| Understanding the difference between your grant and your for your human study. Click the diagram to enlarge and view the details ► |  |
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step-by-step details of how a study will be conducted including objectives, design, procedures, measurements, management and analysis, as well as a discussion of relevant research ethics issues.
development.Funding Opportunity Announcements (FOAs) exist in a variety of domains. In absence of a centralized, comprehensive database, The Office of Sponsored Programs has collected relevant resources to assist our investigators in locating and applying for external funding.
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Single ( ) for Multi-Site
The NIH policy requires the use of a single IRB to accomplish IRB review and approval for all domestic sites. This applies to most grants and contracts submitted to NIH on or after January 25, 2018 that involve multi-site non- . The 2018 revised federal “Common Rule” also contains a new requirement for single IRB review for studies that involve multiple institutions effective January 21, 2020. This is separate from the NIH policy and applies to all federally-funded .
Learn more about recommended grant language for a Single IRB review plan.
The lead PI must consult with the (IRB) when selecting a single IRB. IRB will typically issue a Letter of Support documenting the university’s willingness to use the specified single IRB ( ). You should keep this letter in your study files. You may choose to include it in the grant application; however, NIH does not require this.
Please note: The IRB will assess fees for this service and must review the budget if the IRB will be the . A standard fee schedule has not been released at this time. The IRB will provide fee information for the budget based on the type of study.
Contact UTHSA IRB at 210-567-8250 or IRB@uthscsa.edu to request a consult. The IRB recommends you begin this consult early in the grant preparation process.
Learn more about what info you need when contacting the IRB.
If will be a participating site:
Neither NIH nor require grant applications for participating sites in a multi-site study to include a Letter of Support for use of a single IRB. However, NIH does require the lead PI to “obtain confirmation” from participating sites that their institutions are willing to rely on a specific, single IRB. At , this confirmation is provided by the OCR, in writing (an email or an emailed Letter of Support). This written confirmation should be saved by the participating investigator and can be provided to the lead PI for inclusion in the grant application at their discretion.
Contact OCR at 210-567-8555 or IRBreliance@uthscsa.edu to request this documentation.
Learn more about what info you need when contacting the OCR.
The Department of Population Health Sciences provides statistical support for bioinformatics and applied epidemiology, and offers computational biology and informatics expertise, including database design and application development, as well as , evaluation, and health policy expertise.
Interested in improving the quality of your grant application?
The GrantSeekers 2.0 program is designed to give investigators the opportunity for an internal and external review process prior to submission of their NIH, VA or other proposals. Initial reviews are provided via a review of an oral presentation provided by the investigator. The makeup of the review panel is determined by the investigator based on the ability to provide critical reviews for the subject matter and can include an external reviewer. The Expanded GrantSeekers program facilitates external peer review and support at other stages of the grant development process, including early-stage development, preliminary data for scored but unfunded proposals, and manuscript review.
All proposals for external funding that require either a signature by an HSC Authorized Official or a budget must be reviewed by OSP. OSP requires that you allow three (3) business days for review of your proposal, regardless of whether it is paper or electronic submission.
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The VPR CTO provides assistance to local investigators developing a .
Contact VPR CTO at VPRCTO@uthscsa.edu or, use this link to complete the . Include as much information about your trial idea as possible.
(EMR) Data Warehouse - The Clinical Informatics Division (CIRD) curates a data warehouse that is accessible to researchers through multiple software tools such as i2b2 or TriNetX.
The All of Us Program (part of NIH) is an ambitious effort to gather health data from one million or more people living in the United States to accelerate that may improve health.
There are free, self-service data platforms for UTHSA investigators to conduct preparatory to query building, project feasibility and cohort exploration.
(EMR) Data Warehouse- The Clinical Informatics Division (CIRD) curates a data warehouse that is accessible to researchers through multiple software tools such as i2b2 or TriNetX. Assessing the patient population using data from the and University Health Systems EMRs is a very useful tool in determining study feasibility.
UT Health EPIC Slicer-Dicer - is a self-service reporting tool within EPIC that allows physician researchers ready access to 's clinical data that is customizable by patient populations for data exploration such as population assessment.
Contact EPIC Support Desk: 210-450-4800; utmsasupport@uthscsa.edu
Plan
UT Health SA Find-a-Study is a service provided by the Office of for connecting people interested in participating in a study to investigators with research studies open enrollment .The website allows patients to search for studies or register as a volunteer to be contacted by researchers for general interest or interest in a specific study.
& Marketing for Clinical Trials
You can contact the , for consultation to learn about the multiple tools and methods available.
ResearchMatch.org
ResearchMatch is a free and feasibility analysis tool for researchers. Investigators with IRB-approved studies can use the ResearchMatch system to find potential participants who meet their needs in terms of health conditions and locations from a pool of individuals who have previously signed up with ResearchMatch.org.
investigators can access at no charge the database of volunteers who have expressed interest in participating in clinical studies by enrolling in the ResearchMatch.org registry. The national maintained registry can be used to assess feasibility of participants available to recruit for IRB approved studies. For more information, contact : Karen Schultz, Institute for Integration of Medicine & Science schultz@uthscsa.edu
Minority Participation Ideas
The EMPaCT Consortium YouTube channel at may also be of interest to researchers seeking to encourage minority in their studies.
Vanderbilt University's free-to-audit course on Coursera titled “Faster Together, Enhancing the of Minorities in Clinical Trials.” .
(EMR) Data Warehouse - The Clinical Informatics Division (CIRD) curates a data warehouse that is accessible to researchers through multiple software tools such as i2b2 or TriNetX. Assessing the patient population using data from the and University Health Systems EMRs is a very useful tool in determining study feasibility.
Federal Regulations provide for additional protections for specific populations who may be particularly vulnerable to or as participants. These protected populations include , , and individuals with , as well as pregnant women, , and . In most cases, justification for including these protected populations is required. When it is appropriate to include these populations in research, it is important to consider their vulnerabilities and make provisions to minimize risks.
Learn more about vulnerable populations.
Trial Innovation Network (TIN)
is a participating organization in the Trial Innovation Network (TIN). Contact the local TIN representative Dr. Shweta Bansal bansals3@uthscsa.edu
TIN is a collaborative initiative within the Clinical Translational Science Award (CTSA) Program and is composed of three key partners – the CTSA Program Hubs (e.g., UT Health SA), the Trial Innovation Centers (TICs), and the Innovation Center (RIC).
The Trial Innovation Network offers investigators the opportunity to request consultations and resources for multicenter clinical trials and studies. These are designed to help investigators, for example, develop proposals into protocols, enhance study operations, or improve and retention. Some consultations developed into clinical protocols may be implemented in the Network and within the CTSA Program.
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