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.

 

Epic for Research Participant Recruitment

The Office of Research Services (ORS) and the Epic Clinical Transformation Group are pleased to invite the Mount Sinai clinical research community to unlock the potential of the Epic Electronic Health Record (EHR) system for clinical research subject recruitment. Originally piloted by the Clinical Trials Office of Tisch Cancer Institute (TCI), Epic Clinical Trial Alerts (CTAs) can help make a meaningful match between clinical researchers and clinicians who have recently seen potentially eligible subjects for their studies.

Epic CTAs create alerts, visible to care providers at the point of care, in the Epic EHR for patients matching screening criteria for a clinical trial. The provider can then discuss with the patient and choose “yes, interested” in which case an inbox message is sent in Epic to the designated research personnel. The patient will then be contacted to discuss the trial further and obtain consent.

Myeloproliferative disorders (MPD) are a group of slow-growing blood cancers in which large quantities of abnormal red blood cells, white blood cells, or platelets grow and spread in the bone marrow. The MPD Program at TCI is one of few comprehensive, multidisciplinary programs in the Northeast offering extraordinary expertise and personalized treatments, backed by extensive research and clinical trials. The Cancer Clinical Trial Office’s MPD Research Program was able to identify 65 additional eligible patients, of which 13 were successfully enrolled in a clinical trial. This EHR CTA pilot accounted for 23% of the new subjects enrolled into MPD therapeutic clinical trials.

For more information, visit http://icahn.mssm.edu/research/resources/office-of-clinical-research/research-subject-recruitment-tools/epic-for-research-participant-recruitment, or Mount Sinai Health System researchers can also contact Joseph Kannry, MD, Lead Technical Informaticist, for further details or with questions about the functionality being offered via the Epic EMR.

 

E-Prescribing Study Medications to the Investigational Drug Service

The Investigational Drug Service (IDS) has implemented e-prescribing for clinical trials. Investigators may electronically prescribe ambulatory medications for outpatient trials to the Investigational Drug Service at Mount Sinai Hospital. There are several advantages to this system. For example, medication orders are linked to GCO numbers in order to avoid protocol deviations. In addition, study-specific templates may be pre-built for the user’s convenience to be updated at the time the order is placed. Please note, if a researcher is e-prescribing controlled substances, they will need to go through an enrollment process to gain the appropriate level of permission to proceed, which can be arranged via their designated department’s enrollment supervisor.

When e-prescribing for research, please take note of the following:

  • Enter the GCO number of the study (GCO#xx-xxxx) into the medication field.
  • Indicate the date due after the directions for use.
  • Refills are NOT authorized for investigational agents.
  • Select Mount Sinai Hospital Pharmacy (ID#74819) by searching “IDS” or “Investigational” or “Mount Sinai” or “Mount Sinai Research.”

This new process has been put into place in anticipation of the New York State’s mandate effective March 27, 2016. Although these regulations do not apply to investigational medications, Mount Sinai Hospital wanted to offer the service to the research community.

For more information about e-prescribing within the Mount Sinai Health System, visit the EPCS Intranet, email the project team: EPCSquestions@mountsinai.org, or contact the IDS at 212-241-2437.

If you have further questions about the e-prescribing mandate, please contact the NY State Bureau of Narcotic Enforcement. Contact information can be found online.

IRB Grand Rounds Returns in Spring

The Program for the Protection of Human Subjects (PPHS) cordially invites you to the latest IRB Grand Rounds, “Ring, Ring – Plan to Phone Screen?,” on April 20th at 12pm in Hatch Auditorium. This session offers insights and expertise from Glenn Martin, MD, DFAPA, CIP, who will be covering the policies and practices of screening potential human subjects in research.

Dr. Martin serves as Senior Associate Dean for Human Subjects Research and Executive Director for the PPHS. Originally appointed as an Institutional Review Board (IRB) member in 1996, Dr. Martin’s commitment to the protection of human subjects has spanned decades. Dr. Martin specializes in ethics in clinical research and lectures to ISMMS medical and graduate students, psychiatry residents at Elmhurst Hospital Center, and trainees at other institutions.  He also conducts patient privacy and research presentations for the entire ISMMS research community.

 

Ideate Now Available for Initial Expedited Projects

In a continued effort to support the clinical research community, the Program for the Protection of Human Subjects (PPHS) is offering researchers an opportunity to use Ideate now for Initial (new) Expedited project submissions to the IRB.

Ideate is an advanced, logic-driven, user-friendly system that is specifically designed to simplify and expedite the research application submission process for investigators and research personnel.

Please contact Lori Jennex (lori.jennex@mssm.edu) directly to discuss this opportunity.

