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Research

Research Overview

Research is an integral part of Vail Health's mission to elevate health across our mountain communities. Our goal is to offer specialized care supported by comprehensive research and education. Many of our physicians and staff have pursued in-depth research and written articles that have been published in the world's top medical journals. Howard Head Sports Medicine develops extensive therapy protocols for rehabilitation, setting new standards for research and innovation in the physical therapy field worldwide. Shaw Cancer Center has opportunities for patients to participate in clinical trials which allow patients access to new methods of treating cancer. In addition, the research and experience of our partners at the Steadman Philippon Research Institute have led to significant advances in the fields of orthopaedics and sports medicine.

New Name: Vail Health HRPP
Previously known as the Vail Health Institutional Review Board (IRB), while this was correct at the time our program has grown greatly over the past few years. Our program has expanded to include both conflict of interest and quality. With the addition of these two components, we fit the model of a Human Research Protections Program (HRPP). Our new department name is Vail Health HRPP. This includes our IRB, research conflict of interest and quality programs.  

AAHRPP Accreditation

AAHRPP Accreditation
The Vail Health IRB protects the rights, safety, and welfare of human subjects through the initial review, approval, and continuing oversight of human subjects research that is conducted by or under the auspices of Vail Health.  Specifically, the IRB ensures that research involving human participants is conducted following the ethical principles outlined in the Belmont Report (written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research), as well as the regulations set forth by the Department of Health and Human Services and the Food and Drug Administration. The Vail Health IRB Committee meets monthly to review research protocols involving human subjects and evaluates both the risks to and protection of those subjects. 

AAHRPP promotes high-quality, ethically sound research through an accreditation process that helps organizations worldwide strengthen their human research protection programs (HRPPs). An independent, non-profit accrediting body, AAHRPP uses a voluntary, peer-driven, educational model to ensure that HRPPs meet rigorous standards for quality and protection. To earn accreditation, organizations must provide tangible evidence-through policies, procedures, and practices—of their commitment to scientifically and ethically sound research and to continuous improvement. As the "gold seal," AAHRPP accreditation offers assurances—to research participants, researchers, sponsors, government regulators, and the general public—that an HRPP is focused first and foremost on excellence.

HRPP Programs

Research Conflict of Interest (RCOI) Program

Public Health Service regulations and AAHRPP standards require that the HRPP has and follows written policies and procedures to ensure that the design, conduct and reporting of research is free from bias resulting from an investigator’s conflicts of interest.

The RCOI Office and Committee ensures research overseen by the Vail Health IRB upholds the highest ethical standards, objectivity, and integrity while continuing to support VH initiatives of high-quality research and protection of human subjects by reviewing annual research conflict of interest disclosures in relation to all proposed and active research studies; and creating management plans for potential or apparent conflicts as applicable.

The RCOI Committee meets the second Monday, of every other month, to review proposed management plans that have been drafted in response to IRB study submissions.

RCOI Meeting Dates
  • November 13, 2023
  • January 8, 2024
  • March 11, 2024
  • May 13, 2024
  • July 8, 2024
  • September 9, 2024
For any RCOI program questions please email researchconflictofinterest@vailhealth.org.
 

Research Quality Program

To help strengthen our HRPP program, we implemented quality audits as of July 1, 2022. This will aide in the post approval monitoring of research projects and their compliance with VH IRB Polices, federal, state, and local regulations along with AAHRPP standards of human subjects in research. All studies that have been reviewed and approved by VH IRB are eligible for quality audits.

Type of Audits:

  • For Cause: continue to be determined by the IRB Board

  • Random: quarterly audit done according to the HRPP Audit Reviews and Risk Stratification Model

  • QA: quarterly internal IRB audit of meeting minutes, determination letters, and approved expedited and exempt protocols

Our quality program also provides educational outreach to our researchers and IRB members through various modalities as well. 
For any research quality program questions please email hrpp.quality@vailhealth.org.

Participant Information

Research Participant Resources

  • Research Participation Brochure: English | Spanish
  • Office for Human Research Protections (OHRP) Videos: The Department of Health and Human Services (DHHS) videos provide basic information on research participation.
  • NIH.GOV contains many useful resources, including information on clinical trials taking place in the United States, and all over the world.
  • CISCRP (Center for Information and Study on Clinical Research Participation) is a non-profit organization to inform stakeholders about clinical research and the role of each stakeholder.
  • CenterWatch provides information on clinical trials for research participants and professional researchers.
  • ClinicalTrials.GOV is a searchable database of active research studies.
 

Research Complaints or Concerns

If you have a general question, concern, or complaint, you should first contact the research team, and specifically, the principal investigator whose name and phone number is listed on the consent form. However, if you have a complaint or concern that you feel should be reported and investigated, please contact:

Vail Health Institutional Review Board (IRB) Office
(970) 479-5137 | irboffice@vailhealth.org

Clinical Trials

Shaw Cancer Center has opportunities for patients to participate in clinical trials which allow patients access to new methods of treating cancer. 

Investigator Resources

Submission Information

  1. Investigator Manual (.pdf)
  2. Consent Templates
  3. Study Resources: Available on the dashboard in IRB Manager.
  4. Link to IRB Manager
  5. Full Board Meeting Dates:
    • July 18, 2024
    • August 8, 2024
    • September 12, 2024
    • October 10, 2024
    • November 14, 2024
    • December 12, 2024
  6. Vail Health HRPP Policy and Procedures
  7. Research Conflicts of Interest Policy FAQ
  8. Training Videos
  9. FDA Investigator-Initiated Readiness for Study Touch-base (FIIRST) Program
  10. Schedule VH HRPP Office Hours
VH IRB participates in the SMARTIRB.

Announcements

HRPP Contacts

HRPP Staff & Contact Information: