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News Stories on Human ResearchProtection and
Commentary by Vera Hassner Sharav

April 1, 2002

Three CardiologistsSuspended from Baylor Clinical Research up to 5 years

FYI

The Baylor College of Medicine Institutional Review Board(IRB) has suspended research privileges from 3 leading cardiologists "afteran investigation into the procedural and ethical aspects of a study led by Dr.Robert Roberts and conducted at both Baylor and the Ottawa Heart Institute(Ontario, Canada) after a patient participating in a study registered acomplaint with Baylor’s compliance officer."

"Dr Robert Roberts and Dr Linda L Bachinski, bothBaylor faculty members, are forbidden to engage in clinical research activitiesat Baylor for 5 years and 1 year, respectively. Dr Michael Gollob, a clinicalfellow and instructor, has been suspended from clinical research at Baylor for aperiod of 3 years. A total of 4 separate, ongoing study protocols involving oneor more of the investigators have been disapproved as a result of the IRBreview."

"Dr. Roberts is currently serves as the Chief ofCardiology, Baylor College of Medicine and the Methodist Hospital, Director ofthe Bugher Foundation Center for Molecular Cardiology, and a Professor ofMedicine, Cell Biology, Molecular Physiology, and Biophysics. He is alsopresident-elect of the American Heart Association, scheduled to take office July1, 2002. Bachinski is an Assistant Professor in the Department ofMedicine."
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http://www.theheart.org/lite.cfm?CJHFLIC

N E W S

Nov 21, 2001 Robert Roberts among three Baylor physicianssuspended from clinical research for up to 5 years

Dr Robert Roberts (Source: Baylor College of Medicine)Houston, TX – Three physicians at Baylor College of Medicine (Houston, TX) havehad their research funding revoked and are forbidden to conduct clinicalresearch for between 1 and 5 years, following an internal investigation byBaylor’s Institutional Review Board (IRB), heartwire has learned.

Dr Robert Roberts and Dr Linda L Bachinski, both Baylorfaculty members, are forbidden to engage in clinical research activities atBaylor for 5 years and 1 year, respectively. Dr Michael Gollob, a clinicalfellow and instructor, has been suspended from clinical research at Baylor for aperiod of 3 years. A total of 4 separate, ongoing study protocols involving oneor more of the investigators have been disapproved as a result of the IRBreview.

The IRB’s decision does not affect any basic science oranimal research studies in which the three may be involved. Their patient careor other clinical duties are not affected, nor will the decision have anybearing on their current faculty appointments. Roberts currently serves as theChief of Cardiology, Baylor College of Medicine and the Methodist Hospital,Director of the Bugher Foundation Center for Molecular Cardiology, and aProfessor of Medicine, Cell Biology, Molecular Physiology, and Biophysics. He isalso president-elect of the American Heart Association, scheduled to take officeJuly 1, 2002. Bachinski is an Assistant Professor in the Department of Medicine.

Study participant voiced concerns
A special subcommittee of Baylor’s IRB opened an investigation into theprocedural and ethical aspects of a study led by Roberts and conducted at bothBaylor and the Ottawa Heart Institute (Ontario, Canada) after a patientparticipating in a study registered a complaint with Baylor’s complianceofficer.

"We have a policy that if any study participantraises a concern, that concern is then investigated. And if it’s found to be ofa serious nature by the internal investigation, a full audit of the studyprotocol is then initiated, looking at all aspects of the protocol," ClaireBassett (Vice President of Public Affairs, Baylor College of Medicine) toldheartwire.

In some instances, the people who gave blood samples andpersonal information were not informed or did not agree to the study beforehand.

"It was found by the subcommittee of theinstitutional review board that the researchers involved did not maintainadequate approval for research activities. They did not document informedconsent appropriately, and in some instances, the people who gave blood samplesand personal information were not informed or did not agree to the studybeforehand," she continued.

Bassett stressed that the IRB’s findings indicated thatthe consequences of the procedural/ethical violation in this study were"informative in nature" and did not affect human safety. "When welooked at it we said, yes, it appears that there were some violations; however,they did not impact the safety of the individuals participating," sheexplained.

Roberts responds
As principal investigator for the research, I must assume fullresponsibility for all actions.

