Document is current

Article History

Received: 27 June 2024

Accepted: 10 May 2025

First Online: 4 June 2025

Declarations

:

: Informed written consent was obtained directly from participants. The study received IRB approval initially through the Illinois Institute of Technology in May 2022 (IRB-2022-92) and through the JBVAMC in December 2022 (JBVA IRB #1675992). All data from this study is kept in a secure, password protected VHA server ensuring that only study personnel have access to the data. Coded HIPAA-compliant data sets will be created and used for the analysis. A contractor, Elevate, is conducting housing condition assessments via an authorization agreement with the IIT IRB. A random and unique study ID will be created and used in all analytic data sets to ensure participants are coded. In the event of any data consistencies, a Social Security Number (SSN)-study identification “key” linking the SSN to the unique study identifiers will be created and used to resolve issues. This key will also be stored in a password-protected file on the VHA server. Identifiable information will not be reused or disclosed to any other person or entity other than those identified in the protocol, except as required by law, for authorized oversight of this research study. If applicable, the IRB, VA Research and Development, and Government Accounting Office (GAO) may have access to research data. No personnel involved in the study may identify, directly or indirectly, any individual patient or subject in any report of such research, or otherwise disclose patient or subject identifiers in any manner.All study personnel with access to Protected Health Information (PHI) are required to maintain current required training modules and follow protocol for maintaining records according to best practices. Any hard copies containing PHI are locked in a file cabinet behind a locked door that only study personnel have access to. PHI that is stored electronically is stored on shared drives that only study personnel will have access to. To view PHI and enter participants’ homes, core members of the non-VA research team obtained Research Service Without Compensation (WOC) employee appointments with the VA. VA WOCs will collect and transfer data directly from patient homes during home visits. All paper documents will be brought back to JBVAMC by VA WOCs. The paper documents are scanned and uploaded to the secure VA research server by the study coordinator via VA scanner. All research records and data (paper and electronic) are stored and destroyed in compliance with Record Control Schedule (RCS) 10-1.In the event of unanticipated problems, serious adverse events, and protocol deviations, in order to be compliant with VHA Directive 1058.01 and JBVAMC policy, the study team will report events that are apparent Unanticipated Problem Involving Risks to Subjects or Others (UPIRTSOs), related or possibly related serious adverse events, and protocol deviations that are apparent noncompliance. We will report the events that are considered immediate reporting events. Other events will be reported annually at the time of the annual status report for minimal risk expedited review studies as per JBVA policy under VHA directive 1058.01. The Research Compliance Officer (RCO) at JBVAMC conducts an annual audit of informed consent documents and all relevant documents related to the project. Any protocol deviations, unanticipated problems, or interim results that may impact the conduct of the study will be communicated to all investigators, staff, and the JBVAMC privacy officer. The lead clinical research coordinator at JBVAMC will communicate any other potential protocol changes to relevant parties.There is a potential risk of loss of confidentiality. Information that identifies the subject will be used in this study and shared with the research staff. However, the research team will make every effort to protect the breach of confidentiality. The data will be coded to protect the confidentiality of the data should someone gain access to it. There is also a potential risk if elder or child abuse or neglect is observed during home visits because the staff are obligated to report it to the Illinois Department on Aging or the Illinois Department of Children & Family Services.

: Not applicable.

: The authors declare no competing interests.