Scott Whittenburg, Ph.D.
452 CERM Bldg.
2000 Lakeshore Ave.
Research Project: Test of Memory Malingering Performance is Unaffected by Laboratory-Induced Pain: Implications for Clinical Use
Research Project: Sensitivity and Specificity of Reliable Digit Span in Malingered Pain-Related Disability
Research Project: Prevalence of Malingering in Patients With Chronic Pain Referred for Psychologic Evaluation in a Medico- Legal Context
Research Project: Detecting Malingering in Traumatic Brain Injury and Chronic Pain: A Comparison of Three Forced-Choice Symptom Validity Tests
Research Project: Detecting Malingered Pain-Related Disability: Classification of the Test of Memory Malingering
Research Project: Detecting Malingered Pain-Related Disability: Classification Accuracy of the Portland Digit Recognition Test
Principal Investigator: Dr. Kevin J. Bianchini
Dear Dr. Whittenburg:
Thank you for your May 21, 2015 report in response to our February 20, 2015 request that the University of New Orleans (UNO) evaluate allegations of noncompliance with Department of Health and Human Services (HHS) regulations for the protection of human research subjects (45 CFR part 46), and for your March 8 and May 6, 2016 responses to questions.
Based on review of your responses, we make the following determinations:
Determinations regarding the above-referenced research
The complainant alleged the following:
1) The above-referenced research was conducted without University of New Orleans institutional review board (IRB) review and approval, contrary to HHS regulations at 45 CFR 46.103(b) and 46.109(a).
2) The investigators involved in the research failed to obtain informed consent of the subjects or their legally authorized representatives for the last five of the studies noted above, contrary to HHS regulations at 45 CFR 46.116.
Based on the documentation provided in your May 21, 2015 and March 8, 2016 correspondence, we have determined that there is no violation of the regulations regarding the complainant’s allegations. No evidence was presented to us indicating that nonexempt human subjects research was conducted without institutional review board (IRB) review and approval or informed consent (or waiver of informed consent).
Your response indicated that the first two research projects were approved by the Loyola University IRB because Dr. Joseph Etherton, a faculty member at Loyola University, was responsible for data collection and maintenance. Drs. Bianchini and Greve, who were faculty members at the UNO at the time, served as co-authors on the manuscripts but had no role in the data collection process and did not analyze or review private identifiable information for these studies, and so IRB review and approval by the UNO IRB was unnecessary. Your response indicated that the last five research projects were not submitted to the UNO IRB for review because Drs. Bianchini and Greve maintained that they were conducting archival research using de-identified data and that they were not conducting research on human subjects as defined in 45 CFR 46.102(f). OHRP has determined that this is a reasonable conclusion based on the information presented regarding this research.
The UNO IRB did not disagree with the position advocated by Drs. Bianchini and Greve. However, the IRB felt that it would have been preferable (although not required) for Drs. Bianchini and Greve to seek guidance from the IRB in making the determination of whether they were conducting human subjects research; such an inquiry would have been similar to UNO’s standard practice of encouraging researchers to obtain guidance when they believe their research qualifies for exempt status. The IRB also felt that researchers and participants would have been better served if the clinicians had obtained consent for using the archived data for research purposes. UNO will be modifying their training materials and website (1) to encourage researchers to consult with the IRB when evaluating whether a particular project involves human subjects research, and (2) to encourage researchers involved in clinical data collection to consider obtaining a priori consent for future research use of archived data whenever there is a reasonable likelihood (even if not a specific plan) that the archived data will later be accessed for research purposes. However, the IRB is fully aware that these admonitions are advisory, and researchers are not required to follow them under current policies and regulations.
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.
Kristina C. Borror, Ph.D.
Director, Division of Compliance Oversight
1101 Wootton Parkway, Suite 200
Rockville, Maryland 20852
cc with enclosures:
Dr. Robert D. Laird, IRB Chair, Louisiana State U - U of New Orleans IRB #1