Have you noticed more emails than usual in your inbox from the GCO, and do you find that a good thing (most of the time)? In June of 2014, the Grants and Contracts Office hired Allison Gottlieb as their new Director of Education for Sponsored Programs, and Allison has been busy reorganizing GCO’s website and creating tools and resources for Mount Sinai’s research community to help them navigate through the submission process. Allison has been working in sponsored project administration at Mount Sinai for 15 years starting her professional career in the GCO as a Grants and Contracts Specialist. Drawing upon that experience, she has created:
- a master application submission checklist and instructions, which enables PIs and their teams to submit virtually administrative error free applications when followed;
- a budget template in Excel with automatic calculation features to handle the simplest and toughest budgets out there;
- SOP memos and checklists for projects with subawards; and
- a series of NIH specific guidance such as for ASSIST grants and required Individual Development Plan (IDP) language for use in RPPR applications.
If you would like to receive GCO’s e-communications and stay up to date on changes that may affect your application submission, please send an e-mail to Allison.Gottlieb@mssm.edu.
In addition to the GCO’s ramped up e-presence, its physical location is also on the move to 150 East 42nd Street, 10th floor. They will be packing up Friday, March 20 and arriving at their new destination on Monday, March 23. Please allow for delays in correspondence on that Friday. Although their box number and the main telephone number remains the same, all individual extensions will change. The GCO will inform you of their new telephone numbers in a separate notification. They look forward to serving you from their new location.
FACTS (Financial Administration of Clinical Trials Services) was created as part of the Research Re-Engineering Program to offer investigators and research personnel centralized and comprehensive services for industry clinical trials. As of January 1st 2015, the FACTS Office has launched a new initiative in which all industry funded Clinical Trial Agreements and Confidential Disclosure Agreements will be reviewed and negotiated by the FACTS Office team instead of the GCO team. This change is being implemented to improve investigator satisfaction and the management of industry clinical trial agreements. It is geared toward making the administrative requirement for starting research more efficient. It will enable us to better serve the faculty engaged in industry clinical trials.
On the contracts negotiation side, we have added two-full time Senior Contract Specialists to the FACTS team.
Mary-Jo has over 20 years of Research Administration experience with an extensive background in negotiating and managing Clinical Trial Agreements. Prior to working at the Icahn School of Medicine, she came from Yale University as the Administrative and Outreach Lead of the Corporate and Complex Contracts Group.
Sandra Londono has 15 years of experience in the areas of transactional and contract law, risk assessment and mitigation, and project management spanning a wide range of industries and activities. Sandra has Certificates in Healthcare Compliance and Pharmaceutical, Medical Device & Compliance Law.
Please send all industry funded clinical trial agreements and Confidential Disclosure Agreements to FACTS@mssm.edu. You can visit the FACTS website at http://icahn.mssm.edu/research/resources/office-of-clinical-research/resources-and-services/clinical-trials-budget-and-billing-operations.
The Program for the Protection of Human Subjects (PPHS) recently announced the Short Form Consent process and policy to the research community during the monthly Research Forum (first Wednesday of the month, from 12 noon- 1 pm). The Short Form Consent process is intended to facilitate the enrollment of non-English speaking subjects under certain circumstances where a fully translated consent form has not been approved by the IRB. The PPHS will review a request to use the Short Form Consent process on a case-by-case basis for use with incidental, unanticipated non-English speaking potential subjects. A Short Form Consent process is approved for a one time use for a specific potential subject, for a specific research study only.
Limitations and Considerations:
This process cannot be used when enrollment of non-English speaking subjects of a particular language group are anticipated, when such a group is targeted for enrollment, or if a significant number of potential subjects come from a specific language group. The Short Form Consent process cannot be used for Spanish speaking subjects. Ad hoc translation of the English consent form is not allowed.
If you plan on requesting to use a Short Form Consent process, the first step is to review the resources available to pay for interpreter services to make sure that the costs associated with services needed to enroll the non-English speaker can be covered by the study budget. Keep in mind that all future communication with the subject will also need to occur in the subject’s preferred language.
If you are planning on enrolling a non-English speaking subject, you need to plan for all research related communication with subjects during all study visits, any phone calls you may receive from the subject, and how you will handle any research emergencies. In addition, if any study materials need to be provided to, or completed by, subjects, those materials will need to be translated into the language understood by the subject.
To Request to Use the Short Form Consent process:
Email Liz Carroll in the PPHS office with the following information: Study ID#, PI, language requested, and basic non-identifiable information about the potential subject/situation. If the Short Form consent is not immediately available from the library in the target language, arrangements for the translation of the Short Form consent will need to be made. The PPHS library currently includes over 20 languages.
Contact Adriana Cifuentes, the Language Assistance Program Coordinator in the Patient Service Center to obtain a dedicated access code. This dedicated access code will allow patient services to invoice you directly for services rendered for research purposes. You should add these fees to the study budget so the sponsor of the research will cover the cost of the interpreter service.
If the use of the Short Form Consent Process is not specifically described in the Consent Process section of your protocol template (#12 under “Non-English Speaking Subjects”), you must submit a modification to add it to your study. Review your protocol template section on the Consent Process to see if you included a section on Non-English Speaking Subjects. Be sure that you indicated that if you have a potential subject who does not speak English or Spanish, you will follow the Short Form Consent Process and comply with the policy. If this section indicates that all consent documents will be translated and approved by the IRB prior to use, submit a modification to the IRB to allow for the Short Form Consent Process. This modification should be submitted to the IRB as soon as possible. A requested Short Form will be released independently of the modification review process.
Please contact Liz Carroll, Assistant Director of Regulatory Affairs for the Program for the Protection of Human Subjects with any questions related to this policy or the procedures to be followed.
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.
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.
To ensure a submission can be accepted by the PPHS office, the following must be true:
- The personnel listed on HRP-211 are the same as the persons listed under the IF# in Sinai Central.
- The current versions of all forms and templates are used.
- 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).
- An InfoEd submission has been started.
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:
Once you are signed up for Yammer, visit this link to join the Ideate conversation:
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.
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.
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: email@example.com). 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 firstname.lastname@example.org.
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 email@example.com.