The Human Study Lifecycle

Developing Your Human Study

• Grant Development - Funding Opportunities

  Finding Funding Opportunities

  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.

  Learn more about current funding opportunities 
• Grant Development - Local Information

  Selected Sources of Local Information

  These pages contain history, information, and statistics about our University and the surrounding areas:

  Information about UT Health San Antonio and our affiliates

  • Learn more about UT Health San Antonio History, Facts, and Figures
  • Learn more about University Health System
  • Learn more about the South Texas Veterans Health Care System

  Facts and statistics for San Antonio and Bexar County

  • The United States Census Bureau website has QuickFacts about states, counties, cities, towns, and zip codes. You can also search for others and compare them from any of these pages:

  • Learn more about Census data for San Antonio, TX
  • Learn more about Census data for Bexar County,  TX
  • Learn more about Health Data and Statistics from the Metro Health District

  Facts and statistics for Texas

  Learn more from the below agencies and organizations.

  • United States Census Bureau QuickFacts for the state of Texas
  • Department of State Health Services Center for Health Statistics
  • CDC National Center for Health Statistics Stats of the State of Texas
  • Texas Cancer Data and Statistics links from Texas Cancer Information
  • The Burden of Diabetes in Texas from the American Diabetes Association
• Grant Development - Single IRB Review Plan

  Single

  a federally mandated, institution-designated regulatory body empowered to oversee Human Subjects Research.

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  (

  Single IRB, the NIH's policy requires the use of a single IRB to accomplish IRB review and approval for all domestic sites in multicenter, non-exempt human subjects research. 

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  ) for Multi-Site

  a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

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  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-

  research that meets the regulatory definition of human subjects research and qualifies for exemption.

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  . 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

  a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

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  .

  Learn more about recommended grant language for a Single IRB review plan.

  • If UT Health San Antonio will be the IRB lead or coordinating site:

  The lead PI must consult with the

  a federally mandated, institution-designated regulatory body empowered to oversee Human Subjects Research.

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  (IRB) when selecting a single IRB. UT Health San Antonio IRB will typically issue a Letter of Support documenting the university’s willingness to use the specified single IRB (

  Single IRB, the NIH's policy requires the use of a single IRB to accomplish IRB review and approval for all domestic sites in multicenter, non-exempt human subjects research. 

  read more

  ). 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 UT Health San Antonio IRB will be the

  denotes the IRB responsible for approval of a specific research study at a given institution.

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  . 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 UT Health San Antonio will be a participating site:

  Neither NIH nor UT Health San Antonio 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 UT Health San Antonio, 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 UT Health San Antonio 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.
• Grant Development - Statistical Planning

  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

  all physical procedures by which information or biospecimens are gathered or manipulation of the subject or the subject's environment performed for research purposes.

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  , evaluation, and health policy expertise.

  Learn more about the services of the Department of Population Health Sciences.
• Grant Development - GrantSeekers

  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.

  Learn more about the GrantSeekers Program.
• Grant Submission - Office of Sponsored Programs

  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. 

  Learn more about proposal preparation and review.
• Protocol Development Service - Investigator Initiated Clinical Trials

  The VPR CTO provides assistance to local investigators developing a

  one type of Clinical Research that follows a pre-defined plan or protocol. Subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

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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.

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  .

  Contact VPR CTO at VPRCTO@uthscsa.edu or, use this link to complete the Clinical Trial Portal on-line submission form.  Include as much information about your trial idea as possible.
• Protocol Development - Sources of Data

  (EMR) - digital version of a medical chart that contains all of a patient’s medical history from one provider or facility.

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  (EMR) Data Warehouse - The Clinical Informatics

  a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

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  Division (CIRD) curates a data warehouse that is accessible to researchers through multiple software tools such as i2b2 or TriNetX.  

  Learn more about the Clinical Informatics Research Division

   

  The All of Us 

  a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

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  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

  a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

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  that may improve health.

  All of Us - Opportunities for Researchers
• Protocol Development - Assessing the Patient Population

  There are free, self-service data platforms for UTHSA investigators to conduct preparatory to

  a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

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  query building, project feasibility and cohort exploration.

  (EMR) - digital version of a medical chart that contains all of a patient’s medical history from one provider or facility.

  read more

  (EMR) Data Warehouse- The Clinical Informatics

  a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

  read more

  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

  is the clinical practice of the Long School of Medicine of UT Health San Antonio

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  and University Health Systems EMRs is a very useful tool in determining study feasibility.

