Submitting to the IRB
Learn more about submitting an application to our IRB for approval to conduct human subject research in a HealthONE facility.
Investigators requesting permission to conduct human subject research involving a HCA-HealthONE facility must submit a application to the HCA-HealthONE IRB for approval. All new research applications, including Exempt Applications, must be submitted electronically to the HCA-HealthONE IRB through IRBNet.
IRBNet is an informatics tool that supports electronic, on-line submission of applications to the HCA-HealthONE IRB. No hard copies of protocols will be accepted.
Getting Started Checklist - For All Investigators
Requirements For All Investigators
Step 1: Contact Facility ECO at each HCA-HealthONE facility where your study will take place
The Ethics and Compliance Officer (ECO) at each HCA-HealthONE facility where your study will take place should be notified. If your study requires the services from a HCA-HealthONE facility, a Facility Services Agreement will be required. The ECO at each facility is your primary contact for making these arrangements. Please contact the appropriate Facility ECO.
Step 2: Gain Access to IRBNet
To obtain access to the electronic submission program IRBNet, all end-users must register with this program. To begin the registration process, go to: www.irbnet.org and click the New User Registration Link. You will be required to fill out basic information (first and last name, and choose a username and password.
All IRBNet users must also agree to the Individual Terms of Use in order to register on the system. Click “Accept” to accept the terms of use and continue. Next, you will need to Select Your Organization. Search to find HCA-HealthONE, your local institution.
As the final step, fill in your contact information. Be sure to use a valid e-mail address. You will need to be able to receive e-mails from IRBNet in order to activate your account.
If you don’t register in IRBNet you won’t have access to your current studies or have the ability to submit any future document to your on-going studies or new submissions.
If you submit IRB documents or on behalf of an investigator, you must register with IRBNet. The Principal Investigator, any co-or sub-investigators, and other research staff personnel involved with the study must also register.
Step 3: IRB Fee Payment
Effective July 1, 2014, the HCA-HealthONE IRB review fee schedule is changing. As part of this change, the HCA-HealthONE IRB will no longer grant fee waivers for the review of a research project regardless of the availability of funding or funding source. An IRB Review Fee Authorization Form must be electronically signed by the Principal Investigator and submitted as part of the IRB submission package.
To access this form you must be registered in IRBNet. This form is located in IRBNet under the Designer tab in the Project Administration menu. This form identifies the responsible party for payment of the IRB review fee. Please refer to the IRB Review Fee Schedule for additional information.
Step 4: Investigator’s Agreement
As a new investigator of a federally-funded project, an Individual Investigator’s Agreement (IIA) Form must be signed by the Principal Investigator and by each of the Sub-PI’s listed on the protocol application. The IIA form is located in IRBNet under the Forms and Templates section.
Step 5: Financial and Other Conflicts of Interests
A Financial and Other Conflicts of Interests Form must be completed and signed by the Principal Investigator and by all Sub-PIs and study personnel listed on each new protocol application. To access this form you must be registered in IRBNet. This form is located in IRBNet under the Forms and Templates section.
Step 6: Mandatory Education Requirement
Mandatory Education Requirement -The Principal Investigator and all personnel (co-PI, sub-PI, study coordinators, etc.) that will intervene or interact with research subjects must complete a valid, within three years, an IRB- approved Human Subject Protections Certification program.
Step 7: Electronic Submission Forms
The completion of an IRBNet electronic application package and all of the relevant documents/ attachments for the research study must be submitted electronically for IRB review and approval No IRB submission documents will be processed that are sent directly to IRB staff e-mails or faxed to the IRB office.
Having problems?
If, at any time, you have questions or problems about how to complete a form or submit electronically, please contact the IRB Administrative Office at (303) 584-2300 for assistance.
As a New Investigator
To submit to the HCA-HealthONE IRB for the first time, the process begins with the following:
Step 1: Contact Facility ECO at each HCA-HealthONE facility where your study will take place
The Ethics and Compliance Officer (ECO) at each HCA-HealthONE facility where your study will take place should be notified. If your study requires the services from a HCA-HealthONE facility, a Facility Services Agreement will be required. The ECO at each facility is your primary contact for making these arrangements. Please contact the appropriate Facility ECO.
Step 2: Gain Access to IRBNet
Obtain access to the electronic submission program, IRBNet, all end-users must register with this program. To begin the registration process, go to: www.irbnet.org and click the New User Registration Link. You will be required to fill out basic information (first and last name, and choose a username and password. All IRBNet users must also agree to the Individual Terms of Use in order to register on the system. Click “Accept” to accept the terms of use and continue.
Next, you will need to Select Your Organization. Search to find HCA-HealthONE, your local institution. As the final step, fill in your contact information. Be sure to sue a valid e-mail address. You will need to be able to receive e-mails from IRBNet in order to activate your account.
If you don’t register in IRBNet you won’t have access to your current studies or have the ability to submit any future document to your on-going studies or new submissions.
