Monthly News & Updates

November 2023 Issue

Please visit the HRPP Website to watch the November 15, 2023 Research Community Meeting and Past Meetings.

Visit our Website

There will be no December Research Community Meeting.

The next Research Community Meeting will be held on Wednesday, January 17, 2024, from 2:00 PM - 3:00 PM ET.

Results from the poll taken in the November 15th Research Community Meeting. Learn more about where to find our policies further in the Newsletter.

New and Revised Policy Review

Policy Review

Several policies related to research have been updated or newly created.
All policies can be found on The Hub at:
The Hub / Policies (Scribble)
LINK to The Hub / Policies
You can see which policies have been added or updated by also going to The Hub at:
The Hub / Departments / Corporate Compliance / Recent Policy Updates
LINK to The Hub / Departments...

The following policies were discussed at our November 15th Research Community Meeting:

BC 10.900: Use of Oncore Clinical Trial Management System (CTMS)
BC 10.250: Research Study Closeout
BC 7.325: Creation, Use or Disclosure of De-identified Protected Health Information
BC 7.330: Use or Disclosure of Limited Data Sets for Research or Public Health Activities
BC 10.100: Misconduct in Research and Scholarly Activities
BC 10.600: Scientific and Feasibility Review Policy
BC 10.800: Effort Certification Reporting
BC 10.700: Travel Policy for Sponsored Programs
BC 10.150: Financial Account Setup for Sponsored Research Programs

(Note: BC refers to a Baystate Corporate Policy)

Updated Single IRB Manuals: Baystate as the IRB of Record and Baystate Ceding to Another IRB

They are finally here!

If you are a study team member of a single IRB study, with either external IRB of record, or with Baystate serving as IRB of record, you will note new manuals in both IRBNet and on the IRB Website.

What began as a re-do of the worksheets, turned into two separate manuals, which include documents for researchers. We are hoping that these manuals help make your work more efficient and somewhat simplified.

Please let our Reliance Analyst, Linnea Rademaker (linnea.rademaker@baystatehealth.org), know if you have any questions.

Click Here for the Baystate as the IRB of Record Manual

Click Here for the Baystate Ceding to Another IRB Manual

Continuing Review or Status Report?

You could be doing less work at continuing review!

Should I submit a Continuing Review or a Status Report for my research project?

In the context of federal regulations governing human subjects research, Continuing Review and Research Status Reports are essential components overseen by Institutional Review Boards (IRBs). Find out more in this article via the link below.

Read the Article by AnneMarie Mal, MDiv, Baystate IRB Analyst

REMINDERS from the IRB Office

Managing Training and Credentials in IRBNet

Effective February 1, 2024, the Baystate IRB office will require all research team members to link their CV's and CITI training to their IRBNet User Profile. Please reach out to HRPP and IRB Staff if you need assistance.

Linking CV's and CITI Training in IRBNet

Baystate Consent Template

A reminder that all projects must use the Baystate Consent Template. Sponsor language may be added to the Baystate template. Consent templates can be found in IRBNet and on our website.

IRBNet Project Expiration Alert

IRBNet sends all study teams multiple warnings when their project is about to expire. The Baystate IRB staff may also send you an email offering assistance in ensuring that your project stays on track.

Unaffiliated Investigators and Associates in Research

We have updated our website to provide detailed information for onboarding an Unaffiliated Investigator and an Associate in Research to your project.

Visit our Website for these Processes

Spotlight on the Stroke Recovery, Neuroimaging, and Brain Stimulation Laboratories

Dr. Gottfried Schlaug

Abraham Madjidov, MS

The Stroke Recovery, Neuroimaging, and Brain Stimulation Laboratories have an extensive clinical trials program. They are currently running five successful clinical trials using the StrokeNet trials platform. Baystate is a leading enrolling site in at least two nationwide trials. Congratulations to Dr. Gottfried Schlaug, Vice-Chair of Research for the Department of Neurosciences and Abraham Madjidov, Clinical Research Coordinator in the Clinical Trials Office.

Updates on StrokeNet Trials

NIH - Office of Research on Women's Health

White House Establishes Women’s Health Research Initiative

The White House has announced the establishment of the Women’s Health Research Initiative within the Office of the First Lady. The initiative aims to improve women’s health in the United States by accelerating research on the unique health needs of women across their lifespans and therefore fundamentally change how we approach and fund women’s health research.

Article Link

Humor for The Holidays

Why did the apple pie go to the dentist?

Because it needed a filling

What happened when the turkey got in a fight? The stuffing was knocked out of him

What do you call a sad cranberry? A blueberry

How did the turkey get home from Thanksgiving? It took the gravy train

What do sweet potatoes wear to bed? Yammies

Why did the turkey cross the road? Because it was the chicken’s day off

What part did the turkeys play in the Thanksgiving Day parade?

They played their drumsticks.

Zoom conversation with Harry C.S. Wingfield, author of "Human Subjects Research: An Insider's View" (Sponsored by SUNY Downstate)

The Human Research Protection Clubhouse at SUNY Downstate is hosting a riveting Zoom conversation with Harry C.S. Wingfield, author of "Human Subjects Research: An Insider's View". The event is free. It will be held on November 28, 2023 at 2:00 PM ET.

Recipe of the Month

The Best Southern Bread Pudding

Something sweet for your holiday table.

Link to the recipe

The Innovator

Check out the Summer/Fall 2023 edition of the The Innovator, produced by the Office of Research.

Click here for The Innovator