AWeb-Based Platform for EducatingResearchers About Bioethics and Biobanking

Ivana Sehovic & Clement K. Gwede & Cathy D. Meade &

Stephen Sodeke & Rebecca Pentz & Gwendolyn P. Quinn

# American Association for Cancer Education 2015

Abstract Participation in biobanking among individuals withfamilial risk for hereditary cancer (IFRs) and underserved/minority populations is vital for biobanking research. To ad-dress gaps in researcher knowledge regarding ethical concernsof these populations, we developed a web-based curriculum.Based on formative research and expert panel assessments, acurriculum and website was developed in an integrative, sys-tematic manner. Researchers were recruited to evaluate thecurriculum. Public health graduate students were recruited topilot test the curriculum. All 14 researchers agreed the curric-ulum was easy to understand, adequately addressed the do-mains, and contained appropriate post-test questions. The ma-jority evaluated the dialgoue animations as interesting andvaluable. Twenty-two graduate students completed the curricu-lum, and 77 % improved their overall test score. A web-basedcurriculum is an acceptable and effective way to provide infor-mation to researchers about vulnerable populations’biobanking concerns. Future goals are to incorporate the cur-riculum with larger organizations.

Keywords Bioethics . eLearning . Biobanking .Medicallyunderserved . Education . Genetics

Introduction

Since 2000, the Collaborative IRB Training Initiative (CITI)Human Subjects Training Program has become the standardcertification option for researchers, providing a Bbasic course^with an overview of the rules, ethics, and best practices re-quired when conducting research with human subjects [1, 2].The Human Subjects Research (HSR) course includes topicssuch as the basics of IRB regulations and the review process,assessing risk to participants, genetic research, informed con-sent, research with vulnerable subjects, and other relevant is-sues [2]. As technological innovations [3] and precision med-icine evolve, new ethical concerns are surfacing that may in-fluence patient/community members’ participation inbiospecimen science. Of particular interest to biomedical andbiobehavioral researchers is the ability to sensitively recruitdiverse subjects, such as individuals with familial risk forhereditary cancer (IFRs) and/or individuals from underrepre-sented racial/ethnic communities to participate in biobankingresearch. Further, our previous research suggests discordancebetween researchers’ perceptions and the expressed concernsand perceived ethical issues among vulnerable and underrep-resented populations [4]. To address this educational gap, wedescribe the steps and processes used to create a web-basedcurriculum to provide biomedical and biobehavioral re-searchers examples of common concerns and ethical issuesthat may arise in the process of conducting research involvingbiospecimen donation for storage in biobanks. When biobe-havioral researchers are aware of community members’ con-cerns and use sensitive methods for recruitment and

I. Sehovic :C. K. Gwede : C. D. Meade :G. P. Quinn (*)Department of Health Outcomes & Behavior, Moffitt Cancer Center,Tampa, FL, USAe-mail: gwen.quinn@moffitt.org

C. K. Gwede :C. D. Meade :G. P. QuinnDepartment of Oncologic Sciences, Morsani College of Medicine,University of South Florida, 12902 Magnolia Drive, MRCCANCONT, Tampa, FL 33612, USA

S. SodekeTuskegee University National Center for Bioethics in Research andHealth Care & College of Veterinary Medicine, Nursing, and AlliedHeath, Tuskegee, AL, USA

R. PentzEmory University School of Medicine, Atlanta, GA, USA

J Canc EducDOI 10.1007/s13187-015-0812-5

communicating about biospecimen donations, the communityis likely to develop trust and confidence needed to participatein biobanking research.

As background, biobanks are repositories of blood, tissue,and other biospecimens used for research with the purpose ofidentifying links between genetic and environmental influ-ences of diseases, such as cancer [5, 6]. Genetic data for manyhereditary cancers, however, such as breast cancer, are mostlylimited to Western European and North American Caucasianpopulations [7], and racial/ethnic minority populations are notwell-represented in large-scale cohort studies and biobanks[8]. In addition, high-quality biospecimens from IFRs are in-strumental in advancing cancer research and can be used toassess gene-environment interactions, estimate cancer risk inmutation carriers, and develop prevention and early detectionstrategies [9]. The recruitment of IFRs and underrepresentedmulti-ethnic community members in biobanking studies of-fers new opportunities for advancing science. Yet, involve-ment in biospecimen research entails a number of unique eth-ical concerns, which researchers should be aware of whenreaching out to specific at-risk or vulnerable populations.For example, IFRs may be reluctant to donate a biospecimenif they fear potential discrimination by insurers and employers[4]. Research suggests IFRs are often unaware of the GeneticInformation Discrimination Act (GINA) or do not trust thelaw to protect their personal health information [4]. Individ-uals from underrepresented multi-ethnic communities may bedistrustful of research due to historical abuse; have concernsabout pain associated with biospecimen donations, such asneedle pricks; or fear their DNAwill be used for purposes theydeem unacceptable, such as cloning [4, 3]. Therefore, Com-munity Engaged Research (CEnR) plays a significant role foroutreaching to IFR and racial/ethnic minority populations [10]by providing the researcher with an understanding of what anew innovation means to a specific community. The insightsand perspectives gained from outreach to IFR and racial/ethnic minority populations can inform the development andevaluation of human subjects’ protections training materials[11].

