NIH Definition of Human Subjects Research: According to 45 CFR 46, a human subject is "a living individual about whom an investigator (whether professional or student) conducting research:

• Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
• Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Decision Tool: Am I Doing Human Subjects Research?

Yes. 

The primary goal of the SW CACTI Pilot Program is to generate preliminary data that leads to competitive extramural funding. 

Awardees are expected to submit an extramural funding application following completion of their pilot project and to report grant submissions and funding outcomes to the SW CACTI Pilot Program. 

Investigators who have previously received two SW CACTI Pilot Awards must demonstrate that they have received a score on an extramural grant submission before they will be considered for another SW CACTI Pilot Award. 

No. 

SW CACTI Pilot Awards are issued for a defined project period. Funds must be expended within the approved award period. Unspent funds are generally not eligible for carryover unless specifically approved by the SW CACTI leadership and NIH, when applicable. 

Investigators should work closely with their departmental financial administrator to monitor expenditures throughout the award period. 

Please refer to the Publications & Grant Acknowledgement page for the current required funding language, grant numbers, Public Access requirements, and instructions for linking publications in NCBI My Bibliography. 

All studies meeting the NIH definition of a Clinical Trial must be registered on ClinicalTrials.gov and have an NCT number assigned to the study. Investigators should make sure the consent has the required language for Clinical Trial registration as it appears in the HRPO consent template. Investigators should register their protocol on CT.gov after receiving IRB approval. Registration is an NIH requirement prior to enrollment of the first participant. For UNM Investigators contact the UNM CT.gov administrator, Hadya Khawaja.

SW CACTI pilot submissions do not require a Funding Proposal to be submitted with the UNM Health Sciences Sponsored Projects Office (SPO).

If your project involves animal or human subjects, Prior Approval from IRB/IACUC is required before the project can begin. IRB/IACUC approval letter, proof of required training for key personnel and any other required documentation are needed before Approval can be submitted. NIH Prior Approval can take up to ten weeks to obtain; this should be considered when developing study timelines to avoid delays.

Applications without IRB submission prior to the current deadline will be administratively disqualified. Submission by the deadline provides HRPO IRB with efficient time to review all submissions prior to the SW CACTI's full application deadline. Projects that do not have IRB determination by SW CACTI’s full application deadline will not be considered for funding. All pilot submissions will be required to submit with their SW CACTI application one of the below IRB letters:

• IRB Letter with Determination of Non-Human Subjects Research
• IRB Letter with Approval of Exemption #1-9 Human Subjects Research
• IRB Letter with Approval of No More Than Minimal Risk Human Subjects Research
• IRB Letter with Approval of Greater than Minimal Risk Human Subjects Research

The following applies to each project:

• Each pilot submission must have its own standalone IRB protocol.
• Amendments or a sub-study/ancillary study to an existing IRB-approved parent protocol are not allowed.
• Pilot application title must match IRB protocol title and be reflected on the approval letter.
• Principal Investigator of the pilot application must match the Principal Investigator on the IRB protocol and be reflected on the approval letter.
• IRB modifications to the approved pilot protocol are not permitted after NIH approval. Every effort should be made to execute the protocol as approved by the IRB, Pilot Review Committee, and NIH.

UNM ONLY
When submitting your UNM HRPO IRB Smart forms:
Study Funding Sources

1. Has this project been submitted to the UNM Health Sciences Sponsored Projects office (SPO)?
   Mark *no* - CTSC funded pilots do not have a SPO Funding Proposal
2. Is this project a clinical Trial?
   Indicate Yes or No
3. Identify each organization supplying funding
   672I CTSC Pilots Department Division/Level 6 672A
      - No funding ID
      - No Grants office ID
      - No attachments

CTSC Submission

1. Is this a Clinical and Translational Science Center (CTSC) Pilot Project?
   Mark Yes
2. When is the IRB Submission deadline?
   Found in the current RFA
3. When is the IRB Approval Deadline for NIH review?
   Found in the current RFA

• Documents can only be uploaded as PDF documents. Applications should adhere to the following formatting specifications:   
• 11‐point Arial font   
• Single‐spaced   
• 0.5 inch margins on all sides   
• 8 1⁄2″ x 11″ (i.e. standard size) paper   
• Pages numbered   
• File Name Format: Institution_PI_ProjectTitle_DocumentTitle_Date 

The online platform REDCap will be utilized to submit applications. Please click here: 

• Individual: SW CACTI Individual Pilot Pre-Proposal 

• Collaborative: SW CACTI Collaborative Pilot Pre-Proposal 

• The lead institution will oversee IRB submission. 
• Each pilot submission must have its own standalone IRB protocol. 
• Amendments or a sub-study/ancillary study to an existing IRB-approved parent protocol are not allowed. 
• Pilot application title must match IRB protocol title and be reflected on the approval letter. 
• Principal Investigator of the pilot application must match the Principal Investigator on the IRB protocol and be reflected on the approval letter. 
• IRB modifications to the approved pilot protocol are not permitted after NIH approval. Every effort should be made to execute the protocol as approved by the IRB, Pilot Review Committee, and NIH.