Commenting on the situation, Roberts pointed out that heis appealing the IRB’s decision. "As principal investigator for theresearch, I must assume full responsibility for all actions," said Roberts."Fortunately, it is a technical problem and did not in any way involvephysical harm or increase the potential for physical harm to any patient. Theimpact of the research has been very significant and I appreciate theopportunity for an appeal."

Published data should be "modified"
Results of the study at the core of the controversy have already beenpublished in the June 14, 2001 issue of the New England Journal of Medicine,1 asreported by heartwire. The study evaluated 70 members of 2 families withinherited familial Wolff-Parkinson-White (WPW) syndrome, ultimately identifyinga gene mutation potentially responsible for the disease. At the time ofpublication, an editorial accompanying the article hailed the discovery as"an exciting glimpse into the intricate pathways that regulate embryonicdevelopment of the atrioventricular conduction system and its function in theadult heart."2

A third action on the part of the IRB has been to contactthe Journal editors, advising them that the paper published in their journalearlier this year "should be modified to reflect that the study did notfollow federal guidelines for human research," Basset stated. A sentenceappearing in the "Methods" section of that paper as published states,"Written informed consent was obtained from all participants according tothe guidelines of Baylor College of Medicine; the National Heart, Lung, andBlood Institute of the National Institutes of Health; and the University ofOttawa Heart Institute."

The man who put molecular genetics on the cardiologymap
The recent decision reflects the heightened emphasis being placed in today’sresearch environment on patient rights, informed consent, and a stringentattention to physical and psychological safety issues. It also marks a dramaticturn of events for a man who, in the opinion of Dr James Young (ClevelandClinic) holds the honor of linking the field of molecular genetics tocardiology.

He has worked tirelessly to promote clinicalcardiologists’ understanding of the molecular biodynamics of the heart.

Roberts, says Young, has made "tremendouscontributions to cardiology" that are by no means eclipsed by the recentinvestigation. "He has worked tirelessly to promote clinical cardiologists’understanding of the molecular biodynamics of the heart and has lead the teamsthat made important discoveries of genes responsible for WPW and hypertrophiccardiomyopathy syndromes," Young told heartwire. "Any issues that havearisen [over his research practices] have to be put into that perspective andunderstood in that context."

Three additional studies stopped
Basset clarified that although 4 protocols have been disapproved, only 1 ofthe studies is known to have violated federal guidelines. Asked whether similarviolations could have been made in the 3 other studies, Bassett responded thatshe did not know whether other transgressions had been made by the researchersin these other studies, but that the present IRB action had been taken solely onthe findings from the one protocol review.

Basset stressed that the actions taken by Baylor’s IRBwere "not a closed issue yet," pending the results of the appeal.These may or may not affect Roberts’ upcoming presidency with the AHA.

"We’re aware of the situation," an AHAspokesperson told heartwire. "As we understand it now, the decision isunder appeal and it is really to early to say what will happen. Right now theissue is between Dr Roberts and the Baylor IRB. When everything is resolved, wewill work with Dr Roberts and discuss the issue at that time."

Not new to scrutiny
This is not the first time that Roberts’ research practices have fallenunder scrutiny. In 1998, Roberts and his institution generated controversy aftera study of arrhythmogenic right ventricular dysplasia led by Roberts in GrandFalls, Newfoundland earned him and his colleagues the title "TexasVampires." In that study, the local population as well as researchers basedin Newfoundland questioned the methods by which Roberts and his co-investigatorsgathered their data and samples. The controversy was explored in depth in afeature radio broadcast on the CBC, Canada’s public broadcasting corporation.Ironically, Roberts himself is originally from Newfoundland.

Asked whether the present IRB findings were similar toconcerns raised in the Newfoundland study, Bassett responded that the two werein no way connected.

"This does not reflect any issue that occurred inNewfoundland," she stated. "I know that there were some issues thatwere raised in Newfoundland and I know that there were concerns on how thingswere being handled on both sides. But this had nothing to do with anything otherthan the Ottawa and US studies."

Related links 
1. Gene mutation identified in Wolff-Parkinson-White syndrome [Heartwire >News; Jun 13, 2001] 
2. Who Owns Life? – Part I [transcript]. "This Morning." CBC radio.March 20, 2000

Shelley Wood shelley@conceptis.com

References
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