The Scandal of Coast IRB

Coast Institutional Review Board (Coast IRB), a private-for-profit ethical review board of

clinical research, horrified the world and research communities after approving fictitious clinical

research with a counterfeit device conducted by fake researchers from a feigned medical

company in April 2009 (Dove, 2009). The high-profit independent IRB which reported revenue of

9.3 million dollars in 2008 fell for the sting operation run by the US Government Accountability

Office (GAO) (Barry, 2009; The Editors of Lancet, 2009).

Starting in January 2008 due to concerns of the capacity, specifically of the IRB system, in

protecting the rights and welfare of research participants amidst a growing amount of clinical

research, GAO investigators conducted the undercover operation to test the key aspects of the

IRB system. GAO investigators fabricated a pilot clinical protocol (first in human) submitted to

three actual independent IRBs (Kutz, 2009). This protocol aimed to demonstrate the safety and

efficacy of the fake medical device, named “Adhesiabloc gel”, to reduce post adhesive abdominal

surgery in women (House Hearing 111th congress, 2009). The Adhesiabloc gel was designed to

match examples of “significant risk” devices according to Food and Drug Administration (FDA)

guidance, and the device also claimed to receive a fake Premarket Notification or 510 (k)

clearance by FDA for being substantially equivalent in both safety and effectiveness to the

existing devices (CFR 21, 2020; Premarket Notification 510(k), 2020; Kutz, 2009).

While the two IRBs rejected the protocol immediately because of serious safety concerns,

Coast IRB, on the other hand, unanimously approved (7:0) the protocol with only minor edits,

deciding the intervention was “probably very safe.” Not until the congressional investigators

contacted Coast IRB, did the IRB discover the fraud and revoke this fictitious study after granting

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the expedited approval five months earlier (Kutz, 2009). Coast IRBs also formerly received a

warning letter from FDA regarding the authorization of conducting the expedited review to the

unqualified IRB member in 2008. In addition, during 2004-2009, Coast reviewed 356 protocols

involving human testing with a hundred percent approval. To be more specific, out of 2,492 votes

cast by board members all except one were in favor of approval (House Hearing 111th congress,

2009). Coast IRB eventually had no choice but closed its door completely on August 31, 2009

(Coast IRB - Independent Review Board for Clinical Trials, 2010).

Also, none of the three IRBs was able to detect the false identification of researchers and

their bogus credentials. A quick check of public online information including fabricated 501(k)

clearance on FDA’s online database could have easily revealed forged documents. These

reflected the extreme vulnerability of the IRB system. As terrifying as it sounds, despite all efforts

and resources put into testing the integrity of the IRB system in 2009, just two years afterward,

Essex IRB, another commercial IRB, fell into a similar trap. It is utterly unjust to research

participants when the companies profiting from their protocol review fail to protect them. This

complicated issue might not be resolved unless the safety of the participants is genuinely

prioritized over financial interests (Zern, 2013).

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References:

Barry, M. (2009). Overseer of Medical Trials, Under F.D.A Pressure, Agrees to Suspension. The

New York Times. https://www.nytimes.com/2009/04/15/business/15device.html

CFR - Code of Federal Regulations Title 21. (2020). U.S. Food and Drug Administration.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=812.3

Coast IRB - Independent Review Board for Clinical Trials. (2010). CoastIRB.

http://web.archive.org/web/20100328010754/http://www.coastirb.com/

Dove, A. (2009). Coast IRB hits treacherous waters. Nature Medicine, 15(5), 470.

https://doi.org/10.1038/nm0509-470b

House Hearing 111th congress. (2009) Institutional Review Boards that oversee experimental

human testing for profit. https://www.govinfo.gov/content/pkg/CHRG-

111hhrg67819/html/CHRG-111hhrg67819.htm

Kutz, G. D. (2009). HUMAN SUBJECTS RESEARCH: Undercover Tests Show the Institutional

Review Board System Is Vulnerable to Unethical Manipulation GAO-09-448T.

http://www.gao.gov/new.items/d09448t.pdf

Premarket Notification 510(k). (2020). U.S. Food and Drug Administration.

https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-

510k

The Editors of The Lancet. (2009). How ethical are for-profit institutional review boards? The

Lancet, 373(9673), 1400. https://doi.org/10.1016/s0140-6736(09)60797-2

Zern, C. O. H. (2013). Is the Customer Always Right? Department of Health and Human Services’

Proposed Regulations Allow Institutional Review Boards to Place Customer Service

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 Ahead of the Welfare of Research Participants. The Saint Louis University Public Law

Review, 32(2), 411- 446.

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