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

Tips from the PPHS

To ensure a submission can be accepted by the PPHS office, the following must be true:

  1. The personnel listed on HRP-211 are the same as the persons listed under the IF# in Sinai Central.
  2. The current versions of all forms and templates are used.
  3. All personnel have completed all education requirements (N.B., the Investigator/research staff course expires after 3 years, and the Refresher course must be completed).
  4. An InfoEd submission has been started.

Join the Ideate Yammer Group

The recently launched Ideate Yammer group is your source for timely updates on Ideate, Mount Sinai’s system for electronic submissions to regulatory compliance offices including the Program for Protection of Human Subjects (PPHS), the Radiation Safety Committee (RSC), the Institutional Biosafety Committee (IBC), the Investigational Drug Service (IDS), the Clinical Research Unit (CRU), the office of Financial Administration for Clinical Trials Services (FACTS) and the Institute for Animal Care and Use Committee (IACUC). On Yammer you will find notices about upcoming go-live events, instructional videos, tips and tricks, announcements on unplanned or unexpected system downtimes, and answers to any questions you may have about using the system.

Yammer is an enterprise social network that encourages collaboration and communication. You can engage in conversations and view what your colleagues have posted.  All groups are located on the left hand side of the screen.  If you have questions about Yammer, join the “Yammer 101” group where you can find helpful tools and tips on how to get started.  Feel free to post your Ideate questions to Yammer and join the conversation!

Visit this link to sign up for Yammer:
https://www.yammer.com/mountsinai.org/?show_signup=true

Once you are signed up for Yammer, visit this link to join the Ideate conversation:
https://www.yammer.com/mountsinai.org/#/threads/inGroup?type=in_group&feedId=4505882

A Brief Refresher on IACUC Functions and IACUC Forms

All activities involving the use of vertebrate animals require prior approval by the IACUC.

Federal regulations require that any activity involving the use of live vertebrate animals in biomedical research, training, or teaching must have prior IACUC approval. The IACUC mandate is to oversee and evaluate all aspects of the Institutional program for animal care as use. This includes all research and educational activities involving animals, as well the veterinary care program.

In order to secure approval, applicants must submit an IACUC Application describing the value of the animal research to human or animal health, design of the study, rationale and justification for using animals, choice of species, alternatives to the use of animals, animal procedures and how the welfare and well-being of the animals is going to be ensured during the course of the study. 

IACUC Applications
There are only two types of IACUC forms: one for the Initial Application and a shorter one for a yearly Progress Report. Both forms are logic-driven, user-friendly, state of the art electronic documents available on line via the Ideate portal: https://ideate.mssm.edu/home. Submission, processing, and review of IACUC applications are all done on line.

Ideate Portal
Learning how to access and use the Ideate portal forms requires attending a brief training session offered weekly by IT trainers. At such sessions users receive an ID and password to the portal. The schedule of training sessions is posted at http://eolas.mssm.edu/e-learn/. This site also has online training modules on how to complete and file IACUC application.

Where to find help with IACUC forms
Help is available from the IACUC office (212-241-0153, e-mail: iacuc@mssm.edu). The IACUC strongly recommends consultation with CCMS Veterinarians (212-241-3008) prior to filing an Application to ensure that appropriate measures are taken to minimize pain and/or distress to experimental animal. Consultations with CCMS Veterinarians are required for studies involving large animals (e.g., non-human primates, pigs, sheep). Consultations with the Biosafety (212-241-5169) and with the Radiation Safety Officers (212-241-2269) are required for studies involving the use of hazardous biological, chemical or radioactive materials.

Where to find help for problems with the Ideate system
Users encountering technical problems in completing or submitting IACUC forms should contact immediately the IT department at ideate@mssm.edu.

Review of IACUC Applications
The IACUC may approve, withhold approval, or require modifications of any proposed activity related to animal use and care before issuing a final approval. An integral part of the IACUC review is also a risk assessment and occupational safety evaluation by the Institutional Safety Officers and by the Institutional Biosafety Committee. Final IACUC approval is granted after all reviews have been completed and PIs have responded adequately to all requests for modifications of a protocol. Approvals are granted for a period of 3 years; for the second and third year of such period, only a Progress Report is required at the beginning of each project year. At the expiration of the 3-year approval period, PIs must submit a new IACUC application.

For additional information, contact the IACUC office at 212-241-0153, Monday-Friday, 9am-5pm or via email at iacuc@mssm.edu.