Scope and Content Element: The bulk of the research files contain records related to Polk’s research in the areas of Gynecology and Obstetrics and AIDS, with the latter being the largest grouping. In addition, several files pertain to other research interests of Polk including coronary heart disease, cancer, hepatitis, and vaccination. The subject files include documents pertaining to transmission, research, and treatment of gynecological and AIDS-related medical disorders. Materials include correspondence, photocopied journal articles, hand written notes, research studies, human subjects forms, research questionnaires, conference programs, lecture materials, papers reviewed by Polk, abstracts, progress reports, grant applications and research proposals for studies by Polk. Interspersed among the subject files are files about faculty and administrators at Johns Hopkins and elsewhere. This series also contains files pertaining to the Joint Committee on Clinical Investigation (JCCI), which was in charge of human subjects review at Johns Hopkins University. JCCI files include procedures updates, research project notification and consent forms for studies for which Polk was the investigator, as well as one annual renewal request for a study for which Polk was a reviewer. GRID, Gay Related Immune Deficiency was an early name for AIDS.
The titles of research projects on forms listing Polk as the principle investigator include: A Case-Control Study of Endometriosis; Cervicitis During Pregnancy Study; Comparative Immunogenicity and Safety of Human Plasma Vaccine vs. Recombinant DNA Vaccine for Hepatitis B in Homosexual Men; Dietary Markers for Epidemiologic Studies of Cancer; Evaluation of HTLV-III Antibody Test; Evaluation of a New Antibody Assay for HTLV-III; Genital Infections and Perinatal Outcomes; Levels of Cefazolin and Deforanide in Pelvic Tissues Over Time; Microbiologic Studies in Women Undergoing Elective Hysterectomy; Multiple Dose, Open-Label Clinical Trial to Determine the Tolerance & Preliminary Efficacy of PHA-23 for Patients with the Acquired Immunodeficiency Syndrome (AIDS); The Natural History of Acquired Immune Deficiency Syndrome (AIDS) in Homosexual Men; Preventing Chlamydial Infection in Children and Infants; Retinopathy of the Acquired Immune Deficiency Syndrome; Risk Factors for Hospital Acquired Surgical Wound Infection after Cardiac Surgery; Risk Factors in the Occurrence of Juvenile-onset Laryngeal Papilloma; The Risk of Adverse Pregnancy Outcome Following Cervicitis During Pregnancy; The Risk of HIV Transmission by Screened Blood; Rubella Vaccine Study; Survey of Use of Prophylactic Antibiotics for Elective Hysterectomy.
Research files contain three sub-series, starting with Gynecology and Obstetrics, then AIDS, and thirdly other research interests. The first two sub-series each contain a set of subject files and a set of research studies records. Files within sections are organized in alphabetical order by folder title.
The bulk of the subject files consist of photocopied journal articles and reprints that were not authored by Polk. These files also contain a small amount of other materials including hand written notes about the articles; teaching materials; correspondence; papers reviewed by Polk; abstracts; progress report data, questionnaires and forms; grant applications and research proposals; and a few reprints and correspondence about publications by Polk, organized topically among the files. The PROM (Preterm Premature Rupture of Fetal Membranes) Study materials include records for a Pilot study and for a multicenter case control study with perinatal centers at several collaborating institutions. Records include correspondence, proposals, notes, human subjects records, research forms, questionnaire, and information about study participants.
The bulk of Polk's Gynecology and Obstetrics subject files comprises photocopied journal articles and reprints that were authored by other scholars. A small amount of records includes information for use in creating teaching slides, teaching notes, lecture schedules, and printed lecture materials; hand written notes on photocopied articles; printed data on studies; printed papers by other researchers; corresondence; newspaper clippings; library search-generated bibliographic lists; conference and workshop programs; abstracts; progress reports; research data; questionnaire forms; grant applications and research proposals for research projects by Polk; and reprints and correspondence about publications by Polk. Studies referenced in the files for which Polk was an investigator include the following:“Cervicitis During Pregnancy Study”, “Levels of Cefazolin and Deforanide in Pelvic Tissues Over Time”, “Microbiologic Studies in Women Undergoing Elective Hysterectomy” [Polk’s participation uncertain], “Preventing Chlamydial Infections in Infants and Children”, “Risk factors in the occurrance of juvenile-onset laryngeal papilloma”, "Rubella Vaccine Study", and “Survey of Use of Prophylactic Antibiotics for Elective Hysterectomy”.