Presently, the CITI HSR training program offers shortmodules on research with vulnerable populations, such as em-ployees, medically vulnerable populations, prisoners, chil-dren, pregnant women, human fetuses, and neonates [12].An additional module presents the challenges of conductinggenetic research in human populations including ethical, legal,and regulatory concerns including a discussion of the issuessurrounding the use of stored biological samples [12]. Whilethese modules provide essential information for biomedicaland biobehavioral researchers recruiting vulnerable partici-pants for biospecimen donation, such as IFRs and racial/ethnic minorities, they only offer a brief overview of eachtopic presented in the same format as other HSR modules.The present lack of racial/ethnic minority and IFR

participation in biobanking studies may be alleviated withadditional, more in-depth training opportunities for re-searchers. This training can aid in increasing awareness offactors facilitating and/or impeding biospecimen donation[13, 14]. To address this training gap, Project 4B: Bioethicsand Biobanking Training for Biomedical and Bio-behavioralResearchers aimed to test the feasibility, acceptability, andeffectiveness of a novel web-based training curriculum forresearchers to improve knowledge of IFR and underrepresent-ed multi-ethnic populations’ perceptions about biobanking.

Methods

Previous research conducted with IFRs, vulnerable communi-ty members, and biomedical and biobehavioral researchersprovided the framework for identifying key curriculum con-tent areas. Detailed results from these focus groups are report-ed elsewhere. Our approach was rooted in the framework ofDiffusion of Innovations [15] with additional questions ex-ploring the novel concept of opportunity loss. The Instituteof Medicine recommends that training for health disparitiesresearchers and clinicians requires the integration of ASK(Attitudes, Skills, and Knowledge) methodology in combina-tionwith the ethical principles of the Belmont Report [16]. Forexample, the ASK methodology directs researchers to thinkabout the needs of vulnerable and high-risk populations byfocusing on the following: (1) Attitudes: examine and under-stand attitudes, such as mistrust, subconscious bias, andstereotyping, that practitioners and/or patients may bring tothe clinical encounter; (2) Skills: acquire the skills to effec-tively communicate and negotiate across cultures, includingtrust-building and the use of important tools to improve com-munication, such as culturally appropriate language services;and (3) Knowledge: gain knowledge of the existence andmagnitude of health disparities, including the multi-factorialetiology of health disparities and the multiple solutions re-quired to eliminate them [16].

Figure 1 depicts a flow diagram of our curriculum devel-opment process. A 4B Expert Advisory Panel (EAP) com-prised of bioethicists, behavioral and clinical researchers,and trainees, and a medical geneticist was engaged throughoutthe development of the curriculum, including analysis of re-sults and review of case study content. Using the steps de-scribed in the diagram, five key domains were identified forinclusion in the curriculum: (1) privacy and confidentiality, (2)communication of personal results, (3) communication ofoverall results, (4) informed consent, and (5) community mis-trust and fear of cloning and genetic research. The content foreach of the five key domains was drafted in the form of a casestudy with scenarios depicting relevant interactions betweenphysicians, researchers, and participants. Table 1 describes thecase study content for each domain. Two members of the 4B

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EAP (RP and SS) who have bioethics specialty were identi-fied to provide more targeted comprehensive feedback andedits for the case studies, including suggestions for post-assessment questions. Based on consultant feedback, a finalversion of the curriculum was prepared for next steps.

