Changes to Human Subjects Certificates of Confidentiality

As previously indicated in communication from the Program for the Protection of Human Subjects (PPHS), all NIH funded protocols that were active on December 31, 2016 (or commenced after that date) and involve human subjects, activities using or generating identifiable human subject data or samples, or the generation of individual level, human genomic data was automatically granted a certificate of confidentiality (CoC) by the NIH, effective October 1, 2017 (Please see the PPHS announcement for details).

In order to assure that the affected participants in qualifying protocols have been, or will be, notified, the PPHS requires that the Principal Investigator submit a copy of the Investigator’s CoC Notification Form for each protocol that received a CoC on October 1, 2017. While it is not required that the plan be fully executed at this time, it is important that the form(s) acknowledging that the plan is being implemented are sent to IRB@mssm.edu as soon as possible, if not done so already.

The PPHS has drafted a letter describing the pertinent information for participants (Spanish translation available upon request); however, research teams that choose to mail/email the letter to participants must also draft a cover letter reminding participants of the study and providing contact information for the study team in the event the participants may have questions. Please note that the original deadline for sending the letter to all participants, or notifying the PPHS that the task has not yet been completed was October 31, 2017.

If you have chosen to contact participants directly (e.g. phone, in-person), you should still complete the Investigator’s CoC Notification Form as soon as possible, if not done so already. If you have not spoken with all participants by November 30, 2017, you will need to re-contact the PPHS with an update on your progress.

If you have not already completed the above mentioned steps, please submit the Investigator’s CoC Notification Form upon receipt of this email, and reference the Guidance and Policies section of the PPHS website for additional details.

 

Discovering and Describing New De-Identified Cohorts of Patients with i2b2 Framework

The Mount Sinai Scientific Computing and Data Science team has launched training resources via PEAK to take researchers step-by-step through the i2b2 (Informatics for Integrating Biology & the Bedside) program, preparing them to take advantage of this cost-effective and efficient way to identify patients for many types of clinical and translational research. The i2b2 framework was developed through NIH funding to make research cohort discovery possible through the integration, standardization, and analysis of heterogeneous data from electronic health record systems. The implementation of i2b2 at the Mount Sinai Health System is supported by ConduITS, the Institutes for Translational Sciences and Mount Sinai’s CTSA (an NIH|NCATS Clinical and Translational Science Award).

To access the training on PEAK, simply click here, or head over to peak.mountsinai.org, sign in and search for “i2b2.” It’s also available through clicking on Online Courses, navigating to Research and clicking on the i2b2 Tutorial.

With an easy to use, drag-and-drop interface, i2b2 enables researchers to query a repository of patient information gathered from multiple sources throughout the Mount Sinai Health System, including electronic medical records, lab results, and demographic data. Using de-identified data, investigators can determine potential cohorts of interest for later obtaining identified or limited data sets with Institutional Review Board (IRB) approval. For more information about the IRB approval process, contact irb@mssm.edu.

This web-based tool works on Windows and Mac, on multiple browsers (Firefox, Internet Explorer, Safari, and Google Chrome) within the Mount Sinai network (on campus or via VPN). Data is uploaded from the Mount Sinai Data Warehouse on a regular basis, but only de-identified data can be accessed through the web client. Mount Sinai researchers can perform queries at http://msdw.mountsinai.org/webclient.

Please email i2b2_support@mountsinai.org with questions or comments.

 

Must See Videos and Podcasts for Human Subjects Researchers

The Grants and Contracts Office (GCO) strongly recommends that human subjects researchers take advantage of educational resources issued by the National Institutes of Health (NIH) to inform grants applications submitted for due dates on or after January 25, 2018.

A primary component of NIH’s initiative to enhance the stewardship of clinical trials is the creation of a new application form that consolidates all Human Subjects and Clinical Trial related information into one place, and also expands the information required for studies that meet the NIH definition of a clinical trial. This new form will be included in the new FORMS-E Application Packages and will be required for all applications with due dates on or after January 25, 2018.

To support this endeavor for Mount Sinai Health System (MSHS) researchers, the GCO would like to highlight the following NIH resources:

To learn more about the new Human Subjects and Clinical Trial Information form which will be included in grant application packages and contract for all human subjects and/or clinical trial research applications beginning for January 25, 2018 due dates, visit the NIH New Human Subjects and Clinical Trial Information Form web site.

For more information about conducting human subjects research at MSHS, please contact the Program for the Protection of Human Subjects.

For more information about NIH grant submissions at MSHS, please click here for a listing of Departmental Grants Specialists at the GCO who can assist you.

 

ISMMS IRB to Review Beth Israel Human Research

As part of the continuing efforts of the Icahn School of Medicine at Mount Sinai (ISMMS) to streamline and unify the submission process to the Institutional Review Boards (IRBs) throughout the system, the Program for the Protection of Human Subjects (PPHS) is pleased to announce that effective May 30, 2017, all Beth Israel human research applications will now follow the ISMMS submission deadline schedule found on the Researcher page on the PPHS website.  With this integration, the ability for the IRB to review projects weekly rather than monthly will assist in improved turn-around times.

