Radiology Umbrella IRB

New Study Form


Use this form to submit a new study for review by the Department of Radiology under the Umbrella IRB.


To prepare your responses in advance, there is a fillable pdf version of this form available: Click here to download.


What types of investigations should I submit?

This form can be used for Human Subjects Research (HSR), QA/QI Projects, and/or other Non-Human Subjects Research (NHR) investigations. A decision guide explaining these categories is available in the Umbrella IRB Manual for Investigators.


What types of HSR studies are eligible?

All HSR must be considered exempt category 4(iii) to be approved under the Umbrella IRB. The Umbrella IRB Manual for Investigators describes exemption criteria in detail.


Questions, concerns, or comments?

Contact the Radiology Research Coordinator, Emily Reese (ejreese@salud.unm.edu, 2-7759, Tiger), or email RadiologyResearch@salud.unm.edu.

Need Help?


If you start filling out this form and are unsure how to respond and/or would like guidance, check the box below, and the Radiology Research Coordinator will reach out to you as soon as possible!

Someone from Radiology Research will follow up with you soon to assist you!


Email Emily Reese (ejreese@salud.unm.edu) if the PI's name is not on this list.

Select
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Please include your name in the Study Team Members field as well.


Select ONE OPTION ONLY.


See the Investigator Manual (pp. 2-3) for a decision guide.


  • Human Subjects Research (HSR): Systematic investigation intended to contribute to generalizable knowledge; PHI is accessed for > 3 subjects who are or could be living.


  • QA/QI: Intent is to assess/improve processes specific to the institution (i.e., intent is NOT to contribute to generalizable knowledge). PHI is NOT accessed by the study team (can utilize Honest Broker).


  • Other Non-Human Subjects Research (NHR): Deceased subjects only, case report (≤ 3 individuals), publicly available data, etc.

Include affiliation (faculty, staff, resident, fellow, medical student). If individual is not with the Department of Radiology, indicate their department as well.


Indicate N/A if no other study team members.


3. Study Team Member Details

In this section, provide the name and role of each member of your study team, and indicate whether or not they will access PHI for the research.


All individuals accessing PHI for research must have complete, up-to-date Human Subjects Research (HSR) Training. This will be verified and must be complete prior to RRSC review.


HSR training is not required for those who will access/view de-identified data only.


Email ejreese@salud.unm.edu to verify your training status or to request information about HSR training.


3a. Study Team Member 1

If not Department of Radiology, provide their department and title.

Role (choose one)
Will this individual access PHI (MRNs, accession #s, Cerner, PACS, etc.) for this study?

If yes, completion of HSR training will be verified prior to RRSC review.


3b. Study Team Member 2

If not Department of Radiology, provide their department and title.

Role (Choose one)
Will this individual access PHI (MRNs, accession #s, Cerner, PACS, etc.) for this study?

If yes, completion of HSR training will be verified prior to RRSC review.


3c. Study Team Member 3

If not Department of Radiology, provide their department and title.

Role (Choose one)
Will this individual access PHI (MRNs, accession #s, Cerner, PACS, etc.) for this study?

If yes, completion of HSR training will be verified prior to RRSC review.


3d. Study Team Member 4

If individual is not Department of Radiology, please also indicate their department and title.

Role (Choose one)
Will this individual access PHI (MRNs, accession #s, Cerner, PACS, etc.) for this study?

If yes, completion of HSR training will be verified prior to RRSC review.


3e. Study Team Member 5

If individual is not Department of Radiology, please also indicate their department and title.

Role (Choose one)
Will this individual access PHI (MRNs, accession #s, Cerner, PACS, etc.) for this study?

If yes, completion of HSR training will be verified prior to RRSC review.


Study Information

All fields must be complete in order to initiate review.

Background and citations are not required but may be included. You may also indicate why this question or project is unique compared to prior published work.


Ex: We will address the question [question]. Hypothesis: The clinical outcome, as measured by recurrence, is improved when x technique is used vs. y technique.

Example Study Plan:


  1. Collect MRNs for diagnosis by... (explain how you will obtain MRNs)
  2. Review charts and imaging for imaging features and clinical data and record in a spreadsheet
  3. Anonymize data by assigning subject IDs and deleting MRNs, then we will perform statistical analysis.

Examples:

  • Adults ≥ 18 years who meet the following criteria: Diagnosis + path report + CT scan within 2 weeks of dx starting in 2017.
  • Children 8-18 who presented to the ED with suspected appendicitis and had US or CT between 2019 and 2021.

Tip for clinical variables: Select variables that are measurable, quantifiable, and obtainable.


Examples:

  • Imaging variables: MRIs, date of scan, equipment model, contrast medium, tracer, number of scans, etc.
  • Demographic variables: age at diagnosis, sex, ethnicity/race, BMI, insurance, etc.
  • Clinical presentation: Reason for exam, blood glucose, LDL, medications w/ dose, stroke score, etc.
  • Clinical outcomes: Recommended follow-up, surgical procedures, length of stay, pathology result, diagnosis, time to diagnosis, tumor volume, etc.


10. EXEMPT CATEGORY 4(iii) CONFIRMATION*


Investigations must meet ALL of the following criteria in order to be considered exempt.


1. The data I will be collecting will have been collected for routine clinical care. There will be no direct interaction between subjects and the study team.


2. One or more study team members will or may access identifiable protected health information (PHI) for this investigation.


3. The crosslink document linking direct identifiers (e.g., MRNs) to subject IDs will be temporary (destroyed once data collection is complete) OR we will not maintain a crosslink.


4. This study does NOT involve external funding or regulatory oversight (e.g., FDA, DOD, DHHS).



Principal Investigator's Assurance

HSC Data Security Best Practices

1. Data Collection: Directly enter data onto a data collection form stored in a secured access folder on an HSC Network Drive (e.g., N:\Research studies Drive, R:\Radiology Research Drive), or in a secure HSC Information Security approved system such as REDCap. PHI should NEVER be saved on personal devices.


2. Data Storage: Data is to be stored on an HSC Secure network drive (e.g., N:\Research studies Drive, R:\Radiology Research Drive). Never retain files on untrusted or insecure storage devices/computers (e.g., on a personal device or locally on your HSC computer hard drive rather than on a network drive). Trusted devices are HSC-managed and provide one or more of the following safeguards: access logs, encryption keys, backups, and disaster recovery capabilities.


3. Data Retention: Data should be retained for at least 3 years after study closure or, for studies including minors, until the youngest participant reaches 22 years of age.