Radiation Safety Committee & Radioactive Drug Research Committee

If a scan, test, or procedure is dictated solely by the clinical needs of the individual participant and varies for each participant, it is considered a clinical procedure and should not be included in the protocol or consent documents.

You must calculate dosimetry for all radiation described in the protocol and include the appropriate radiation language from the Consent Library in the consent documents.

Protocols will require review by the RSC if they meet the any of the following criteria in which case the forms required by the RSC should be submitted in electronic IRB system. This review must be completed prior to review by the IRB.

• Uses a radioactive research drug(s) regulated under the FDA requirements for review by the Radioactive Drug Research Committee (RDRC)
• Involves use of any radiation in pediatric participants (<18 years old) with an annual effective dose > 0.5 rem or healthy pediatric volunteers (any dose level)
• Uses any radiation in healthy adult volunteers, excluding DEXA and chest X-Ray
• Uses therapeutic administration of radioactive materials (Examples include therapeutic use of I-131, Lu-177, Y-90, Th-227, Ra-223, or Ir-192 permanent seed implants. The following would be excluded from required RSC review: Use of linear accelerator such as total body irradiation or high dose-rate afterloader such as brachytherapy for breast or prostate cancer.)
• Involves novel uses of radiation, including any radioactive Investigational New Drugs (IND) and radiation-producing investigational devices
• The radiation itself is the research agent being studied in the protocol (For example: The protocol compares the effectiveness of 2 different doses of radiation therapy; comparison of the effectiveness of drug X vs drug X + radiation therapy; study of the uptake and biodistribution of a novel radioactive tracer.)

Information about submission of RSC reviews in PROTECT can be found in the RSC Researcher's Guide.

You should calculate the total Effective Dose (ED) for all radiation in the protocol before submitting it to the IRB, using the tools available on the RSC webpage. A dose library and totals worksheet will be provided. Using these resources, enter the scans, doses, and frequency of each specific scan conducted within a one-year period in the online spreadsheet. This spreadsheet will calculate the total annual ED for the protocol and the comparable risk assessments that need to be inserted into versions B and C of the informed consent language. Keep this spreadsheet in the study's regulatory binder; it does not need to be included in the IRB submission.

After calculating the total annual ED, add this information to the protocol and consent documents. Include specific approved language about the associated risk based on the dose range in which the total calculated ED falls (< 0.3 rem vs. > 0.3 rem and < 5 rem for adults vs. > 5 rem for adults, with different approved language for pediatric participants). Make sure to include the appropriate radiation risk language in the consent, which you can find in the consent library.

These changes apply to all initial reviews submitted to the NIH IRB after May 15, 2020 unless the protocol has already been submitted for RSC review prior to that date.

For any questions regarding calculation of ED and associated consent language, please contact the RSC Executive Secretary, Teresa Fisher, at 301-496-2253 or RSCExecSec@nih.gov.