As a reminder all initial applications require an e-submission through Ideate.  If the project was originally submitted in Ideate, its continuation application, any modification submissions, and its final report will also be submitted through Ideate.

For projects that did not begin in Ideate, they will continue to be submitted to IRB@mssm.edu.

As always, the PPHS appreciates your attention to this matter and all that 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.

If you have any questions related to the changes above please call the PPHS/IRB office at 212-824-8200.

 

NCATS SMART IRB Online Reliance System Beta Launch

The National Center for Advancing Translational Sciences (NCATS) launched the SMART IRB to provide standard operating procedures to facilitate a single IRB model for multi-site studies.  All 64 CTSA hubs across the country have signed on to SMART IRB including ConduITS, Icahn School of Medicine’s Institutes of Translational Sciences, as well as a number of academic sites that are not in the CTSA network (~180 to date).

Freely available for institutions and investigators, SMART IRB is an integrated, comprehensive platform that allows flexibility in the size and scope of collaboration to enable IRB reliance for multi-site studies across the nation, regardless of funding status. Interested MSHS researchers must contact the Program for the Protection of Human Subjects (PPHS), which supports ISMMS’s participation in the SMART IRB initiative and has procedures to work with the SMART IRB as a Relying institution. In order to initiate SMART IRB review, researchers must go through the ISMMS PPHS Ideate electronic submission system.

The SMART IRB Online Reliance System is a unique tool that helps institutions establish and document single IRB review arrangements. By using this system:

  • Investigators can create and submit requests to use a single IRB for their studies.
  • Collaborating institutions can work together to identify a Reviewing IRB and track and document reliance arrangements on a study-by-study basis.
  • Users have a clear understanding of next steps and are notified when action is required.

The SMART IRB Online Reliance System became available in beta on May 4, 2017. For more information about using the SMART IRB system at MSHS, email irb@mssm.edu.

 

IRB Guidance and Best Practice on Depositing Data Into Large Databases

Increasingly the NIH and other federal funding sources insist that data, especially genomic data, generated in research are put into large nationally accessible databases. If a repository is funded by NIH (such as dbGAP or dbSNP), there are very particular specifications that must be met before researchers can deposit data. Per the requirements of the NIH, the IRB needs to be able to certify certain things. In order to do so, researchers need to have specific information in the protocol regarding the data sharing plan and language in the consent form describing what the researcher is doing with the data, the risks unique to depositing large amounts of genetic data, and what it means to have one’s data in such a database. While this article highlights work funded by NIH and other federal sources, the IRB supports a single standard approach and regardless of funding, suggests all projects meet the criteria listed below if depositing data into repositories. Links to the NIH Policy are at the bottom of this article.

If researchers plan to deposit data into large databases, a clear statement regarding deposits must be in the consent form and best practice is to include an option for subjects to agree/not agree to this use of their research data in the consent form.

Please read this information carefully and keep the suggested language available when crafting consent forms.  It is recommended that you modify your current project and consent forms if your vision is/was to share data and you don’t currently have that process approved in your project.      

Data sharing plans include data type, data repositories to which data will be submitted, appropriate uses of the data and limitations on the future use or an exception to submission which explains why the Institutional Certification criteria cannot be met and must describe an alternative mechanism for data sharing. Please see The NIH Guidance for Investigators in Developing Genomic Data Sharing Plans for more information.

If you are planning on depositing data into a large-scale repository, NIH requires the IRB must assure certain criteria are met:

  1. The protocol for the collection of data is consistent with 45 CFR 46;
  2. Data submission and subsequent data sharing for research purposes are consistent with the informed consent of study participants from whom the data were obtained;
  3. Consideration was given to risks to individual participants and their families associated with data submitted to NIH-designated data repositories and subsequent sharing;
  4. To the extent relevant and possible, consideration was given to risks to groups or populations associated with submitting data to NIH-data repositories and subsequent sharing; and
  5. The investigator’s plan for de-identifying datasets is consistent with the standards outlined in the GDS (Genomic Data Sharing) Policy.

In order for the IRB to make the assurance, it needs to review the protocol, data sharing plan details, and informed consent document.

The protocol needs to include information about the data sharing, future use and deposits to repositories, in addition to statements about the potential privacy risks to the subjects and their families (as well as to their kin group or population, if a specific population or group is being targeted or investigated).

The informed consent document must include detailed information about future use including what data will be shared, with whom and for what purposes. In addition to detailed future use language, the following language must be used:

 

IRB Approved Language for Consent Form(s):

Under Description

To do more powerful research, it is helpful for researchers to share information they get from studying human samples. They do this by putting it into one or more scientific databases, where it is stored along with information from other studies. Researchers can then study the combined information to learn even more about health and disease. If you agree to take part in this study, some of your genetic and health information might be placed into one or more scientific databases. There are many different kinds of scientific databases; some are maintained by [institution], some are maintained by the federal government, and some are maintained by private companies. For example, the National Institutes of Health (an agency of the federal government) maintains a database called “dbGaP.” A researcher who wants to study the information must apply to the database. Different databases may have different ways of reviewing such requests. Researchers with an approved study may be able to see and use your information, along with that from many other people. Your name and other information that could directly identify you (such as address or social security number) will never be placed into a scientific database. However, because your genetic information is unique to you, there is a small chance that someone could trace it back to you. The risk of this happening is very small, but may grow in the future. Researchers will always have a duty to protect your privacy and to keep your information confidential.