Investigators are responsible for submitting any peer-reviewed journal articles resulting from research funded by this award to PubMed Central (PMCID), the NIH digital archive of biomedical and life sciences journal literature. This will generate not only a PubMed number (PMID) but a PMCID number, as well. See NOT-OD-12-160.html.

All publications, grants, and presentations resulting from research funded by the SW CACTI or using SW CACTI resources should cite the SW CACIT as a contributing source of support and indicate the SW CACTI’s citation as follows:

"This project is supported by the Southwest Center for Advancing Clinical & Translational Innovation (SW CACTI), funded by the National Center for Advancing Translational Sciences, National Institutes of Health, award number UM1TR005466"

Supporting Documentation
Guide to PMID-PMCID Numbers.pdf
Author Submission PMCID.pdf
PubMed How To.pdf

To serve as a Principal Investigator (PI) on a SW CACTI Pilot you must have a primary appointment as a UNM HSC/UA faculty member who is:

• junior or senior investigator
• Appointment is 0.50 FTE or greater
• Tenure track or non-tenure track
• Researcher, clinical educator or lecturer

Examples of positions not generally eligible to serve as PI:

• Primary appointment is under UNM Main or Veterans Association
• Adjunct faculty
• Visiting faculty
• Volunteer faculty
• Postdoctoral fellows
• Staff, students, and other positions without a letter of academic title

If I have been previously funded by the SW CACTI Pilot Program, am I eligible to be funded again with a different project? 

Applicants are eligible for no more than a total of two SW CACTI pilot awards, after which they need to demonstrate that they have received a score for an extramural grant submission before they will be considered for another SW CACTI pilot award. 

Projects with a Translational Science focus are encouraged and will be scored favorably during the internal review process effective June 2023.

Open Access Article: Opportunities and Challenges in Translational Science
NCATS: Translational Science Principles
SW CACTI: Translational Science Panel 2023

NCATS Definitions:

• Translation: The process of turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and communities – from diagnostics, preventions, and treatments to medical procedures and behavioral changes.
• Translational Research: The endeavor to traverse a particular step of the translational process for a particular target or disease.
• Translational Science: The field of investigation focused on advancing the scientific and operational principles underlying each step of the translational process.

Purely non-human animal research does not qualify as translational research for funding under this program. If choosing to submit a proposal with vertebrate animal research, there must also be a human component.

The NIH defines a clinical trial as: 

"A research study in which one or more human 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." 

Clinical Trials are NOT supported under the SW CACTI Pilot Program. 

Investigators are encouraged to review the NIH Clinical Trial Decision Tool if they are unsure whether their project meets the NIH definition of a clinical trial. 

Basic Experimental Studies with Humans (BESH) involve prospective studies with human participants designed to understand fundamental aspects of human biology or behavior without evaluating the effectiveness of a clinical intervention. 

Projects meeting NIH BESH criteria may be allowable under certain NIH funding mechanisms. 

Applicants whose studies involve human participants should carefully review the NIH BESH guidance to determine whether their proposed research meets these criteria. 

(Link to NIH BESH guidance.) 

Pilot award recipients are expected to disseminate the results of their research through scholarly publications, presentations, and other appropriate scientific products. 

All publications resulting from SW CACTI Pilot funding must: 

• Acknowledge the appropriate SW CACTI grant support.  
• Comply with current NIH Public Access Policy requirements.  
• Be linked to the appropriate NIH award in NCBI My Bibliography, when applicable.  
• Be reported to the SW CACTI Pilot Program as part of ongoing award tracking and annual reporting. 

Award recipients are expected to: 

• Complete all required regulatory approvals before beginning the project.  
• Submit required progress reports and milestone updates.  
• Meet with assigned program staff as requested.  
• Submit an extramural funding application.  
• Report publications, presentations, and other scholarly products resulting from the award.  
• Acknowledge SW CACTI funding in all applicable publications and presentations.  
• Comply with all NIH and institutional policies throughout the award period.