Submitting to the IRB

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.