AURPC Ancillary Review

The All-University Radiation Protection Committee (AURPC) is responsible for reviewing all protocols that include ionizing radiation. Examples include:

Diagnostic X-Rays: CT scans, DXA scans, dental x-rays, fluoroscopy, x-rays, etc.
Diagnostic Nuclear Medicine: MUGA, bone scans, PET scans, etc.
Therapeutic Radiation: Accelerator, GammaKnife, Brachytherapy (Gamma Tile, Eye Plaque, HDR), Lutathera, Pluvicto, Iodine Therapy, etc.
Investigational New Drugs involving radioactive isotopes (with IND or without)

AURPC Review Required If:

Study contains research related radiation (OR)
Study contains standard of care radiation (OR)
Any combination of research and standard of care radiation

AURPC Review NOT Required If:

Study is only requesting records of radiation procedures (AND)
There are no radiation procedures listed as part of the Schedule of Activities in the protocol

Submission Overview:

Complete AURPC Application to the best of your ability
Submit AURPC Application, Protocol, Consent Form, Parental Consent Form, and Assent Forms to Department of Radiation Safety (DRS) contact.
Work with DRS Contact to finalize application and any consent changes.
AURPC reviews studies on a weekly basis. The review takes approximately one week.
Complete any committee requested modifications.
DRS Contact will provide approval memo and approve the ancillary review in ETHOS.

NOTE: AURPC Ancillary Review can occur before or after submission to ETHOS. Review
can occur concurrently with IRB review.

Human Use Application and Resources

All links and contact info can be found on the Human Use Application and Resources website.

Current DRS Contact: Dr. Bryce Armstrong, [email protected], 612-839-0551

Completing the AURPC Application

The AURPC Application is an online Google Sheet template.

Navigate to the link above.
Click “USE TEMPLATE” in the upper right corner of the webpage. This opens an editable version of the application.
Click “Share” in the upper right corner and then add the DRS contact as an ‘editor’.
Blue boxes are fillable throughout the form.
If you are unsure about any areas, the DRS contact will help fill them in.

Section 1: All Applicants

Complete the contact information.
If there has not been an ETHOS Study # assigned, leave blank or type ‘pending’.
Include full study title. Text will wrap to fit the box.
Provide a description of all ionizing radiation in the study (study related and SOC). For each type of procedure, indicate the following:
- Type of study
- Part of the body imaged
- Frequency of the procedure (how many in the first year, how many in following years?)
- Is the procedure for research or done as Standard of Care (SOC)?
- If the procedure is fluoroscopy, how long is the fluoroscopy time?
- If the procedure involves CT along with a radioactive material (like PET-CT), is the CT diagnostic or for attenuation only?
- Indicate the facility where the procedures will be performed

Section 2: All Applicants

Answer “Yes” or “No” to the condition for exemption.
- If the subject would receive these same radiation procedures (and at the same frequency) if they were not in the study, the answer would be “Yes.”
- All other procedures would be study related, and the answer would be “No.”
If you have answered “Yes,” proceed to Section 9 and have the application signed. See “Download Instructions” at the end of this document.
If you have answered “No,” proceed to the next section.

Section 3: For All Studies with Research Related Radiation

This section describes which of the following sections need to be filled out based upon the radiation being used in the study.

Section 4: For All Studies with Research Related Radiation

If the study contains any basic x-ray or DEXA exams, fill in the corresponding blue boxes based on the maximum possible exams in one year. This is typically the first year.
- The SOC column is for the number of Standard of Care exams.
- The Research column is for the exams that take place solely due to being in the study.
- Dosimetry will auto-calculate and contribute to the total dose in section 8.
Fill in all dropdown boxes in the Study Population section (lines 82-87.)

Section 5: For Research Related Diagnostic Radiation

Fill in what you can, the DRS contact will help with this section if you are unsure.
Examples of what would be in this section: CT scans, the CT portion of PET/CT scans, Fluoroscopy procedures, HRCT scans, etc.
Dosimetry will auto-calculate and contribute to the total dose in section 8.

Section 6: For Research Related Diagnostic and Therapeutic Radiopharmaceuticals

Fill in what you can, the DRS contact will help with this section if you are unsure.
Examples of what would be in this section: Nuclear medicine exams (MUGA scans, Bone Scans, etc.), I-131 ablation, Y-90 therapy, Lu-177 therapy, etc.
If the radiopharmaceutical is approved as an Investigational New Drug (IND), include the number in line 137.
Dosimetry will auto-calculate and contribute to the total dose in section 8.

Section 7: For Research Related Accelerator or Sealed Source Therapeutic Radiation

Fill in what you can, contact Radiation Oncology for help filling in this section.
If this section is filled in, it will require an extra signature in section 9.

Section 8: For All Studies with Research Related Radiation

If the dose is not from a radiation therapy procedure:
- Line 157 tells you which example to include in the consent forms.
- Line 159 or 160 tells you the number that fills in the blank in the example text.
- Copy and paste the example into the consent and/or parental consent forms.
- Edit the text to include the number and types of procedures (only list the research related procedures, not the clinically indicated procedures
- Edit the text to reference singular or multiple procedures (this/these, procedure(s), etc.)
- Fill in the blank with the appropriate number.
- The second paragraph may be deleted if there is no clinically indicated radiation.
If the dose is from a radiation therapy procedure:
- You may skip the example templates
- The consent must include a statement of risk for the radiation dose, any potential radiochemical toxicity or adverse reactions, and all potential side effects from the radiation including the potential for secondary cancers.

Section 9: For All Studies

Obtain the PI’s signature. Electronic signatures are acceptable.
The application may also be sent from the PI’s x500 (University email) indicating their approval in lieu of a signature.

Download Instructions

From the Google Sheet application, click “File – Download – PDF” and it will be properly formatted and ready to save.
Always work directly within the Google Sheet application. Downloading to Excel will mess up the form and the PDF’s made from it.

Submission Instructions

Email the following to the DRS contact:
- Protocol
- Signed Application
- Consent/Parental Consent/Assent
- Any associated imaging or therapy manuals
You may submit the application to ETHOS, but it is not necessary. Upon approval, the DRS contact will upload an approval memo when signing off the ancillary review.

Common Issues

Missing or confusing information in the description in Section 1.
- Procedures are not indicated as SOC or study related.
- Frequency is given in cycles instead of procedures per year.
- Part of the body being imaged isn’t indicated.
- CT’s done in conjunction with PET or SPECT aren’t indicated as either diagnostic or attenuation only.
Protocols often indicate either an ECHO or a MUGA in the Schedule of Activities. PI’s will usually indicate that only ECHO’s will be done. If they indicate a MUGA could be done, it needs to be added to the application.
Study Population section not completed.
Consent form contains prior existing contradictory information after our consent risk language is added.
Missing pregnancy exclusions in the consent if pregnant individuals are excluded from the study.

Common Questions

Is there AURPC required Assent Form language?
- No. We ask to see the Assent Forms to make sure they exist and to make sure there isn’t any risk language that is contradictory to the main Consent or Parental Consent Forms, but don’t require anything specific.
Can existing radiation risk language remain in the Consent Form?
- Generally, yes. Include the AURPC risk language in a track changes format before sending to the DRS contact. They will work with you to eliminate any
  contradictory risk language.

Version date: March 11, 2025

AURPC Review Required If:

AURPC Review NOT Required If:

Submission Overview:

Human Use Application and Resources

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