Secondary Research

• At minimum, upload an application and a protocol.
• Upload a list of data elements or a case report form if the data are too long or difficult to describe in the protocol.
• Submit the study through the Human Research Portal if data are collected from Children's Hospital Colorado or if the research is funded through CU.
• Upload external approvals for data collected from Children's, Denver Health or the VA (see box #1 on Initial Submission page). 
• Upload a copy of the funding proposal for funded research. 
• Make sure every investigator has uploaded a CV into InfoEd and has completed required CITI training and annual financial disclosures.
• If the PI is a mentee (i.e., student, fellow, resident, or other trainee), complete and upload the signed mentor and mentee forms.

• Dates are identifiers under HIPAA (e.g., dates of clinic visits, dates of diagnosis, dates of progression, etc.) 
• A Limited Data Set can include dates and town or city, state and zip codes, but no other identifiers. A Limited Data Set is still PHI and is not a de-identified data set.
• If you are working with De-identified data, it means there are no identifiers included in your data set, and you do not have a code to connect the data set back to identifiable subjects or a data set with identifiers.
• Assume that free text fields from an electronic health record will include identifiers.

• Names
• All geographical subdivisions smaller than a State*
• All elements of dates (except year)*
• Telephone numbers
• Fax numbers
• E-mail addresses
• Social Security numbers
• Medical records numbers
• Health plan beneficiary numbers
• Account numbers
• Certificate/license numbers
• Vehicle identifiers, serial numbers, license plates
• Device identifiers and serial numbers
• URLs
• Internet Protocol (IP) address numbers
• Biometric identifiers (e.g., fingerprints, voice recordings)
• Full face photographic images and any comparable images
• Any other unique identifying number, characteristic, or code
• Free text fields from an EHR may include any identifiers above

* See the HIPAA page for a more detailed description

Please note: the Applications cannot be opened in the browser. You must download the PDF and then open it from the downloads folder into Adobe Acrobat or another PDF viewer.

Data and/or Specimen Collection, #6: “Check any identifiers that will be sent to you or recorded in research records.”

This question is about identifiers that are in possession of the researcher at any point. It is not about identifiers that might be seen (but not possessed) by the researcher.

Data and/or Specimen Collection, #6: "Check one:"

• At no point will any identifiers be recorded for this study
• Identifiers will be retained for a reasonable period of time for data collection
• The identifiers checked above will be recorded and retained through study completion

There are no wrong answers to the above question as long as it is consistent with the protocol and other answers in the application.

• Fully describe the data you are collecting for the research. Alternatively, upload a list of the data elements or a case report form.
• If we are receiving data from another institution, or we are sending data to another institution, describe the data sharing process.

Be clear and consistent about any identifiers that will be saved in your research records, even if the identifiers are saved temporarily. Make sure your protocol and application match each other, particularly about what identifiers are used and how they are protected. 

Secondary Research can be approved as Expedited, Exempt, or Not Human Subjects Research depending on the use of identifiers. There are no wrong answers to which identifiers will be utilized as long as it is consistent across study documents.

In short: Tell us what you are doing, what identifiers you need for your research, and how you will protect them.