Rhode Islanders’ attitudes towards the development of a statewide genetic biobank

RESEARCH ARTICLEFor reprint orders, please contact:[email protected]

Rhode Islanders’ attitudes towards the development of a statewide genetic biobank
Roberta E Goldman1†, Caroline Kingdon2, Jared Wasser3, Melissa A Clark4, Robert Goldberg5, George D Papandonatos6, Edward Hawrot2 & Gideon Koren3
†Author for correspondence1Warren Alpert Medical School of Brown University, Department of Family Medicine and Center for Primary Care and Prevention, Memorial Hospital of Rhode Island, CPCP, 111 Brewster Street, Pawtucket, RI 02906, USATel.: +1 401 729 2924;Fax: +1 401 729 2494;E-mail: [email protected] University, Department of Molecular Pharmacology, Physiology and Biotechnology, Providence, RI 02912, USA3Warren Alpert Medical School of Brown University, Cardiovascular Research Center, Division of Cardiology, Department of Medicine, Rhode Island Hospital, Providence, RI 02903, USA4Warren Alpert Medical School of Brown University, Department of Community Health and Program in Public Health, Providence, RI 02912, USA5University of Massachusetts Medical School, Worcester, MA 01655, USA6Brown University, Center for Statistical Sciences, Providence, RI 02912, USA

part of

Keywords: biobank, biospecimen storage, genetic analysis, mixed-methods feasibility study, personalized medicine, sudden cardiac arrest, sudden cardiac death, ventricular fibrillation

10.2217/17410541.5.4.339 © 2

Aims: To explore the attitudes of a voluntary subset of Rhode Island residents towards the potential development of a large, prospective, population-based study of sudden cardiac arrest, which will include a biobank to store blood for future biochemical and molecular analyses. Methods: A mailed survey and focus groups. Results: Survey respondents and focus group participants indicated willingness to provide biospecimens, medical history and personal lifestyle information, and to undergo medical tests. Both datasets included multiple concerns regarding long-term storage of biospecimens and personal information, and the need of potential biobank participants for detailed information regarding study protocols and oversight. Conclusion: A biobank has high potential for successful participant recruitment in Rhode Island if preceded by preparatory steps of public engagement and transparent mechanisms of addressing the population’s concerns and questions.

A biobank, also known as a biorepository, is afacility that collects, stores, processes and distrib-utes biological samples and the epidemiologicaland clinical data associated with those samples [1].Biobanks, while a seemingly recent phenome-non, have in fact been in existence in varyingforms over the past several hundred years [2].Guy’s Hospital in London has been preservinghuman tissue samples in its Gordon Museumsince 1608 for teaching and research purposes [3].This repository, where biological samples arestored together with the clinical data belongingto that sample, continues to facilitate research;for example, tissue samples stored at the museumfrom the 18th century are being examined on acellular level today to try to identify malariastrains prevalent at that time.

As medicine, information and technologycontinue to develop and complement oneanother, biobanking offers novel opportunitiesto study the complex interaction between genesand the environment. For-profit, non-profit, andcollaborations between academic and for-profitentities are increasingly entering this burgeoningscientific arena [4–6]. In anticipation of an era ofpersonalized medicine, where treatments may betailored according to genetic assessments,biobanking promises to be an essential tool forobtaining new biomedical knowledge and trans-lating this knowledge into improved diagnostics,promotion of optimized clinical practices, andmore effective preventative treatments [7].

The modern biobank movement, as charac-terized by the large cohort studies being assem-bled in Europe and elsewhere in the world, have

been facilitated in these other countries by broadlyintegrated national healthcare systems [101], a tra-dition of willingness of the population to par-ticipate in health surveys, and, in some cases, bylegislative actions providing a clear mandate ofgovernmental support and oversight [102–104].In the international arena, it has become clearthat harmonization across biobanks will beimportant in obtaining the full advantage ofinformation aggregated from multiple nationalefforts [105]. The Organization for EconomicCo-operation and Development has recognizedthe importance of setting standards forbiobanks, and has published draft guidelines forhuman biobanks and genetic research databases[106]. Biobanking in the USA comprises a decen-tralized system with inconsistent standards [8],although guidelines have been developed [9]. Incontrast to in Europe, much less is knownregarding the feasibility of implementingbiobanks in the USA. The NIH, among otherfederal health agencies, has been consideringdeveloping a biobank of samples and informa-tion from a large cohort of volunteers [10]. TheGenetics and Public Policy Center at JohnsHopkins University has been commissioned togather feedback from the general public on theissue of biobanks [107]. A series of focus groups,community leader interviews, ‘town halls’ and anational survey are being pursued by the centeras vehicles to obtain insights into public opin-ion. At a more regional level, Rhode Island (RI)has been suggested as a state that is friendly topopulation studies, and is a microcosm of theUS population at large. As such, many in the

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RESEARCH ARTICLE – Goldman, Kingdon, Wasser et al.

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state feel that the RI population could wellserve as a pilot trial of the biobank concept inthe USA. The state is well suited to host abiobank, since it has a stable, genetically diversepopulation of 1.1 million, and the small size ofthe state facilitates community outreach, enrol-ment and engagement. It was therefore judgedimportant to implement a mixed-methods fea-sibility study in RI that would provide essentialinformation regarding public perceptions ofresearch studies involving the acquisition ofgenetic information.

The disease put forward for the initial focus ofstudy for the proposed RI Biobank (RIBB) issudden cardiac arrest (SCA). SCA is the mostcommon cause of death in many parts of theworld. In recent years, a number of inherited car-diac diseases have been identified as contributingsignificantly to SCA [11,12]. Importantly, newexperimental models in large mammals havedemonstrated that identical mutations wouldresult in inherited SCA phenotype due to malig-nant ventricular arrhythmias [13]. Epidemio-logical studies have highlighted a familialpredisposition to SCA in patients with ischemicheart diseases, supporting the role of an SCAgenetic substrate in the absence of inherited spe-cific mutations in the human genome, whichsegregate as Mendelian diseases. However, theunderlying molecular determinants of SCA incommon acquired heart diseases, such as coro-nary heart disease, remain elusive. The proposedstudy is a large, prospective, population-basedstudy of SCA that would include a biobank tostore blood for future biochemical and whole-genome association studies to elucidate thegenetic determinants of SCA. It would serve as alarge pilot study to establish the infrastructurefor an ‘opt-in’ statewide RIBB. The RIBBintends to be a new resource for biomedicalresearch, clinical genomics and personalizedmedicine that will integrate a collection of bio-fluids with corresponding patient data, includingmedical history, lifestyle-related information anddetailed electronic medical records. Many popu-lation-based biobanks have been established inEurope [14], but the RIBB would be the firststatewide population-based repository of its kindin the USA.

The biologic specimens in a biobank can beas diverse as solid tissues, blood, saliva or anyother tissue or fluid containing nucleated cells[15]. In the proposed RIBB SCA study, the sam-ples that would be obtained are likely to beblood, and the data would be the medical

history information pertaining to the donor ofthe biospecimen, detailed information regard-ing lifestyle practices, and his or her familymedical history.

Much has been written regarding the ethicalissues that demand consideration when abiobank is being established [16,17,108], andregarding consideration of such issues as pri-vacy and confidentiality [18,19], informed con-sent [20–22], and health inequalities across socialand racial groups [23,109,110]. The extant litera-ture informed not only the content of the focusgroup questions, but also the very makeup ofthose groups. Given the great potential for pub-lic concern regarding long-term storage of bio-specimen and personal information, earlypublic consultation and engagement is seen askey to acceptance of the research vision and theviability of a biobank [24,25].

This paper reports on the multimethod feasi-bility study that we conducted with a voluntarysubset of Rhode Islanders to begin the process ofpublic consultation (which would continueshould the SCA study go forward), to gauge thewillingness of RI residents to participate in aprospective, population-based study of cardio-vascular diseases and SCA, including a biobankto store blood for future analyses, to exploreconcerns that potential participants may have,including those of confidentiality and securityof their personal data, to identify attitudesaffecting logistical issues that are to be addressedin the study, and to understand how social anddemographic factors may affect participation.

