Awareness of risks of biobank research may affect public attitudes toward consent.

Abstract

CorrespondenceIn their recent paper, Botkin et al. (2014) contribute much-needed data on public attitudes toward genetic research andthe use of residual tissues for scientific research. Informedconsent is a critical factor affecting public acceptance ofbiobanks for genetic research. The authors claim, Bbiobank-dependent research has been safe, with no published reports,to our knowledge, of harm to individuals from breaches ofprivacy or confidentiality.^ This premise is used to justifythe researchers’ decisionto present the opt-out consent modelto participants as the Bpreferred^ consent model, with whichfocus group participants can disagree if they so choose.Yet, there exist at least two cases in the literature in whichresearch participants perceived themselves harmed throughbreach of privacy in biobank-dependent research. One isBeleno et al. v. Texas Department of State Health Services,inwhich bloodspotsfromnewbornswereplacedina biobankforfuturegeneticresearchwithoutparentalconsent(Carnahan2011).Inthiscase,theplaintiffsobjectedtothenon-consensualseizure and storage of genetic material. They argued it shouldbe a parent’s decision whether their infant contributes to abiobank, and that the banking of samples without consent con-stituted unreasonable search and seizure (Carnahan 2011). Thecase was settled out of court when the State agreed to destroyover four million banked blood samples and disclose all finan-cial transactions involving the samples (Carnahan 2011).Another case of perceived harm resulting from biobankresearchisHavasupaiTribev.ArizonaStateUniversityBoardof Regents, in which genetic material taken from Havasupaitribe members, with consent for the purpose of studying dia-betes, was used to study schizophrenia, alcoholism, and in-breeding. This was done contrary to participants’ wishes andwithout consent (Mello and Wolf 2010). This case, too, wassettled out of court when Arizona State University Board ofRegentsagreedtocompensatetheHavasupai$700,000,returnall blood samples in the university’s possession, return alldocuments containing research derived from those samples,terminate IRB approvals for all existing and new researchusing the samples,and provide a list of entities to which sam-ples had been transferred (Drabiak-Syed 2010). Sources ofperceived harm in this case include the use of genetic mate-rials for research without consent, and encroachment on thetribe’s privacy, dignity, and culture (Drabiak-Syed 2010).Atthistime,noconsensusexistsontheappropriateconsentmodel for biobanking (Master et al. 2012). Yet, Botkin et al.(2014) chose to inform study participants of their own Bclearpreference for the opt-out approach^, and openly acknowl-edged that in doing so they Balmost certainly influenced theresults^infavorofopt-outconsent.Thisomissionofpertinentinformation regarding perceived harm from biobank-dependent research may have introduced a significant bias tothestudy.Evidently,aBlackofpublishedcasesofharmduetobreach of privacy or confidentiality^ was a tenuous justifica-tionfortheauthors’decision,inlightofpublishedinstancesinwhich participants perceived violation of these rights to suchan extent that they filed suit against researchers.