Teleflex Supports Independent Investigator Initiated Studies

An investigator-initiated study is a Teleflex supported study initiated, developed, designed, and managed by a qualified third-party investigator who assumes sole responsibility for the conduct and management of the research.Through our Investigator Initiated Studies (IIS) Research Grants Program, Teleflex is committed to empowering the future of healthcare by fostering the advancement of scientific knowledge, improved patient outcomes, and the quality of healthcare through original, diverse, independent investigator-initiated proposals. We invite you to submit your proposal for support.


Eligibility

Who is eligible?

An investigator is responsible for conducting the study in accordance with the protocol (developed by the investigator), applicable institution policies, generally accepted standards of GCP/GLP, and all applicable laws and regulations governing the performance of the study. Submissions must be in English.”

Investigator must:
  • Be qualified by training and experience (including appropriate licensure as needed) to lead the proposed research from clinics, hospitals, academic centers, universities, community practice or networks, professional associations, and learned societies.
  • Not be excluded, debarred, suspended, or otherwise ineligible to participate in health-care programs
  • Not be an employee of Teleflex
  • Be the originator of the research idea and author the concept/protocol

Areas of Research Interest

Research Topics
Vascular Access Effectiveness of Arrowg+ard technologies
Observational studies for PICC, CICC, and midline
Cost effectiveness of Arrowg+ard technologies
Comparative studies for AGBA vs. other technologies
Performance and clinical application of EZIO
Novel studies with DLX and VPS navigation systems
Cardiovascular Coronary Vascular Interventions
Complex coronary heart disease, including chronic total occlusions
Vascular access management in aortic interventions (EVAR/TEVAR/Aortic rupture)
Genitourinary UroLift® studies in challenging anatomical presentations (e.g., large prostate volume, elevated bladder neck)
UroLift® combined with focal prostate cancer therapies
Optimization of implant density and software-guided procedural planning
Novel uses of rectal spacers during cancer treatment by ablative technologies
Novel applications of injectable bulking agents
Hematology/Oncology Safety and effectiveness of QuikClot Control+ (QCC+) in internal and external bleeding scenarios
Clinical utility of the Arrow® OnControl® powered system for bone and bone marrow biopsy procedures
Comparative clinical or economic effectiveness of QCC+ versus standard of care and alternative hemostatic agents
Respiratory Use of supraglottic airway devices in airway management
Bariatric Surgery Patient outcomes following Laparoscopic or Robotic Sleeve Gastrectomy procedures performed using the Titan SGS Stapler, immediate and greater than one-year post index procedure.
Novel techniques for Laparoscopic or Robotic Sleeve Gastrectomy procedures using Titan SGS Stapler.
Health economics evaluation related to use of Titan SGS Stapler for Laparoscopic or Robotic Sleeve Gastrectomy procedures (length of hospital stay, direct cost, readmissions).
Comparison of the Hem-o-Lok PurplePlus large ligation clip vs. metal medium-large ligation clips, both delivered through 5mm ports
General and Urological Surgery Evaluation of Hem-o-Lok PurplePlus large ligation clip used in minimally invasive surgical procedures, including short-term and long-term outcomes.
Novel uses of Hem-o-lok medium-large ligation clip delivered by Auto Endo 5 Automatic Clip Applier or Hem-o-Lok PurplePlus large ligation clip delivered by manual appliers.
Evaluations of the immediate and 1 year plus outcomes of Weck EFX Shield fascial closure device for minimally invasive surgical port closures of 10mm to 19mm.
ENT Surgery Value of Vitality Scopes in laryngeal procedures.

Submission and Approval Process

IIS Research Grant Submission



  • Complete application
  • Signed and dated CV
  • Research proposal/protocol
  • Requested Support (detailed budget for funding)
  • Planned deliverables, timeline, and defined milestones
  • Measures to be taken to confirm compliance with all applicable laws and regulations

Grant Panel Review and Determination



  • Submissions received by the end of the quarter are reviewed by the end of the following month
  • Applicant will be notified via email of the grant review status (approved/declined)

Documentation and Research Agreement



  • Approved protocol
  • Institution W9
  • IRB/EC/IACUC/Regulatory Approval Documentation
  • PI training GCP/Animal Care and Use training
  • Registration on clinical trial database (if applicable)
  • Initiation of research agreement between Teleflex and Affiliated Institution

Contract Execution and Release of Grant Award



  • Fully executed research agreement
  • Grant distribution initiated per research agreement terms