A 4B website (Fig. 2) was created to host the curriculumalong with informative pages for project results and papers,other relevant publications, and links to additional online re-sources (such as the Human Genome Project andGenome.gov) [17]. A web-based curriculum was chosenbased on researcher learning preferences identified duringthe formative research phase. To create an engaging course

that may be more effective at generating interest than standardformats, four of the case studies were selected to include an-imated, audio portions. A large, searchable database of car-toonists (CartoonStock) was utilized to identify an animatorwith the desired art style for our case studies. The case studydialogue audio was recorded bymembers of the research teamand volunteers and sent to the animator as well as transcriptsof the dialogue which included detailed information aboutpreferred backgrounds, poses, character details, and context.A snapshot of the case study animation is presented in Fig. 3.A snapshot of the pre/post-assessment questions can be foundin Fig. 4.

Fig. 1 Project 4B curriculum, development process

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To test the feasibility and acceptability of the web-basedtraining curriculum, we collected preliminary feedback fromresearchers and obtained their reactions to the curriculum.Researchers who previously agreed to be re-contacted duringthe formative research focus groups received an e-mail invi-tation to review the Project 4B curriculum. Using modifiedDelphi procedures [18, 19], participants were requested tocomplete six evaluation forms: one form for each case studyand one form for the overall website structure. Case studyforms assessed case study effectiveness, content relevance,clarity of post-test questions, and accompanying dialogue an-imations. The website form assessed ease of navigation, ap-propriateness of aesthetics (font, layout, colors, and images),overall appeal, and reader engagement. All sections of theforms included free response boxes for detailed suggestionsand comments. A waiver of informed written consent wasobtained from the University of South Florida InstitutionalReview Board. Participants received a $30 gift card after com-pleting the evaluation forms.

To pilot the effectiveness of the curriculum, we recruitedcurrent public health graduate students to pilot test the curric-ulum. A study flyer was posted on the College of PublicHealth bulletin board. Interested students contacted the studycoordinator by e-mail or telephone and were scheduled toattend one of the pilot test sessions. Sessions were held in areserved computer lab within the college and required nomorethan 60 min of participant time. At the start of each session,

students were provided with a hard copy of the pre-test (iden-tical to the online post-test). After completion of the pre-test,students received a link to the Project 4B website, a uniqueusername and password, and headphones for the audio por-tions. Students were provided with detailed instructions onnavigating the course website, which included all five casestudies and corresponding post-assessment questions. Stu-dents received a $30 gift card for their time.

Results

A total of 14 researchers evaluated the website and five casestudies in terms of case study effectiveness, relevance, clarityof post-test questions, and accompanying dialogue anima-tions. The majority either strongly agreed or agreed that thecase studies were easy to understand (100 %), adequatelyaddressed the issues for that domain (84 %), and containedappropriate post-assessment questions (90 %). Suggestionsfor improvement included creating additional, more challeng-ing questions, expanding on key terms or issues, andrephrasing statements for clarity. The majority either stronglyagreed or agreed that the animations were interesting (92 %)and would appeal to biomedical and biobehavioral researchers(85 %). A few researchers (36 %) perceived that the anima-tions facilitated learning and retention of the content. In addi-tion, one researcher noted the lack of animation for case study

Table 1 Project 4B case studies

Case study title Case study objectives

1. Privacy and confidentiality • Identify the unique privacy concerns of healthy controls with a family history of hereditary cancer• Explain the scope of the Genetic Information Discrimination Act of 2008• List ways participants may perceive this law• Identify layman’s terms that facilitate subject’s understanding to use in the consent form• Be prepared to provide verbal explanations in conjunction with the consent form document• Identify signs indicating participants may have questions or concerns they cannot articulate

2. Communication of personal results • Develop a plan for patient recontact in the case of a clinically actionable accidental discovery• Evaluate the consent form document to ensure that participants are informed about the terms of recontact• Identify the role of an honest broker in biobanking research• Explain how biospecimens and health information will be stored and accessed by the research team

3. Communication of overall results • Develop a plan to provide study updates to research participants• Identify ways to present research results and progress that are appropriate and relevant to participants• Identify the need for effective communication during each stage of the research study• Describe the unique concerns of participants with a family history of cancer, such as viewingbiospecimen donation as an Binvestment^ and wanting researchers to acknowledge a Bface behind thesample.^

4. Informed consent • Identify different formats for consent form documents (blanket consent, menu consent, study-specificconsent)

• Identify the ethical and research advantages/disadvantages of each format

5. Community mistrust and fear of cloningand genetic research

• Identify concerns that may arise when conducting research with racial/ethnic minorities and underservedpopulations, such as fear of cloning and invasive procedures.

