Request for IRB Application for Study on Top Surgery and Gender Dysphoria (University of Illinois at Chicago)

May 1, 2023

Via electronic mail
Ann Sauseda
requests@muckrock.com

Re: FOIA Request 23-550

Dear Ann Sauseda:

I write to respond to your request dated and received in my office on April 24, 2023, under the Illinois Freedom of Information Act (FOIA) in which you requested:

“I am writing to request a copy of the Institutional Review Board (IRB) application for the study titled "Top surgery and chest dysphoria among transmasculine and nonbinary adolescents and young adults," conducted by researchers at the University of Illinois and Northwestern University.

This research was funded/supported by Northwestern University Clinical and Translational Sciences Institute, funded in part by a Clinical and Translational Science Award grant from the National Institutes of Health (UL1TR001422) that contributed to collection, management, analysis, and interpretation of the data. I understand that the IRB materials I am requesting may be stored under any of the following study identification numbers for your research protocols: SP0052757, UL1TR001422, or NCT04195659. Please provide the relevant documents associated with these identifiers in accordance with my request.

I am requesting the IRB application submitted for approval prior to the commencement of the study and any amendments/modifications filed after the study began. I am not asking for any identified participant data (IPD).

Journal: JAMA Pediatrics
Title: "Top Surgery and Chest Dysphoria Among Transmasculine and Nonbinary Adolescents and Young Adults"
Published online: September 26, 2002
Principle Investigators: Mona Ascha and Sumanas W. Jordan
Funding: Northwestern University Clinical and Translational Sciences Institute is funded in part by a Clinical and Translational Science Award grant from the National Institutes of Health (UL1TR001422)

Given that your study has received federal funding through the NIH, it falls under the purview of the Freedom of Information Act (FOIA). As such, I am entitled to request access to the following documents and information related to your research:
Consent and assent templates, along with any modifications.
Study information templates.
Recruitment templates and worksheets.
Details on potential risks or benefits to participants.
Comprehensive research protocol, including study design, data management and analysis, and ethical considerations.
Any additional documents required for review by the IRB.
Submissions pertaining to any modifications made to previously approved research within this study.

Additionally, please provide me with the name and contact information of the official who will review my request.

The requested documents will be made available to the general public, and this request is not being made for commercial purposes.”

Information responsive to your request is available and attached. These are public records numbering 13 pages. Portions of these records have been redacted or withheld pursuant to the following section(s) of the Act:

* 140/7(1)(a) that exempts from disclosure “Information specifically prohibited from disclosure by federal or State law or rules and regulations implementing adopted under federal or State law.” In this case, certain records are covered by and exempt from disclosure pursuant to the Illinois Medical Studies Act, 735 ILCS 5/8-2101.

* 140/7(1)(f) that exempts from disclosure “Preliminary drafts, notes, recommendations, memoranda and other records in which opinions are expressed, or policies or actions are formulated, except that a specific record or relevant portion of a record shall not be exempt when the record is publicly cited and identified by the head of the public body.” This includes drafts.

* 140/7(1)(i) exempts from production “Valuable formulae, computer geographic systems, designs, drawings and research data obtained or produced by any public body when disclosure could reasonably be expected to produce private gain or public loss.” This includes research information that, if disclosed, could lead to private gain or public loss.

* 140/7(1)(j)(iv) exempts from disclosure “course materials or research materials used by faculty members.” This includes faculty research information.

You have a right, under the law, to seek a review of this response by the Public Access Counselor (PAC) in the Office of the Attorney General. The PAC may be reached by phone at 877-299-3642, by email to public.access@ilag.gov, or by postal mail to Leah Bartelt, Public Access Counselor, Office of the Illinois Attorney General, 500 South 2nd Street, Springfield, Illinois 62701. You also have the right to seek judicial review under section 11 of this Act.

If you have questions for our office, please contact 217-333-6400.

Sincerely,

Kirsten Ruby
Director, External Relations and Communications
and Chief Records Officer

May 19, 2023

Via electronic mail
Ann Sauseda
requests@muckrock.com

Re: FOIA Request 23-663

Dear Ann Sauseda:

I write to respond to your request dated and received in my office on May 12, 2023, under the Illinois Freedom of Information Act (FOIA) in which you requested:

“Please see the following appeal to the incomplete results to the public records request submitted to your agency on 04/24/2023:

I would like to express my gratitude for providing some of the records requested in our previous correspondence. However, I noticed that the documents received were not a complete set. Specifically, you provided Version 1.1 of the Assent but not Version 1.2. Additionally, for the Consent and Parental Permission, you only provided Version 1.2 and not the original approved version. As our FOIA request was intended to cover all documents and corresponding amendments, and since we are in agreement that the Consent, Assent, and Parental Permission are obtainable, I am requesting that you provide the missing versions.

Furthermore, the documents you provided indicate that the study would include standard-of-care self-report questionnaires. These questionnaires were offered in REDCap and should have been part of the IRB submission to show the IRB committee the questions and responses that would be asked. Because these are not exploratory tests and scales, I am requesting a copy of the REDCap XML file without data.
The questionnaires involved in the study are as follows:
1. The Kozee Transgender Congruence Scale
2. The Utrecht Gender Dysphoria Scale
3. The Olson Chest Dysphoria Scale
4. The Body Image Scale GS
5. The Steps to Transition Scale

6. The Parental Support of Gender Variance Scale

I appreciate your attention to this matter and look forward to receiving the missing versions of the documents and the REDCap XML file.”

Regarding the first paragraph of your request, the 1.1 and 1.2 versions of the consent documents that were previously provided to you under FOIA file number 23-550 are the only finalized documents that are responsive to your request. There are no IRB-approved amended consent documents. The draft versions of the documents that you requested were withheld in full pursuant to the following section of the Act:

* 140/7(1)(f) that exempts from disclosure “Preliminary drafts, notes, recommendations, memoranda and other records in which opinions are expressed, or policies or actions are formulated, except that a specific record or relevant portion of a record shall not be exempt when the record is publicly cited and identified by the head of the public body.” This includes drafts.

Regarding the second paragraph of your request, each of the named scales is a standard of care measure used during the course of clinical care, not for research. The IRB did not approve the use of those documents as the scales are not being used for research purposes. The research protocol includes a general description of the tools and cites the tools for reference but does not contain the specific tools. Files in REDCap are not maintained or used by the University for research; therefore, the University does not possess any responsive records to this request. These records are data files maintained in private medical records at outside healthcare institutions.

You have a right, under the law, to seek a review of this response by the Public Access Counselor (PAC) in the Office of the Attorney General. The PAC may be reached by phone at 877-299-3642, by email to public.access@ilag.gov, or by postal mail to Leah Bartelt, Public Access Counselor, Office of the Illinois Attorney General, 500 South 2nd Street, Springfield, Illinois 62701. You also have the right to seek judicial review under section 11 of this Act.

If you have questions for our office, please contact 217-333-6400.

                                    Sincerely,

                                 Kirsten Ruby
                                       Director, External Relations and Communications
                                       and Chief Records Officer