News & Announcements

August 19, 2021

Research Activation

Effective August 16, 2021, safety protocols related to conducting human subjects research during the pandemic, will be reviewed by the Human Research Protection Program (HRPP) before the IRB review. In certain circumstances, the HRPP will consult with the representatives from the Office of Environmental Health and Safety, Off Campus Research and Fieldwork Committee, and Human Subjects Research Review Committee, who have conducted these reviews since the beginning of the research reactivation phase.

Investigators will submit safety plans in IRES IRB, the HRPP electronic system. EHS Integrator will no longer be used for this purpose.

Instructions

  • Investigator must complete ‘Supplement to IRB Submission and Requests to Use External IRB – Safety During Pandemic’ form available in Other Forms tab in IRES IRB Library. Exception: investigators conducting secondary data analysis research and clinicians requesting an emergency use of a test article or device do not need to complete this form. 
  • The form should be uploaded as a supporting document along with the research documentation and submitted in IRES IRB.
  • The HRPP will contact the investigator and primary contact for the study within 2 business days should there be any questions about the proposed safety plan.
  • Once the safety plan is accepted, the study will proceed to the IRB for review or will receive authorization to use external IRB.

August 7, 2021

IRES IRB Upgrade

The IRB and HRPP electronic system, IRES IRB, is scheduled to undergo an upgrade to the most recent version of the system. The upgrade is scheduled to begin after 5 pm on Thursday, August 12th. It should become available to users on Tuesday, August 17th, mid-afternoon hours. There will be no access to IRES IRB between these dates.

There is no change in the schedule of the IRB meetings. In case of emergencies and urgent actions that require IRB approval, contact the HRPP office at hrpp@yale.edu. The IRB will be able to conduct urgent reviews during the time the system is down.

What changes to expect

There are three types of changes that are being implemented: changes to navigation, changes in questions on pages in the electronic submission, and changes to the submission and reviews processes. Examples of some of these changes are listed below:

  1. Navigation
    • My Inbox moves to a tab called Dashboard
    • Shortcuts to Library, Help Center, IRB Submissions, IRB Reports move from Menu on the left side to the top of the screen
    • The study record shows a MENU of all pages on the left side of the screen to visually represent progress while completing the electronic application
    • Overall feel and look of the system is changed to allow for an easier navigation
  2. Screens
    • Questions are removed from several pages of the electronic application
    • A new page with research location is added
    • New questions regarding repositories and sharing of the specimens are added
    • Supporting Documents page is consolidated with local consent and recruitment materials page
  3. Processes
    • Changes are introduced to the process for requesting use of external IRBs and updating the system after the study is approved by the external IRB
    • Several minor changes are made to the internal IRB processes with no impact to the researchers

First Actions after the Upgrade

The upgraded system will include new questions on two existing study screens (Study Scope and Use of Technology in Research) and a new page (Local Research Locations). The estimated time to answer these questions is less than 5 minutes. Investigators will need to provide answers to the new questions and verify information on the new page at the time of the first modification on the protocol or before any pending modification or initial study receives IRB approval. A new function called ‘Validate’ is available to help identify missing answers throughout the electronic application. See below for details:

First Modification, Continuing Review with Modification, Study Update on an approved protocol

Before submitting these actions to the IRB, go through all screens to verify and correct the information on all pages. Answer any missing questions.

First Continuing Review on an approved protocol

No changes can be made to the protocol record at the time of continuing review. If you wish to provide answers to the newly added questions, you will need to create Continuing Review and Modification. Pending Continuing Reviews will be processed as usual.

Modifications, Continuing Review with Modifications, and Initial Submissions pending IRB review

You will be asked by the IRB and HRPP staff to provide answers to the newly added questions before the IRB approval is issued. If the submission receives a determination of Modifications Required to Secure Approval or Deferral, you will need to answer the new questions before submitting your response in IRES IRB.

