Quarterly IRB Newsletter

October 2017

IntegReview IRB has daily meetings for the review of Phase I - Phase IV research in the U.S., Latin America, Japan and also collaborates with a Canadian IRB on Canadian site reviews.  We now have the capability to collaborate on IBC review for gene
therapy and gene transfer research.   

We offer a 24-48 hour turnaround following each meeting.  Thank you for your continued support and please contact us today to discuss your upcoming IRB needs.

FDA & OHRP Issue Joint Guidance on IRB Meeting Minutes
 
FDA and OHRP issued a joint guidance in September 2017 t o assist institutions and IRBs in preparing and maintaining minutes of IRB meetings that meet the regulatory requirements for minutes set forth in FDA and HHS regulations.  The guidance also provides general recommendations on the type and amount of information to be included in the minutes.

IRBs have been cited in OHRP Determination Letters and FDA Warning Letters for failing to prepare and maintain adequate minutes. For this reason, OHRP and FDA believe providing recommendations on the type and amount of information to include in minutes will help IRBs meet the regulatory requirements for minutes.

 
Promotion Announcements!

IntegReview is so proud to recognize these two outstanding team members.  Join us in congratulating these women in their recent promotions from Assistant Coordinator to Coordinator, Co-chair for two of IntegReview's committees .     
 

Bridget Briseno
IRB Coordinator, Co-chair
Thursday Board
Francine Lopez, CCRP
IRB Coordinator, Co-chair
Friday Board

In this new position as IRB Coordinator, Co-chair, they will be responsible for coordinating and facilitating a weekly IRB meeting as a voting IRB member, processing the day-to-day administrative activities that support the IRB and act as the main contact to clients for the studies in which their board oversees. 
 
IntegReview Personally Invites You



Use code SSSINTEGREVIEW  to receive $100 off registration
 

Meet the IRB Staff

Sylvia Zamarripa
Quality Assurance (QA) Associate
 
As a QA Associate, Sylvia performs an in-depth quality review on study-related documents submitted for clinical research studies to ensure they are in alignment with government guidelines and accreditation standards prior to IRB review.
 
Sylvia was born and raised in Austin.  She enjoys baking, cooking, entertaining, traveling and spending time with her three daughters; Isabel (10), Juliana (8) and Graciela (6).

Kristy Cave
IRB Administrative Associate I
 
Kristy's responsibility as an IRB Administrative Associate I is to assist the IRB committees by processing study-related material following initial IRB approval in alignment with government guidelines and accreditation standards. 

Kristy is the mother of two precious boys, Cash (6) and Denver (4).  She enjoys cooking for her friends and family, traveling the world, helping on the family farm, and playing/watching sports with her kids.
  IRB Waivers for Clinical Investigations Involving
No More than Minimal Risk
 
On December 13, 2016, the 21st Century Cures Act (Cures Act) was  signed into law and is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently. 

The Cures Act amended the Federal Food, Drug and Cosmetic Act (FD&C Act), to provide FDA with the authority to permit an exception from informed consent requirements when the proposed clinical testing poses no more than minimal risk to the human subject and includes safeguards to protect the rights, safety, and welfare of the human subject. 


  Protect Yourself During Cold & Flu Season
 
The best way to reduce your risk of exposure to a cold or the flu virus in your workplace is to use the basic hygiene precautions listed below and to avoid close contact with ill people. If your job involves contact with patients or other healthcare services, then you may need to take additional precautions.
 
1. Get vaccinated!
2. Wash your hands
3. Sanitize surfaces
4. Avoid sick people
5. Cover your coughs/sneezes
6. Don't touch your eyes/nose/mouth
7. Don't use a coworker's phone/desk/computer
8. Stay in shape - healthy diet/rest/exercise 
Autumn Harvest Pasta Salad
 
In transitioning from summer to fall, try this very colorful pasta salad that we are sure will be a great seasonal dish for any party this time of year!


 
  
Webinar Opportunities

The following is a list of upcoming webinars that we thought may be of interest to Sponsors, Investigators and study staff:

October 17, 2017, 10:00 am ET
and
October 19, 2017, 3:30 pm ET           *Free to AAHRPP Clients*  /  $90 non-member

 
November 21, 2017, 12:00 pm ET      *Free to SCRS Members*  /  $79 non-member
 
 
December 12, 2017, 12:00 pm ET     *Free to SCRS Members*  /  $79 non-member

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

October 6-8:  Site Solutions Summit; Boca Raton, FL (Exhibitor, Speaker)
Speaker:  Lynn Meyer, CCRP on "Don't Ignore the Regulatory Red Flags - Lessons We've Learned"

San Antonio, TX (Training)
 
November 9-11:  AEA Conference; Washington, DC (Exhibitor)
 
November 14-16: MAGI West; San Francisco, CA (Speaker)

Quick Links
 
IRBManager (portal)
STAY CONNECTED

IntegReview IRB | 512.326.3001| http://www.integreview.com