Participants & methodsThe sponsors of the RIBB survey and focusgroup feasibility study were Brown University(RI, USA), a major university located in RI,and Lifespan, a not-for-profit comprehensive,integrated academic Healthcare System (HCS)consisting of several academic hospitals. Thefeasibility study was coordinated and centeredat the Cardiovascular Research Center ofRhode Island Hospital with the purpose ofguiding the teams involved with the potentialdevelopment and implementation of the SCAstudy and the RIBB. Approval for the use ofhuman subjects was sought and obtained from theinstitutional review boards of all sponsoring andparticipating institutions. In addition, instru-ments developed for both the survey and focusgroup phases of the feasibility study were reviewedby the multi-institutional RIBB guidance andbioethics committees.

Personalized Medicine (2008) 5(4) future science groupfuture science group

Rhode Islanders’ attitudes towards a statewide genetic biobank – RESEARCH ARTICLE

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Survey design, participants, instruments, data collection & analysisA 22-item mailed questionnaire survey wasdeveloped in English. In total, 20 of the ques-tions offered a multiple-choice response and twowere open-ended, requiring a written response.Survey data were collected from November2006–September 2007 from a random sample ofmen and women aged 50–80 years who reside inRI. This age range was selected because of anincreased incidence of SCA in this age group; theincidence of SCA in the general US populationis approximately 1:1000; however, for thisselected age group, the incidence ranges from 2.8per 1000 in people aged 50–59 years to 13.6 per1000 years in people aged 60–69 years [26].There was no monetary or in-kind incentive forparticipation in this survey. Participants wererandomly selected from the RI voter registry toreceive a survey in the mail. The voter registra-tion list was considered because it was publiclyavailable and inexpensive, and chosen becauseanalysis of the list showed that demographiccharacteristics of registered voters in RI closelymirrored those of the US census data for RIin 2000.

The survey was developed by an inter-disciplinary team of researchers, including twoexperienced epidemiologists, one of whom hadrobust expertise working with the RI populationin this age group. There were no previous USstudies on which to base survey questions,although the questions were discussed at lengthwith colleagues elsewhere in the country whowere proposing a similar public consultation.The concerns of RI residents regarding confiden-tiality of genetic data had been highlighted asearly as 2000 [27], so survey questions weredesigned to provide meaningful informationregarding RI residents’ attitudes towards a state-wide biobank. Question topics included: interestin study participation, number of hours willingto spend at an initial study visit, willingness toprovide genetic samples, and lifestyle and demo-graphic characteristics. Two open-ended ques-tions allowed recipients to voice their questionsand concerns about potentially participating inthe RIBB. The survey was accompanied by a let-ter outlining the SCA project, using language atapproximately the eighth grade reading level.This letter stated that the study “would focus onheart disease and other illnesses that may run infamilies”, and that it “would help medicalresearchers learn better ways to prevent, diagnoseand treat heart disease and other illnesses in the

future”. It was explained that “answering thequestions in the enclosed survey will help us bet-ter understand whether the people of RI wouldbe interested in participating in such a study inthe future”.

Quantitative data analysisData from all surveys were entered into an in-house, web-based data-entry program located atthe Cardiovascular Research Center and con-nected via a secured line to a database located onservers at the Brown University Center for Statis-tical Sciences. One individual entered all thedata. Double data entry was conducted on 10%of the sample and accuracy was confirmed at99.8% level. Frequency distributions werepresented for all variables.

Focus group design, participants, instruments, data collection & analysisWe used the focus group method to benefit fromthe interactive discussion among participants thatis fostered during the discussions; participantsrespond not only to direct questions from themoderator, but to questions and ideas posed byother participants. During May and June 2007,we conducted ten focus groups with a total of 81participants: eight groups involved English-speaking adults (including one group consistingof participants of varying black heritage back-grounds whom we will refer to in this paper asAfrican–American) and two involved Spanish-speaking adults. The focus groups were con-ducted in community settings throughout RI toinclude both rural and urban areas and individu-als from all socioeconomic groups. Eligibility cri-teria were age 50 years or older (again to include asample within the age range appropriate for astudy of SCA), and residence in the geographicregion where a group was being held. Recruit-ment involved varied community-based strate-gies, as were appropriate to the particular settings,including posting flyers in public spaces, face-to-face recruiting in community locations, and seek-ing the assistance of staff in the sites where thefocus groups were to be held, such as in seniorcenters, public libraries and a church.

A discussion guide with a core set of questionswas created for this project. The guide was mod-ified according to comments from the projectguidance and bioethics committees, reviewed,and modified again before being finalized, trans-lated into Spanish, and submitted to the humansubjects review boards for approval. During thefocus groups, the moderator supplemented the

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Table 1. DemographRhode Island reside

Demographic charac

Age (years)

50–69

≥70

Sex

Male

Female

Education level

Less than high school

Some high school

Completed high school

Some college or technic

Completed college

Completed more than c

*For all adults aged 25 yeaGED: General Educational

listed questions with spontaneous probes to seekfurther explication or clarification of a comment,and to explore unanticipated topics raised by theparticipants. Data are reported in this paper onthe following topics: familiarity with the con-cepts of genetics and DNA; reactions to the ideaof a statewide biobank; concerns regarding abiobank; information desired by potential par-ticipants prior to their registration for the study;issues that enhance or impede trust in such amedical study; attitudes towards personalizedmedicine; willingness to participate in a study ofcardiovascular diseases; and suggestions forenhancing acceptance of a biobank study amongRhode Islanders.

Prior to beginning the 2-h discussions, par-ticipants signed an informed consent docu-ment. Focus groups were moderated by abilingual (English/Spanish) medical anthro-pologist (REG), with the assistance of a nursepractitioner (CK). To enhance participants’comfort during the discussions, we includedAfrican–American and Latina cofacilitators asappropriate. The focus groups were digitallyaudio-recorded and professionally transcribedin the original language. A meal was served ateach focus group and participants receivedUS$30 for their time and effort.

Qualitative data analysis Two coauthors (REG and CK) conducted prelim-inary analyses on an ongoing basis as each focusgroup transcript was completed. We recognized

that we were reaching data saturation when webegan to hear repetitive comments, with littlenew data generated in the final groups. We thenused the in-depth qualitative analysis method ofimmersion/crystallization [28], which entailed lis-tening to the focus group tapes and repeated re-reading and discussion of the transcripts in theoriginal English or Spanish to identify emergingthemes and salient topics.

ResultsSurvey resultsFrom the 10,000 mailed survey questionnaires, atotal of 1135 (11%) were returned. Attemptswere made to follow-up with nonrespondents bytelephoning those previously mailed at three dif-ferent times, and by leaving a cost-free telephonecallback number if there was nobody to take thecall. After 1 month, this process was discontin-ued as we received no positive responses frompeople contacted in this way. It is acknowledgedthat this low rate of response may bias the resultsobtained; it is very difficult to quantify expectedresults of a blind mail survey as much of this datais unpublished. There is some recent evidencethat nonresponse need not induce nonresponsebias [29].

Table 1 shows the demographic characteristics ofsurvey respondents. Of the respondents, 71%were aged between 50 and 69 years; the remaining29% were aged over 70 years. In total, 56% weremen, and 52% of the respondents had a collegedegree or higher compared with approximately

ic characteristics of survey questionnaire respondents (n = 1135) compared with all nts (Census 2000).

teristics Study sample (n) Study sample (%) Census 2000 (%)

806 71 73

329 29 27

636 56 48

499 44 52

23 2 8*

23 2 14*

or a GED 193 17 28*

al school 307 27 17*

250 22 23*

ollege 341 30 10*

rs and older.Development.




Table 2. Comparing

City (Census 2000)

Cranston

East Providence

Newport

Pawtucket

Providence

Warwick

Woonsocket

Total city residents

25% of the RI population according to the 2000RI Census [111]. Table 2 compares the percentageof those respondents coming from seven RI citieswith the percentage of the state populationrepresented by those cities [111].