Files are arranged alphabetically by research topic.
The first folder contains confidential information in an item dated 4/1/1986. The second folder contains confidential salary information in an undated, handwritten budget entitled "Cervacitis Contract." The third folder contains confidential information in items dated 9/24/1985; 5/7/1985; and 5/16/1985. The fourth folder contains confidential information in an item dated 5/7/1985 and a second copy of the "Cervacitis Contract". It additionally contains protected health information, including hospital identification numbers, in an undated printout entitled "Data Listing of First and Second Lab Cultures".
The second folder contains confidential employee information, including social security numbers and salary information, in a grant evaluation entiteld "Evaluation of the Role of Genital Mycoplasmas in Involuntary Infertility ..." It contains additional confidential employee information in a grant application entiteld "Application for Basic Research Grant" (n.d.). The third folder also contains confidential employee information in the form of social security numbers in undated pages numbered 98-148.
Materials comprise data for research studies conducted by Polk as well as journal articles co-authored by Polk. Journal articles include: Onderdonk et. al., "Methods for quantitative vaginal flora studies," American Journal of Obstetrics and Gynecology, Vol. 128, No. 7 (Aug 1977):777-781 (including draft of article); John G. Bartlett & B. Frank Polk, "Bacterial Flora of the Vagina: Quantitative Study," Reviews of Infection Diseases Vol. 6, Suppl. 1 (March-April 1984): S67-S72.
Folder contains protected health information for study patients including names and treatment.
Folder may contain sensitive financial information.
[Folder 6] PROM Pilot Study--Baltimore Human Studies, Johns Hopkins Hospital. — 1983;n.d.. — 1 folder
[Folder 7] PROM Study Correspondence. — 1982-1983;1985;1988;n.d.. — 1 folder
[Folder 8 - 12] PROM Study Data Collection Form, Infant Data form, and Patient Questionnaire. — 1983-1984;n.d.. — 5 folders
Folder 11 contains protected health information in a completed PROM Study Data Collection Form.
[Folder 13] PROM Study Infant Data . — 1984-1985;1988. — 1 folder
[Folder 14 - 15] PROM Paper: "Predictor of Preterm Premature Rupture of Fetal Membranes: A Multicenter Case-Control Study". — 1964;1977;1982-1986;1988;n.d.. — 2 folders
PROM Study Paper. Collaborating institutions were from: Baltimore--Johns Hopkins University and Sinai Hospitals; Boston; Minneapolis; Pittsburgh; San Antonio; Seattle; Burlington, Vermont; San Francisco; and Washington, D.C.
In 1986 the first AIDS Treatment and Evaluation Units (ATEU) were established by the National Institutes of Health to examine treatment options for HIV infection. Johns Hopkins was one of 19 centers approved by the NIH as a federally funded ATEU. The research was focused on new treatments that prevented HIV from replicating. The unit was set up to test experimental drugs on AIDS patients. The Principal Investigator of the Johns Hopkins ATEU was John Bartlett, Chief of the Division of Infectious Diseases. Data from ATEU studies was gathered and analyzed by the AIDS Clinical Trials Coordinating Center to facilitate collaborative studies and speed up the evaluation of drugs.
The AIDS Clinical Trials Group (ACTG) was established in 1987 and funded by the Department of Health and Human Services. The objective was to broaden the scope of the AIDS research of the NIAID. It established the largest network of clinical investigators and clinical trials units in the world. The mission was to investigate the viral and immune pathogenesis of HIV infections and its complications; to evaluate approaches and strategies for treatment; and promote the publication and dissemination of study findings.