Updates to studies under external IRB purview

Any pending update to the study under an external IRB purview will be discarded at the time of the upgrade. Updates currently pending HRPP acknowledgment that cannot be successfully processed prior to the upgrade (as a result of a pending ancillary review) will be recreated on behalf of the PI after the upgrade.

Training

Recorded sessions on changes in the new system and revised quick guides will be available on the HRPP website prior to the upgrade. They will also be posted in the Help Center in IRES IRB once the upgrade is completed.

There are two different types of live training sessions available via Zoom throughout the end of August:

  • Changes in IRES IRB for studies under Yale IRB purview
  • Changes in IRES IRB for studies under External IRB purview

Registration is available through Training Management System.

Sessions on using IRES IRB for individuals who have not used the system before will resume in September.

May 1, 2021

Procedure on Research Staff Engaged in Research Projects

Effective May 1, 2021 a new procedure was published regarding listing research staff members in the IRES IRB record

The research record in the IRB electronic system, IRES IRB, must include the names of at least the following team members engaged in human subjects research under Yale IRB or HRPP purview:

  • Principal Investigator (PI),
  • PI Proxy, if one is identified for the study,
  • Investigators,
  • Individuals external to Yale who require a reliance agreement OR Unaffiliated Investigator Agreement, and
  • Other members of the research team who report financial interests related to the research.

Team members who do not meet these criteria do not need to be listed in IRES IRB.

If the Principal Investigator wishes to list all of the members of the research team in IRES IRB, the study team members page in the system includes a selection of available roles to further describe research roles of each individual.

Note: The IRB can always require listing additional members of the research team.

September 1, 2020

September Updates

Effective September 1, 2020, the following changes are being implemented to the HRPP and IRB practices:

  1. The Yale IRB increase number of meeting from a minimum of 10 times per month to meeting a minimum of 20 times per month by adding new IRB panels;
  2. New submission deadlines are being introduced;
  3. Watermarking of documents practice is revised so that the approval watermark will no longer be applied at the time of IRB approval of the continuing review;
  4. The dates for the second and all subsequent continuing reviews of research will be based on the date the continuing review is approved (with or without modifications) by the IRB.

View the detailed announcement that was sent to the research community on September 1, 2020.

July 7, 2020

Release of New IRB and HRPP Documents

This notice describes changes to the existing IRB documents and changes that have been implemented in July 2020 to the HRPP and IRB processes. Please contact the hrpp@yale.edu with any questions regarding the changes and how it will affect your research.

Summary

July releases:

  1. New to Yale IRB
  2. New Protocol Templates and access to a Protocol Builder too
  3. Revised Consent Glossary
  4. Parental Permission and Assent Forms
  5. Certificate of Confidentiality Quick Guide

Detailed Description

New Yale IRB Submission Form

Change

The previous version of the submission form, called Yale Site Addendum, is no longer be available in IRES IRB for use as of Monday, July 12, 2020. A revised submission form will be posted in IRES IRB. The new document consists of required sections that must be completed for all submissions of non-exempt research to Yale IRB and supplemental sections that are required only for certain types of research. The form includes extensive guidance and walks investigators through some of the more complicated regulatory requirements (e.g. FDA regulated research with devices, etc.). A recorded training will be posted later in the summer.

What this means for your research

The new Submission Form must be used for all new non-exempt research regardless of funding and uploaded in the Supporting Documents page in IRES IRB. Research already approved is considered grandfathered-in and does not require researchers to submit the new form.

If you already started completing the existing Yale Site Addendum for an initial submission that has not been sent for IRB review, you can still use that document for the next 3 months. However, Yale IRB will stop accepting initial submissions utilizing the outdated form on October 19, 2020

New Protocol Templates and Protocol Builder access

Change

A well though-out and well-written research protocol leads to better quality research and makes the IRB review processes more efficient. To help Yale investigators develop quality investigator-initiated research protocols, the following is available to all investigators:

New word versions of protocol templates in IRES IRB for researchers to use without use of any additional software:

  • Research with Devices
  • Research with Drugs
  • Observational Study of Individual or Group
  • Repository
  • Social-Behavioral Research

A new Protocol Builder tool to help develop protocols. (The use of this tool is not required.)

