March 2018
IRB Quarterly News
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Editor's Note
It's March and already a sunny, warm springtime in beautiful Austin, TX. We feel this is as good a time as any to extend a warm thank you to our clientele for putting your trust in us to oversee your research projects. IntegReview IRB is happy to serve the research community, locally, nationwide and extending into Japan & Latin America. Our mission at IntegReview IRB has always been to provide unsurpassed ethical review services while acting as an advocate for research study subjects and we have been accomplishing this for 19 years.
Thank you for your continued support!
Melissa Meyer, CCRP
President, IntegReview IRB
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ACRP Releases CRC Competency Guidelines
On January 30, 2018, ACRP released the first-ever competency guidelines for Clinical Research Coordinators (CRCs).
"Variance is the enemy of quality," says Jim Kremidas, ACRP Executive Director. "The ad hoc manner in which we hire and train CRCs is failing to improve quality in clinical research conduct. We are also failing those at the front lines of clinical research by leaving them without consensus guidance on what we expect from them, and how they can grow in their careers." We hope these guidelines will provide CRCs with the support they need while improving operational quality and trial outcomes for all stakeholders in the clinical research community," Kremidas says.
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TransCelerate BioPharma Inc., a non-profit organization dedicated to improving the health of people around the world by simplifying and accelerating research and development of innovative new therapies, has unveiled a new global campaign designed to help increase awareness of the growing need for clinical trial participants. The campaign, called “One Person Closer,” focuses on inspiring healthcare professionals (HCPs) to consider clinical research as a possibility for their patients, incorporate the topic into their daily practices, and have meaningful conversations with patients about opportunities to participate in clinical trials.
Click on the logo to learn more and to join the conversation.
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How Often Does the IRB Meet and What Types of Research are Accepted?
IntegReview IRB has daily meetings for the review of research in the U.S., Latin America, Japan and rely on an accredited Canadian IRB for all Canadian site reviews. We also collaborate on IBC reviews for gene therapy and gene transfer research. We offer a 24-48 hour turnaround following each meeting. We can accommodate your requests for an unscheduled meeting as well, please contact us to discuss.
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- FDA Update -
Payment and Reimbursement
to Research Subjects
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In January the FDA published updates to the
Payment for Research Subjects: Information Sheet
to clarify that reimbursement for travel expenses to and from the clinical trial site and associated costs such as airfare, parking, and lodging are acceptable under current practices. This update is in response to inquiries FDA received from stakeholders about appropriate reimbursement practices. The title of this information sheet has been revised to reflect these changes. The new title is
Payment and Reimbursement to Research Subjects
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Grilled Pineapple Lemonade
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A perfect Spring drink...this twist on classic lemonade is the divine union of fruity & smoky. Use your outdoor grill to lend extra smoky depth.
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Joey Mitchell, L.V.N., CCRP
IRB Administrative Associate II
Joey's responsibility as an IRB Administrative Associate II is to assist the IRB committees by processing study-related material following initial IRB approval in alignment with government guidelines and accreditation standards. Joey is originally from Louisiana, but has been an avid Austinite for 23 years. He has an interest in biology, horticulture, history, doing projects around his new home and spending time with friends and husband, Jon, and their dog, Rowdy.
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Melanie Castillo
Assistant IRB Coordinator
As an Assistant IRB Coordinator, Melanie provides assistance to the IRB Coordinators/Co-Chairs with all activities associated with the planning, conduction, and follow-up of IRB meetings, while also processing studies that meet the criteria for expedited review as identified in the Federal Register. Outside of the office Melanie enjoys boating, fishing, glamping, movies, and monthly road trips with her husband. She takes care of her family...two kids in college, her Mother and one wienie dog. Her motto is "Live for today and always celebrate your victories, no matter how small."
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IntegReview IRB Joins the SMART IRB Platform
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Launched in 2016, SMART IRB is funded by the NIH Clinical and Translational Science Awards (CTSA) Program. The platform is intended to serve as a roadmap for institutions to implement the NIH
Policy on the Use of a Single Institutional Review Board for Multisite Research
. SMART IRB was designed to harmonize and streamline the IRB review process for multisite studies, while ensuring a high level of protection for research participants.
One of SMART IRBs goals is
Harmonization
...to implement strategic, efficient, and cooperative approaches to single IRB review between institutions and IRBs. IntegReview IRB had an interest in joining this platform to help eliminate the burden and challenges that emerge from implementing single IRB reviews. One of the ways to aid in this goal is by the use of their
Online Reliance System
, which is used to request, track and document reliance arrangements on a study-by- study basis. There are currently over 400 participating institutions involved in this helpful platform. Click on the SMART IRB link below to learn more.
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IntegReview Personally Invites You
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D
IA Annual Conference
June 24-28, 2018
Boston, MA
Two Valuable Registration Offers Courtesy of IntegReview IRB, Booth #1606
[Update cart with
Promo Code: 5902E18E
before checkout]
Includes full day access to Exhibit Hall from 10:00AM-6:00PM on Monday, 9:30AM-5:00PM on Tuesday, or 9:30AM-4:00PM on Wednesday with morning and afternoon refreshment breaks.
Register now
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$100 discount off the Full Annual Meeting Registration
[Update cart with
Promo Code: 5902E18
before checkout]
Includes Monday Welcome Reception, admission to all sessions, exhibits, refreshment breaks, luncheons, and six months of free access to all available online presentation slides.
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