Notice to NIH Community RE: RSC

April 16, 2020

Nicole Grant

Subject line: IMPORTANT CHANGE to the IRB and RSC Review of Research Protocols Using Radiation and Radiation Dosimetry Calculations for NIH protocols

On May 15, 2020, there will be two important changes (noted below) in the way total effective doses of radiation are calculated and reviewed for protocols under the purview of the NIH IRB. 

Scans, tests and procedures that involve radiation that are specified in the protocol are considered by the IRB to be research procedures.  If the scan, test or procedure is dictated solely by the clinical needs of the individual participant (and therefore vary for each participant), then this is considered clinical and should not be included in the protocol or the consent documents.  The IRB has no regulatory authority over the practice of medicine and can only review proposed research and associated risks. Dr. Jonathan Green, OHSRP Director, presented an educational session regarding differentiating research vs. clinical procedures for the purpose of research protocol submissions.  A videocast of that presentation can be found (inside the firewall or via VPN) here, and the slides are also available here.

• First change: Only protocols that fall into specific categories that have been pre-determined by the RSC and IRB will continue to undergo Radiation Safety Committee (RSC) review prior to review and approval by the NIH IRB.
  • Investigators will no longer designate in the IRB application whether the radiation is medically indicated or research.
• Second change: Dosimetry must be calculated for all radiation described in the protocol since, as described above, the IRB considers all protocol dictated procedures as research scans, procedures etc.
• Third change: Submissions to the RSC will be done via a new submission form in iRIS rather than by email.

Protocols will require RSC review (or RDRC if applicable) if it meets any of the following criteria: (this will be provided as a checklist in iRIS).

• Uses a radioactive research drug(s) regulated under the FDA requirements for review by the Radioactive Drug Research Committee (RDRC)
• Involves the use of any radiation in pediatric participants (<18 years old) with an annual effective dose >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)

Protocols that fall into one of these categories will continue to be reviewed by the RSC as they are now, but submission of the required forms will be via iRIS. The RSC may determine at the time of review that continuing review by the RSC is not necessary.  As noted above, RSC will be calculating total effective dose (ED) based on all radiation listed in the protocol.

Note:  At the time of IRB review, the IRB may refer any protocol to the RSC for review if it deems RSC expertise is required.

For protocols that no longer require RSC review,

Investigators will calculate the total ED for all radiation in the protocol prior to IRB submission using the tools available on the RSC webpage.  A dose library and totals worksheet will be provided.  Using these resources, investigators will enter the scans, doses, and frequency of each specific scan will be conducted within a one-year period in the online spreadsheet.  This spreadsheet will be used to calculate the total annual ED for the protocol, and it should be retained in the study’s regulatory binder. It does not need to be included in the IRB submission.

Once the investigator has calculated the total annual ED, this information must be added to the protocol and consent documents along with specific approved language regarding 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)  Investigators are responsible for ensuring that the appropriate radiation risk language is included in the consent. Consent language can be found on the IRBO website.

These changes will apply to all initial reviews submitted to the NIH IRB after May 15, 2020 unless the protocol has already been submitted for RSC review. For protocols that are currently approved by the NIH IRB, the PI should update the protocol and the risk language in the consent at the time of the next planned amendment to include the total ED for all radiation.

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.  For IRB related questions, please contact the IRBO at 301-402-3713 or irb@od.nih.gov.