1. Research Overview: This dataset is comprised of clinical consent forms, collected as part of Dr. Elizabeth Umberfield's dissertation research of at the University of Michigan. The research aimed to enable representation of clinical consent forms and their permissions within the Informed Consent Ontology. These efforts were supported by the Rackham Graduate Student Research Grant, and Dr. Umberfield's doctoral training was supported by the Robert Wood Johnson Foundation Future of Nursing Scholars Program.


2. Methods:
Consent forms were collected using two methods: direct contribution by healthcare facilities and systematic web searching. Only those forms discovered through systematic web-searching (i.e., publicly accessible) are included in this dataset. Forms collected through direct contribution by healthcare facilities are excluded based on the original data protection agreements with participating sites. Consent forms were converted from their original file format (most often .pdf files) to text files (.txt) using optical character recognition (OCR) and conversion tools built into Adobe Acrobat DC or MS Word (for .doc). For each consent form, a unique file identifier, search terms used, URL, date uploaded (if available), date last modified (if available), and date retrieved was documented. Facility metadata assigned by Centers for Medicare and Medicaid Services, including unique identifiers, name, location, and facility type, were mapped to and recorded for each form. 


3. File Inventory: The zip folder for this dataset includes:
- '_README.txt': this document
- 'Data Dictionary and Form Metadata.xlsx': a .csv file listing all consent forms included in Dr. Umberfield's dissertation research (n= 134) and their metadata presented in the methods section above
- 'consent forms_pdf': a subfolder of all .pdf files for included consent forms that were either publicly accessible or able to be deidentified (n= 102)
- 'consent forms_txt': a subfolder of all .txt files for included consent forms that were either publicly accessible or able to be deidentified (n= 102)

The files included in the above-mentioned subfolders can be mapped to the consent form metadata in 'Data Dictionary and Form Metadata.xlsx' using the unique form identifiers listed under the variable 'document_id'



4. Definition of Terms and Variables:

Variable Name	Definition
PDF Included	yes: document included in published datset; no: document not included in published dataset
TXT Included	yes: document included in published datset; no: document not included in published dataset
document_id	unique identifier stem for all included consent form files 
Retrieval Method	The search strategy used to identify sampled health care facilities (see methods section)
Facility ID	Unique facility IDs provided by Centers for Medicare and Medicaid Services (CMS) and the Agency for Healthcare Research and Quality (AHRQ), as published in open-access lists on Data.gov
Hospital Name	The hospital's name, as published in open-access lists on Data.gov
City	The hospital's address, as published in open-access lists on Data.gov
State	The hospital's address, as published in open-access lists on Data.gov
Zip Code	The hospital's address, as published in open-access lists on Data.gov
Hospital Type	The hospital's type, as published in open-access lists on Data.gov
Search Terms	The search terms used to identify that particular consent form, if identified through internet searching
URL	The URL for particular consent form, if identified through internet searching
Date Uploaded	The date the consent form file was published online (if avaialable)
Date Retrieved	The date the research team identified and retrieved the consent form file
Date Last Modified	The date the consent form file was last updated by the facility (if indicated on form)
CTSA Site (University)	For all forms identified through 'Retrieval Method'>CTSA, the CTSA-funded research institution affiliated with that consent form's  hospital or facility


5. Use and Access: This dataset is released under an Attribution 4.0 International (CC BY 4.0) license. This license lets others distribute, remix, tweak, and build upon your work, even commercially, as long as they credit you for the original creation.


6. Informed Consent: Informed consent and Institutional Review Board review was not required because human subjects and their data were not involved in this analysis; only blank, unsigned consent forms were collected and analyzed.