Table 3 shows the survey responses to a subsetof the multiple-choice questions included in thesurvey; this subset is about participation in apotential biobank in the state.

Of the 1135 adults who responded, 76% saidthat they were more than somewhat interested inparticipating in a future biobank study in RI,and only 10% said that they did not know orwere not at all interested in participating. Anhour-long questionnaire to register for a biobankstudy was not considered too long, and respon-dents were not unduly concerned regarding theprospect of physical tests. Indeed, more than halfof respondents said that they would be preparedto spend 2 h or more at a first appointment toparticipate in the study. Nine out of ten respon-dents said that they would be willing to answerquestions regarding personal and family medicalhistory, exercise and eating habits, and generalitems about their family. However, there wasevidence that they would be slightly more reluc-tant to answer questions related to smoking,alcohol use and employment history. Only 6%of respondents said that they would beunwilling to give a blood or urine sample; therewas more reluctance to provide a buccal swabfrom their cheek.

Approximately 80% of respondents indi-cated that they would be willing to allow a bio-specimen to be stored for possible geneticanalysis, and 81% stated that they would bewilling to allow medical researchers to reviewtheir medical records.

More than four out of five respondents indi-cated that they would be willing to travel toProvidence (the state capital) to participate iftravel expenses were covered.

Free-text responses to Rhode Island Biobank mailed surveyOf the 1135 respondents to the mail question-naire, more than half (n = 591) included a free-text written response to one or both of the twoquestions posed that allowed free-text entry:“What questions would our team of medicalresearchers need to answer for you before youagreed to take part in our possible futurestudy?” and “What concerns do you have aboutparticipating in this future study?”

The desire for further details regardingbiobank study protocols was paramount in theresponses, followed by expression of varyingconcerns regarding data security and participa-tion logistics. One in four of those requestingfurther information were interested in the gen-eral purpose of the study and what the benefitto themselves and others would be if they wereto participate. Over 10% wanted to knowwhether they would have access to the results ofany tests performed, and whether these resultswould be explained by the researchers alongwith treatment options. For example, a managed 53 years asked “If a medical problem isdiscovered during my participation in thestudy, will a doctor intervene and explain thesituation and what my options might be?”There were also concerns that pre-existing ail-ments and conditions might preclude some ofthe respondents from participating in theproject. As a woman aged 68 years wrote, “Ihave had chronic high blood pressure for quitea few years, how would this [the study] affectthe actual medications I am taking now?”

Approximately 3% of respondents wanted todiscuss the decision to enrol with their physicianbefore agreeing to participate, and would wish fortheir physician to be informed of test results. A69-year-old man said, “I would have to seekapproval from my primary physician and cardio-logist before agreeing to participate.” One person

Rhode Island populations (Census 2000) and biobank respondents by city.

Residents (n) Total state population (%) Respondents (n) Total respondents (%)

79,000 14.9 74 14.9

49,000 9.2 52 10.4

26,000 4.9 17 3.4

73,000 13.8 58 11.6

174,000 32.8 140 28.1

86,000 16.2 126 25.3

43,000 8.1 31 6.2

530,000 498



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Table 3. Questions and response rates (n = 1135) .

Answers Response rate (%)*

1. How interested would you be in joining this possible future study if you had to answer a survey with questions about your health?

Not at all interested 8

Somewhat interested 13

Moderately interested 25

Very interested 51

Not available 0

Don’t know 2

2. How willing would you be to answer questions about your health if the survey took up to 1 h to finish?




Very interested 48

Not available 0

Don’t know 1

3. How interested would you be in joining the study if you had to have some physical tests performed such as having your blood pressure measured and having a blood sample taken?




Very interested 53

Not available 1

Don’t know 1

5. What is the longest amount of time that you would be willing to spend at the clinic to take part in the study?

2 h or less 47

3 h or more 27

Not available 7

Don’t know 19

10. We are interested in learning about the health of study participants over several years. If we sent you a survey in the mail about your health once a year, how willing would you be to answer the questions about your health each time you received the survey?

Not at all willing 6

Somewhat willing 9

Moderately willing 19

Very willing 64

Not available 2

Don’t know 1

11a. Would you be willing to answer questions about your personal medical history?

No 5

Yes 92

Not available 3*Percentage may not total 100 owing to rounding.




11b. Would you be willing to answer questions about your family medical history?

No 6

Yes 91

Not available 3

11c. Would you be willing to answer questions about your current or former job?

No 7

Yes 88

Not available 5

11d. Would you be willing to answer questions about your family?

No 6

Yes 90

Not available 4

11e. Would you be willing to answer questions about your exercise habits?

No 6

Yes 91

Not available 3

11f. Would you be willing to answer questions about your eating habits?

No 5

Yes 91

Not available 3

11g. Would you be willing to answer questions about your smoking?

No 7

Yes 89

Not available 4

11h. Would you be willing to answer questions about your alcohol use?

No 7

Yes 89

Not available 4

12. As part of the planned study, there are several different ways that you might be able to answer questions about your health. Which way would you prefer to answer the questions?

A researcher asks you the questions and marks your answers 10

You read the questions yourself and mark your answers on paper 25

You read the questions yourself and mark your answers on a computer 13

Not available 5

Don’t know 3

14a. Would you be willing to have a blood sample taken?

No 6

Yes 90

Not available 3

14b. Would you be willing to have a urine sample taken?

No 6

Yes 90

Not available 4

Table 3. Questions and response rates (n = 1135) (cont.).


*Percentage may not total 100 owing to rounding.



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without health insurance wanted to know whethershe would receive treatment if the investigationrevealed a medical problem.

A very small portion (3%) of persons respond-ing to our pilot survey wanted more informationregarding pecuniary reward and/or travelexpense reimbursement, although the surveyspecifically indicated that only travel expenseswould be paid. As one 75-year-old asked, “Howwill I be compensated for my time?” Only twopeople asked whether or not they could elect todiscontinue participation in the study at a laterdate. Approximately 10% of all respondents wereworried about how they would get to and fromthe clinic appointments if, as we suggested, theclinic was to be held at a central location in thestate capital. Just over 1% of respondents wereanxious about availability and ease of parking atthe central study location.

Approximately one in five respondents wantedto know more about the motives and experienceof the study investigators, staff performing therequired medical tests, or the institutions thatwould be funding the research. These queriesranged from one woman who asked, “Will allmedical staff involved have the required medicalcertifications?” to another who stated, “I wouldwant to know who was sponsoring and paying forthe study (if a drug company)”. An elderly dia-betic explained that her refusal to give a bloodsample might be overcome “If it was a super phle-botomist…” In total, 2% of respondents were

worried that they might be too old, while othersfelt that because they had no presenting illnessthey would not be of value to the study. Some24% of respondents were concerned that theymight have to take experimental medications aspart of the study. The possibility that by partici-pating in the study people were more vulnerableto discovering hidden illnesses was expressed byone respondent, who said, “I have a terrible fearof dying and I would be concerned that theywould find something wrong”.

Although only two people worried about theirability to participate in a study conducted inEnglish, this may be a poor indicator of potentiallanguage limitations because individuals withlimited English proficiency were not likely tohave returned the questionnaire.

Nearly 20% of all respondents expressed con-cern regarding the amount of time that could beinvolved if they elected to be part of the study,particularly if it interfered with work or otherdaily activities. The next most-noted concernwas how researchers would maintain confidenti-ality of participants’ personal and genetic infor-mation. One woman wrote, “Confidentialityissues – especially for genetic testing – couldimpact insurance, if genetic markers arepresent…” Respondents were somewhat lessconcerned by researchers’ access to these datathan they were by outside agencies’ potentialaccess, including insurers, the government, thepolice force and employers.

14c. Would you be willing to have a hair sample taken?

No 8

Yes 87

Not available 4

14d. Would you be willing to have a sample from the lining of your cheek taken?

