The Human Study Lifecycle

Finding Funding Opportunities

Selected Sources of Local Information

Single Institutional Review BoardInstitutional Review Boarda federally mandated, institution-designated regulatory body empowered to oversee Human Subjects Research.   ( sIRBsIRBSingle 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.    ) for Multi-Site ResearchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.  

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-exempt human subjects researchNon-Exempt Human Subjects Researchresearch that meets the regulatory definition of human subjects research that does not qualify for exemption. Includes clinical trials, non-clinical trial research and research data or specimen repositories.   . 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 research.

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 Institutional Review Board (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 (sIRB). 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 IRB of recordIRB of Recorddenotes the IRB responsible for approval of a specific research study at a given institution.   . 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 OCRmail@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 intervention, evaluation, and health policy expertise.

Learn more about the services of the Department of Population Health Sciences.

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.

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.

The VPR CTO provides assistance to local investigators developing a clinical trialClinical Trialone 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.   protocolProtocolstep-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.  .

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.

Electronic Medical Record (EMR) Data Warehouse - The Clinical Informatics Research 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 Research 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 research that may improve health.

All of Us - Opportunities for Researchers

There are free, self-service data platforms for UTHSA investigators to conduct preparatory to researchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.   query building, project feasibility and cohort exploration.

Electronic Medical RecordElectronic Medical Record(EMR) - digital version of a medical chart that contains all of a patient’s medical history from one provider or facility.   (EMR) Data Warehouse - The Clinical Informatics Research 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 PhysiciansUT Health Physiciansis the clinical practice of the Long School of Medicine of UT Health San Antonio   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

RecruitmentRecruitmenta pre-enrollment activity used to find potential subjects.   Plan

• A well thought out plan is a must if you hope to meet your recruitment goal. 
• Set realistic recruitment targets
• Target the population - Where are you most likely to find these individuals?
• Reduce barriers to recruitment 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 Clinical ResearchClinical Researchthe broad category of biomedical or health outcome research designed to assess pre-defined groups of individuals.  for connecting people interested in participating in a research study to investigators with research studies open enrollmentEnrollmentthe 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.   .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

Recruitment & 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 recruitment and feasibility analysis tool for researchers. Investigators with IRB-approved studies can use the ResearchMatch system to find potential participants who meet their enrollment 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 schulz@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 enrollment in their studies.

Vanderbilt University's free-to-audit course on Coursera titled “Faster Together, Enhancing the Recruitment of Minorities in Clinical Trials.” https://www.coursera.org/learn/recruitment-minorities-clinical-trials.

Electronic Medical RecordElectronic Medical Record(EMR) - digital version of a medical chart that contains all of a patient’s medical history from one provider or facility.   (EMR) Data Warehouse - The Clinical Informatics Research 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 PhysiciansUT Health Physiciansis the clinical practice of the Long School of Medicine of UT Health San Antonio   and University Health Systems EMRs is a very useful tool in determining study feasibility.

Learn more about the Clinical Informatics Research Division

Federal Regulations provide for additional protections for specific populations who may be particularly vulnerable to coercionCoercionoccurs 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.   or undue influenceUndue Influencethe offer of inducements excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance.   as researchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.   participants. These protected populations include prisonerPrisonerany 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.   , childrenChildrena 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.   , and individuals with impaired decision making abilityImpaired Decision Making Abilitydiminished autonomy is present when an individual has either impaired decision-making ability or is subject to undue influence or control by others.   , as well as pregnant women, fetusFetusa developing human organism from the time of implantation until delivery; generally, refers to later phases of development.  , and neonateNeonateare newborns who are 30 days old or younger.   . 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)

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 Recruitment 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 recruitment 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