Protected Health Information is contained in the first folder in the following documents: All HIV culture reports; 4/1/88; Enter/Update Old Specimen Information 4/12/88; Enter/Update Old Specimen Information 4/18/88. Protected Health Information is contained in the second folder in the following documents: Enter/Update Old Specimen Information 4/29/88; Specimen Report Selected for Protocol: SC 6/6/88; 6/13/88; 6/17/88; 8/12/88; from 6/24/88-7/7/88
[Folder 133 - 136] Nutrition and AIDS: Dietary Markers for Epidemiologic Studies of Cancer. — 1985;1988. — 4 Folders
A follow-up study of participants in the "Natural History of Acquired Immune Deficiency Syndrome in Homosexual Men"
The first folder contains Confidential Information in the following documents: grant application (various salaries) The third folder contains Confidential Information in the following document: Personnel detail for 01 year (various salaries) The fourth folder contains Confidential Information in the following documents: Detailed budget for the first 12 month budget period (various salaries)
The first folder contains confidential information in the following documents: First Grant Application (pg 1, 2, 13, 16, 19 have SSN and pg 8 has salaries); Second Grant Application (pg 1, 6, 7, 12, 14-16, 18, 21, 24-39, 41, 43-49 have SSN, pg 4 and 8 have salaries) The second folder contains PHI in the following documents: February 19, 1987
[Folder 182] San Francisco Men's Health Study (S.F.M.H.S). — 1985 - 1986. — 1 Folder
This folder contains PHI in the following documents: December 24, 1986; Patients/Dates of Influenza Vaccine Study; November 19, 1986; HIV + Arc Vaccine; HIV + AIDS Vaccine; HIV + AIDS on AZT; HIV - (non-SHARE patient, non risk group) vaccine; HIV - (share patient); HIV - Asymptomatic; 19 February 1987
[Folder 207] Vaccine Workshop, NIAID (National Institute of Allergy and Infectious Disease). — 1986. — 1 Folder
[Folder 208] Vaccine Workshop, US Public Health Service Scientific Workshop on AIDS Vaccine. — 1987. — 1 Folder
[Sub-sub-sub-series 22.214.171.124] MACS (Multicenter AIDS Cohort Study), SHARE (Study to Help the AIDS Research Effort), & Related Studies. — 1983-1988. — 4 Boxes (4.8 cubic feet)
In 1983, Frank Polk, Epidemiologist, designed a study to follow the natural history of AIDS among gay and bisexual men. The National Institute of Allergy and Infectious Diseases (NIAID) within the National Institutes of Health funded Polk’s project as part of a collaborative study known as the Multicenter AIDS Cohort Study (MACS). Polk was the principle investigator and an advisory board member of SHARE, the Study to Help the AIDS Research Effort, the name of the Baltimore center of MACS. Starting in 1983, collaboration began among the Johns Hopkins University School of Medicine, the Johns Hopkins University School of Hygiene and Public Health, the City of Baltimore, the State of Maryland, local gay organizations, and the University of Maryland. Study participants were seen at the Johns Hopkins Hospital Moore Clinic on four evenings a week and on one weekend day. They were given medical evaluations at three to six month intervals.
Polk recruited a lawyer who was a lobbyist and gay rights activist to lead the SHARE Advisory Board and to select Board members, which helped to reach men in the gay community, learn about their concerns and political issues, and obtain their confidence. It was important to ascertain that the investigators were not evaluating homosexuality per se. Another concern was that the researchers would guarantee confidentiality to volunteers who feared being stigmatized. In 1987, the Johns Hopkins University Department of Epidemiology, within the School of Hygiene and Public Health, was awarded a contract to be the Center for the Analysis and Management of the MACS study data (CAMACS). MACS is a longitudinal study and is still ongoing. The three other centers are located in Los Angeles, Philadelphia, and Chicago.
Files cover every aspect of the MACS study including SHARE Advisory Board records (minutes, notes, correspondence, and directories); committee meeting records, including the Steering Committee; proposals (technical and business); research study protocols; forms and form letters; Human Subjects guidelines; study related papers; abstracts for conferences and journal articles; MACS studies of AIDS related conditions; budget information; questionnaires; laboratory records; reports (annual reports, progress reports, final report); materials about the Chicago and Los Angeles sites; computer equipment; statistics; and information for the media.