Under Risks

Group Risks
Although we will not give researchers your name, we will give them basic information such as your race, ethnic group, and sex. This information helps researchers learn whether the factors that lead to health problems are the same in different groups of people. It is possible that such findings could one day help people of the same race, ethnic group, or sex as you. However, they could also be used to support harmful stereotypes or even promote discrimination.

Privacy Risks
Your name and other information that could directly identify you (such as address or social security number) will never be placed into a scientific database. However, because your genetic information is unique to you, there is a small chance that someone could trace it back to you. The risk of this happening is very small, but may grow in the future.  Since the database includes genetic information, a break in security may also pose a potential risk to blood relatives as well as yourself. For example, it could be used to make it harder for you (or a relative) to get or keep a job or insurance.  If your private information was misused it is possible you would also experience other harms, such as stress, anxiety, stigmatization, or embarrassment from revealing information about your family relationships, ethnic heritage, or health conditions.

There is a Federal law called the Genetic Information Nondiscrimination Act (GINA). In general, this law makes it illegal for health insurance companies, group health plans, and most large employers to discriminate against you based on your genetic information.  However, it does not protect you against discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.

For more information on the GDS policy, data use limitations, writing data sharing plans, and more visit  https://gds.nih.gov/06researchers1.html.

For Guidance on Future Use and Large-Scale repository considerations from the PPHS, please refer to PPHS Guidance.

 

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.

 

PPHS Takes Steps to a Uniform and Integrated Submission Process

The Program for the Protection of Human Subjects (PPHS) Office reports the following updates to the integration of IRB operations across the Mount Sinai Health System (MSHS), and the ongoing implementation of IDEATE, Mount Sinai’s new electronic system for research application submissions.  Together, these policy changes and the establishment of IDEATE will create a more uniform and efficient process for starting a human subject research project.

 Effective immediately:

  • The 229R Reliance form is no longer required for multisite research.  For research occurring at more than one Mount Sinai Health System site, the PPHS Office will accept the System Chair’s signature as approval for all sites. The System Chair can designate this signing authority, and only one signature will be required regardless.  This signature is currently affixed to the HRP-211 form, but this will change as the PPHS further integrates our processes into IDEATE.
  • All federally funded projects will be submitted through the PPHS Office, regardless of the project’s Health System site of origin. This change will support a more streamlined submission process and allow for better coordination of grant approvals with federal agencies.
  • All new multisite projects involving Icahn School of Medicine at Mount Sinai and/or The Mount Sinai Hospital will be submitted to the PPHS Office, either through the current process or IDEATE, when applicable.  Applications for these multisite projects should not be submitted to another Health System site for review. Initial expedited projects will be submitted through IDEATE as the new system is rolled out to each department.  The PPHS Office has already made this change with select departments, whose investigators will now submit all initial expedited projects through IDEATE, regardless of the project’s Health System site of origin.  As more departments begin using IDEATE for project submissions, they will also use the new system for research at all Health System sites.  As the IDEATE rollout schedule accelerates, the PPHS Office will work closely with each department as they adopt the IDEATE submission process for initial expedited projects.
  • All Exempt projects to be conducted at any site within the Health System will be submitted through IDEATE.
  • Full Board projects will be submitted through IDEATE on a pilot basis over the next several weeks to ensure a smooth transition process.  It is anticipated that all Full Board projects will be submitted through IDEATE beginning Q3 2016. If you are interested in using your Full Board project for the IDEATE pilot, please contact me at lori.jennex@mssm.edu or (212) 824-8203.

 Projects not impacted by the changes above at this time:

  • Multisite projects that do not involve Icahn School of Medicine at Mount Sinai and/or The Mount Sinai Hospital should be submitted to the IRB of the Health System site where the majority of human subject interventions will take place (e.g., Mount Sinai Beth Israel).
  • Single site, non-federally funded Full Board projects should continue to be submitted to that Health System site’s IRB.

Making Changes to Research Personnel in IRB Submissions

The Program for the Protection of Human Subjects (PPHS) is releasing a new guidance document this week that clarifies their procedures regarding the change of research personnel. To better serve researchers and their staff, this guidance has been broken down into three easy-to-understand categories, contact person, personnel changes that require IRB review and approval prior to their implementation, and personnel changes that do not require IRB review and approval prior to their implementation.

Researchers and staff will be able to quickly determine what category applies to their change using clear and concise lists. From there, they can determine their next steps and obligations. Make sure to keep an eye on the PPHS’ Researcher’s Palette, Guidance and Policies to obtain the latest guidance on this and all other IRB-related requirements.

For more information, contact Liz Carroll, Assistant Director of Regulatory Affairs of the PPHS.

 

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.