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Please visit the HRPP Website to watch the April 17, 2024 Research Community Meeting and past meetings.
The next Research Community Meeting will be held on Wednesday, May 15, 2024, from 2:00 PM - 3:00 PM ET.
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Institutional Policies Replacing Department SOPs | | |
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Department SOP's will be replaced with Institutional Policies.
The purpose of the transition is to provide research departments with broad, encompassing institutional research policies that will be reviewed and updated at regular intervals.
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The following policies have been approved by the Baystate Policy Management Committee and are available on The Hub and linked below:
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Data Use Agreements (DUAs) | |
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A DUA is utilized when two institutions or organizations plan to share data, including limited data sets (data stripped of certain identifiers).
A DUA establishes parameters around data use and disclosure, access permissions, safeguards, and prohibits attempts to identify individuals.
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The IRB serves as the privacy board and reviews applications to ensure compliance with the common rule and HIPAA.
- Information Security (ISO) Review:
Use of personal devices for storing or transmitting PHI or PII is discouraged. Non-Baystate devices must undergo IS verification and User Agreement.
After IRB and ISO approval, a letter from the IRB is issued.
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Like all Baystate Health employees, clinical research personnel entering rooms, ED bays, and inpatient areas should follow infection control best-practices.
Since many research encounters are not documented in the electronic health record, Infection Prevention & Control cannot rely on CIS for employee contract tracing should a research participant subsequently test positive for a pathogen of concern. For this reason, all research staff are required to follow the precautions below to ensure employee and patient safety.
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Let us know how we are doing!
Please take a few short moments to complete this survey and tell us how the HRPP and IRB staff are doing. Give us feedback on how we can best serve you.
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Revisiting the Proposed sIRB Mandate (WCG Webinar) | |
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In this webinar, WCG experts will provide actionable steps you and your teams should take now to ensure your studies are ready when the sIRB is mandatory. By joining this interactive webinar, you will:
- Have ample opportunity to ask questions about the sIRB NPRM.
- Receive insights surrounding the FDA's process, providing clarity on the intricacies and timelines involved.
- Walk away with practical steps to prepare whether you're a site, institution, sponsor, or CRO.
- Discover the benefits of working with a partner who works with your SOPs.
- And much more!
Date/Time: Thursday, May 2, 2024
12:00PM - 1:00PM ET
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2024 Dissemination of Research Open House
Date/Time: Tuesday, May 7, 2024
6:00PM - 7:00PM ET
Course Type: Live online
This event is an opportunity for study participants to learn about the results of the study in which they participated. It is also an opportunity for the general public to learn more about research happening at Tufts Medical Center and Northeastern University. This hour-long Zoom event will include two 15-minute presentations given by the researchers. The audience will also have a chance to ask questions for 15 minutes following each presentation.
Enroll Here
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Best Practices for Working with Research Participants
Date/Time: Thursday, May 16, 2024
1:00PM - 2:00PM ET
Course Type: Live online
In this live Zoom session, you will learn from the lived experiences of past and current research participants in a panel discussion format. Panelists will talk about their experiences as research participants, with a focus on actionable methods that research staff can use to better engage with current and future participants. Attendees will also have the opportunity to ask their own questions in breakout groups.
Enroll Here
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HIPAA Compliance and Privacy for Researchers
Time to Complete: 25 minutes
Course Type: Self-paced Online
In this course, you will learn how to adhere to HIPAA’s Privacy rule and the related IRB requirements as a clinical researcher. We will use case studies and real-world examples to highlight key considerations.
Enroll Here
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Sample Size and Power for Grants and Research Proposals
Time to Complete: 45 minutes
Course Type: Self-paced Online
Learn how to write a sample size justification for your research proposal or grant application. This course will provide you with a comprehensive understanding of the importance of determining an appropriate sample size for your study. You will learn how to calculate the sample size needed to achieve sufficient power to detect the effect you are looking for in your study.
Enroll Here
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Report From the World Health Organization (WHO) | |
Benefits and risks of using artificial intelligence for pharmaceutical development and delivery
Although AI holds great potential in optimizing and advancing clinical research, the risks and ethical concerns it presents must be considered when using it in clinical trials, the World Health Organization (WHO) cautions in a recent report.
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FDA Warning Letter Teaches Sites Lessons on How to Avoid Doomed Trials
To avoid being caught out by sponsors that don’t follow clinical trial regulatory requirements, sites should make sure before they accept a trial that its monitoring, site activation and site coordination efforts are compliant, a lesson driven home by a recent FDA Warning Letter.
Link to Article
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Herb & Olive Oil Focaccia
With its Mediterranean flavors and light, airy texture, this focaccia doesn't need much to accompany it. Share as an appetizer just as is; or at most, perhaps alongside a creamy goat cheese.
Link to Recipe
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April is National Humor Month | |
Q. A couple of pranksters broke into the local police station and stole all the lavatory equipment.
A. A spokesperson was quoted as saying, “We have absolutely nothing to go on.”
Q. Which day is the worst to propose on?
A. April Fools’ Day.
Q. How can you tell when April is happy?
A. It has a little spring in its step.
Q. How did the skeleton know that April showers were on the way?
A. He could feel it in his bones.
Q. What do you call a sunny day that follows two rainy April days?
A. Monday.
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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 | |
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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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