Noteworthy collection documents include a description of CAMACS and how study data would be managed (See CAMACS file); a paper titled “MACS: Rationale, Organization, and selected characteristics of the participants” (see Data Abstracts and Publications file); Final Report “The Natural History of Acquired Immune Deficiency Syndrome (AIDS) in Homosexual Men,” September 29, 1987 (See Reports); and the October 1983 SHARE Advisory Board minutes that contain notes on the rationale for the study, the advantage of having a cohort study, interest in addressing psychological stress and depression, concerns over possible weaknesses in the study, how to address Gay issues that researchers were unfamiliar with, facilitating discussion about gay social and political issues, issues pertaining to methodology, the study’s relationship with the press, and Johns Hopkins personnel policies concerning gay employees.
MACS-related studies include: Diarrhea Study; Evaluation of Delayed Hypersensitivity to Skin Testing Among Gay Men; Evaluation of a new Antibody Assay for HTLV-III; and Neuropsychological Studies (Neurologic and Psychiatric Manifestation of the HTLV-III Infection or Neoropsych Study).
The MACS/SHARE Study records includes a set of subject files and a set of correspondence files. Subject files are arranged in alphabetical order by folder title.
Polk’s research correspondence includes letters from the Dean of the School of Public Health, D. A. Henderson; the President of Johns Hopkins University, Steven Muller; Director of the AIDS Clinical Unit at the Johns Hopkins Hospital, John Bartlett; the Mayor of Baltimore, William Donald Schaefer; as well as letters to the U. S. Department of Education about children with AIDS attending school; correspondence with leaders of local and state Gay Rights Organizations; pilot study participants’ feedback; and Guides for Institutional Review Boards for AIDS Studies.
For the most part, correspondence is organized in alphabetical order by correspondent’s last name. Some letters are filed by the subject of the letter or by the name of the organization.
See also files about Polk's colleagues interspersed among the B. Frank Polk Collection. These files are located in the AIDS subject files and the correspondence files from the Department of Epidemiology records.
[Folder 1] Correspondence A: Allen - American Academy of Physician's Assistants - AIDS Speaker Bureau - AIDS Study Group. — 1983;1984. — 1 folder
Includes correspondence with James Allen, the American Academy of Physician's Assistants, the AIDS Speaker Bureau, and the AIDS Study Group.
Includes correspondence with Dennis Baker, John Bartlett, Bill Bell, Brad Bender, Donna Bernal, Sue Bird, Darrell Bishop, George Blackburn, David Blake, Blood Bank, Dorothy Boan, Charles Bowers, Bernard Branson, Ford Brewer, Sam Broder, Ron Brookmeyer, the Bureau of Examining Boards, Sandra Burke, Arthur Bushel.
Contains protected health information in an item dated 4/9/1985. Contains potentially confidential personnel information in items dated 11/30/1984, 12/17/1984, and 2/25/1985.
[Folder 3] Correspondence C: Case - Chalow - Chang - Charache - Chrousos - Coles - Committee on the Use of Specimens in AIDS Study -Cooper. — 1983 - 1985;n.d.. — 1 folder
Includes correspondence with Patricia Case, Thea Chalow, Nancy Chang, Sam Charache,George Chrousos, Carolyn Coles, the Committee on the Use of Specimens in AIDS Study, and Philip Cooper
Contains potentially confidential information in items dated 5/30/1984 and 6/29/1984.
Includes correspondence with Sukon Kanchanaraksa, Richard Kaslow, Shep Kellam, Robert Kelley, John Killen, Lawrence Kingsley, Kirk Klebe, Ron Klein, Mary Knudson, Ivan Kramer
Contains potentially confidential salary information in a budget atteched to an item dated 11/30/1984 and an item dated 1/29/1983.