  Learn more about the Clinical Informatics Research Division

  UT Health EPIC Slicer-Dicer - is a self-service reporting tool within EPIC that allows physician researchers ready access to UT Health San Antonio'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
• Protocol Development: Recruitment and Marketing Plan

  a pre-enrollment activity used to find potential subjects.

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  Plan

  • A well thought out plan is a must if you hope to meet your 

    a pre-enrollment activity used to find potential subjects.

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    goal. 
  • Set realistic

    a pre-enrollment activity used to find potential subjects.

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    targets
  • Target the population - Where are you most likely to find these individuals?
  • Reduce barriers to

    a pre-enrollment activity used to find potential subjects.

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    in the study design
  • Consider factors that will affect the length of time it will take to recruit
  • Find-A-Study

  UT Health SA Find-a-Study is a service provided by the Office of

  the broad category of biomedical or health outcome research designed to assess pre-defined groups of individuals.

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  for connecting people interested in participating in a

  a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

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  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.  

  View your study information on Find-a-Study

  a pre-enrollment activity used to find potential subjects.

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  & Marketing for Clinical Trials

  You can contact the Marketing, Communications & Media division, for consultation to learn about the multiple tools and methods available. 

  ResearchMatch.org

  ResearchMatch is a free

  a pre-enrollment activity used to find potential subjects.

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  and feasibility analysis tool for researchers. Investigators with IRB-approved studies can use the ResearchMatch system to find potential participants who meet their

  the process of seeking eligible participants and obtaining their consent to participate in the research. Enrollment generally starts with recruitment, leading to screening for eligibility, and consent to enroll in the study.

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  needs in terms of health conditions and locations from a pool of individuals who have previously signed up with ResearchMatch.org. 

  Learn more about ResearchMatch.org

  UT Health San Antonio 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 https://www.youtube.com/user/EMPACTconsortium/featured may also be of interest to researchers seeking to encourage minority

  the process of seeking eligible participants and obtaining their consent to participate in the research. Enrollment generally starts with recruitment, leading to screening for eligibility, and consent to enroll in the study.

  read more

  in their studies.

  Vanderbilt University's free-to-audit course on Coursera titled “Faster Together, Enhancing the

  a pre-enrollment activity used to find potential subjects.

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  of Minorities in Clinical Trials.” https://www.coursera.org/learn/recruitment-minorities-clinical-trials.

   

  (EMR) - digital version of a medical chart that contains all of a patient’s medical history from one provider or facility.

  read more

  (EMR) Data Warehouse - The Clinical Informatics

  a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

  read more

  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 UT Health Physicians and University Health Systems EMRs is a very useful tool in determining study feasibility.

  Learn more about the Clinical Informatics Research Division
• Protocol Development - Protections for Vulnerable Populations

  Federal Regulations provide for additional protections for specific populations who may be particularly vulnerable to

  occurs when an overt threat of harm is intentionally presented by one person in order to obtain compliance from another. To be coercive, a subject who refuses must be made worse off than if he or she would have been, if never asked even if the harm is only perceived.

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  or

  the offer of inducements excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance.

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  as

  a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

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  participants. These protected populations include

  any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial or sentencing.

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  ,

  a person who has not attained the legal age of majority under the applicable law of the jurisdiction in which the research will be conducted (18 years in the state of Texas), and therefore as a general rule cannot consent to treatment or procedures involved in research.

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  , and individuals with

  diminished autonomy is present when an individual has either impaired decision-making ability or is subject to undue influence or control by others.

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  , as well as pregnant women,

  a developing human organism from the time of implantation until delivery; generally, refers to later phases of development.

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  , and

  are newborns who are 30 days old or younger.

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  . 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.
• Multi-Center Trial Development - Trial Innovation Network

  Trial Innovation Network (TIN)

  UT Health San Antonio 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

  a pre-enrollment activity used to find potential subjects.

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  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

  a pre-enrollment activity used to find potential subjects.

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  and retention. Some consultations developed into clinical protocols may be implemented in the Network and within the CTSA Program.

  Learn more about the Trial Innovation Network

  Learn more about the Trial Innovation Centers (TICs)

  Learn more about the Recruitment Innovation Center (RIC)

  Learn more about how to submit a proposal