studies became aware of the breach in confidentiality and reported it to the IRB as an unanticipated problem involving risks to subjects or others in November of 2016.  This event was not reported to OHRP; however, your response explains that the event was not reported to OHRP because your investigation was still pending.

OHRP had not been notified of the event when the complainant contacted us in February 2017.  HHS regulations at 45 CFR 46.103(a) and (b)(5) require, among other things, that unanticipated problems involving risks to subjects or others and serious or continuing noncompliance be reported promptly to OHRP.  We determine that the recruitment email sent with other study subjects’ email addresses, albeit inadvertent, constituted a breach of subject confidentiality that represented an unanticipated problem involving risks to subjects or others.  This problem should have been reported to OHRP promptly. Please see Guidance on Reporting Incidents to OHRP: https://www.hhs.gov/ohrp/compliance-and-reporting/guidance-on-reporting….

Corrective Actions taken by Columbia:

According to Columbia’s response to OHRP in April 2017, the following are corrective actions taken by the principal investigator and the research team:

Dr. Schnall placed email recruitment procedures on voluntary hold until a secure process for sending recruitment emails to potential participants was fully developed and implemented.
The study sponsor was notified of the event.
The employment of the study coordinator who sent the recruitment email was terminated.
All members of the study team have re-taken the University’s HIPAA Privacy and Information Security Training.
A manual, “Best Practices for Maintaining Privacy and Confidentiality for Study Participants,” has been developed by the principal investigator and reviewed with the study team. This manual was posted inside of each study team member’s workspace.
Study team members are required to participate in the University’s Research Compliance Foundations course.
An apology letter was sent to the study subjects to notify them of the breach of confidentiality and to apologize for any for the inconvenience that it caused.
An unanticipated problem incident report including the above corrective actions was sent to OHRP on April 19, 2017.

These corrective actions adequately address this determination.  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 that might alter this determination.

We appreciate your institution’s continued commitment to the protection of human research subjects.  Please feel free to contact me if you have any questions.

Sincerely,

Lisa R. Buchanan, MAOM

Operationally-in-Charge

Division of Compliance Oversight

cc: 

Ms. Brenda Ruotolo, Executive Director, Human Research Protection Office, Columbia University

Dr. Rebecca Schnall, Principal Investigator, Columbia University
Dr. Patricia A. Grady, Institute Director, National Institute of Nursing Research (NINR)
Dr. Marguerite Kearney, Director, Division of Extramural Science Programs, NINR
Dr. Sherry Mills, Director of Office of Extramural Programs, National Institutes of Health (NIH)
Dr. Michelle Bulls, Director of OPERA, Office of Extramural Research, NIH
Dr. Sherry Rodgers, NIH
Dr. Lauren Milner, Office of Science Policy, NIH
Dr. Pamela Wernett, Office of Science Policy, NIH
Dr. Joanne Less, Food and Drug Administration