[Folder 12] Correspondence L: Laboratory Works Group - [Patient name redacted] - Laqueuer - Laughon - Leavitt - Leder - Lietman - Luety - Luete - Lundberg. — 1984 - 1985;1988
Includes correspondence with the Laboratory Works Group - [Patient name redacted], Peter Laqueur, Barbara Laughon, Richard Leavitt, Mary Leder, Paul Lietman, Randy Luety or Randy Luete, George Lundberg
Contains protected health information in items dated 1/3/1984 and 9/17/1984, and in two unique items both dated 6/28/1984. Also contains potentially confidential salary information in an item dated 3/28/1985.
Includes correspondence with MACS Principle Investigators, John Mann, Joseph Margolik, Charles McCarthy, Donald McCorkel, Steve McLaren, Jacques Mention, David Miller, Santo Mirable, Tom Moench, Kenneth Morgan, Steve Muller, Alvaro Muñoz
Contains potentially confidential information of an evaluative nature in items dated 1/17/1984 and 12/11/1984. Contains potentially confidential salary information in an item dated 11/30/1984.
Includes correspondence with Alfred Saah, Jeffrey Sacks, Lois Salzman, William Schaefer, Steve Sears, SHARE Advisory Board, SHARE Clinic Physicians, SHARE Clinic Staff, SHARE Investigators, Thomas Simpson, Smithkline Bioscience Laboratories, Joe Stewart, Leslie Sugar, Toni Sutherland, Robert Sweeney, Dan Synkowski
May contain protected health information in an item (with attachments) dated 1/8/1988 and in a handwritten undated letter. Contains potentially confidential information of an evaluative nature in items dated 1/8/1985 and 11/30/1984.
Includes correspondence with Richard Ambinder, John Bartlett, Ron Brookmeyer, Sharon Buck, Pat Case, George Chrousos, Don Craven, Clyde Crumpacker, Curt Decker, Roger Detels, Earl Diamond, Jules Dienstag, Deborah Douglas, Robert Edelman, Lois Eldred, Robin Fox, Harold Ginzburg, Evelyn Goldberg, Leon Gordis, George Grady, Donald Henderson, Gary Hoffman, Toni Hood, Dick Kaslow, John Killen, Marvin Kirsch, Rich Leavitt, Lynn Loriaux, Risa Mann, Andy Monjan, Mary Monk, Jack Mulholland, Alvaro Munoz, Patrick Murphy, Bill Narayan, Jim Narer, Paul Ness, Nancy Odaka, David Ostrow, John Phair, Richard Platt, Viera Provost, Chuck Rinaldo, Noel Rose, Al Saah, Steve Schimpf, Alan Scott, David Snydman, Ellen Taylor, Timothy Townsend, Mei-Cheng Wang, Barbara Werner, Warren Winkelstein
Contains protected health information in an item from a study participant dated 10/13/1983 and an item mentioning a participant dated 7/20/1984. Contains potentially confidential, evaluative information regarding a study contractor in items dated 10/23/1984 (3 copies) and 11/1/1984.
Contains protected health information in: an item dated 8/21/1987 that appears to be written by a study participant; undated handwritten notes titled "JHH - Dupont Biotech" that potentially contain patient names; an undated photocopy of handwritten notes titled "V1-V2" which contain study participant numbers; and undated typed data entitled "Pittsburgh" that potentially contains study participant numbers. Also contains potentially confidential, evaluative information in items dated 9/30/1986 and 12/3/1987.
Contains protected health information in: a handwritten table dated 7/14/1986 that may contain study participant numbers; an item dated 7/10/1986 that contains study participant numbers; an item dated 5/27/1986 that contains donor numbers. Also contains a document titled "Cold Spring Harbor Lab Abstract" that is marked as "confidential."
May contain protected health information in the form of possible patient identifiers in a results chart attacted to an item dated 7/22/1986.
