June 11, 2018 - University of California San Francisco (UCSF)

Dear Dr. O'Lonergan:

 

Thank you for your March 30, 2017 report in response to our February 16, 2017 request that the University of California San Francisco (UCSF) evaluate allegations of noncompliance with Department of Health and Human Services (HHS) regulations for the protection of human research subjects (45 CFR part 46).  

 

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:

 

1) A complainant alleged that the research recruitment procedures did not minimize the possibility of coercion in violation of HHS regulations at 45 CFR 46.116, that state, among other things, that an investigator shall seek consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.  According to the allegation, when the complainant declined to participate in research, she was met with physical and psychological intimidation and retaliation, including coercive confinement in a small room while collection of information occurred without her consent. 

 

Based on the documentation provided by UCSF, the alleged encounter in question occurred at the UCSF Memory and Aging Center, a multidisciplinary center with providers in neurology, psychiatry, geriatric medicine, and neuropsychology with complementary skills related to memory. The complainant went to the Center for a memory assessment due to memory loss or lapses. A letter was sent to the complainant in advance of the clinical appointment providing detail about what to expect during the visit including patient interview, attendant/caregiver interview, neurological examination, and cognitive testing, and the expected duration of the memory assessment (up to a full day). In addition to five witness interviews describing the clinical encounter indicating the patient’s “warm and congenial” demeanor, UCSF Patient Relations and Risk Management found that appropriate procedures were followed during the clinical appointment, they were unable to validate the report of inappropriate treatment or communication, and that the treatment, tests, and recommendations were only for the purpose of a comprehensive clinical evaluation. In addition, the UCSF’s internal Office of Civil Rights investigated the complaint, and noted that one possible source of the complainant’s questions about the testing could have been how it was listed on her Explanation of Benefits documentation, i.e., a single test battery administered during the visit was reflected in two line items, once for the technician administering the test and another for the provider reviewing and interpreting the data.

 

In addition, UCSF’s response stated that information about existing research study opportunities was provided to the complainant according to standard procedures, the complainant declined to participate, and information about the complainant was neither used nor disclosed for the research studies discussed.  In addition, both professors involved have provided signed statements indicating they did not use or disclose any of the complainant’s information for research purposes.  

 

Since no information was provided by the complainant that refutes UCSF’s findings, we determine that this allegation is unproven.

 

 

2) The complainant alleged that the tests that she underwent were for research purposes, not clinical care, and were done without her consent in violation of HHS regulations at 45 CFR 46.116 that state, among other things, that no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. According to the allegation, the complainant underwent an unauthorized comprehensive evaluation, neuropsychological screening, and neurological evaluation for research purposes without her consent.

 

Based on the documentation provided by UCSF, the tests and evaluations performed on the complainant were standard procedures for a memory assessment at the Memory and Aging Center, and were performed for clinical purposes. In addition, information regarding the types of examinations, evaluation, and testing to be performed and the likely timeframe involved was provided to the complainant prior to the appointment in an appointment

summary letter. 

 

Since no information was provided by the complainant that refutes UCSF’s findings, we determine that this allegation is unproven.

 

 

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,

 

 

cc:

Dr. Christopher Ryan, Human Research Protections Program Director, UCSF

Dr. Joel Kramer, UCSF

Dr. Joanne Less, Food and Drug Administration

Dr. Richard Hodes, Director, National Institute on Aging, National Institutes of Health (NIH)

Dr. Walter J. Koroshetz, Director, National Institute of Neurological Disorders and Stroke, NIH 

Dr. Sherry Mills, Director of Office of Extramural Programs, NIH

Dr. Michelle Bulls, Director of OPERA, Office of Extramural Research, NIH

Dr. Sherry Rodgers, National Institutes of Health NIH

Dr. Lauren Milner, Office of Science Policy, NIH

Dr. Pamela Wernett, Office of Science Policy, NIH