Application Process

What to Expect When Collaborating in Research with San Ysidro Health

‍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.

1. Authorization Process:

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:

• Resources and benefits the project brings to SYHealth patients and to the organization in general. Alignment with organization’s priorities and contribution to their mission of improving the health and well-being of the communities they serve with access for all.
• Adequate protections for HSR participants and their protected health information (PHI)
• Approval from department(s) likely to be impacted by the research
• Feasibility of the project (resources needed such as facilities, staff, systems, etc.)

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.

2. Institutional Review Board (IRB) Approval Process:

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 reviewcommittee@syhealth.org

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:

• HIPPA Compliance
• Cultural and linguistic competency and sensitiveness
• Diversity, equity, and inclusion
• Literacy or language barriers
• Appropriate use of incentives/ coercive recruitment
• Resource and timing concerns
• Clinic staff involved
• Other concerns as seen fit

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.

3. Implementation:

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.

Apply

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 reviewcommittee@syhealth.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.

1. Protocol
2. Human Subjects Research Protection Training Certificate
3. Informed Consent
4. Data Collection Instrument(s)
5. Flyers
6. IRB approval (if already obtained)
7. Other

If you have any questions about the Research/QI project application process, contact us at reviewcommittee@syhealth.org