[Folder 126 - 129] Leavitt, Richard, University of Maryland Cancer Center (UMCC). — 1983 - 1986;n.d.. — 4 folders
Folder 126 contains documents from 1985
Folder 127 contains documents from 1983 to 1986
Folder 128 contains documents from 1985 to 1986
Folder 129 contains documents from 1983 to 1986
Folder 126 contains protected health information in the form of study participant data in an item dated 12/2/1985 (Fox to Leavitt) and a separate item dated 12/2/1985 (Leavitt to Fox, BFP, et. al.), as well as in items dated 11/27/1985 and 12/16/1985. Folder 127 contains protected health information, in the form of study participant data, in items dated 4/10/1985, 10/27/1983, and 4/9/1985. Folder 127 additionally contains confidential information regarding salaries in "Schedule A," attached to an item dated 2/9/1986. Folder 128 contains protected health information in the form of study participants' identification numbers in items dated 2/22/1985, 3/21/1985, 3/26/1985, 8/26/1985, a data printout "May 1984", and 12/11/1985. Folder 128 additionally contains confidential information of an evaluative nature in items dated 2/26/1986 and 8/8/1986 and salary information in an undated document entitled "Personnel -- Year 02". Folder 129 contains potential protected health information in a undated data printout entitled "T Cell Control Data." It contains additional protected health information, in the form of study participants' identification numbers, in items dated 1/2/1986 and 7/2/1985. Folder 129 additionally contains confidential salary information in items dated 12/30/1985, 11/1/1985, 7/8/1983, 8/15/1983, 1/11/1985 (original and copy revised 3/28/1985) and an undated document entitled "Attachment 5 and 6: Budget."
Research study titled "Neurologic and Psychiatric Manifestations of HTLV-III Infections"
Folder 142 contains potentially confidential salary information in an undated document entitled "AIDS-Prospective Dementia." Additionally, a draft article in the folder, entitled "Psychosocial & Neuropsychiatric Aspects" is marked confidential. Folder 143 contains protected health information in an undated, handwritten note and attachment from BFP to "Ellen" which contains patient names and identification numbers. Folder 144 contains protected health information in an item dated 12/4/1985 which contains patient names and identifiers. This folder additionally contains confidential salary inforamtion in an application dated 2/13/1986 and confidential evaluative information in an item dated 6/2/1986. Folder 145 contains protected health information in a packet dated 12/4/1985, which contanis patient information. Folder 145 also contains confidential information in a C.V.. Folder 146 contains protected health information in an item dated 11/5/1985, containing study participants' identification numbers and results. Folders 147-148 contains no protected health or confidential information. Folder 149 contains confidential personnel information in two attached items dated 9/11/1986 and 9/10/1986. Folder 150 contains protected health information in a report dated 10/21/1986 (6 copies) which includes study participants' identification numbers.
Technical Proposal for "The Natural History of Acquired Immune Deficiency Syndrome (AIDS) in Homosexual Men"
Folder 197 contains confidential employee information in the form of social security numbers on pp. 5-6. Folder 199 contains confidential employee information in the form of salary information on pp. 130, 133, 136, 139, 142 & 145.
[Folder 200 - 201] Technical Proposal - University of California, Los Angeles - Los Angeles. — n.d.. — 2 folders
Technical Proposal for "The Natural History of Acquired Immune Deficiency Syndrome (AIDS) in Homosexual Men"
Folder 201 potentially contains protected health information in a letter of support that identifies an unnamed individual's health condition.
This folder contains protected health information in data printouts of SHARE participants HIV antibody status, which included participant identification numbers, and in a set of handwritten results of "ARC" patients, whic also incldue participant identification numbers.
[Folder 203] MACS Philadelphia HTLVIII and Evaluation. — n.d.. — 1 folder
Folder 207 contains confidential student information in an item dated 10/10/1987 which includes details about a student's grade and social security number. Folder 209 may contain protected health information in photographs of individuals with AIDS. It additionally contains confidential student information in the form of a social security number included on a term paper.
This folder contains confidential employee information, including salary information and social security numbers, in five personnel forms dated 7/15/1987 and in undated budgets for the main SHARE project and for various departments involvement in SHARE.
Folder 238 contains protected health information in a handwritten, undated document entitled "Seroreverters V1 -> V2," which contains participant identification numbers. Folder 239 contains protected health infomation in a chart entitled "List of V2 Participants ..." which included participant identification numbers.
