The University of Iowa

MRPC Application Form Assistance

eMRPC (electronic Medical Radiation Projection Committee) Form System

This system will integrate closely with HawkIRB and allow the person filling out the HawkIRB form to carry forward information from HawkIRB to the new eMRPC system thus eliminating some of the duplicative entry of information.  The new system simplifies the process of filling out the required fields for MRPC forms and makes it easier to ensure that your form will not get returned for being incomplete.  Further, due to the integration with HawkIRB, the status of the MRPC review will be visible to you as part of your HawkIRB application.

Additionally, the system will facilitate the signature of outside facility forms related to internal or external radiation at a facility other than UIHC or PBDB using DocuSign. The sooner you transition to using the new eMRPC system the sooner you will benefit from the automation of data from HawkIRB into the MRPC application and a streamlined esubmission process! 

Starting a new MRPC form: 

As you initiate a new IRB application form in HawkIRB, questions answered in section V will trigger MRPC review.  This will require an eMRPC submission.  Prior to submitting the new HawkIRB application form, you will be presented with a request to create an MRPC form.  Once you do so, you will be able to follow a link from HawkIRB to the MRPC system to complete the required information and submit your MRPC form for review.  Details from the HawkIRB application will autopopulate into the MRPC form.  Your MRPC form must be submitted to the MRPC committee concurrently with your new IRB application form in HawkIRB. 

If you have a new IRB application form in HawkIRB in progress:  

If you have a new IRB application form in HawkIRB pending where you have already attached an MRPC document prior to the weekend we transition to the new eMRPC system, you will be able to continue to submit your protocol based on having that attachment.  This means the review will be completed as has been done in the past.  If you would like to transition to the new process you will have to remove any attachments you have uploaded to HawkIRB for MRPC.  Once you do so, you can proceed completing an eMRPC application in the new system. 

 

If you remove the last MRPC attachment from a new IRB application in HawkIRB: 

If you remove the last MRPC word document attachment on a new IRB application in HawkIRB, you will have to use the new eMRPC system to have an MRPC review completed.  If you would like to replace an attachment based on changes requested without having to switch to using the new system, you will have to add a new attachment before removing the current attachment. 

Modifications: 

Pending modifications in HawkIRB that have existing word document MRPC attachment(s) will be reviewed for a limited time.  Sometime over the next year we will require that all MRPC reviews be completed using the new electronic system including any pending modifications under IRB review.   

IRB approved research that has already been approved with MRPC word documents: 

If you have an approved IRB application, you will not need to do anything until the time comes to submit a new modification.  In that case, you will be able to use the attachment system as described above for a limited time.  However, you will eventually have to use the new electronic system and a further communication will go out before that time.  Your approved MRPC forms will be copied over to the MRPC system to allow you and the MRPC committee to find MRPC forms all in one place.  You can continue to see these in HawkIRB as well. 

General Information Section

 

Diagnostic x-rays (short form option)

Answer 'Yes' if the research radiation applied to the subject is limited to the types of listed and result in a total effective dose < 100 mrem. This option allows an expedited review. Please note that conebeam CT (CBCT) and weight0bearing CT (WBCT) do not fall into this category even though the effective doses for these procedures are typically less that 100 mrem.

 

Principal Investigator Section

 

Faculty Supervisor

A faculty supervisor is only required when the Principal Investigator is not a UI faculty member.

 

Therapeutic Radiation Information Section

Possibility of No Therapeutic Radiation because the subject did not meet eligibility criteria

For example, if a research-related diagnostic procedure could be used to exclude a subject from receiving the therapeutic radiation, you would answer 'Yes'

 

Rationale for Use Section

 

Rationale for Use of ionizing Radiation

Sample Text: "In this patient population, CT scans are typically performed clinically every 6 months over the two year period of this project.Since this protocol requires CT scans every 3 months, then the CT scans at 3 months, 9 months, 15 months, and 21 months would all be considered research, while those performed at 0 months, 6 months, 12 months, 18 months, and 24 months would be SOC.

 

Protecting Breastfeeding Infants

 

Examples may include storing up breast milk prior to a procedure involving a radiopharmaceutical, or switching to feeding your child formula until the radiopharmaceutical is no longer present in breast milk.

 

Study Arm name

 

Name the different study arms in a way that describes their differences (i.e. 'Subjects Receive Chemo only' vs. Subjects Receive Radiation and Chemo'

 

Identity and Justification of Radiation Procedures Section

 

Rationale for Use of Research Radioactivity or Ionizing Radiation Procedures

Briefly describe the research purpose of using the ionizing radiation procedure (e.g. CT scan, x-ray, PET scan...). Where it makes sense, include why a procedure involving ionizing radiation is preferred over an alternative, such as ultrasound, that does not involve exposure to ionizing radiation.

 

Number of Subjects

 

An answer to this may simply be a reference to the sponsors protocol that is in IRB, although a reference to the page(s) is helpful. For example: "Up to 10 patients will be enrolled at UIHC. Statistical Analysis is provided in the Sponsor Protocol on pages 38-40." If this is investigator initiated, a couple sentence summary of the statistical justification is in order. For example: "Primary efficacy endpoint is defined as the Kaplan Meier estimate of time to first occurrence of stroke, cardiovascular death at 36 -months. The hypothesis is that the experimental procedure is non-inferior for the occurrence of the previously listed events. A sample size of 3000 subject provides 90% power for the Primary Effectiveness Endpoint analysis. "

 

Radiation Procedures Section

 

PET or PET /CT Radiopharmaceutical Effective Dose Equivalent

 

The effective dose equivalents for commonly used PET or PET/CT procedures are included within the eMRPC application.  If the information is not available, you will be linked to the MRPC consultant who will assist you in the effective dose equivalent estimate.

 

PET or PET/CT Clinical Procedures

 

Scans that are performed as part of the subject’s standard of care medical treatment.

 

PET or PET/CT Research Procedures

 

Number of scans performed only because the subject is enrolled in this research protocol

 

SPECT or SPECT/CT Effective Dose Equivalent

 

The effective dose equivalents for commonly used SPECT or SPECT/CT procedures are included within the eMRPC application.  If the information is not available, you will be linked to the MRPC consultant who will assist you in the effective dose equivalent estimate.

 

Gamma Camera Radiopharmaceutical Effective Dose Equivalent

 

The effective dose equivalents for commonly used Gamma Camera radiopharmaceutical procedures are included within the eMRPC application.  If the information is not available, you will be linked to the MRPC consultant who will assist you in the effective dose equivalent estimate.

 

Outside Facility Internal Radiation Section

 

Radioactive Materials License Owner

This will need to be either an Authorized User in Radiation Oncology or PET, or Principal Investigator with an active Radioactive Materials Use Authorization. Contact the University RSO if you need to confirm whether or not an individual is approved to use radioactive materials.  Also, the RSO will provide assistance in clarifying what information is being requested such as the radiation safety concerns and the instrumentation quality assurance.