All Human Subject Initial Expedited Projects to be Submitted in Ideate Beginning 5/31/16

The Program for the Protection of Human Subjects (PPHS) is moving forward in its roll-out of the IDEATE electronic submission process. Currently all Exempt projects are being reviewed through IDEATE, and starting Tuesday, May 31, 2016, all Initial Expedited applications from all departments must use IDEATE.

Research Administration has been working for many months on this new electronic submission process using a program called IDEATE, which will be used when applying for human research project approval.  At this time IACUC and some IRB submissions are reviewed using the software, and the plan is for the submission program to serve all research administration offices (i.e. PPHS, IDS, RSC, IBC, CRU, etc.) and allow all of the research offices to electronically review a single application! This will be a marked improvement over the current state where multiple different submissions may have to be made for a single project.

There is no required training, but the PPHS encourages you to connect with the IDEATE@mssm.edu team for assistance.  Remember that an IF submission must first be created through Sinai Central, all education requirements must be met for everyone on the team, and an InfoEd submission started by the research team before a submission will be accepted by the PPHS.  The PPHS also suggests that your researchers register with IDEATE for access to the system and ask that they update their profiles (adding their CV) before they begin their first submission. 

Please follow the helpful links below for assistance.

IMPORTANT NOTE: Currently, only Firefox browser is supported for IDEATE at this time: Download Firefox

We encourage your feedback over the next several months, as we make this system robust and fix the emerging issues.  Thank you in advance for your attention to this very important project.

 

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.

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