This folder contains protected health information in data attached to an item dated 8/13/1986, which contains participant identification numbers. It contains additional protected health information, in the form of patient names, in results attached to a letter dated 8/7/1985.
[Folder 260] Virus Isolation Case Control Study. — 1986. — 1 folder
Materials pertain to research treating AIDS patients with experimental drugs including antiretroviral drugs, such as AZT. Includes drug literature; drug fact sheets; ACTG (AIDS Clinical Trials Group) Committee meeting minutes and correspondence; workshop programs; Polk’s hand written notes; copies of AIDS drugs articles; ATEU (AIDS Treatment Evaluation Units) records including progress reports; copies of grant applications; research study protocols; JCCI correspondence and consent forms; patient medical records; analyses and summaries of clinical data; and copies of papers. Contains correspondence with Pharmaceutical companies and from physicians to JCCI Acting Chairman concerning patient’s response to treatment.
Polk was the investigator on the following Studies of AIDS related illnesses treated with drugs: DHPG Compassionate Use in Patients with Serious or Life Threatening Cytomegalovirus Infections; Multiple Dose, Open-Label Clinical Trial to Determine Tolerance and Preliminary Efficacy of HPA-23 in Patients with AIDS; Study Comparing Ribavirin to Placebo in Asymptomatic Pre-AIDS Patients.
Files are arranged in alphabetical order by the name of the drug studied.
Folder 2 contains possible protected health information in a letter dated 7/13/1988. It also contains possible study participant information in two copies of an undated list. Folder 2 contains confidential personnel information in the form of salaries and social security numbers in a grant application.
This folder contains protected health information related to study participants in an undated Data Management report, which contains participant's study identification numbers, and in a report attacted to a letter dated 7/14/1987, which contains participants' identification numbers and status in the study.
Folder 5-7 contain protected health information throughout the entire folder, including the initials, names, ages and conditions of participants in the DHPG trial. Folder 8 contains protected health information in: a letter dated 6/5/1986 which references a study participant; a completed study consent form, which contains the study participant's name, date of birth, and study identification number; an undated results printout, which contains participant initials and test results; undated Medical Record Notes; and completed Patient Information forms. Folders 9-10 contain protected health information throughout their entirety. Additionally, Folder 9 may contain confidential study information.
This folder contains protected health information in: a memo dated 4/8/1987 which documents study participant initials and the medications they received; a letter from BFP dated 10/10/1985 which contains the name of and information on a study participant; a letter to BFP dated 7/5/1985 which contains study participant initials; and a completed consent form dated 7/7/1985 which contains the name of a study participant.
This folder contains protected health information in: a letter dated 5/27/1986 which lists study participants' initials and test results; an undated, handwritten list of study participants' names and social security numbers; 16 pages of completed forms which contain participants' identification numbers, initials and a variety of test results; five pages of Drug Accountability forms which contain study participants' initials and treatmant; letters dated 4/29/1986, 3/10/1986, 3/25/1986, & 3/17/1986 which contain participants' initials and results; a graph which cotains participants' initials; and an undated JHH Investigational Drug Data sheet which contains participants' names and treatments.
Folder 3 contains protected health information in a questionaire (date illegible) which notes a patient identification number and in six pages of lab reports from April 1987. Folder 3 additional contains potentially confidential evaluative information in a letter dated 12/1/1986.
Folder 14 contains documents from 1982 - 1987, n.d.
Folder 12 contains protected health information in the form of study participant identification numbers in items dated 7/14/1983; 4/7/1983; 3/16/1983; 6/1/1983; 4/22/1983. This folder additionally contains potetially confidential evaluative information in a letter dated 6/9/1983.
The first folder contains protected health information in an undated study document with a table dated July 1981-June 1982 (p.4), which contains patient initials, hospital numbers, and treatments. It contains additional protected health information in an item dated 6/12/1984. This folder also contains confidential information in an item dated 3/8/1984. The third folder contains protected health information in an item dated 3/20/1986; two unique items both dated 6/19/1985; and an item dated 3/11/1985.