No 13

Yes 80

Not available 7

15. How willing would you be to allow medical researchers to keep your samples for a possible confidential genetic test?

Not at all willing 9

Somewhat willing 9

Moderately willing 21

Very willing 49

Not available 3

Don’t know 9

Table 3. Questions and response rates (n = 1135) (cont.).


*Percentage may not total 100 owing to rounding.




Table 4. Focus group

Characteristics

Sex

Male

Female

Age (years)

50–55

56–60

61–65

66–70

71–75

76–80

81–85

>86

Education

Less than 12th grade

High-school diploma

GED

Technical school

Certificate program

Some college

Bachelor’s degree

Master’s degree

Other

Employment status

Working part time

Working full time

Not employed

Retired

GED: General Educational

Focus group resultsCharacteristics of the 18 male and 63 femaleparticipants in the focus groups are shown inTable 4.

Familiarity with the concepts of genes & DNASome people in all groups had enough familiar-ity to talk at least superficially about inherit-ance and genes, and there were usually one ortwo in each group who brought up the topic ofthe human genome. A couple of people men-tioned the decoding of James Watson’s com-plete genome, which was in the news at thetime of focus group implementation, and oth-ers mentioned television commercials for stat-ins advertising the need for medication owingto heritability of high cholesterol. An Afri-can–American participant mentioned thatOprah Winfrey had had some ‘DNA coding’performed to discover her ancestry, and a

participant in a rural focus group mentionedthat a farmer in RI was addressing the genetics ofendangered animals. As one of the higher-income participants stated, “We toss that genething around quite casually now”, although gen-erally participants were more familiar with theterm DNA than with genes or genetics. Thestrongest influence on people’s working knowl-edge of genetic analysis was prime-time televi-sion, particularly ‘Law & Order’ and the ‘CSI(Crime Scene Investigation)’ shows, whichincorporate high-tech machinery and seeminglymagical science to solve each episode’s crimes.Owing to what they have seen on television,many believed that individual genetic analysis ismore accessible to the general public than is cur-rently the case. This is demonstrated by theexchange during one focus group:

• Participant (P)1: “I’m all in favor of medicalresearch. But I was wondering. If you werestaying in the hospital for any number ofdays and they take your blood type, do theyautomatically do a DNA on that blood?”

• Moderator (M): “No.”• P1: “They’re not allowed?”• M: No, it’s that it’s very expensive.”• P1: “Oh, because you watch CSI, and they got

somebody’s DNA, and they run it through.There’s like 80 million things that go in, andthey’re looking for a match. You know, wheredo they get all this DNA from?”

• P2: “So if you want to get a test, a DNA andfind out about your own genetics, can you?”

Some participants appeared mystified by theexotic nature of DNA and genetics. They did notrealize, like Participant 1 below, that wheneverthey have blood drawn, as Participant 1 told usshe had done that very morning, they have pro-vided specimens that contain DNA. Many weresimultaneously searching to figure out if storingDNA for research is really any different or moreprofound than when they give information totheir doctors.

• P1: “Other than DNA … don’t you do that allthe time? I mean you go into a doctor’s office,and it seems like … you’re filling out an appli-cation, the medical history. I mean I’ve done it50 times.”

• P2: “Yeah right, it’s true.”

• P3: “Now do I trust?”

• P1: “I’ve never given DNA before… I’m giv-ing my family history, my own history. Youknow, you do it over and over and over again.”

participant characteristics.

White African–American Latino Total

12 3 4 19

49 8 12 69

11 1 2 13

10 0 6 16

7 1 1 9

11 1 3 15

9 5 0 14

7 2 0 9

5 2 0 7

1 0 0 1

2 3 3 8

16 6 5 27

0 0 1 1

0 0 0 0

2 0 0 2

12 1 4 17

12 1 1 14

11 0 0 11

5 1 0 6

11 1 4 16

13 0 9 22

4 1 2 7

33 10 0 43

Development.



348

• P3: “But basically we’re going to be giving theinformation that we only know ourselves fromour parents, you know?”

• P2: “It’s on electronic equipment.”

• P1: “What’s secret anymore anyways? I meanreally when you think about it.”

And some were looking to the future, even if itis beyond their lifetime: “You know, I think it’s[the proposed study] fantastic because even if Idon’t live to see it … I would say you know howat such a year you have a mammogram and sucha year you do this. I would say years from now atsuch an age you have a DNA”.

Some Latino participants wondered whetherthey were more susceptible to some diseases thanpeople of other ‘races’, and owing to this concern,envisioned the benefit of a biobank study:

• P1: “When you do this study, God will knowour grandchildren – we’ll be, who knows, dead.”

• P2: “For one’s heredity, because there aremany diseases that are hereditary.”

Reactions to the idea of a statewide biobankMostly positive comments exemplified partici-pants’ initial reactions to hearing about thebiobank project. Most participants felt that if thestudy can help discover cures for diseases or bettertreatments for diseases, then it is a good idea. ALatino participant noted that although it may be“frightening, it is necessary to collaborate in ana-lyzing what will come in the future”. One partic-ipant told us that her husband had coincidentallyreceived a RIBB mail survey and declined toanswer it until she urged him to do so. Sheexplained: “I guess it’s the age we live in, and it’sgreat [advancing medical technology includingDNA analysis]. And I don’t understand whymore people wouldn’t want it. That’s why I getupset with my husband. ‘Well why don’t youwant to [fill in the survey]?’ And then he sur-prised me because the things that said would yoube willing to have blood, he said yes to all thatstuff. So he’s willing to do it. I think sometimessome men need to just be kind of nudged”.

A participant received enthusiastic nods ofagreement when he stated: “And then you mightnot get a cure out of it personally, but the satis-faction you get from knowing that somedaysomeone is going to benefit from it and betterunderstand your problem”.

Latino participants understood that thebiobank would not benefit them personally, buttheir descendants, and they commented about

how good it would be if a person understoodthat he or she was predisposed to particular dis-eases and could take precautions: “The silent dis-ease is the most dangerous, it’s always inside andwhen it comes out there is nothing at that pointone can do”.

Some African–American participants expressedconcerns stemming from past injustices done toAfrican–Americans through medical research:

• P1: “If you went and took the DNA of thesepeople here, you would also know how toexterminate them through the DNA.”

• P2: “Genocide.”

• P1: “I’m not going to say that [genocide]because it may be one or two. They’ve done it… So when you look at all these bad thingsthat have happened I kept it in my mind a lotof people are forgiving. I’m forgiving too. ButI also remember. It won’t happen to me again… If you’re talking about something positive,okay … but if you just want to know aboutme, and I know nothing about you, you con-trol my destiny. The DNA, now you knowhow I function. You can get rid of me when-ever you want. And that’s the way I look at it.What I’m trying to rationalize here is outsidethis room you may run into other people thatthink the same way I do. And how do youcultivate that so that they feel comfortable insitting down and letting you do a DNA?”

• P3: “I think you’re going to run into trust issues.”

Participants’ specific concerns regarding a statewide biobankOverall, participants’ generally positive orienta-tion towards a biobank in RI did not precludetheir having multiple concerns and fears associ-ated with such a project, which are detailed below.The types of concerns noted were similar fromgroup to group, with the exception of the Span-ish-speaking group. The participating Latinos didnot spontaneously generate any concerns thatwould be a barrier to their participation (outsideof not wanting to give blood if they are not sick),and they did not agree that any of the potentiallyproblematic issues that the facilitator asked themabout would be of concern to them. By contrast,some of the African–American participants voicedthe strongest concerns, particularly regardingwhat kinds of discrimination they would face afterproviding researchers with the information andDNA samples required by the study. The mostcommon categories of participants’ questions andconcerns are detailed below.