 

IRB Standardization of Processes Across MSHS

The PPHS and the IRB offices at the Mount Sinai Health System sites have been successfully integrating policies, practices, and forms this year. Below are some key policies and processes that have been adopted by all sites:

  1. Consent process, policies, and template:
    • In April 2015, a system-wide consent template was introduced and became mandatory throughout the system on May 1, 2015. All informed consent documents should be on the 4/1/15 template version.
    • In October, 2015:
      • The HIV in Research Consent must be used when HIV testing will occur within the research setting, including as part of screening for a research study.
      • Consent documents for storing data/specimens will use the same future use language boilerplate.
      • Consent documents when depositing data/specimens in large repositories will use the same boilerplate language. (See Guidance on Future Use and GWAS)
    • In August, 2015:
      • all sites adopted the ISMMS/MSH Phone consent process for minimal risk research when collecting PHI.
  2. Policies:
    • Short Form Consent Policy. In August, all sites adopted the ISMMS/MSH Short Form Consent Policy. All requests must be made in advance to IRB@mssm.edu. Each request is evaluated on a case-by-case basis. (It is rare that a fully translated consent document is not required; ad hoc translation is not allowed).
    • Policy on use of external IRBs. In July, all sites agreed to allow for the use of commercial IRBs. These remain limited to specific types of projects and are evaluated on a case-by-case basis. All requests to use a commercial IRB must be sent to IRB@mssm.edu using HRP-229A. There is a one-time administrative set up fee of $575 for industry sponsored research permitted to use a commercial IRB for the official IRB review of the study. For additional information, please review the Use of Commercial IRBs under Guidelines and Policies
  3. Guidance documents:
    • Recruitment methods (revised 10/7/15)
    • Screening guidance

As always, we appreciate all you do to protect the research volunteers who agree to take part in the research conducted by Investigators working within the Mount Sinai Health System.

 

New Pre-screening Feature in ResearchMatch

ResearchMatch.org, the free, disease neutral, and secure registry of research study volunteers that is available to the Mount Sinai research community, has announced the launch of a new pre-screening feature for new and existing studies!

  • Now in addition to contacting volunteers with their IRB approved ResearchMatch ad, researchers will have the option of including a link to a REDCap pre-screening survey.
  • This allows them to pre-screen potential volunteers from the list of people that they contact.
  • Prescreening surveys must be created in REDCap and must be IRB approved.
  • The URL for the survey is simply uploaded into ResearchMatch when they upload their IRB ResearchMatch ad.

What will the potential volunteer see?

  • When the volunteer clicks “yes” on the confirmation page, they will then be redirected to the REDCap survey in question.
  • Their submitted survey goes directly to the researcher.
  • ResearchMatch will add that volunteer to the list on the Researchers Enrollment Continuum and mark them as ‘contact in process’.

What do the researchers need to do next?

  • Create a concise REDCap prescreening survey that will allow them to filter potential volunteers.
  • Ask for IRB approval. The questions must relate to the IRB approved study and should ask volunteers to provide their name and email in the survey for tracking.
  • Next time you use ResearchMatch for recruiting, add your new URL!

For questions, contact the Vanderbilt ResearchMatch Liaisons at info@researchmatch.org or Madrid Poultney, the Mount Sinai Institutional Liaison, at madrid.poultney@mssm.edu. For assistance with REDCap, contact Evie Andreopoulos at evie.andreopoulos@mountsinai.org.

Sign up for ResearchMatch training at https://www.researchmatch.org/researcher-training.

 

All MSHS Sites Allowed to Use Commercial IRBs

In July, the Program for the Protection of Human Subjects (PPHS) announced that all sites within the Mount Sinai Health System can use commercial IRBs in accordance with the Icahn School of Medicine at Mount Sinai’s policy.

All requests to use a commercial IRB must be sent to IRB@mssm.edu using HRP-229A.  The PPHS office must approve any request to submit an application to the commercial IRB.  While the official IRB review will then be conducted by the external IRB, all other institutional requirements must be met. These are including but not limited to Investigational Drug Service review, Radiation Safety Committee review, submission to the Grants and Contracts Office, Conflict of Interest disclosure and management, and fulfillment of education requirements.  Requests will be evaluated to ensure these institutional requirements have been met before a study team will be granted permission to move forward with their application.

There is a one-time administrative set up fee of $575 for industry sponsored research permitted to use a commercial IRB for the official IRB review of the study.

The 229A form is available on the Forms and Documents Kiosk on the PPHS website.

For additional information, please review the Use of Commercial IRBs under Guidance and Policies.

After reviewing the 229A form and Commercial IRB guidance and policies, if you have questions about the policy and if your study might qualify, please contact Liz Carroll at liz.carroll@mssm.edu or 212-824-8225.

 

New Consent Templates Required for PPHS/IRB Submissions

As of Friday, May 1, 2015, the Program for the Protection of Human Subjects (PPHS) began requiring the use of new consent templates, version date 4/1/2015, for IRB submissions. Version date 4/1/2015 templates highlight the ongoing efforts of the PPHS team to implement the usage of Mount Sinai Health System documents, replacing different site specific boilerplate language with a unified template. In addition, the HIPAA section of the templates has been revised to incorporate all hospitals within the Health System and eliminates the need for stand-alone HIPAA documents for each hospital engaged in the research.

The updated consent forms are now mandatory for the following submissions:

  • initial submissions to the PPHS,
  • continuation submissions still active to future enrollment (Note, the currently approved consent document must be transferred over to the latest version even if there are no other changes being requested.), and
  • modification submissions affecting the consent template.

Research teams can obtain the latest document templates on the PPHS website, in the Forms and Documents Kiosk under “Consent Templates.” For a detailed account of the changes made to these documents, the PPHS has made “tracked changes” versions of the documents available at the top of the page, along with a PDF history of changes, entitled “PPHS Forms and Documents Version Revision History.”

For more information about PPHS templates, procedures, and policies, or if you have questions about these changes, contact the PPHS Office at irb@mssm.edu or 212-824-8200.

The PPHS Introduces a Short Form Consent Process

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.