Approved Grant Uses

Can be used for Cannot be used for
Funding for legitimate, documented, study-related expenses Defray a recipient's ordinary operating expenses outside of the research (i.e., expenses for activities that the recipient is already required to perform or customarily performs)
Provision of Teleflex products, in reasonable quantities limited to the duration of the research Support research that has already occurred
Provision of product data, feedback, or technical information Directly or indirectly, or explicitly or implicitly, influence or encourage the recipient to use, purchase, recommend, sell, arrange for, or recommend the use, purchase, or sale of any Teleflex product or as a reward for any such past behavior
Technical or case support based on Teleflex's capabilities and expertise Support consulting or other services to Teleflex
Assistance in data collection Support poster or abstract presentations at Third Party Educational Conferences unless:
  • Detailed costs are in writing in the existing Research Agreement, meeting the following requirements:
  • Selection of the presenter is done independently, and
  • Teleflex is not involved in the selection process
  • Consulting on collection and interpretation of data from Teleflex
    *An IIS grant will not be provided or offered as an inducement or reward for using, ordering, or recommending Teleflex products.
    • Completed Grant Application (download starter packet)
    • Research proposal that includes the objective(s), design, methodology, inclusion and exclusion criteria, recruitment plan, diversity plan, adverse event reporting, and safety plan.*
    • Current signed and dated curriculum vitae (CV) of the investigator*
    • Current medical license
    • W-9 for the institution(s) with which the research is affiliated, including name, address, and federal tax identification number for US based studies; If a study is conducted outside the United States, but funded through a U.S. based Teleflex entity complete form W-8BEN
    • Documentation of training (e.g., GCP training for human research; ACU training for pre-clinical research)
    • Full research protocol approved by the IRB/Ethic's Committee/IACUC
    • Review board approval: Institutional Review Board/Ethics Committee / Institutional Animal Care and Use Committee
    • Requested support, including the type and amount of product and/or a detailed budget*
    • Planned deliverables, timeline, and defined milestones*
    • Measures to be taken to confirm compliance with all applicable laws and regulations*
    * Required at submission
    • Adherence to deliverables and milestones of the research activities including:
      • Monthly Status updates
      • Enrollment timeline
      • End of study report or Manuscript
      • Journal and Conference submissions (if applicable)
    • Clinical studies will be conducted in adherence to Good Clinical Practice (GCP)
    • The investigator will be solely responsible for all aspects of the research activities
    • The recipient must provide specific evidence that the research grant was used as intended, if requested
    • Authorization for Teleflex to audit the expenditure of research grant funds
    • Return of any unused product and/or funds
    • Acknowledgment of Teleflex's right to advance review of manuscripts, abstracts, and presentations before submission/dissemination
    • Acknowledgment of Teleflex's right to utilize the study data, in accordance with applicable laws and regulations
    • Fulfill all requirements to obtain review by and/or approval from applicable geographical regulatory bodies and the supporting documentation
    • Compliance with all applicable laws and regulations, including the disclosure of Teleflex's support for the research activities
    • Compliance with the requirement to register the research on the applicable geographical clinical trial database(s)
    * Where local law is stricter or conflicts with this Global Research Grants policy, local law takes priority. If a deviation from this policy is required, Legal and Compliance must first be consulted.

    Grant Submissions Review Schedule

    Submissions must be submitted by:

    • March 28
    • June 27
    • September 26
    • December 19

    To be reviewed at the subsequent Grant Panel meeting.


    The Teleflex Grant Panel meets quarterly during the months of:

    • January
    • April
    • July
    • October

    The Grant Recipient must provide the following

    Study Execution:

    • Monthly status reports regarding enrollment and study progress
    • Milestone reports before next tranche of product/funds will be released
    • Continuing review approvals
    • Updated investigator documents

    Study Completion:

    • Milestone reports
    • Reconciliation of product grant distributions and return of all unused product
    • Review board acknowledgement of study closure report
    • Documentation of completed obligations for applicable geographical clinical trial database

    Reporting and Dissemination of Results:

    • Study results report
    • Manuscript review by Teleflex
    • Manuscript journal submission
    • Abstract review by Teleflex
    • Abstract conference submission
    • Data transfer per agreement
    • Reconciliation of financial grant distributions and return of all unused funding

    Application Submission

    Choose ONE of the below options for submitting your application:

    1. Download the grant application starter packet (IIS Research Grant Application, Research Proposal Template, Budget template):

      Download

      Email completed documents to: IISResearchGrants@teleflex.com

    2. Submit your application via the online portal: