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.

 

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.

 

Good Clinical Practice Refresher Course Now Available Through CITI Program

In response to a growing interest in the Good Clinical Practice (GCP) Refresher course, the Program for the Protection of Human Subjects (PPHS) has now made a refresher course available via the CITI program for Icahn School of Medicine at Mount Sinai. Although there has been no change in institutional requirements, the PPHS wanted to make it easier for those who work on studies with external sponsors who require completion of a GCP Refresher every three years to conveniently get it.

What you need to know:

  • The GCP basic course name has been updated to GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus), which is the necessary precursor for the GCP Refresher.
  • All credits transferred from the GCP course, so no one lost any credits due to this change.
  • The GCP course now indicates that it expires every three years, enabling one to take the GCP Refresher course to comply with sponsor requirements.
  • The PPHS office is not mandating this additional course (the refresher).

If you completed the GCP course over three years ago, when you log in to https://www.citiprogram.org/ your main page will indicate that you have incomplete coursework. If your sponsor requires a refresher every three years you can access it here. If your sponsor does not require the Refresher course, you can confirm your training status by clicking “View Previously Completed Coursework” under “My Learner Tools for Icahn School of Medicine at Mount Sinai.” You will be directed to a screen that includes the Basic Course. By clicking on “View” in the “Completion Report” column, you can print or save proof of your completion.

If you have any questions about this new resource or PPHS training requirements, contact the PPHS at irb@mssm.edu.

 

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.

 

IDEATE Electronic Submissions System for Human Subjects Research Rollout Plan Announced

After more than a year of analysis, research, and planning, the Program for the Protection of Human Subjects (PPHS), in cooperation with Research Information Technology (IT) and the Research Administration Reengineering Program, began implementation of a new electronic submission process for human subject protocols using a software program called Ideate, which will ultimately replace current research submission processes, including InfoEd. Currently, only the IACUC office uses Ideate for reviewing and approving protocols, but eventually all of the research administration offices (including PPHS) will use it and review a single application. Ideate has been customized for the School’s research administrative offices to be an integrated, user-friendly online form that will significantly improve the protocol submission process for investigators and research personnel.

Research Information Technology plans to roll out this exciting system gradually to ensure the system has adequate performance and functionality for every department. It is being implemented in stages for human subject protocols according to this schedule, which was distributed to the research community in May. Exempt applications began migrating to Ideate, effective May 1, 2015, and their migration will be completed by early June 2015. Expedited projects will be submitted through Ideate by August 2015. Finally, Full Board projects will be the last stage of the Ideate rollout for human subjects research, with an anticipated completion in November 2015.

Research personnel and investigators should refer to the Rollout Schedule for their departments’ listings and plan accordingly based on the kind of project they and their research staff will be submitting. The PPHS and Research IT are committed to working closely with research teams, department by department, to provide additional details and assistance as their rollout dates approach.

The PPHS team encourages your feedback over the next several months, as they make this system robust and fix the emerging issues, and thank you in advance for your support during the rollout process. If you have any questions or concerns, please contact the PPHS office at IRB@mssm.edu or call (212) 824-8200.

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.

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