How to Vet an IRB:Expose and Fix Problems Before They Threaten Your Trial

Held May 7, 2009

Is your IRB complying with human subject protection regulations?

A recent congressional investigation created a fake IRB and registered it with HHS. It also got a real IRB to approve a trial for a made-up product even though there were no data from animal testing and no description of the ingredients —crucial details for any clinical research.

How solid is your IRB, and will you pay for its mistakes?

Study sponsors that don’t make sure their IRBs are in compliance are gambling with the future of their products, running the risk of having the FDA shut down their trials or reject their applications.

But it’s not as simple as asking if an IRB is registered with the government. What documents do you need to review to determine if the IRB’s activities match its written SOPs? What is the role of the audit report? What can you learn from the way federal regulators perform audits? And how much responsibility for human subject protection falls on you?

In this 90-minute audio CD/Transcript, human research protection experts Theresa Straut and Amy Schwarzhoff of respected IRB Chesapeake Research Review will explain to drug and device sponsors what their responsibilities are under the regulations, the key steps in auditing an IRB, what to look for and how to address shortcomings.

Sign up your entire team to listen in and discover:

  • An overview of the regulatory requirements for clinical research (subpart A)
  • How the responsibility for patient protection is shared among the sponsor, IRB and researcher
  • What you can learn from the way the FDA and HHS Office of Human Research Protection conduct audits
  • How to ensure an IRB’s activities match its written SOPs — what documents and reports should you ask for?
  • How to address problems in an IRB when preparing the audit report
  • The benefits of using an IRB accredited by the Association for the Accreditation of Human Research Protection Programs

Don’t use the wrong IRB and end up with a flawed study that could endanger your applications. Order now and you'll get an opportunity to ask your toughest questions during the Q&A session.

This audio CD/Transcript is a must for anyone charged with ensuring the integrity of their company’s clinical data, including:

  • Compliance officers
  • Drug development officers
  • Clinical project specialists
  • Clinical managers
  • CRO specialists
  • General/corporate counsel
  • Consultants/service providers

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Theresa Straut, BA, CIP, RAC, is executive director of IRB services at Chesapeake Research Review, Inc., where she is responsible for the IRB Operations, Compliance and Special Projects departments. Prior to joining Chesapeake Research Review, Inc., she was director of regulatory affairs for Quintiles, Inc., focusing on GCPs, IND and NDA submissions, as well as managing internal processes and SOPs.

Amy Schwarzhoff, BS, CIP, is executive director of consulting services, for Chesapeake Research Review, Inc. She has worked with Chesapeake Research Review, Inc. since 1995 in consulting services, IRB operations and as an alternate IRB member. Amy currently directs Chesapeake Research Review, Inc.'s consulting services team in providing compliance audits, human research protections programs assessments, training and educational programs for institutions, IRBs and investigators and Association for the Accreditation of Human Research Protection Programs  accreditation and reaccreditation support.

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