Human Subjects Radiation Safety – Reengineered

In the past, all human subjects research protocols involving ionizing radiation required review by Mount Sinai Medical Center’s Radiation Safety Committee (RSC) before submission to the Institutional Review Board (IRB). This included a submission to the RSC for all protocols even if ionizing radiation was “medically indicated” for diagnosis or clinical management of the patient. This process also resulted in lengthy consent form documents that discussed exposure levels for procedures that were considered part of their standard of care for an existing condition, disease progression, or suspected medical condition.

Effective June 2014, PPHS implemented the following procedures identified on Form HRP 211 Appendix D. This form includes a table that clearly guides researchers to the requirements for their particular protocol. Depending on the nature of the use of radiation outside of standard of care, this matrix advises investigators about whether they need to fill out other forms, indicate an authorized user and credentialed reader, obtain RSC Subcommittee Review, and/or complete the Dosimetry Wizard.

A novel interactive dosimetry table is now available to calculate the total effective dose of research related radiation and provide standardized radiation exposure consent form language. The language produced for the risk section of the consent form incorporates only radiation dispensed for research.

The review and management of human subject research protocols are now stratified based upon the highest level of anticipated research specific radiationin milliSieverts (mSv) by subject participation-year.

Visit http://icahn.mssm.edu/research/resources/program-for-the-protection-of-human-subjects/researchers-palette/radiation-safety for links to the new Dosimetry Wizard, instructional videos, and related forms.

Related article:

Welcoming Diane Winiarski, Research Safety Analyst for Radiation Safety

Welcoming Diane Winiarski, Radiation Safety Analyst

Diane Winiarksi, RN, BSN joined the PPHS team in October 2014 as the new Radiation Safety Analyst. She plays a key role in the processing and evaluation of all human subject research protocols employing ionizing radiation in research. She joined Mount Sinai in 2011 in the Department of Risk Management and brings over twenty years of diverse experience in clinical research, patient advocacy, clinical risk management, performance improvement, and record review. With her firm knowledge base in HIPAA and corporate compliance and her strong history of patient and research participant advocacy, she provides expert support for both researchers and administration alike.