Clinical Research Operations

Submissions to the Radiation Safety Committee (RSC)

Purpose: To identify the process for submitting protocols to the Radiation Safety Committee (RSC) for those studies that contain research-indicated imaging. 

Step 1:  Determine if a protocol meets the criteria for submitting to the RSC

Review the protocol to verify it involves research-indicated radiologic studies (CT, PET, etc.) or the use of any radioactive agent, isotope, or nuclide

• Note: Radiation Safety Committee Website: http://drs.ors.od.nih.gov/rsc/Pages/index.aspx 

Step 2: Submit

Submit a Protocol to the RSC for initial review or amendment

• Note: The only time an amendment needs to be submitted to RSC is of the amount of radiation exposure has changes, or if the patient population has increased.

Complete the form NIH 88-23 (a) "Application for Authorization to use Radiation in Research Involving Human Subjects".

• Link: http://drs.ors.od.nih.gov/Documents/88-23(a).pdf 
• Note: You will need to contact an authorized user of the radiation or radioactive agent to assist in completing the dosimetry table on the form.

Obtain appropriate signatures on NIH 88-23 (a) form.

Review the radiation exposure consent language and add it to standard informed consent document.

• Link:  http://drs.ors.od.nih.gov/Documents/informed_consent.pdf

Send the following documents to RSC Lead Clinical Protocol Reviewer (*Sarah Kindrick, MD, DRS  (kindricks@mail.nih.gov))* via email:

• NIH 88-23 (a) form
• Protocol
• Consent document(s)
• Cover memo

Respond to stipulations (if applicable)

Respond to comments in an outlined memo format or in body of email.

Send Response memo and revised documents back to RSC.

Process Approval Form

Upload approval form NIH 88-23 (a) into the Study Documents section in iRIS.

Attach approval form NIH 88-23 (a) to initial IRB submission in iRIS.

Triennial Review

Re-submit documents to the RSC every three years.

• Note: The Principal Investigator (authorized user of the radiation) will receive email notification from RSC about 60 days before the expiration date.
• If radiation has changed:
• Send the following documents to Lead Clinical Protocol Reviewer Sarah Kindrick, MD, DRS  (kindricks@mail.nih.gov) via email:
• • NIH RSC triennial review form ** indicate radiation changes
  • revised NIH 88-23 (a) form
  • current version of the protocol
  • current version of the consent document(s)

Upon approval by the RSC:

• Upload approval form NIH 88-23 (a) into the Study Documents section in iRIS.
• Attach approval form NIH 88-23 (a) to initial IRB submission in iRIS. 

Deviations and Adverse Events

Complete the Radiation Safety Committee Incident Report found at: http://drs.ors.od.nih.gov/Documents/Radiation_Safety_Incident_report.pdf.

Email to: Sarah Kindrick, MD, DRS  (kindricks@mail.nih.gov).

Resources:

• Radiation Safety Committee Website: http://drs.ors.od.nih.gov/rsc/Pages/index.aspx;
• Radiation Safety Services Website: http://drs.ors.od.nih.gov/services/Pages/index.aspx;
• NIH 88-23 (a) "Application for Authorization to use Radiation in Research Involving Human Subjects"  Link: http://drs.ors.od.nih.gov/Documents/88-23(a).pdf  
• Radiation exposure consent language. Link: http://drs.ors.od.nih.gov/Documents/informed_consent.pdf
• Radiation Safety Incident Report: http://drs.ors.od.nih.gov/Documents/Radiation_Safety_Incident_report.pdf