Paul A. Lombardo, PhD, JD toot omnes attae ey ae powers LAW Paul A. Lombardo, PhD, JD Regents’ Professor & Bobby Lee Cook Professor of Law Georgia State University College of Law Kayte Spector-Bagdady JD, MBE Assistant Professor, Dept. Obstetrics and Gynecology Chief, Research Ethics Service, Center for Bioethics & Social Sciences in Medicine University of Michigan Medical School 10 November 2017 Centers for Disease Control and Prevention Attn: FOIA Office, MS-D54 1600 Clifton Road, N.E. Atlanta, Georgia 30333 Dear Sir or Madam, We respectfully submit this request under the Freedom of Information Act (5 U.S.C. § 552 as amended) in relation to the following topic: L IL UL Vv. From 1932 until 1972, the U.S, Public Health Service (PHS) conducted what was formally referred to as the “Tuskegee Study of Untreated Syphilis in the Negro Male” in Macon County, Alabama (“Tuskegee Study”). During that study, PHS physicians and other health care workers collected thousands of samples of human blood, spinal fluid, and tissue retrieved during autopsies from more than 600 research subjects. From 1946 until at least 1953, representatives from the PHS performed or supported STD experiments in Guatemala (“Guatemala Study”) that included collection of biospecimens including, but not limited to: blood samples, spinal fl biopsy material, and tissue taken during autopsies from more than 5,000 research subjects.? Records in the U.S. National Archive indicate that at least some biospecimens from both the Tuskegee Study and the Guatemala Study were sent for analysis and storage to the Centers for Disease Control and Prevention (CDC) as well as the National Institutes of Health (NIH) (see Supplementary Materials). In 2008 Dr. Janet Nicholson, the Senior Advisor for Laboratory Science for the Coordinating Center for Infectious Diseases at the CDC testified to the U.S. House of. Representatives Committee on Science and Technology subcommittee on Investigations and Oversight that archived biospecimens were only destroyed in 1“extremely rare circumstances.”6 Subsequently, the CDC searched 1,000 of its own laboratory rooms and inventoried and documented over 8 million stored samples in its biorepositories.” We therefore request the following documents with respect to the inventories and schedules created and maintained by the CDC concerning its biorepositories: 1. Internal inventories of the biospecimens identified by the CDC that were generated as part of either the Tuskegee Study or the Guatemala Study. More specifically, we request internal summaries that detail the numbers and types of biospecimens in storage that were collected as part of the Tuskegee Study or Guatemala Study. 2. Internal summaries that describe and/or enumerate Tuskegee Study or Guatemala Study biospecimens prepared by the Division of Laboratory Systems as part of the CDC and Agency for Toxic Substances and Disease Registry (ATSDR) Specimen Packaging, Inventory, and Repository (CASPIR). 3, Any documents that apply to the reevaluation, review, retention, or destruction of any biospecimens collected as part of the Tuskegee Study or Guatemala Study. 4. Any emails or correspondence related to the ongoing retention, secondary research, or destruction or disposition of biospecimens collected as part of the Tuskegee Study or Guatemala Study. Our request relates to concerns that current CDC biorepositories likely contain material collected during the Tuskegee Study and Guatemala Study, and that serious ethical and policy questions remain over the proper handling, use, and/or disposition of that material. This request is not meant to exclude the production of any other records that, though not specifically requested, would have a reasonable relationship to the subject matter of this request. In the event that access to any of the requested records is denied, the FOIA provides that if only portions of a requested file are exempted from release, the remainder must stil be released. We therefore request that we be provided with all non-exempt portions that are reasonably segregable. We further request that you describe the deleted material in detail and specify the statutory basis for the denial as well as your reasons for believing that the alleged statutory justification applies in this instance. For any material you decided not to release, please state your reasons for not invoking your discretionary powers to release the requested documents in the public interest. Such a statement will be helpful in deciding whether to appeal an adverse determination, and in formulating arguments in case an appeal is taken. We reserve our right to appeal the withholding or deletion of any information and expect that you will list the office and address where such an appeal can be sent. We anticipate that you will make the requested materials available within the statutorily prescribed period. We also request that you waive any applicable fees as disclosure of these materials meets the statutory standard for waiver of fees in that itis clearly “in the public interestbecause furnishing the information can be considered as primarily benefiting the general public,” 5 U.S.C. § 552(a)(4)(A). Disclosure of the requested information is in the public interest because itis likely to contribute significantly to public understanding of the publically financed maintenance of human biological specimens in the CDC biorepositories and the ultimate disposition of two highly controversial and well-known research protocols in the history of federally funded work. In addition, given the recent proposed revisions to the U.S. Human Subjects Research Regulations—and in particular its focus on secondary research with human biospecimens—the public is currently highly engaged in the ethics of the retention of research specimens. We have no intention of using the information disclosed for financial gain. We are affiliated with Georgia State University College of Law and the University of Michigan Medical School and this request is made for scholarly purposes. We have published material on the Tuskegee Study and Guatemala Study previously,2# and plan to use the material we have requested to disseminate further information on the topic of those studies and their ethical legacies. Failure to respond in a timely manner shall be viewed as a denial of this request and we may immediately file an administrative appeal. We therefore thank you in advance for your prompt reply as well as your time and attention to this important matter. Sincerely, Gus olor — Paul A. Lombardo, PhD, JD Regents’ Professor & Bobby Lee Cook Professor of Law Georgia State University College of Law Ko S9— Kayte Spector-Bagdady JD, MBE Assistant Professor, Dept. Obstetrics and Gynecology Chief, Research Ethics Service, Center for Bioethics & Social Sciences in Medici University of Michigan Medical SchoolReferences 1, Summary of the Ad Hoc Committee to Consider the Tuskegee Study, 6 February 1969, CDC Papers, National Archives, Morrow, Georgia. Presidential Commission for the Study of Bioethical Issues. “Ethically Impossible”: STD Research in Guatemala from 1946 to 1948. Washington, D.C.: Government Printing Office; 2011. Cutler J to Ashburn LL. Procurement of Unstained Sections. January 7, 1957. PCSBI HSPI Archives (In: National Archives, Morrow, Georgia): CTLR_0001531-37. Olansky $, Harris A, Cutler JC, Price EV. Untreated syphilis in the male Negro: twenty-two years of serologic observation in a selected syphilis study group. AMA Arch Derm, 1956;73(5):516-522. Venereal Disease Research Laboratory. Report on Serologic Follow-up on Patients Done at CDC in 1953, Samples sent from Guatemala, 1953. PCSBI HSPI Archives (In: National Archives, Morrow, Georgia): CTLR_0001433-76. Statement of Janet Nicholson, PhD, Senior Advisory, Laboratory Science Coordinating Center for Infectious Diseases, CDC before the U.S. House of Representatives Committee on Science and Technology, Subcommittee on Investigations and Oversight. September 9, 2008. CDC. Next Steps: Biosafety and Biosecurity at the CDC. December 16, 2014. https://www.cde.gov/about/lab-safety/nextsteps.html. Accessed November 5, 2017. Spector-Bagdady K, Lombardo PA. “Something of an adventure”: Postwar NIH research ethos and the Guatemala STD experiments. J Law Med Ethics 2013;41(3):697-710. Meagher K, Spector-Bagdady K. Present Lessons from Past Infractions: STD Research in Guatemala in the 1940s as an Ethics Case Study. Teaching Ethics: Journal of the Society for Ethics Across the Curriculum 2014;53(14):53-76.