April 2019
IRB Quarterly News
Melissa 2014
Editor's Note

IntegReview IRB is a proud member of AAHRPP and has maintained the value of a fully accredited IRB since 2007. We take great pride in our commitment to follow rigorous standards for ethics, quality, and protections for human research. 

Vice President of Compliance, Melanie Flores, CIP, CCRP, maintains the company's accreditation standing and will be diligently working on this project over the next upcoming months. We will be applying for reaccreditation of our HRPP this September for renewal in 2020. 

We appreciate you entrusting us with the oversight of your research and our commitment to protecting your research participants.

Melissa Meyer, CCRP
President, IntegReview IRB
IntegReview IRB
Career Center

IntegReview IRB is busier than ever and continually growing and we are currently looking for highly motivated people that have the ability to multi-task in a fast-paced environment.  Spread the word !

Regulatory Compliance Dept.:
Quality Control (QC) Assistant

If you happen to know someone in the Austin area looking for work please send them our way. 

To review job descriptions and our application process CLICK HERE !
IRB Guidelines Available in IntegReview's Electronic Portal
Our clients have asked over the years for our guidance on topics, such as "What are IntegReview's requirements for submitting recruitment material?" and "How do I determine if my research project falls under the category of exempt?"  Our IRB Staff listens and we strive very hard to not only provide the best in customer service, but to assist researchers, research staff, Sponsors, and CROs with adequate information related to federal and IRB requirements. 

IntegReview IRB has developed a directory of Guidelines and other helpful documents in IRBManager and named it ' Useful Links '.  When logged into IRBManager this directory can be located in your Dashboard view in the far left-hand column. You will find guidelines for the following: Exempt and Expedited Review Determination, Informed Consent, Recruitment Materials, Significant Deviations, Safety Reports.

We hope you find this resource helpful and please reach out if you have suggestions to add to this directory.
News About OHRP's Education & Outreach Program

Whether you are interested in furthering your education with workshops, attending upcoming events, obtaining free education materials or reviewing the latest Q&As, the Division of Education and Development (DED) is committed to furthering OHRP's mission to conduct outreach and educational events, and provide educational materials to further this goal.

Still have questions about the Revised Common Rule?  CLICK HERE to access Q&As that cover the transition provision, the assurance process, exemptions, IRB review, informed consent, etc.

CLICK HERE to access OHRP's Education & Outreach program to learn more about all of their upcoming workshops and events.
Patient Perspectives in Clinical Trials
In March, the CTTI and the FDA collaborated on the workshop, "Enhancing the Incorporation of Patient Perspectives in Clinical Trials" that gathered input from patients, caregivers, industry, academic researchers, and expert practitioners on the challenges and barriers to patient participation in clinical trials. The video recordings of this workshop are now publicly available - you may obtain direct access of the recordings by  CLICKING HERE .
Finalized NIH Guidelines for Gene Therapy Research

On April 25th, the National Institutes of Health (NIH) finalized a proposal to amend the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules to streamline the oversight of gene therapy research. This proposal, which was developed in conjunction with the FDA, included amending the NIH Guidelines to eliminate duplicative review and reporting requirements for human gene transfer protocols and refocuses the role of the NIH Recombinant DNA Advisory Committee (RAC) as a transparent forum for science, safety, and ethics of emerging biotechnologies. After a 60-day public comment period, the NIH Guidelines have been updated to reflect these changes and the RAC has been renamed the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC). 

Our quarterly S.T.A.R. Award Winners are voted on by their peers, and are recognized for their admirable work ethic and dedication to providing excellent service!

Levi Machado
IRB Training Administrator
Quarter 2
Spinach Pesto Pasta with Shrimp

Spinach, pesto, and shrimp...OH MY!  This low calorie pasta recipe will be a family favorite at your
dinner table! 
*Tip: use store bought pesto to save a little extra time in the kitchen. 
Meet the IRB Staff
Alyson Stockton
Quality Control (QC) Associate

As a QC Associate, Alyson provides quality control on study-related documents in alignment with government regulated guidelines in regards to the protection of human subjects involved in clinical research, with special emphasis placed on enhancing and maintaining the quality of services provided to our clients.

Alyson enjoys her country life, living on 10 acres in the beautiful Texas Hill Country with her husband, 2 dogs, and 2 horses.
Jessica Villegas
Quality Assurance (QA) Assistant

Jessica provides assistance to the QA Associates and the Regulatory Compliance Department on the quality assurance of study-related documents in alignment with government regulated guidelines to assure the protection of human subjects involved in clinical research.

Jessica and her 3-year old son take pleasure in reading, exploring, and learning new things together. She enjoys self-help literature, BBQs and spending time with her family. 
IntegReview IRB Personally Invites You
DIA Annual Conference
June 23-27, 2019
San Diego, CA

Two Valuable Registration Offers Courtesy of IntegReview IRB
Booth #1917

$150 One Day Exhibit Hall Only Pass
[Update cart with Pro mo Code: HALL19002 before checkout]

$100 discount off the Full Annual Meeting Registration
[Update cart with Promo Code: VIP19002 before checkout]


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