Who are the sponsoring institutions for the RIBB?There are at least three different institutionalsponsors planned for the RIBB – a major univer-sity, a not-for-profit comprehensive, integratedacademic HCS that consists of several academichospitals, and a well-known hospital that is itselfpart of the HCS. Most participants felt that theseare honorable entities and reasonable ones to con-duct such a study. However, opinions differedregarding which entity engenders the most trustand why, often stemming from misconceptionsregarding the training, experience and roles ofhospital- versus university-based researchers.Some participants felt that it would be better todesignate the specific well-known hospital as thesponsor rather than the HCS because the hospitalhas more name recognition. However, some asso-ciated the hospital and HCS with hospital billsand a healthcare monopoly, and so held negativefeelings; would be less likely to open a letter sentfrom a healthcare institution than from the uni-versity. Some felt that there is a difference in theroles, motivations and biases of investigatorsemployed in a university compared with in a hos-pital. Participants of all economic and educationalstatuses expressed interest in being involved withsomething that Brown University is sponsoring,and said they would be delighted to open a letterfrom the university inviting them to participate ina biobank study. An exchange from a focus groupheld in a small, working class city illustrates this:

• P1: “How many people during a course of alifetime get a letter from Brown University? Itdoesn’t happen. So immediately it’s got yourattention.”

• P2: “I think it’s a good point because peoplewill probably see something from [the HCS]and say, ‘Oh, what, did I not pay a bill?”

Others, however, felt that the HCS or a hospi-tal would be the more effective primary sponsorof the biobank because that is where the experi-enced doctors are, and therefore the people whobest know how to do medical research are at thehospitals: “I have more confidence in the univer-sity because they’re distant. They’re not as close. Iwould rather universities and scientists be doingit than the hospitals”.

What are the credentials & experience of the biobank project investigators?Participants in most of the focus groups wanted toknow not just what the sponsoring and affiliatedinstitutions would be for a future biobank study,but also the credentials of the specific investigators

in charge, and of the personnel working on thestudy. One participant was concerned about theconduct of the study: “Well trust … I would defi-nitely try and inquire as to who is the person that’sconducting the survey … what kind of credentialsdo you have? Are they qualified to do it? Howlong have they been employed? So you are in asense putting your trust to that person”.

And another explained concerns about ensur-ing that study evaluations would be performedby competent professionals: “I don’t even knowwho Dr X is [the contact investigator listed onthe focus group consent form]. But he’s got aPhD after him, and his name sounds like hemight be somebody. But I don’t know who he is.But at least he’s affiliated with Brown apparently,and that gives him a lot of credence as opposedto somebody who might be associated with thehospital where they’ve got hundreds and hun-dreds of doctors. So I think the evaluator of theresults is the one who you have to have faith in toget anything out of it”.

How can biobank participants be assured that the ethics of the current investigators will be maintained into the future?Many noted that with a long-term study such aswe are proposing (storing participants’ data for atleast 20 years and likely longer), administration ofthe project will change hands over time, leavingthe study open to interpretation by a new genera-tion of scientists. The moderator asked them tocomment on possible mechanisms to amelioratetheir concerns about this, for example, by having arolling membership on the steering (governance)and bioethics committees that always includesmembers with longer institutional knowledgeeven as some are replaced by new members. Con-cerned participants felt that a rolling membershipwould be helpful, but still expressed that nothingcan guarantee what will happen in the future:

• P1: “You wonder 30 years is the same people onresearch as researchers who gave their wordsand assurances and what happens next?”

• P2: “Or what it might branch off into, youknow?”

• P3: “That’s the chance you take.”

How can biobank participants be assured that use of their DNA & survey data is limited to what is listed in the informed consent process?Focus group participants were informed by themoderator that the informed consent for thebiobank study will necessarily be somewhat



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open-ended owing to the future potential and sci-entifically evolving nature of the project. Manyexpressed concern about this. However, with fur-ther discussion in each group it became evidentthat it was specifically the use of their DNA forcloning that they were anxious to prohibit, ratherthan any preference for their DNA to be used inthe study of some diseases to the exclusion of oth-ers. Most focus groups included one avid sciencefiction reader among the participants, and it wasusually this person who initially raised the issue ofcloning, followed by others who then added theirvoices to the discussion of this topic. The focusgroup participants generally would like to see theexclusion of cloning clearly stated in the consentform, although, as with everything discussed,there were participants who noted that no matterwhat is on the consent form, there can be no guar-antees about what will happen in the future. AnAfrican–American participant expressed thethoughts of many: “In essences it’s your geneticblueprint, so you lose yourself a little bit becauseyou’re no longer in control.”

Another person explained how sciencefiction reading can influence one’s thoughtsabout research:

• P1: “I think the research is a very importantthing. It also scares me a little bit sometimes.”

• M: “In what ways?”

• P1: “Well, I’m a big science fiction fan. Andresearch is not always portrayed really – what’sthe word that I want to use? Ethically. It’s notportrayed a lot of times honestly. There’s a lotof – it’s almost like politics. It starts out withvery, very good intentions and then moneyand greed and power and a lot of other thingscome into play. And so things get tainted. Andso that’s the other end of research for me. Youknow, it’s almost like a double-edged sword.”

Some participants had no concerns regardingwhat happens in the future with their DNA andsurvey data, particularly if the materials are usedafter their death. While this subset of participantswas generally able to envision benefits of theproject for their children and grandchildren, fewfelt that their participation in the study couldhave detrimental effects on their descendents,even if they were to be cloned.

Will biobank participants get the results of their genetic analysis?While many posed this as a question, most actu-ally assumed that receiving their genetic analyseswould be an integral part of participation in the

biobank project. Given that the study involves ananalysis of their health status, many felt certainthat if there was something wrong with them, theresearchers would tell them. Most were veryinterested in getting their results, particularly ifthey were already diagnosed with a chronic dis-ease. Others wanted the results more for theirdescendants’ sake than for their own sake. In fact,it most likely will not be possible in this develop-ing RIBB study to provide the genetic analysisresults to the participants, and this became animportant sticking point for many people in thefocus groups; they could not accept that partici-pants will not receive their genetic analyses, andthey returned to this topic over and over againduring the course of the discussions. The primaryreason participants gave as a basis for their atti-tude is that if they are going to donate their infor-mation to the project, they or at least theirchildren/grandchildren should benefit in someway as well. Participants stated that they wouldlike to know what, if anything, they are predis-posed to so that they can take steps to amelioratethe disease’s effects and to warn their childrenabout their potential predisposition. However,when we explained, in detail, the proposed studyprotocol (that some people’s DNA and surveydata will not be analyzed for years to come), mostrelented and stated that despite their desire forindividualized results, it would be worthwhile toparticipate in the study even if they could notobtain their own genetic analysis.

A minority of participants expressed relief thatthey would not get their own results from partic-ipation because they did not want to know whattheir “genes have to tell” them. Some felt thatthey did not need genetic analysis to know whatdiseases they are likely to get; they know this bylooking at their parents’ health status.

• P1: “If something shows up that we don’t haveanything to help, what good is it to know? Imean that could be very depressing to some-body to know, and they will eventually findout. But it would be a lot better to find outwhen you’re at the point that you have to dealwith it than living always anticipating thatsome day you’re going to wake up…”

• P2: “Well it’s good to know eventually to getyour affairs in order. You don’t have a will youbetter make one up.”

• P3: “…When you’re dealing with the diseaseis one thing, but to know … I often think thatif we ever knew everything that was going tohappen to us most of us wouldn’t manage.”




• P4. I just think about my mother. If anythinghappened to her it will happen to me. It justfollows suit.”These thoughts were echoed in the Spanish-

speaking groups, although not all were inagreement:

• P1: “Yes, there are many people who in realitydon’t participate in the studies for fear thatsuddenly they are going to say, ‘Ah, you havethis.’ And so they say, ‘Better that I’m going todie this way, without knowing the truth, andthat they don’t tell me that I have somethingbecause then there’s nothing else to do butthink until the time [that I die].”

• P2: “No, but there are people who want toknow what they have. I would always like toknow, when they do a test, I want them alwaysto tell me the truth.”

