Thank you for your interest in conducting a research or quality improvement project in collaboration with San Ysidro Health
San Ysidro Health (SYHealth) is committed to engaging in high quality research or quality improvement (QI) projects that are patient-centered, community-participatory, and culturally competent. The purpose of a Research/Quality Improvement Project is to benefit our patients, organization’s clinical practice and the surrounding community. As such, translational research and Quality Improvement projects with direct impact on these goals are accepted.
There is a 2-step application process for the implementation of a research or QI project at SYHealth. The first step requires receiving authorization from SYHealth administrators to conduct the project. The second step involves the Institutional Review Board (IRB) review (or ethical review for QI projects) for Human Subjects Research Protection. The details of both steps can be found below.
The initial request must be made to the Research Department. This is done using the Concept Paper and Registration Form. The Research Department will route these documents to the appropriate parties, including senior leadership, who will make their initial assessment based on criteria, including, but not limited to:
The authorization process takes approximately 4-6 weeks. If the project is authorized, it means that all necessary and relevant parties at SY Health are aware of the intent of the research or QI project and that it is authorized to be conducted in collaboration with SYHealth. This is not an approval to implement the research study.
Once your project has been authorized to be conducted in collaboration with SYHealth, the project must receive IRB approval before implementation.
The Office for Human Research Protection (OHRP) requires that all grant-funded research projects receive IRB review and approval from an IRB that is registered with the OHRP. SYHealth has an internal IRB committee that can be utilized only for projects that are not grant funded. Please carefully review the following options to determine what type of review is right for your project:
1. If you are a SYHealth employee who is conducting a research or QI project that is not grant-funded, your project may undergo IRB review through SYHealth’s Internal IRB Committee.
2. If you are an employee of SYHealth conducting a grant-funded research project, your project is required to undergo IRB review with an OHRP-registered IRB as well as review through SYHealth’s Internal IRB Committee. For support in identifying an IRB of record, please email email@example.com
3. If you are an external partner of SYHealth conducting either a grant-funded or non-grant-funded research project, please obtain IRB approval from your institution’s IRB as well as approval through SYHealth’s Internal IRB Committee.
The Research Department at SYHealth is responsible for overseeing the progress and compliance of research and QI projects at SYHealth. This includes maintenance of compliance files such as IRB approval letters, informed consent, valid Human Subjects Research Protection training certificates, documentation of SYHealth’s reliance on the partnering institution's IRB, progress reports and final reports. The implementation of the projects and/or any research activities cannot proceed until such documents are on-file.
All projects conducted in collaboration with SYHealth are subject to review by SYHealth’s Internal IRB Committee. SYHealth’s Internal IRB Committee may make final recommendations to the protocol or patient facing documents to protect its vulnerable population. These recommendations are related to:
This IRB approval process may be done concurrently with authorization if study documents are available. Please expect the IRB review and any modifications to take up to 2 weeks. SYHealth’s Internal IRB Committee will issue a Letter of Approval (LOA) when all patient facing documents are satisfactory and the protocol is acceptable.
Once the project has been authorized with the organization, has received external IRB approval (if required), and has been approved by SYHealth’s Internal IRB Committee, the project may be implemented.
Any changes made to the project, except those intended to reduce risk, must be approved by all oversight committees, including SYHealth’s Internal IRB Committee. Furthermore, SYHealth asks that any publication or presentation as a result of the project reference the organization as “A Federally Qualified Health Center in San Diego.” SYHealth kindly asks that you review the full list of considerations listed on the LOA before implementation.
If you are ready to submit your project for authorization at SYHealth, please download and complete the Concept Paper and Registration Form from the website and submit to the Research Specialist at firstname.lastname@example.org.
Upon submission, you will receive an email from the Research Specialist confirming receipt and assigning you a unique SYHealth Project ID number. The Research Specialist will be in contact with you regarding your project and the expected timeline for approval, as well as if any additional information is needed for authorization.
If you have any questions about the Research/QI project application process, contact us at email@example.com
It is recommended that you do not continue the development of your protocol until you are authorized to conduct a project by SYHealth Leadership. While SYHealth aims to support our staff’s goals and improve patient care and health, the organization must consider the feasibility of the study in comparison to the risks and costs. For this reason, it is recommended that you submit a concept paper highlighting the goals, objectives, and benefits of the project, and begin development if and only if the project receives authorization.
SYHealth works in collaboration with many institutions such as UCSD, SDSU, NYU Langone Health, and others to support the projects of research staff or students alike. The IRB approval of these institutions is respected and will serve as the governing authority over these projects. However, SYHealth takes additional precautions that are specific to our vulnerable population and their local context, such as digital/health literacy barriers, linguistic or cultural barriers, and others. For this reason, we review all projects for ethical considerations from an FQHC perspective.
SYHealth is responsible for the welfare and protection of its patient population throughout the research process including the results of research whether they be negative or positive. SYHealth reserves the right to review all potential publications to determine whether the population could be easily identified or whether the care provided would cause distress to others within our patient population. We ask all partners that you remove the name of “San Ysidro Health” in your publication and replace it with “A Federally Qualified Health Center in San Diego.” If you wish to use San Ysidro Health’s name, please complete a “Manuscript Clearance Form” and submit a draft of your publication to firstname.lastname@example.org to learn the exact determination of your publication.
If you need to make a change to an existing project, please download the “Project Progress Report” from the website, complete and send to the email@example.com with any revised documentation including an IRB approval if required. Your project may be subject to review before amendment approval
If you need to extend your project registration with SYHealth, please download the Project Progress Report, complete and send to the firstname.lastname@example.org with an extended IRB approval if required. You may be subject to review before approval.
If you need to close your project registration with SYHealth, please download the “Project Progress Report,” complete and send to the email@example.com.