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Contact erahelp@colorado.edu for assistance. 

Contact erahelp@colorado.edu for assistance.

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You will complete human subjects training and download your completion certificate via the CITI website. Additional information about human subjects training requirement can be found here.

The DHHS provides the following definitions for both “human subjects” and “research.” The IRB must review all activities that meet both of these definitions.

Human subject means a living individual about whom an investigator (whether professional or student) is conducting research:

(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Undergraduate students cannot be Principal Investigators (PIs) on projects with human subject research. A CU ��«����Ƶ faculty member (who is eligible to be a PI) must be the PI on the project and students can be listed as Co-Investigators.

Graduate students can be Principal Investigators (PIs) on projects with human subject research, but they must have a CU ��«����Ƶ faculty member as a Faculty Advisor. All graduate students conducting human subject research at CU ��«����Ƶ must have a Faculty Advisor. Follow the instructions in the Faculty Advisor Review Form prior to submitting a protocol for review.

The IRB strongly discourages this. All research is different, and information included in previous research may not be necessary or the new research may require information that is not included in previous research. Using IRB templates and following the instructions provided ensures all necessary information in included. 

Review times vary depending on submission volume and research risk level. Exempt and non-exempt reviews generally take 10-15 business days. More than minimal risk research, which requires review at a convened IRB meeting, may take longer. 

Once you have sent in a submission for review, you may check on the status in at any time. The listed status in eRA is the most recent action performed on the study file. For step-by-step instructions to check the status of any review, refer to "Submission Status" in the eRA Submission Guides. 

Upon successful submission, you will receive an email indicating your submission was received. 

Each school district has specific requirements for their research review. This occurs in addition to CU ��«����Ƶ IRB review. Researchers are responsible for contacting the school district you are wanting to conduct research in; be aware of their review deadlines and policies. 

Contact the IRB at irbadmin@colorado.edu for additional information.

Identifiable data can be linked to an individual (either directly or via a code with a key). 

De-identified data cannot be linked (in any way) to an individual.

Coded data used a code and a key to link data to an individual. Coded data is considered identifiable. 

Contact irbadmin@colorado.edu and indicate that you need to make changes to a submission that has not yet been reviewed. Include your name, study title and IRB record number in your email. 

Privacy is about people and where and how they share information with researchers. It involves an individual’s ability to decide what information people share and how much, where, when, and the conditions around sharing.

Confidentiality is about data and the practices for managing and protecting information. It refers to the treatment of identifiable information that an individual has disclosed in a relationship of trust, with the expectation that it will not be divulged to others without permission.

The IRB may return protocol submissions to the Principal Investigator (PI) for changes. Requests for changes will be marked with the following statuses: Incomplete, Modifications Required or Deferred.

• Incomplete: It lacks key documents or information that makes it impossible for the IRB to review. Common missing information includes incorrect or incomplete Human Subjects training, missing protocol documents, and missing consent forms.
• Modifications Required: It requires minor changes before approval can be issued. These modifications may be determined by an individual reviewer via expedited review or by Board members at a convened IRB meeting.

Deferral: Substantial modification or clarification is required, or the IRB is unable to review the submission adequately due to insufficient information (e.g., the risks and benefits cannot be assessed with the information provided). The Response to Deferral submission must be reviewed at a convened IRB meeting.

First, read the letter and any additional documents carefully. Then you will create a Response submission in to submit the changes. 

For step-by-step instructions, refer to “Response Submission” in the eRA Submission Guides.

All changes related to IRB approved research must be reviewed and approved by the IRB before the changes may be implemented. This includes, but is not limited to, changes in study staff, recruitment, procedures and funding. 

Amendments are submitted to the IRB via . For step-by-step instructions, refer to “A����Ի峾��Գ�”&�Բ�����;in the eRA Submission Guides.