Application Process
Premier Health uses external Institutional Review Boards (IRBs) for the review and approval of all new applications for clinical trials. Investigators must fill out the appropriate forms and submit the documentation to one of the Premier Health-designated IRBs to secure approval before conducting any research at Premier Health.
For clinical trials sponsored by the Premier Health research community, the Wright State University (WSU) IRB will be used. The Western Institutional Review Board (WIRB) is approved by Premier Health and the Clinical Trials Research Alliance (CTRA) for review of industry-sponsored clinical trials.
Please do not send petitions for new studies directly to the external IRB. All submission materials for new research proposals in which Premier Health is engaged (Premier Health employees, Premier Health facilities, Premier Health students, Premier Health patients, Premier Health Health Information, etc.) are to be directed through the Premier Health Clinical Research Center.
Contact the Premier Health Clinical Research Center (contact information below) if you have any questions or need assistance.
Obtain the forms required to submit an application to the WSU IRB from WSU IRB.
Premier Health Clinical Research Center Intranet Website
The Premier Health Clinical Research Center, accessible only from the Premier Health network, maintains an intranet website. The forms and information needed by the investigator for submission of protocols in which Premier Health is engaged are available on this website.
Protecting Confidentiality of Electronically Stored Data
Premier Health requires that data be stored on a Premier Health file server that provides regular backup and security. Data must NOT be stored on the local C: drive of computers, or any other form of removable media. All data with Protected Health Information (PHI) should be stored in a password-protected file whether it is in Word, Excel, Access or some other database. Premier Health IT customer support can assist investigators with arranging for data storage on a Premier Health file server. The Clinical Research Center at Premier Health has computer workstations that meet these requirements, as well as statistical programs to assist with data analysis.
Electronic Medical Record (EMR) Access
Premier Health uses the EPIC “inbasket” process to provide EMR access to researchers doing retrospective chart review. This process permits the researcher access to only those patient records specified in the research protocol. Contact the Clinical Research Center at Premier Health for assistance with setting up an “inbasket” account for a retrospective study.
Premier Health Human Institutions Investigation and Research Committee (HIRC)
The HIRC, which is site-specific to the research, reviews research proposals for hospital-specific issues. These issues may include:
- Use of the same patient population for more than one study
- Timing of surveys relative to other activities
- Sufficient support capability, including funding, for studies
- Research oversight and administration.
Both HIRC and IRB approval are required before a study may be conducted at Premier Health.
Location and Contact Information
Premier Health Clinical Research Center
Weber Center for Health Education, 6th Floor
One Wyoming St.
Dayton, OH 45409
Phone: (937) 208-2238(937) 208-2238
Fax: (937) 208-5075(937) 208-5075