What steps will be taken to secure the confidentiality of personal information on the computer & protection from identity theft?Other than Latinos, people in all groups men-tioned identity theft as a concern because manyhad either had this happen to them or to peoplethat they knew. However, some participantsexpressed doubt that anyone could easily linkthe information collected as part of the biobankwith a person’s identity, and even if this waspossible, doubted that anything detrimentalcould be done with their personal information.Some stated that confidentiality can not beassured, but as one person noted: “I thinkthere’s a point where you just have to trust”.Others believed that it is futile to even try tokeep your identity secure: “Just give it out.Who cares? My theory is if they want to findout something about you, they’re going to findit out. That’s why they’re researchers.” Somewere concerned about the government morethan about profiteering hackers:

• P1: “The fear of losing your privacy because itis related to the government. Somebody isgoing to try to find out something about yourprivate life.”

• P2: “They will find out definitely. I don’tlike that at all. I don’t like the government inmy business.”

• P1: “They’re too much in our business as it is.”

• P2: “They know much too much about allof us.”

Nevertheless, most focus group participantsstated that, despite these concerns, they would

join a biobank study because “you can’t live in ashell – otherwise there’s no progress”.

Latinos felt that the chances of a breach insecurity causing them damage were ‘remote’.However, they conceded that Latinos who haveundocumented status in the USA would beunlikely to risk participation for fear of informa-tion being accessed by the immigration authority,resulting in deportation.

What is the potential for discriminatory use of participants’ DNA & survey data in the future?Participants raised issues of the potential fordiscrimination in every focus group except theLatino group. African–American focus groupparticipants demonstrated the most concernabout this and were the most conflicted aboutwhether African–Americans should take part ina statewide biobank. Some expressed wantingto benefit from the potential future medicaladvances that the study may generate, and yetwere aware that it may be too risky for them toparticipate because African–Americans in theUSA were tragically mistreated in the past bymedical researchers. During the 40-year Tuske-gee Study of Untreated Syphilis in the NegroMale, beginning in 1932, African–Americanmen were excluded from syphilis treatmentwithout their informed consent to allowresearchers to observe the natural course of thisdisease [30]. Two participants discussed thepotential for African–Americans to benefitfrom future medical research:

• P1: “Considering Tuskegee and all the thingsthat happened in the past, moving forwardminorities need to participate in research.Minorities need to be empowered so thatthese things do not happen again. So what canwe do? What are some things that are still inour power to make this happen so that we’renot taken advantage of?”

• P2: “Again you’re going back to a trust issuebecause you can’t erase 300 years of mistrustin a heartbeat. So you’re going to have to workhard at it, and you’re going to have to educate,and that’s the key. You’re going to have to edu-cate the groups, the ethnic groups to what youreally are trying to do, but again, the Tuskegeething is a big thing because of the fact thatfamilies for years never knew. And that’s stillto this day because I know my grandfatherhad it because of the experimentation. So it’s atrust issue. And that’s probably going to be thebiggest drawback to your research.”



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White participants from all parts of RI alsoraised concerns regarding potential discrimina-tion resulting from their provision of DNA sam-ples, and pursued the topic from a variety ofangles. The types of discrimination people spokeabout included barriers to obtaining health andlife insurance or getting into trouble with the lawand having “your DNA used against you”. Fewraised issues of employability. When the modera-tor asked them to comment on this as a potentialconcern, most literally scoffed, explaining thatthey are already retired from work, and those whoare not will retire during the course of the study.

Concerns regarding study logisticsMany otherwise interested people mentionedlogistical concerns that could serve as barriers toparticipation in a biobank study. Despite the factthat RI is the smallest US state, residents areunaccustomed to traveling distances, and feltthat a central location in Providence, the statecapital, would discourage participation. Trans-portation, gas and parking were issues frequentlyraised, particularly since this study would enrollparticipants aged at least 50 years. Some felt thatpeople would be unwilling to devote the timeneeded to fulfill study requirements, while othersfelt that a one-time, lengthy visit (possibly up to4 h) at the start of the study, and yearly surveyupdates by telephone would not be prohibitive.Some were concerned about having enough pri-vacy when filling out the survey, and others, par-ticularly the Latinos, mentioned fear that theneedles used to take the DNA blood samplewould not be clean. Other logistical concernsincluded the potential role of pharmaceuticalcompanies in the research, the potential for someentities to earn income through the study or saleof the donated DNA, and whether the studywould be successful in enrolling a true represen-tative sample of Rhode Islanders, includinghard-to-reach populations such as the poor,homeless and disabled.

Familiarity with sudden cardiac arrest & interest in participating in a study of this disease Prior to specifically discussing SCA with focusgroup participants, moderators asked partici-pants which diseases they thought should beincluded in future biobank studies. The diseasesthat were most often listed were Alzheimer’s dis-ease, cancer (generally, or specific cancers, suchas breast or lung) and diabetes. Few participantsspontaneously mentioned heart disease, and

nobody mentioned SCA. When moderatorsthen asked participants to comment on theimportance of heart disease and SCA as a subjectof study, participants often appeared surprisedthat they had not thought of heart disease them-selves. Most claimed that this disease is as impor-tant as the others to study through geneticanalysis. Almost all participants were unfamiliarwith the terms ‘sudden cardiac death’ and ‘sud-den cardiac arrest’, although after hearing a defi-nition, there were people in all groups who knewsomeone who had died from SCA.

Opinions regarding the potential of personalized medicine Personalized medicine was explained to focusgroup participants as science leading to theapplication of genetic analyses to allow patientsto avoid taking a medicine or a particular formor dose of a medicine that is specifically danger-ous for them, or that would cause them signifi-cant side effects. Participants stated only positiveopinions regarding the potential for personalizedmedicine, and did not raise any ethical, logisti-cal, economic, political or medical concernsabout it.

Participants’ suggestions for enhancing the success of a biobank Focus group participants had a variety of con-crete suggestions for enhancing the potentialsuccess of a biobank study in RI. Their sugges-tions were gleaned from analysis of the tran-scripts and addressed issues of advertising, mediacoverage, recruitment, implementation andretention, and are listed in Box 1.

Discussion This mixed-methods feasibility study wasdesigned to explore Rhode Islanders’ attitudestoward potentially participating in a statewidebiobank and study of SCA, and to identify logis-tical facilitators and barriers and specific areas ofconcern that must be addressed in order for stateresidents to feel comfortable about providingpersonal history information and a DNA speci-men for storage. The survey and focus groupdata complement each other in that the focusgroups allowed us to explore the issues in-depthwith participants, while the closed- and open-ended questions on the mailed survey providedinformation on similar topics from a larger, ran-domly selected sample of adult men and women.Overall, we found agreement of findings fromthe two datasets.




Box 1. Focus group

Promote study aware

• Hold community mee• Use local print, radio • Ask doctors to recom

Provide credentials

• Provide detailed infor• Send recruitment lette

Clarify the study prot

• Clearly explain the de• Clearly state at the ou

procedures, nor will it• Explain who will bene• Outline what particip• Outline where, how a

and confidentiality.

Enhance the convenie

• For participants’ convor have a mobile part

• As a courtesy and incinitial survey.

• Have flexible enrolme• Reach male participan• Ensure hospitable and• Maintain contact with

update. This might be• Obtain permission to

Possibly our most important finding is that,while Rhode Islanders in the study had numer-ous questions and concerns about a biobank,most also expressed positive attitudes about hav-ing this kind of study developed in the state forthe sake of future generations, and most statedthat they would likely participate should theRIBB be implemented. This level of willingnessis consistent with the findings of a meta-analysisthat 80% of people would donate a specimen ifasked to do so [22]. The finding parallels otherstudies’ results that feelings of altruism towardsthe expected benefits for future generations mayhelp people to overcome their concerns aboutparticipating in research involving genetic analy-sis [31,32]. Nevertheless, it must be recognizedthat altruism and transparency around studyprotocols may go just so far, and that for somepotential participants, the desire to participatemay hinge on the promise of a two-way benefitflow, where the participants gain as much fromthe study as the researchers do [33].

