Quarterly IRB Newsletter

March 2017

IntegReview IRB has daily meetings for the review of research in the U.S., Latin America, Japan and collaborates on Canadian site reviews.  We offer a 24-48 hour turnaround following each meeting. 

Contact us today to discuss your upcoming IRB needs.

Antibacterial Drug
Development
by the
ABDD Program


CTTI has conducted research to identify the challenges of conducting pediatric antibacterial trials.  Their recommendations offer practical, evidence-based strategies that can be applied by research sponsors, investigators, and site staff to improve the quality and efficiency of pediatric antibacterial trials. These include tips on determining the timing of pediatric trials, methods for streamlining trial design to decrease burden on sites and families, special considerations for conducting trials with neonates, approaches for improving the informed consent process, and ways to increase engagement with healthcare providers. 

CTTI's research that showed 80% of clinicians surveyed identified parent concerns about their child participating in research to be a barrier for completing research studies with children. This emphasizes the need for better engagement with parents throughout a clinical trial, including during the initial design stage.
 
CLICK HERE to access the full article.
 
IRB Review for Canadian Sites 

Effective January 1, 2017 , IntegReview IRB began its collaboration efforts with Veritas IRB to provide IRB oversight for Canadian sites involved in multi-investigator trials submitted to IntegReview.
 
When requested by a Sponsor, IntegReview IRB and Veritas IRB will collaborate on protocol-level review processes. Veritas IRB will rely on IntegReview for the scientific review of the protocol and then conduct a facilitated review in order to address issues specific to Canada. Canadian Investigators/sites will be submitted directly to Veritas IRB for review and oversight. Each IRB will be individually responsible for investigative sites under their jurisdiction.
 
Please contact our office for additional information about Canadian reviews.





HHS Common Rule at 45 CFR, Part 46, Subpart A enhances protections for research participants and modernizes oversight system

The long-awaited final rule updating the Common Rule ("Final Rule") was issued on January 19, 2017.   IntegReview is in the process of analyzing the new regulations and how they alter the current Common Rule, as well as how they differ from the Notice of Proposed Rulemaking (NPRM) for the Common Rule that was published eighteen months ago.   
 
The NPRM proposed a number of significant changes to the rules for oversight and conduct of human subjects research, including certain requirements concerning the use of non-identified biospecimens in research and IRB review for multi-site studies. The Final Rule implements some, but not all, of the proposed changes, walking back some of the more controversial proposals. 
 
The Final Rule is scheduled to go into effect on January 19, 2018.  However, the compliance date for the provisions regarding single IRB review is January 20, 2020.
 
For more details CLICK HERE.  
Meet the IRB Staff

Lana Caperton, B.S.
Quality Control Associate

As a QC Associate, Lana provides quality control on study-related documents in alignment with government regulated guidelines and IntegReview SOPs in regards to the protection of human subjects involved in clinical research.  Lana is very active and likes to run, ride her bike & swim.  She also enjoys reading, writing screenplays and likes spicy (Thai) food. 
 
An original Texan, Lana moved to New York to work for a pharmaceutical company, but returned to Texas.  She feels happy in her home town, Austin, and has expressed her love for her job and coworkers!

PROMOTION ANNOUNCEMENTS!
It is our great pleasure to announce that Levi Machado, CCRP has been promoted to IRB Training Administrator.  This promotion is in recognition of the exceptional work that Levi has done for the company over the past 7 years.  He will be responsible for the new and ongoing training of IRB staff and IRB Members in regards to job-specific responsibilities, federal regulations, IntegReview policies and procedures and AAHRPP standards.  
 
 
 
Francine Lopez, B.S. 
Assistant IRB Coordinator
 
Francine recently acquired the position of Assistant IRB Coordinator after only 7 months working in the Operations Dept. as an IRB Administrative Associate II.  Her main focus now is to provide assistance to the IRB Coordinators/Co-chairs with all activities associated with the planning, conduction, and follow-up of IRB meetings.  
 
Francine graduated from the University of Texas- at Austin with a B.S degree in Human Development and Family Sciences. She lives with her husband, Rick, her daughter, Alessandra, and her "fur-baby," Lucy. Together they enjoy spending time at Town Lake, live music and comedy, attending sports events, and watching Mickey Mouse Club House!

View our full Organizational Chart.

Training Opportunity 

IntegReview IRB is proud to be an Exhibitor at the 53rd Annual DIA Conference and would like to offer you an invitation to attend.  See below for discounts!

The DIA 2017 theme this year is "Driving Insights to Action", and takes place June 18-22, 2017 in Chicago, IL.   
  
Visit www.diaglobal.org for detailed program information.

As a way to welcome you to the show, IntegReview IRB has two valuable registration offers for you!
Register now - $150 One Day Exhibit Hall Only Pass
[Update cart with Promo Code: 5902E17E before checkout] 
Includes full day access to Exhibit Hall on Monday, Tuesday, or Wednesday. Food functions not included.

Register now - $100 discount off the Full Annual Meeting Registration
[Update cart with Promo Code: 5902E17 before checkout]
Includes full access to Exhibit Hall Monday thru Wednesday, and Meeting Sessions Monday thru Thursday.

See you in Chicago!


Green Garlic and Pea Soup

The cold winter has passed and now comes Spring.  The warm sun comes out, the flowers are in bloom.  Green is spring...bright, fresh, and new. 


 Ingredients:
2 bunches green garlic (about 1 lb.)
4 Tbsp. olive oil, divided
2 cups shelled fresh peas (from about 2 lb. pods) or frozen peas, thawed
1/3 cup heavy cream
4 cups water
Kosher salt and freshly ground black pepper

Preparation:

Cut dark-green tops from green garlic and slice crosswise ½" thick; slice bulbs and pale-green stalks crosswise ¼" thick.  Heat 2 Tbsp. oil in a large saucepan over medium heat.  Add bulbs and stalks, season with salt and pepper, and cook, stirring often, until beginning to soften, 8-10 minutes. Add tops and cook, stirring often, until soft, about 3 minutes.
 
Add 4 cups water to saucepan and bring to a boil. Add peas, reduce heat, and simmer gently until peas are bright green and tender, about 5 minutes.  Let cool slightly, then purée soup in a blender with remaining 2 Tbsp. oil, adding water to thin if needed, until smooth. Strain soup through a fine-mesh sieve into a clean saucepan, pressing on solids; season with salt and pepper. Reheat briefly (to preserve color) before serving.
 
Beat cream with a whisk in a medium bowl to soft peaks; season with salt and pepper. Serve soup with a swirl of whipped cream.  Serves 4.
 
CLICK HERE to print recipe.
 
2017 Networking & Training Opportunities  
Rick Clemens
Rick Clemens
Vice President
of Business Development
Sarah Attwood
Director of
Client Services 

Here is a list of where IntegReview IRB will be throughout the year.  We hope to meet you in person!  If you are interested in arranging a meeting with our Business Development Group during these events, please send us an e-mail to

April 28-30:  AERA Conference; San Antonio, TX  (Exhibitor)

April 29-May 2:  ACRP Conference; Seattle, WA  (Exhibitor)
 
May 22-24:  MAGI West Conference; Philadelphia, PA  (Panel Speaker)
 
June 18-22:  DIA Conference; Chicago, IL  (Exhibitor)
 
October 6-8:  Site Solutions Summit; Boca Raton, FL (Exhibitor)
 
San Antonio, TX (Training)

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