March 4, 2020 - Bloomsburg University of Pennsylvania

Dear Dr. Tapsak:

Thank you for the August 19, 2016, September 30, 2019 and November 22, 2019 responses to our July 11, 2016, September 3, 2019 and November 15, 2019 requests that Bloomsburg University (Bloomsburg) evaluate allegations of noncompliance with Department of Health and Human Services (HHS) regulations for the protection of human research subjects. While it appears that the research in question was not supported by HHS, Bloomsburg University of Pennsylvania, at the time that the alleged noncompliance occurred, had an assurance of compliance with our office that states that subpart A of 45 CFR part 46 applies to all research, regardless of the source of support. In other words, your institution has voluntarily chosen to provide OHRP with oversight authority over all research with human subjects that you conduct, including research that is not funded by HHS. It is our understanding the activities described in this letter were initiated prior to January 21, 2019, and remain subject to the pre-2018 Requirements (i.e., the requirements as 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.

The complainant alleges that the institution applied an exemption to the above-referenced research activities, even though these activities did not qualify for exemption pursuant to section 46.101(b) of the pre-2018 Requirements. The complainant alleges that the studies were incorrectly determined to be exempt under exemption 2 ("Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior...."). The complainant further alleges that the studies involve more than educational tests, survey procedures, interview procedures or observation of public behavior.

In its response, Bloomsburg acknowledged that the designation of the seven studies examined as “Exempt” under section 46.101(b)(2) of the pre-2018 Requirements was incorrect. Section 46.101(b)(2) of the pre-2018 Requirements limits the exemption to research involving educational tests, survey procedures, interview procedures or observation of public behavior.^1.

Based on our review of the documents Bloomsburg provided in your report, including the Bloomsburg institutional review board (Bloomsburg IRB) records and other pertinent information, we make the following determinations.

Determination:

All seven studies (King Ovar, Horan, Lolley, Tewell, Davis, Kocher and King Concussion) go beyond the use of educational tests, survey procedures, interview procedures or observation of public behavior, which are the only activities exempted by section 46.101(b)(2) of the pre-2018 Requirements. The King OVAR study used a rotational chair to influence eye movements. The Horan study involved an intervention on children ages 7 to 12 to suppress specific eye movements induced by an intervention of high velocity rotations in a rotational chair. The Lolley study used a brainstem auditory evoked potential signal to stimulate changes by placing a microphone in the ear canal. The Tewell study measured the effects of compression socks on an individual’s somatosensory system. The Davis study used clinical interventions of varying sound levels from soft to painfully loud.

Two of the studies (the Kocher study and King Concussion Study) are different from the other five studies in that they involved the analysis of data collected from other research studies. While that activity is similarly not included as an activity exempted under section 46.101(b)(2) of the pre-2018 Requirements, there might be a question as to whether the studies could be exempted under section 46.101(b)(4) of the pre-2018 Requirements. That exemption applies to research using existing data or specimens, if the data or specimens are publicly available or if the information is recorded by the investigator such that subjects cannot be identified.

The Kocher study obtained data that was originally collected about athletes for non-research purposes at the beginning of the spring sports season and compared these data to existing data for non-concussed subjects collected from another study. Based on the information provided, at least some of the research data was not in existence at the time the study was determined to be exempt. Also, according to the documentation provided, the Principal Investigator had access to study participants’ identifiable private information and the code through which he could readily ascertain the identity of the subjects. The second part of the exemption at section 46.101(b)(4) requires that information be “recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.” This study would not qualify for exemption under section 46.101(b)(4) of the pre-2018 Requirements.

The King Concussion study analyzed existing data from various student athletes who had been referred to the Vestibular and Balance Program for oculomotor test evaluations to assess which of the tests were more accurate. According to the protocol provided, the Principal Investigator had access to study participants’ identifiable private information and he could readily ascertain the identity of the subjects. As noted above, the second part of the exemption at section 46.101(b)(4) requires that information be “recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.” According to the study application, “the PI will have access to the document linking participants with their research code numbers.” Consequently, this study would also not qualify for an exemption under section 46.101(b)(4) of the pre-2018 Requirements.

Therefore, based on the information provided, we find sufficient evidence to determine that non-exempt human subjects research was conducted without appropriate IRB review and approval, which is a violation of sections 46.103(b) and 109(a) of the pre-2018 Requirements for all seven studies.

Corrective Actions:

We understand that Bloomsburg has implemented the following actions to resolve the issues raised in this letter:

• A new IRB chair was appointed in 2015 with the necessary experience and appropriate training in Federal research regulations.
• The Principal Investigator for the seven studies has since left the institution, after the completion of the studies. An electronic records system has been implemented to improve tracking and record retention.
• Additional training has been provided to the IRB administrator, staff and committee members to better understand and apply the research regulations including the type of research that may be exempted.

These corrective actions adequately address these determinations. 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 conclusion.

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 Buchanan, MAOM
Director, Division of Compliance Oversight

cc:
Sadie Hauck, Director of Research and Sponsored Programs, Human Protections Administrator, Bloomsburg University of Pennsylvania IRB
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