Request for IRB Application for Study on Top Surgery and Gender Dysphoria (Northwestern University)

To Whom It May Concern:

Pursuant to the Illinois Freedom of Information Act., I hereby request the following records:

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.

In the event that there are fees, I would be grateful if you would inform me of the total charges in advance of fulfilling my request. I would prefer the request filled electronically, by e-mail attachment if available or CD-ROM if not.

Thank you in advance for your anticipated cooperation in this matter. I look forward to receiving your response to this request within 5 business days, as the statute requires.

Sincerely,

Ann Sauseda

To Whom It May Concern:

I wanted to follow up on the following Illinois Freedom of Information Act. request, copied below, and originally submitted on April 24, 2023. Please let me know when I can expect to receive a response.

Thanks for your help, and let me know if further clarification is needed.

To Whom It May Concern:

I wanted to follow up on the following Illinois Freedom of Information Act. request, copied below, and originally submitted on April 24, 2023. Please let me know when I can expect to receive a response.

Thanks for your help, and let me know if further clarification is needed.