When IRB documents are submitted by the PI or on behalf of an investigator, all end users must be registered with IRBNet. The Principal Investigator must electronically sign all submissions before the IRB will conduct a review of the submission package.
Step 3: IRB Fee Payment
Effective July 1, 2014, the HCA-HealthONE IRB review fee schedule is changing. As part of this change, the HCA-HealthONE IRB will no longer grant fee waivers for the review of a research project regardless of the availability of funding or funding source. An IRB Review Fee Authorization Form must be electronically signed by the Principal Investigator and submitted as part of the IRB submission package.
To access this form you must be registered in IRBNet. This form is located in IRBNet in the Forms and Templates section. This form identifies the responsible party for payment of the IRB review fee. Please refer to the IRB Review Fee Schedule for additional information.
Step 4: Investigator’s Agreement
As a new investigator of a federally-funded project, an Individual Investigator’s Agreement (IIA) Form must be signed by the Principal Investigator and by each of the Sub-PI’s listed on the protocol application. The IIA form is located in IRBNet under the Forms and Templates section.
Step 5: Financial and Other Conflicts of Interests
A Financial and Other Conflicts of Interests Form must be completed and signed by the Principal Investigator and by all Sub-PIs and study personnel listed on each new protocol application. To access this form you must be registered in IRBNet. This form is located in IRBNet in the Forms and Templates section.
Step 6: Mandatory Education Requirement
Mandatory Education Requirement -The Principal Investigator and all personnel (co-PI, sub-PI, study coordinators, etc.) that will intervene or interact with research subjects must complete a valid, within three years, a Human Subject Protections Certification program.
Step 7: Electronic Submission Forms
The completion of an IRBNet electronic application package and all of the relevant documents/ attachments for the research study must be submitted electronically for IRB review and approval No IRB submission documents will be processed that are sent directly to IRB staff e-mails or faxed to the IRB office.
Having problems?
If, at any time, you have questions or problems about how to complete a form or submit electronically, please contact the IRB Administrative Office at (303) 584-2300 for assistance.
Obtaining Services from a Facility
For any human subject research study that may require the services from any of the HCA-HealthONE facilities a Facility Services Agreement will be required. The primary contact for making these arrangements is through the Ethics and Compliance Officer (ECO) assigned to each facility.
ECO’s are available to assist researchers in making arrangements for research-related services and drafting contractual agreements. It is strongly recommended to contact the appropriate ECO prior to obtaining final IRB approval in order to avoid delays in starting your project. The type of services involved may include one or all of the following:
- Inpatient/outpatient services
- Pharmacy
- Lab Services
- Radiology
- Nursing Services
- Other
Facility Ethics and Compliance Officer contact numbers
The Medical Center of Aurora
(303) 695-2834
Clinic Services
(303) 584-8221
North Suburban Medical Center
(303) 450-4510
Presbyterian/St. Luke’s Medical Center
(303) 839-6772
Rose Medical Center
(303) 320-2646
Sky Ridge Medical Center
(720) 225-1362
Spalding Rehabilitation Hospital
(303) 363-5605
Swedish Medical Center
(303) 788-5141
Obtaining Access to IRBNet
In order to submit any IRB application for HCA-HealthONE IRB review, all users must first register with IRBNet.
- New User Registration
To begin the registration process, go to: https://www.irbnet.org and click the New User Registration Link - Basic Account Information
Fill out your first and last name, and choose a username and password. - Individual Terms of Use
All IRBNet users must agree to the Individual Terms of Use in order to register on the system. Click “Accept” to accept the terms of use and continue. - Select Your Organization
Search to find HCA-HealthONE, your local institution. - Contact Information
Fill in your contact information. Besure to use a valid e-mail address, i.e. Outlook address. You will need to be able to receive e-mails from IRBNet in order to activate your account.
Connecting to and Using the Electronic Submission System
Once an end user has registered and activated their account with IRBNet, the next step in the process is the completion and submission of the IRB application package and attaching all of the relevant documents for the research study directly into the electronic submission program. End-users can utilize the IRBNet program from any computer with internet access.
- Access IRBNet at: http://irbnet.org
- Log into IRBNet using your username and password and click “Login”.
- You will be automatically directed to the Submission Manager page. This page will give you access to your current projects and allow you to submit new research projects.
For complete instructions and training resources on how to utilize the IRBNet program, please go to the following sites:
On-line Training Videos
Log into: http://irbnetresources.org
Researcher resources:
http://irbnetresources.org/tresources/training.html
Username: hca-healthone
Password: training1
After an IRB application is submitted into the IRBNet program, and before it is accepted, an IRB Administrative staff member will conduct a preliminary review of the application to make sure all of the required information has been provided and the necessary documents have been attached. If all the materials have been submitted, an IRB staff member will accept the submission into the electronic system for further IRB review.
If the submission is missing any of the required documents, the submission will be unlocked and the submitter will receive an e-mail indicating what is missing from the application. Accepting applications at this stage does not indicate IRB approval has been granted.