• List ways in which this population may be mistrustful due to historical abuse in research• Identify ways to address these sensitive topics in a manner that acknowledges and addresses participantconcerns

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3 and perceived a decrease in effectiveness of Bdelivering themessage.^When assessing the website as a whole, the major-ity of researchers either strongly agreed or agreed that it waseasy to navigate (73 %); was laid out using appropriate colors(73 %), fonts (91 %), and images (90 %); and would appeal tobiomedical and biobehavioral researchers (82%). Suggestionsfor improvement included increasing the overall font size andexpanding resources to include news articles.

For the pilot test portion of the study, 22 public healthgraduate students were recruited to complete the curriculumand 19 pre- and post-test questions. Seventeen students (77%)improved their overall test score after completing the casestudies. Three students (14 %) had no change in score andtwo students (9 %) did slightly worse. Overall, there was anaverage 1.9 point score increase after completing the curricu-lum. The average pre-test score was 69.6 % and the averagepost-test score was 79.4 %.

Discussion

Focus group results from the initial project highlighted theneed to address gaps in researcher knowledge specific to eth-ical concerns on biobanking and biospecimen donationamong IFRs and ethnical/racial minority populations. Thisresearch led to the development of a novel, web-based trainingcurriculum focusing on key ethical concerns of this popula-tion. The decision to host this curriculum on the web wasbased on previous focus groups where researchers were askedabout their learning preferences, specifically regarding thebest format for disseminating the curriculum, their interest ina web-based course, their experiences with web-based plat-forms, and if the 4B curriculum should be required in a man-datory module program, such as CITI. The majority of re-searchers felt that an in-person or web-based course wouldbe significantly more effective at improving knowledge

Fig. 2 Project 4B website home page

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compared to a mandatory module within CITI. Although theyacknowledged that standard CITI coursework was informa-tive and necessary, they felt that many learners often completethe modules as quickly as possible and do not focus on spe-cific, detailed information that may not be relevant to theirfield of study.

Consequently, the goal of this curriculum was to presentcontent in a new and engaging way that would generate inter-est while assisting learners in processing difficult research

concepts. It has been shown that visual aids, such as animationand acted analogical scenarios of concepts, are successful atBdemystifying^ research concepts and engaging learners at agreater level compared to textbooks and other typical methodsused in research training [20]. In addition, including a videosupplement to a typical text-based case study resulted inhigher frequencies of clauses relating to data exploration, the-ory building, and theory evaluation, suggesting that videocomponents stimulate cognitive processes [21]. A survey of

Fig. 4 Case study pre/post-assessment questions screenshot

Fig. 3 Case Study 2 animationscreenshot: BCommunication ofPersonal Results^

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medical students’ learning preferences revealed that half of therespondents perceived that visual aids of any sort increasedtheir concentration Ba lot^ and that animations combined withthe blackboard platform [22] were optimal teaching aids [23].When choosing an animation art style, the goal was to identifya balance between the gravity of the topic and success atgenerating interest with the animated component. The selectedanimator created a simple, traditional style with vivid colorsthat did not introduce a comedic or caricature aspect to themessage being conveyed. In addition, the animator receiveddetailed guidelines on the appearances of the case study char-acters, including body position, facial expressions, race and/orethnicity, and gender.

Previous research has shown that the use of CEnR with theintended population improves the quality of researcher train-ing materials, resulting in higher scores on relevance of thematerial, overall satisfaction, module quiz scores, and a trendtoward higher self-efficacy [11]. By conducting focus groupswith IFRs and other vulnerable populations, the final curricu-lum included material directly contributed by the populationunder study. Incorporating the beliefs, attitudes, and knowl-edge of community members in the development of researchertraining materials can help ensure that the curriculum high-lights key concerns, provides culturally sensitive and respon-sive education, and is reflective of the target population [11,24, 25].

Conclusion

Participation in biobanking among underserved racial/ethnicminorities and other vulnerable populations is crucial to re-ducing cancer health disparities. One way to improve partici-pation is to educate biomedical and biobehavioral researchersabout common concerns, which include fears regarding lossof privacy and confidentiality, discrimination from employersor insurance companies, mistrust of researchers due to histor-ical abuse, and fears of cloning and invasive procedures. Aweb-based bioethics and biobanking curriculum with animat-ed case studies is a feasible and acceptable way to provideinformation to these researchers. Future plans focus on incor-porating the Project 4B website and curriculum with nationalorganizations for wider dissemination of material.

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