  • YCCI and HRPP acquired a license to Protocol Builder, a web-based application that offers a wide range of protocol templates that can be utilized by researchers conducting biomedical and social, behavioral, and education research studies. Protocol Builder can be assessed by any member of Yale with an active Yale netID at https://app.protocolbuilderpro.com/register/yale-university. Once you complete a protocol in Protocol Builder, you can generate a WORD or PDF file of the document and upload the document into the IRES IRB system.

Other publicly available templates such as the following:

  • National Institutes of Health (NIH) e-Protocol Writing Tool or word versions of the NIH templates for Phase 2 or 3 clinical trials that require Investigational New Drug applications (IND) or Investigational Device Exemption (IDE) applications and Behavioral and social sciences research; and
  • Protocol templates available via TransCelerate suite. You can learn more about the Clinical Content and Reuse Initiative, which made the sharing of common protocol template and statistical analysis plans possible, by watching a video created by TransCelerate.

Yale does not require a use of a specific protocol format as long as all of the elements of a research protocol are included in the document.

What this means for your research
The Yale HRPP and IRB will continue accepting protocols authored by external entities such as cooperative groups or industry sponsors. In addition, previously approved IRB approved research does not need to be transferred to the new Protocol Template.

The previous versions of the non-exempt biomedical and social behavioral research protocol forms are no longer be available on IRES IRB for use as of July 12, 2020. Because we recognize that it is a significant change for researchers and research coordinators you may continue to use an older version of the protocol application (and submission form) for 3 months. Yale IRB will stop accepting initial submissions utilizing the outdated templates on October 19, 2020. Again, previously approved studies are considered grandfathered-in and no changes are necessary.

Training

Protocol Builder offers instructional videos and training that can accessed when you log in. A webinar for Yale users will be offered early in the fall. It will be recorded and posted on the Protocol Builder page. You will be notified about the exact date.

Where you can direct your questions
If you have questions about this new resource, you can contact HRPP Office at hrpp@yale.edu. If you have technical questions about how to use Protocol Builder, please contact their customer support at 844-563-1042.

Revised Consent Glossary

A revised Consent Glossary with new suggested language and numbering is available in the Consent Forms tab in the Library section of IRES IRB. Refer to the glossary when drafting consent forms for human subjects research.

Parental Permission and Adolescent Assent Forms

The Parental Permission form was revised to meet the regulatory standards of 2018 regulations. The Adolescent Assent form was also revised to offer simplified language accessible to adolescent participants in research studies. No changes are required for ongoing, IRB approved research. Both templates are available in the Consent Forms tab in the Library section of IRES IRB.

Certificate of Confidentiality Quick Guide

As a result of recent changes to the process of applying for a Certificate of Confidentiality from NIH for non-NIH funded studies, the HRPP created a quick guide on the topic. It provides researchers with information needed to submit a request for a Certificate of Confidentiality. It is available in the Handbooks and Manuals tab of the IRES IRB Library.

If you have any questions about this notification, please, contact Yale HRPP.


April 28, 2020

Yale COVID-19 Human Subjects Research Oversight Committee Process

Yale University is committed to conducting research on COVID-19 to combat the ongoing Pandemic. To streamline and fast track study activation and implementation, Yale established a COVID-19 Human Subjects Research Oversight Committee process. The announcement about the process was sent to the research community. Questions should be sent to Yale Clinical Research Resources team at clinicalresearchresources@yale.edu. Additional information is available on the Yale COVID-19 page (“Research, Clinical & Data Driven Responses to COVID-19”)

-