Monthly News & Updates

March 2024 Issue

2024 Research Community Meeting Schedule

Visit our Website

Please visit the HRPP Website to watch the March 20, 2024 Research Community Meeting and past meetings.

The next Research Community Meeting will be held on Wednesday, April 17, 2024, from 10:30 AM - 11:30 AM ET.

Waiver of Consent

With the harmonization of the FDA with the New Common Rule, FDA regulated studies may now qualify for a waiver of consent if all other requirements are met. The IRB has developed a flowchart to assist the research community in determining whether their research qualifies for a waiver. This flowchart can be applied to all research studies, not just FDA regulated research. A PowerPoint presentation is also available to assist study teams in understanding the flowchart. These resources are available on the IRB website and below. If you have any questions regarding these resources, you may reach out to L. Cliff Rhodes in the IRB office at louis.rhodes@baystatehealth.org.

Flow Chart

PowerPoint

What is “Local Context” in single IRB?

The federal regulations for single IRB are well-detailed on the OHRP website. Research teams often ask why the non-reviewing IRB needs to spend so much time reviewing and documenting things.

Full Article

For questions about single IRB, contact Linnea Rademaker, our sIRB reliance analyst at linnea.rademaker@baystatehealth.org.

Spotlight on Baystate Researcher: Tashanna Myers, MD

"When you practice medicine, you are limited by the patients you can touch. But when you do a clinical trial, your impact can be limitless." -Dr. T. Myers

Listen to the 6-minute interview of one of our top Baystate researchers, Dr. Tashanna Myers, on the Inspired Physician Leadership Podcast as she talks about what inspires her to make an impact for her patients as a leader.

Become an IRB Member

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.

Click here to learn more

What are Pragmatic Clinical Trials?

A pragmatic clinical trial is a large, efficient study conducted in the real world that provides evidence for adoption of an intervention into clinical practice.

Dr. David Shurtleff of the National Center for Complementary and Integrative Health (NCCIH) discusses the unique work of the NIH Collaboratory.

NIH Collaboratory investigator Dr. Lesley Curtis answers the question, “What do we mean when we talk about ‘pragmatic clinical trials’?”

More About NIH Collaboratory and Pragmatic Clinical Trials

Why Are We Talking About Pragmatic Trials?

Healthcare in the United States is increasingly complex and expensive, and there is a great need for more evidence to inform decisions that lead to improved, efficient, and affordable care.

The Embedded Pragmatic Clinical Trial Ecosystem

To achieve generalizable results in an efficient manner, embedded PCTs (ePCTs) commonly take place in the setting where patients already receive their usual clinical care.

Improving Black Participation in Clinical Trials: Bridging the Gap

Black participation in clinical trials, and the underrepresentation of minority groups in general in trials, remains low. This lack of diversity can lead to skewed results that may not accurately reflect the efficacy of medical interventions across all populations. It is therefore important to work towards increasing Black participation in clinical trials, which begins with understanding the barriers to participation and taking steps to address them.

Improving Black Participation in Clinical Trials

Informed Consent

FDA Works to Make Informed Consent Easier to Understand

To improve the informed consent process, the U.S. Food and Drug Administration and the Office for Human Research Protections have published a draft guidance titled “Key Information and Facilitating Understanding in Informed Consent.”

Link to FDA Voices

Patients Embrace Digital Elements in Electronic Consent

Patient response to new digital components in the electronic informed consent (eIC) process is overwhelmingly positive, with nearly three-fourths of respondents to a recent survey saying they find enhanced eIC more personable, engaging and informative.

Link to Study Findings

Use of Data Monitoring Committees in Clinical Trials

Guidance for Industry

This guidance provides recommendations to help sponsors of clinical trials determine when a data monitoring committee (DMC) (also known as a data and safety monitoring board (DSMB) or a data and safety monitoring committee (DSMC) or an independent data monitoring committee (IDMC)) would be useful for trial monitoring and what procedures and practices should be considered to guide their operation.

Document Link

A Columbia Surgeon’s Study Was Pulled.

He Kept Publishing Flawed Data.

From The New York Times...

The quiet withdrawal of a 2021 cancer study by Dr. Sam Yoon highlights scientific publishers’ lack of transparency around data problems.

Click Here for the Full Article

Recipe of the Month

Chocolate Crinkle Cookies

Fudgy on the inside with a crispy, powdered sugar outer later, they are loved by kids and adults alike.

Recipe

March Humor

Q. Why should you never start a conversation with Pi?

A. Because it will go on forever!

Q. How does the Easter Bunny manage to distribute eggs across the globe in one morning?

A. He takes his hare plane!

Q. Why is it bad luck to run over a four-leaf clover?

A. It will press your luck!

Q. What happens when your bracket busts?

A. March saddness!

Q. Why is everyone so tired at the end of the third month of the year?

A. 31 days is a long March!

The Innovator

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.

Click here for The Innovator

Past issues of The Innovator can be found here: Website

Email Michael Boland at michael.boland@baystatehealth.org if you have something that you would like included in a future newsletter.