A large proportion of our survey respondentssaid that they were willing to have tests done andbiospecimens taken, although a smaller percent-age indicated that they would be willing to have

their specimens stored for future genetic analysis.The reduction in willingness may be a result ofsurvey respondents’ lack of clarity about why thisstorage may be worthwhile, and points to theneed to adequately explain the biobank studyrationale and logistics to potential participants.By contrast, focus group participants, who hadthe opportunity to ask questions, hear an expla-nation of the rationale and processes of abiobank and discuss the prospects of medicalbenefits for future generations, were more fullyin favor of long-term storage, despite their hav-ing security concerns. This finding underscoresthe necessity of identifying the concerns andquestions prevalent within the population thatwill be recruited for participation, so that infor-mational materials and communication strategiescan address these issues in a rigorous and thor-ough manner early on. This process may alleviatefears and enhance trust among potential partici-pants, which may lead to increased enrolmentand retention in the study.

It has been acknowledged in previous studiesthat the success of any biobank is dependent onthe willingness of the population approached tocontribute samples for both research and

participants’ suggestions for enhancing the success of a biobank.

ness

tings throughout the state to explain the goals of the study.and television media widely for recruitment, including Spanish-language media.mend the study to their patients, or advertise the study in their medical offices.

mation on the qualifications of the researchers conducting the study.rs on university letterhead, and include the investigators’ credentials to do this research.

ocol

tails of what participation will entail.tset that the study will not require a change in lifestyle behaviors, taking medications, undergoing painful involve stem cell research, animal research or using the DNA for cloning.fit from the study, and how.ants will learn about their own health or genetic status, and what they will not find out.nd the duration for which the DNA and survey information will be stored, and plans for maintaining security

nce, comfort & continuing interest of participants

enience, transport participants via a shuttle service to the centralized study location, have regional centers, icipation center that will visit communities throughout the state.entive, provide food for the participants when they come to give their DNA sample and complete the

nt, as some Rhode Island residents will leave the state during the winter months.ts through the women in their lives; the women will help ‘twist their arms’. professional behavior from study staff. participants through the year and through the years of the study, not just with the yearly telephone survey accomplished through a periodic newsletter for study participants.collect relevant information from the next of kin upon the death of the participant.



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storage [34], which can be fostered by the mainte-nance of a transparent and inclusive stanceregarding study policies [16]. There have been alimited number of studies assessing the popula-tion factors that affect participation and deter-mine attitudes regarding tissue donation forfuture genetic research. A 2002 mail surveyundertaken in Sweden with almost 3000 respon-dents concluded that most of the general publicwould be willing to donate a sample to a biobank[34]. The 2003 National Health and NutritionExamination Survey study in the USA looked atgender and racial/ethnic differences in consentfor storage of biologic specimens, finding thatwhile there was wide acceptance among surveyrespondents for allowing storage of specimensfor future genetic research across many demo-graphic variables, females and black respondentswere least likely to consent to this [35]. In addi-tion to concerns regarding storage of theirDNA specimen, some in our feasibility studywere concerned about having blood samplesdrawn by needle, an issue noted previously inthe literature [36]. The report of the Task Forceon Large Population Studies in the USA in 2006concluded that the public’s willingness to partic-ipate in a large population project such as abiobank must be assessed before embarking onsuch an expensive endeavor, and that sufficientproject resources should be dedicated to thesepublic consultation activities [37].

It was notable that in our sample of Spanish-speaking Latino focus group participants, fewexpressed distrust in medical research or concernthat their personal information and DNA mightbe misused. This may be owing to their lack offamiliarity with medical research, and their con-sequently lower tendency to imagine the myriadways in which their rights might be violated as aresult of research participation. Our findings areconsistent with other studies that have shownLatinos to be as willing as, and at times morewilling than, non-Latino whites to participate inmedical research [38], although it has also beenshown to be necessary to approach Latinos withculturally appropriate means of recruitment inorder to gain their participation [39]. While bothAfrican–American and white focus group partici-pants expressed apprehension regarding potentialdiscriminatory use of their personal informationand DNA specimens, the concerns differedmarkedly in nature. For the white participants,concern was more theoretical than based in expe-rienced reality. By contrast, African–Americans

in the USA have a history of experiencing abuseat the hands of medical researchers [30], and theanxiety of these focus group participantsstemmed from the belief that participationwould result in discrimination for people of theirrace. A recent study found that African–Ameri-cans who had heard of the Tuskegee Study ofUntreated Syphilis in the Negro Male were morelikely than whites who had heard of the study tobe willing to participate in biomedical research[40], and other studies have found that a vast arrayof sociocultural and structural issues may impactAfrican–Americans’ willingness to participate inmedical research [41]. Howard University (Wash-ington, DC, USA), a historically black institu-tion, is sponsoring a biobank for the collection ofspecimens and data from only African–Ameri-cans, which may enhance trust among potentialparticipants [42]. Therefore, researchers mustdirectly address, with transparency, the means bywhich the rights of human subjects will be guar-anteed, although this is just one important issueamong many that may impact the participationof African–Americans and other vulnerable pop-ulations in studies such as a biobank. Going intothe future, implementation of the recently passedUS Genetic Information Nondiscrimination Actof 2008 may help assuage some concerns regard-ing potential discriminatory use of donatedDNA specimens. The Act will make it illegal forinsurance companies and employers to access anindividual’s genetic information or requiregenetic testing, and to discriminate based on theindividual’s or his/her family members’ geneticinformation [112].

Participants in our focus groups expressedconcern that the informed consent for biobankparticipation would likely not outline the spe-cific studies to be conducted with the donatedspecimens. When it was explained that this ismostly owing to the evolving nature of scientificinquiry going into the future and the inability atthe time of consent to predict which diseaseswill develop and, therefore, which diseases willbe studied, most participants understood this.However, they remained concerned regardingthe guarantees they could expect as investigatorsand ethics change with the passage of time,which is in contrast to other studies that havefound that some populations, such as a sampleof residents of Sweden, expressed little concernregarding informed consent for the use of theirgenetic material [43], and that most peoplewould be willing to provide one blanket consent




at the time of specimen donation [22,44]. Barrobserved that people are more motivated to par-ticipate in medical research by their own “spe-cific life stories” than by the specifics includedin an informed consent regarding confidentiality,security of information and study protocols [45].By contrast, our feasibility study participantsexpressed concerns regarding all of these ele-ments, and a strong desire for detailed informa-tion before they would be comfortable decidingto participate in a biobank. The discrepancymay be due to the particular context of Barr’sstudy, whereby women were asked to quicklydecide, prior to the birth of their baby, to pro-vide consent to donate umbilical cord samplesand maternal blood specimens. Most of thewomen agreed, while a lower percentage werewilling to answer a health and lifestyle question-naire. Our survey respondents also appearedmore willing to provide DNA samples than theywould be to provide certain personal lifestyleinformation. There is a growing literaturereviewing and debating the multitude of ethicalissues involved in biobank research, includingthe proper methods of gaining informed con-sent [46,47]. Proposals have been put forward foruniversal protocols to attend to the unique ethi-cal and logistical elements of providing for trulyinformed consent for biobank studies, whichoften rely on broad or blanket consent forresearch going into the future [21,48], for the spe-cific circumstances of each biobank project [49,50],for the special case of children’s consent [51], andto resolve the highly contested issue of the rightto withdraw consent for use of one’s DNAmaterial [52,53].

Many biobank studies conduct DNA analyseson only subsets of the stored specimens, and onlyat such a time as sufficient numbers of partici-pants develop the characteristics of interest to thespecific study objectives. Most focus group partic-ipants initially expected that they would receivetheir genetic analysis upon provision of theirDNA sample, and some were disturbed or disap-pointed that this would not be the case. This is incontrast to a Swedish survey that found that mostparticipants would only want to receive geneticinformation on health risks if treatments for thecondition were available [43]. After the groupmoderators explained why immediate DNA anal-ysis and feedback is not possible in the RIBBstudy, most understood and accepted that theywould gain little for themselves beyond theknowledge that they would contribute to medicaladvances for their descendants’ benefit.

