1. Research
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Research Approvals and Biosafety

The Icahn School of Medicine at Mount Sinai maintains the highest standards for transparent and ethical conduct of research, in compliance with federal, state, and international guidelines and regulations. Accordingly, you must obtain appropriate approvals to work with biologics, animals, and/or human subjects. Our Research Roadmap provides detailed information on the requirements for human subject basic science research.

Through our Biological Safety Program, we also monitor all laboratory activities that involve biohazards materials, including pathogenic organisms and biological toxins.

FAQs: Obtaining Approvals

InfoEd is the software program the Icahn School of Medicine uses to internally route and manage a subset of School supported projects and all sponsored project applications. InfoEd is also used to submit competitive, single project National Institutes of Health (NIH) and federal sponsored projects electronically to these agencies. These applications are called “System to System Submissions” or “S2S” applications.  InfoEd is the system used to transmit the application directly to the extramural funding agency.

RUTHis an electronic submission system for both our Program for the Protection of Human Subjects (PPHS) office and researchers to manage research projects involving human subjects. For the PPHS office, RUTH streamlines the workflow of reviewing and approving studies. Meanwhile, for researchers, RUTH streamlines the process of having studies (requiring new requests or multiple submissions) approved.

Learn how to navigate InfoEd through modules covering new record setup, budget development, non-competing continuations, and Single Project Competitive Federal (System-to-System) application submissions. Training classes are offered in Peak online, and in an on-demand format. Go to Peak > Online Courses > Functional > Research. For more information, or to ask a question, please open a ticket through Service Now.

To attend training sessions for RUTH, you can visit our training calendar on the Research Administration Portal. Additionally, training videos can be found by searching for “RUTH” on the Research Administration Portal or on Peak.

Both InfoEd and RUTH are compatible with all leading browsers.

You can access InfoEd on and off campus through the program's secure server with your Mount Sinai Single Sign-On User ID and password. Access RUTH by logging in with your Mount Sinai Single Sign-On credentials.

If you have any questions about accessing InfoEd, please open a ticket through Service Now.

You can request a research username and password for InfoEd through Service Now. Select Help Topic “New User Request” from the drop-down menu. Please note that InfoEd Proposal Development Demo 1 is required for individuals preparing the InfoEd application. A PI does not need to complete this requirement if their only InfoEd responsibility is to finalize (i.e., approve) the application. Attach certificate of completion to the Service Now ticket when requesting InfoEd access.

Please also note the PI must have access to InfoEd to approve and submit the proposal even if he/she is not preparing the details of the application in InfoEd. In order to gain access to InfoEd, he/she can opt out of attending the InfoEd class. To request access , open a Service Now ticket and from the “Help Topic” drop down menu, select “InfoEd / New User Request.” In the “Issue Summary” field, please adapt the suggested language, “Please allow the PI, Dr. XX, access to InfoEd. He/she has not attended the InfoEd Required Training. In addition, please delegate [name of person] and give him/her the ability to edit and create my proposals and make sure they are added to all the communications generated through InfoEd. I understand that Research Administration IT (RAIT) can support the delegate (i.e., obtain assistance via the RAIT ticket system) but cannot support the PI until the PI has attended the class.

You do not need to request a username or password for RUTH, as you can log in using your Mount Sinai single sign-on username and password. If you have any issues doing so, please contact us.

Once your InfoEd account is created, it is linked to your single sign-on User ID and password. RUTH is accessed via single sign-on credentials as well. To reset your password on InfoEd and/or RUTH, please visit our password reset services.

For SSO /login/password issues, the main contact is the Academic IT Support Center: ascit@mssm.edu

FAQs: Biosafety in Research

A biological hazard, or biohazard, is a biological substance that poses a threat to the health of humans, animals, and/or the environment. This includes infectious agents or hazardous biologic materials. Infectious agents include bacteria, viruses, fungi, other microorganisms and their associated toxins, or a substance containing an organism capable of infecting and causing disease in a susceptible human or animal host. We measure the degree of risk based on the virulence of the potential disease or injury, the potential route of exposure, and by the availability of preventive measures and effective treatments.

Recombinant DNA (rDNA) is a molecule of DNA that has been modified, either through genetic recombination or through laboratory techniques, and can replicate in a living cell. Recombinant nucleic acids are constructed by cloning techniques or by recombination of nucleic acid molecules.

Synthetic nucleic acid (sNA) molecules are those that are synthesized or amplified by chemical or other means. This definition includes molecules that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules.

Molecules that result from replication of recombinant and synthetic nucleic acids qualify as recombinant and synthetic nucleic acids.

The CITI Program is the default training platform for laboratory biosafety. Two training courses, Core Training Requirements and Biomedical Research, are required for all laboratory staff handling biohazards in basic research and clinical laboratories. There is also a supplemental training course, Recombinant DNA and Synthetic Nucleic Acids, that is required for any laboratory staff conducting research with rDNA and/or sNA. Additional guidance on the training curriculum for Basic Sciences is available through our Research Roadmap.

Research projects that involve biohazardous agents, viral vectors, or rDNA and/or sNA require approval by the Institutional Biosafety Committee (IBC). The Principal Investigator or designated proxy must submit an eSafety research registration that covers use of biohazardous agents in basic research and clinical laboratories.

If the study involves human or animal subjects, you also need approval from the Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) approval, respectively. These entities also perform ongoing auditing and monitoring.

The IBC, IRB, IACUC, and Program for the Protection of Human Subjects offer resources to address any additional questions you may have.

Policies, procedures, and guidelines on working with biologics are found at the following: