About the HealthEast Institutional Review Board (IRB)

Community hospitals and clinics provide unique opportunities for research, utilizing a patient population different from more academic settings. However, just as in an academic setting, protection of the rights and safety of research subjects is critical.

The HealthEast Institutional Review Board (IRB) reviews proposed research activities, ensuring that the rights and welfare of research participants are protected. Board members are volunteers from the East Metro community and HealthEast employees. Meetings are held the third Monday of every month.

The IRB has the authority to approve, require modifications in, or disapprove research activities involving human subjects. All proposed research using HealthEast facilities, patients or staff is subject to review prior to implementation.

Before submitting an IRB application, the investigator must:

• Obtain HealthEast Research and Education department approval
• Obtain approval from the relevant HealthEast site administrator(s)
• Develop a budget, ensuring any needed funding
• Complete human subjects research education

Recently approved IRB studies

• Effectiveness of a Tibetan Medicine Intervention in a Mind-Body Skills Group: This is a prospective pilot study designed to test the effectiveness of a Tibetan medicine lifestyle intervention in a Mind-Body Skills Group.
  Bernadette Clevenger, MD

• Select ACS: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of 2 Doses of RO4905417 (R1512) Administered to Patients with Non ST-Elevation Myocardial Infarction (Non-STEMI) Undergoing Percutaneous Coronary Intervention (PCI): This is a phase IIa multicenter, randomized, double-blind, placebo-controlled study comparing two doses of RO4905417, a human recombinant monoclonal antibody, versus a matching placebo.
  Carmelo Panetta, MD

• Double-Blinded, Placebo-Controlled, Prospective Study on Patient Satisfaction and Functional Outcomes Following the Use of the OrthoCor Knee Brace: A prospective, double-blind, randomized, comparative clinical investigation designed to determine the effects of the OrthoCor Active Knee System on patient pain, satisfaction and short-term functional outcomes when used for a period of 12 weeks.
  Primary investigator: Daniel Hoeffel, MD

• Study of ICP Monitoring in Critically Ill: A prospective, multi-center observational study designed to describe intensive care nursing practice for intracranial pressure management (ICP) among critically ill patients at risk for intracranial hypertension.
  Primary investigator: Tess Sierzant, MS, RN

• Effect of Aerobic Exercise on Cognition following Traumatic Brain Injury: A prospective interventional study designed to examine the effect of cardiorespiratory fitness on working memory and executive function following traumatic brain injury.
  Primary investigator: Jeanne Lojovich, PT, NCS

• Caregiver Burden in Alzheimer's Disease, Lewy Body Dementia and Frontal Lobe Dementia: A prospective research study designed to better understand the effects of caregiver burden as they relate to different dementia diagnoses and stages of the disease in order to identify appropriate supports and interventions.
  Primary investigator: Jeanette Foizie