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Please visit the HRPP Website to watch the February 21, 2024 Research Community Meeting and past meetings.
The next Research Community Meeting will be held on Wednesday, March 20, 2024, from 2:00 PM - 3:00 PM ET.
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Baystate Health Interpreter and Translation Services | |
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Tim Moriarty, MPA, CHI-Spanish, Manager, and Abraham Hernandez, Translations Coordinator, presented at the 2/21 Clinical Research Community meeting on Interpreter and Translation Services available for the research community at Baystate.
Baystate's policy states that we will support diversity and provide its patients and their family members who are limited English proficient (LEP), Deaf, hard of hearing, or Deaf-Blind by providing spoken language and sign language interpreters, and by translating documents to and from English.
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In an effort to provide coherent forms and templates, the IRB staff have revised the Informed Consent Form template and HSRD form. | |
Updated Informed Consent Form Template | |
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The Informed Consent Form template has been revised to have clear instructions, easily identifiable required language and suggested language.
Beginning Monday 2/26/2024, all new study submissions that are Investigator initiated will be required to use this template.
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The Informed Consent Form template will be in IRBNet in the Documents for Researchers dropdown. All new study submissions not utilizing this template will be requested to do so within the analyst’s pre-review.
- Industry sponsored studies will not be required to use this template, but they may do so. If study teams use the Baystate template, they will not be required to complete the Consent Checklist.
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Informed Consent Form riders are no longer located at the end of the Informed Consent Form template. They will be listed in IRBNet in the Documents for Researchers dropdown underneath the Informed Consent Form template.
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Updated Human Subject Research Determination (HSRD) Form | |
- In the new HSRD form, the IRB staff have revised the instructions and questions to be more clear and relevant to the form.
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This form was added to IRBNet in the Documents for Researchers dropdown and should be used for all HSRD submissions.
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Beginning Monday 2/26/2024 the old HSRD form will no longer be accepted and all submissions with the old form will be returned to the Principal Investigator for revision.
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The following policies were recently approved by the Baystate Health Policy Management Committee.
You can find these policies in the SCRIBBLE policy management system by clicking the policy tab on THE HUB and searching for the policy name.
- BC 1.120 - Solicitation and Distribution • NEW!
- BC 1.600 - Americans with Disabilities Act (ADA) Services for Patients
- BC 7.120 - Notice of Privacy Practices (NoPP)
- BC 7.310 - Release of Protected Health Information/Personal Information to Third Parties (Business Associate Agreement Policy)
- BC 7.210 - Disclosure to Family and Others Involved in the Patient's Care
- BC 6.700 - Website and Mobile App Governance Policy
- BC 8.200 - Space Rental Agreements with Potential Referral Sources
- BC 10.850 - Research Regulatory Document Maintenance and Archiving
- BC 10.950 - Principles of Documentation and Date Management
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Using External IRBs For Your Multi-site, Federally-Funded Study | |
By Linnea Rademaker, PhD, CIP
IRB Reliance Analyst
In this memo we provide some helpful information to facilitate approval of your multi-site study. Key points are:
- Be sure to schedule a consult with the single IRB analyst before agreeing to cede review to an external IRB.
- Baystate utilizes several large, commercial IRBs for many of our studies that have external IRB oversight.
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Participant-Centered Informed Consent Training (OHRP) | | |
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By AnneMarie Mal, MDiv
IRB Analyst
Consider taking the Participant-Centered Informed Consent Training provided by the Office of Human Research Protections! This training is for anyone in the research community who plans, writes, or reviews consent forms for research involving human participants.
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Voluntary service as an IRB member is a great opportunity to help improve the research enterprise at Baystate, deepen personal knowledge on human research, and may create future professional opportunities. If you or someone you know would like to learn more about becoming an IRB member at Baystate, please email irbprotocolsubmissions@baystatehealth.org.
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A BIG THANK YOU to everyone for working so hard on linking their CV's and CITI training to their IRBNet user profiles. The HRPP and IRB team are very grateful for all of your efforts.
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What is the Open Payments™ Program? | |
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The Open Payments program is a national disclosure program that promotes a more transparent and accountable health care system. Open Payments houses a publicly accessible database of payments that reporting entities, including drug and medical device companies, make to covered recipients like physicians.
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From the US Department of Health and Human Services... | |
HHS Office for Civil Rights Issues Guidance
The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) is issuing guidance to U.S. hospital and long-term care facility administrators, reminding organizations of their independent obligations under Centers for Medicare and Medicaid Services (CMS) regulations to ensure that facility visitation policies, including during a public health emergency, do not unlawfully discriminate on the basis of religion; as well as their obligation not to discriminate on other protected bases under federal civil rights laws, against patients or other individuals receiving care.
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“The Principles of the Belmont Report and the Ethics of Human Research”, presented by OHRP’s Senior Advisor to the Director, Dr. Ivor Pritchard!
Join OHRP on Thursday, February 29 at 3:30-4:45 pm EST to hear Dr. Ivor Pritchard talk about the Belmont Report ethical principles of justice, beneficence, and respect for persons, their application to research involving human participants, and how they may have evolved in response to changes in society and the research landscape.
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Trials See Spike in Social Media, Patient Advocacy and Website Recruitment Approaches | |
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The utilization of websites for trial recruitment has nearly tripled since 2019, while social media platforms and patient advocacy groups have doubled in use, according to study by the Tufts Center for the Study of Drug Development (CSDD) that offers new insights into the top recruitment methods used for trials post-pandemic, among other data.
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Introducing Matt Rogers, PhD
IRB Analyst (Board 2)
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Greetings! My name is Matt Rogers, and I am glad to be joining the Baystate Health team as an IRB Analyst. My research background includes a PhD in Human Movement Science, several peer-reviewed publications, and multiple conference presentations. I was also a Human Subjects Protection Specialist for the University of New Mexico IRB.
In addition to research related jobs, I have spent a good portion of my career in the world of occupational health, industry and hospital ergonomics, and physical rehabilitation. My career has taken me to seven different states, but I am now happy to call New Mexico home. I have been a long-distance runner since the age of 13, including collegiate cross-country and track, and I also coach several runners.
I am looking forward to working with the Baystate research community and helping everyone reach their goals.
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Lemon-Garlic Shrimp Orzo Skillet
This dish makes a deliciously easy weeknight dinner! Prepare in one pan in just 30 minutes.
Recipe Link
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Q. Where do most people eat on Leap Day?
A. IHOP.
Q. Why did the man get fired from the calendar factory?
A. He took a few days off in February thinking nobody would notice.
Q. Why was the math book sad on Leap Year?
A. Because it had too many problems and only an extra day to solve them.
Q. What do you call a frog born on February 29th?
A. Leap frog.
Q. Why was the man planning to tie the knot on February 29th?
A. So he can tell his spouse he only forgets their anniversary once every four years!
Q. What’s a great thing about leap-year jokes?
A. That you only hear them repeated every 4 years.
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Check out the Winter 2023/2024 edition of the The Innovator, produced by the Baystate Office of Research.
The Office of Research publishes The Innovator quarterly (winter, spring, summer, fall). Each issue highlights a few of our projects or researchers, and lists upcoming events.
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Past issues of The Innovator can be found here: Website | | | | |