It is noteworthy that few focus group partici-pants listed heart disease among those diseasesimportant to research through a biobank. Inaddition, no participant raised the topic of SCA,despite the rate of SCA in RI being high, andonce the moderator gave participants a descrip-tion of this disease, some in each group admit-ted knowing someone who had had SCA.Participants then expressed strong interest inhaving the condition studied, and in participat-ing in such a study. There are a number of pos-sible ways to interpret these findings, includingthat the participants may not have consideredSCA, in contrast to the diseases that they didmention, such as cancer and Alzheimer’s disease,to be of genetic origin. In addition, RhodeIslanders may be so accustomed to knowingpeople with heart disease, who often live foryears with good care of this chronic condition,that they do not perceive heart disease as some-thing that would benefit from genetic andmolecular analysis. The subset of heart diseaseresulting in SCA, by contrast, claims a lifequickly, which may be so shocking to those closeto the victim that the actual cause of death maybe misunderstood or does not remain long intheir consciousness. It is put out of mind, and sodoes not come to mind when consideringimportant diseases to study with the aim ofdeveloping genetic tests and personalized medi-cine. In the UK, for example, considerableattention is being placed on these issues, includ-ing preparedness of the population to addresstheir potential genetic propensity for SCA [54,55].We cannot definitively explain why focus groupparticipants responded as they did regardingSCA, but our findings indicate that awarenessof SCA is exceptionally low among RhodeIslanders and that it will be essential to providepublic education about this disease early onduring the community engagement stages ofthe biobank study.

These feasibility studies have several limita-tions that must be acknowledged. Our responserate for the mailed survey was only 11%. It hasbeen shown that a higher response rate is notautomatically indicative of better data, and thatpursuing nonrespondents or offering incentivesmay indeed degrade a sample, so this lowresponse rate may not be significant in terms ofdata quality, but is rather more of a concern aswe consider how to engage the RI public in theSCA study [56]. The characteristics of surveyrespondents may have differed from nonrespon-dents in that they have a higher education level,



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limiting the generalizability of our study find-ings. However, this confirms what has frequentlybeen found when the demographics of respon-dents to mail surveys are analyzed [57]. It doessuggest that the biobank per se is likely to attracta more educated public, even with random sam-pling, and efforts will need to be made to follow-up invitations, and to oversample among the lesseducated using a variety of approaches. The sur-vey was conducted only in English, and so pre-cluded participation of non-English-speakingRhode Islanders. In addition, the survey did notcollect data on race or ethnicity of respondents,and so our findings may not reflect those thatwould result from a subgroup analysis byrace/ethnicity. While our qualitative feasibilitystudy was comprised of focus groups conductedthroughout the state of RI, and included partici-pants of all socioeconomic groups, it was neces-sarily small, consisting of no more than onegroup per region, and only one group with Afri-can–American participants and one with Span-ish-speaking Latinos. Few men attended thefocus groups, although more men responded tothe survey than did women.

Despite these caveats, we believe that this fea-sibility study provided essential primary-leveldata with which to formulate a preliminaryunderstanding of Rhode Islanders’ attitudestowards a potential statewide biobank and studyof SCA. Our multimethod approach allowed usto triangulate our findings from the rich, qualita-tive focus group data, the responses in partici-pants’ own words to the open-ended surveyquestions, and their responses to the quantitativequestions. These feasibility study results haveafforded us the ability to begin gauging publicacceptance of such a project, identifying many ofthe potential confounders to participation, andto continue the process of community engage-ment that is so critical prior to launching abiobank study.

Future perspectiveSudden cardiac arrest claims the lives of approxi-mately 350,000 Americans each year [58].Implantable cardioverter/defibrillators are increas-ingly being utilized prophylactically in an attemptto reduce mortality in patients perceived to be athigh risk for SCA [59,60]. However, despite morethan 25 years of effort at identifying risk factorsfor SCA, no single test has been identified thatperforms with satisfactory sensitivity and specific-ity to guide prophylactic use of implantablecardioverter/defibrillators [61]. The population

burden of SCA has not significantly decreased,and it is clear that new approaches are needed toreduce the rate of SCA further. Emerging evi-dence indicates an important role for genetic pre-disposition to SCA; however, the moleculardeterminants have remained elusive [62].

Although the identification of monogenic dis-eases has been an important step forward inunderstanding the molecular basis of SCA, it isnow time to use the information obtained toaddress topics that could have a greater impacton public health [63]. In fact, the several loci asso-ciated with SCA syndromes account for only asmall population-attributable fraction. From thestandpoint of public health, it is more attractiveto invest in the identification of common mod-est-risk alleles that may account for a greaterpopulation-attributable fraction.

Based on the feasibility studies reported here,we do plan to establish a biobank of archivedblood samples from randomly selected volunteersin an at-risk age group for SCA. These bloodsamples would serve as a source of genomic DNAand protein biomarkers that could be examinedfor their associations with an increased likelihoodof developing SCA and other cardiovascular endpoints of contemporary public-health and clini-cal concern. This prospective, population-basedstudy would help establish a biorepository linkedto lifestyle and epidemiological data provided bythese volunteers. We hope that the study wouldbe used to elucidate the underlying genetic andenvironmental factors leading to an increasedincidence of cardiovascular morbidity and cardiacdeaths in RI. We believe that this RIBB wouldserve as a valuable resource and a scaffold forfuture studies related to aging, as well as pros-pective studies aimed at the implementation ofpersonalized medicine.

AcknowledgementsMany people have given of their expertise and support, andwe would like to particularly thank Al Buxton and Ed Wingof Rhode Island Hospital, Lifespan, Sana Syed and ChrisKemp of Brown University, Garrett Sullivan and GretchenSloane of Memorial Hospital of Rhode Island, and AmitKoren of the Monitor Group. We are also appreciative ofMary Ann Machado of the Cardiovascular Research Centerfor administrative assistance.

Financial & competing interests disclosure This work was financially supported by Seed Funds from theOffice of the Vice President for Research (Clyde Bryant andDean Eli Adashi) at Brown University and the office of thePresident of Rhode Island Hospital (Joe Amaral and Arthur




Executive summary

• In recent years, a num

• Feasibility studies werpopulation-based stud

• Rhode Islanders have possibility of such a fu

• Rhode Islanders had nprotocols and require

• Rhode Islanders had minformation, confiden

• However, most feasibstate, and stated thei

• To successfully recruitdiscussions of study pand personal history i

Klein), Lifespan. The authors have no other relevant affilia-tions or financial involvement with any organization orentity with a financial interest in or financial conflict withthe subject matter or materials discussed in the manuscriptapart from those disclosed.

No writing assistance was utilized in the production ofthis manuscript.

Ethical conduct of research The authors state that they have obtained appropriate insti-tutional review board approval or have followed the princi-ples outlined in the Declaration of Helsinki for all human oranimal experimental investigations. In addition, for investi-gations involving human subjects, informed consent has beenobtained from the participants involved.

ber of inherited cardiac diseases have been identified as the cause of sudden cardiac arrest (SCA).

e conducted to gauge the willingness of Rhode Island (RI) residents to participate in a prospective, y of cardiovascular diseases and SCA, including a biobank to store blood for future analyses.

low awareness of SCA, but expressed interest in participating in a study of SCA when presented with the ture study.

umerous questions regarding the credentials of study investigators and institutional sponsors, study ments, and logistical elements of participation.

any concerns about a biobank, including the security and future use of their DNA and personal tiality, and potential discriminatory use of their genetic analyses.

ility study participants also expressed positive attitudes about having this kind of study developed in the r interest in participating.

and retain participants for a biobank in RI, it will be essential to engage the public with transparent rotocols and policies, and provide clear explanations of the rationale and goals for the use of their genetic nformation going into the future.

6. Martin JB, Kasper DL: In whose best interest? 13. Brunner M, Peng X, Liu GX et al.:
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Rhode Islanders’ attitudes towards the development of a statewide genetic biobank

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