To serve as a Principal Investigator (PI) on a CTSC Pilot you must be a contract (paid) UNM faculty member who is:

• Primary appointment under UNM HSC (junior or senior)
• 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

Applications without HRPO 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 CTSC’s full application deadline. Projects that do not have HRPO IRB determination by CTSC’s full application deadline will not be considered for funding. All pilot submissions will be required to submit with their CTSC application one of the below HRPO IRB letters:

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

When submitting your 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

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

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

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.

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?

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.

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. To have an account created, contact the UNM CT.gov administrator, Samiha Mateen.

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 CTSC or using CTSC resources should cite the CTSC as a contributing source of support and indicate the CTSC’s citation as follows:

“This project was supported by the National Center for Research Resources and the National Center for Advancing Translational Sciences for the National Institutes of Health through Grant Number UL1TR001449, The University of New Mexico Clinical and Translational Science Center."

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