Christopher S. Brown, PhD
Vice President for Research
University of Alabama at Birmingham
701 20th Street South
Birmingham, AL 35294-0107
Research Project: Coronary Artery Risk Development in Young Adults (CARDIA)
Principal Investigator: Cora E. Lewis
Protocol Number: 268201300026C-5-0-1
Research Project: MOST Second Renewal: A Bone and Joint Health Study (MOST-RII)
Principal Investigator: Cora E. Lewis
Protocol Number: F000329007
Research Project: 03/16 Action for Health in Diabetes Extension Study Research Project (LOOK AHEAD)
Principal Investigator: Cora E. Lewis
Protocol Number: 5U01DK057008-18
Research Project: Primary Care Obesity Management in the Southeast Promise
Principal Investigator: Gareth Dutton
Protocol Number: 5R01DK106041-02
Research Project: Osteoporotic Fractures in Men MROS Renewal
Principal Investigator: James M. Shikany
Protocol Number: 4U01AG042140-17
Dear Dr. Brown:
Thank you for the December 29, 2017, February 8, 2019, October 15, 2019 and November 21, 2019 responses to our November 27, 2017, January 5, 2019, September 3, 2019 and November 15, 2019 requests that the University of Alabama (UAB) evaluate allegations of noncompliance with the Department of Health and Human Services (HHS) regulations for the protection of human research subjects. It is our understanding that the activities described in this letter were initiated prior to January 21, 2019, and remain subject to the pre-2018 Requirements (the requirements published in the 2016 edition of the Code of Federal Regulations at 45 CFR part 46, Subpart A). Please note that regulatory sections listed below refer to sections in the pre-2018 Requirements.
On July 26, 2017, a complainant alleged that very old blood pressure manometers and at least two jars of mercury, each jar originally containing several pounds of mercury belonging to the CARDIA Study (Coronary Artery Risk Development in Young Adults), spilled or leaked in rooms used for study visits in the above research studies and in restrooms in the UAB building in which research subjects were seen. The complaint included a list of five studies (referenced above) in which research subjects may have been exposed to the mercury. The complaint alleged specifically that subjects in the MOST Second Renewal: A Bone and Joint Health Study (MOST) would spend up to 2-3 hours in the exam room. If it was found that this mercury spill was an unanticipated problem that exposed subjects or others to risks, this event would have been required to be promptly reported to the reviewing institutional review board (IRB), appropriate institutional officials, the department or agency head, and OHRP, as required by 45 CFR 46.103(a) and (b)(5)(i) and 46.108(a) of the pre-2018 Requirements. At the time the complainant contacted OHRP, such a report of an unanticipated problem had not been submitted to our office.
According to UAB officials, they received an anonymous email on January 19, 2017 that reported a mercury leak at one of the buildings on UAB’s campus. UAB officials immediately engaged an industrial consultant, which included an American Board of Industrial Hygiene certified industrial hygienist to assess and oversee remedial efforts to address the problem.
The entire building was closed to business on January 20-22, 2017 and scanned for mercury vapor to mitigate and isolate any problem areas. Based on the consultant’s report dated February 21, 2017, the spill occurred in an office space with carpeted floors. The report also noted that mercury was removed from a variety of other places in the surrounding vicinity. According to the report, the mercury vapor concentrations at all times remained below the National Institute for Occupational Safety and Health (NIOSH) recommended exposure limit (REL) of less than 50 ug/m3 average per eight hour day.1.
Based on our discussions with UAB officials and our review of the documents that UAB provided in its report that included the UAB institutional review board (IRB) records, the report from the industrial consultant summarizing the mercury remediation oversight and monitoring services, and other pertinent information, we make the following findings.
The information provided by UAB officials indicates that, of the five studies listed in the complaint, only subjects enrolled in the MOST study might have accessed the affected space. Further, subjects were not seen in the carpeted office space with the highest concentration of mercury and UAB is not aware that any of the subjects were on site in the affected areas from discovery through the completion of remediation. The consultant’s report indicated that at all times the rooms of highest concentration were within industry standards for an average eight hour day.
The UAB IRB Chair reviewed the report completed by the consultant. Since there was no indication that participants in the MOST or any other study were at any greater risk of harm, the UAB IRB determined that no further action was warranted.
45 C.F.R. § 46.103(a) and (b)(5)(i) of the pre-2018 Requirements, requires the prompt reporting of “any unanticipated problems involving risks to subjects or others.” The consultant’s report indicated that mercury vapor at the time of remediation remained below the NIOSH REL at less than 50 ug/m3 average per eight hour day. Further, according to UAB, study participants were not seen in the room where mercury concentrations were found and UAB is not aware that any participants were on site in the affected areas from discovery of the mercury spill through the completion of the mediation. Although study staff regularly travelled to other areas on the seventh floor and to the first floor, mercury air levels remained less than 1.0 ug/m3 in the elevators and approximately 0.1 ug/m3 in the first floor lobby.
Therefore, based on the information provided and our discussions with UAB officials, we make no finding of non-compliance with 45 CFR 46.103(a) and (b)(5)(i) and 46.108(a) of the pre-2018 Requirements, which require, in part, that the institution have and follow written procedures for ensuring the prompt reporting to the IRB, appropriate institutional officials, and the department or agency head of any unanticipated problems involving risks to subjects or others.
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 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.
Lisa Buchanan, MAOM
Director, Division of Compliance Oversight
Mr. Adam J. McClintock, MBA, CIP, Director, Office of the IRB, UAB
Mr. Jonathan Miller, MPPA, Assistant Vice President for Research, UAB
Dr. Joanne Less, Food and Drug Administration
Dr. Griffin P. Rodgers, Director, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health (NIH)
Dr. Michelle Bulls, Director, OPERA, Office of Extramural Research, NIH
Dr. Pamela Kearney, Director, Division of Human Subjects Research, Office of Extramural Research, NIH
Dr. Adam Berger, Director, Division of Clinical and Healthcare Research Policy, Office of Science Policy, NIH
Mr. Taunton Paine, Office of Science Policy, NIH
1. Environmental Protection Agency, National Elemental Mercury Response Guidebook, March 2019, page 36. https://response.epa.gov/_documents/MercuryResponseGuidebook/National_Elemental_Mercury_Response_Guidebook_2019.pdf accessed October 16, 2019.