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"Who owns your poop?": insights regarding the intersection of human microbiome research and the ELSI… Hawkins, Alice K; O’Doherty, Kieran C Oct 7, 2011

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DEBATE Open Access“Who owns your poop?": insights regarding theintersection of human microbiome research andthe ELSI aspects of biobanking and relatedstudiesAlice K Hawkins1 and Kieran C O’Doherty2*AbstractBackground: While the social, ethical, and legal implications of biobanking and large scale data sharing are alreadycomplicated enough, they may be further compounded by research on the human microbiome.Discussion: The human microbiome is the entire complement of microorganisms that exists in and on everyhuman body. Currently most biobanks focus primarily on human tissues and/or associated data (e.g. healthrecords). Accordingly, most discussions in the social sciences and humanities on these issues are focused(appropriately so) on the implications of biobanks and sharing data derived from human tissues. However, rapidadvances in human microbiome research involve collecting large amounts of data on microorganisms that exist insymbiotic relationships with the human body. Currently it is not clear whether these microorganisms should beconsidered part of or separate from the human body. Arguments can be made for both, but ultimately it seemsthat the dichotomy of human versus non-human and self versus non-self inevitably breaks down in this context.This situation has the potential to add further complications to debates on biobanking.Summary: In this paper, we revisit some of the core problem areas of privacy, consent, ownership, return ofresults, governance, and benefit sharing, and consider how they might be impacted upon by human microbiomeresearch. Some of the issues discussed also have relevance to other forms of microbial research. Discussion ofthese themes is guided by conceptual analysis of microbiome research and interviews with leading Canadianscientists in the field.Keywords: human microbiome, health research, consent, privacy, ownership, return of results, policy, biobanks,ELSI, research ethicsBackgroundBiobanks, loosely defined as large collections of biologi-cal tissues samples, often with some degree of linkedclinical or medical information, have received consider-able attention in the ELSI (ethical, legal, social issues ofgenome research) and scientific literature in recent years[1-3]. This attention is due not just to the complexity ofthe issues raised by biobank related research, but alsobecause they call into question established researchethics norms and accepted practices[4]. The nature ofthese ethical conundrums has been well documented,with research focused on issues such as privacy,informed consent, ownership of samples and informa-tion, secondary use of biological specimens, benefit shar-ing and governance [5-8]. While these biobank issuesremain problematic and unresolved, other areas ofscience are moving ahead rapidly, and have the potentialto further complicate matters[9]. In particular, thispaper considers recent large scale research effortstowards studying the human microbiome, and thepotential social and ethical implications of this researchfor biobanks.* Correspondence: kieran.odoherty@uoguelph.ca2Department of Psychology, University of Guelph, Guelph, ON, N1G 2W1,CanadaFull list of author information is available at the end of the articleHawkins and O’Doherty BMC Medical Genomics 2011, 4:72http://www.biomedcentral.com/1755-8794/4/72© 2011 Hawkins and O’Doherty; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the CreativeCommons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, andreproduction in any medium, provided the original work is properly cited.Humans can be thought of as a complex of both micro-bial and human cells, a ‘super-organism’ [10] containingover 100 trillion microbiota that are essential for nutri-tion, immunity and pathogen resistance[11]. Whilst someare harmful, the majority of human cell and microbialcell interactions are mutually beneficial, and essential tohuman physiologic functions and day to day activities[12]. Research on the human microbiome aims to eluci-date the relationship between human health, physiology,and behaviour and the various microbial communitiespresent in different areas of our body (including themucosa, gastrointestinal tract, urogenital system andskin)[13,14]. The goal of the Human Microbiome Project(HMP), established in 2007, is to characterize the role ofmicrobiota in human health and disease. More specifi-cally, the HMP investigates such basic science questionsas whether humans share a common core microbiomeand whether particular changes in the human micro-biome lead to changes in human health and disease states(http://nihroadmap.nih.gov/hmp/)[15]. It is hoped thatthis research will lead to benefits such as: a better under-standing of human nutritional requirements (includinghow individuals will respond to specific diets), resultingin innovative food production and distribution strategies[10,16,17] and other public health benefits[18,19];increased knowledge of areas amenable to microbialtransplantation and successful manipulation[11]; forensictools[20,21]; and pharmaceutical improvements knownas ‘pharmacomicrobiomics’[17,22].Human microbiome research, in and of itself, raises anumber of ethical, legal and social considerations[23].However, the specific focus of this paper is how theseconcerns overlap with those debated in the biobank lit-erature and we therefore confine our discussion toissues relevant to this particular context. The types ofinformation and samples collected by different biobanksvary, but with increasing research efforts pertaining tothe human microbiome, it is inevitable that an increas-ing number of biobanks will include collection of speci-mens required for genomic studies of microbiotaassociated with humans. To date there has been littleattention as to how human microbiome research mayaffect or further compound the issues debated in thecontext of biobanks. It is the purpose of this paper tobegin to investigate and discuss some of these questions.Our discussion is informed by both the scientific lit-erature on human microbiome research and the ELSIliterature on biobanks. Most importantly, though, wedraw on a series of 45 in-depth interviews that wereconducted by K.O. in 2009 to 2011. These semi-struc-tured interviews consisted of a series of open-endedquestions on the topic of the social and ethical implica-tions of the HMP, and were conducted either in-person,or over the phone. Interview participants wereresearchers working on the Canadian MicrobiomeInitiative, and were invited to participate based on satis-fying any of three criteria: (i) currently funded to con-duct research on the human microbiome; (ii) attendanceat a meeting hosted by the Canadian Institutes of HealthResearch (CIHR) in 2008, the purpose of which was todiscuss the form funding for the Canadian MicrobiomeInitiative would take; (iii) referral based on expertise ina particular aspect of research relevant to the social andethical aspects of the HMP. Taken together, intervie-wees represented multidisciplinary expertise on therange of body sites being targeted for study in the HMP,and a spectrum of basic and applied researchers as wellas clinicians. The content of individual interviewsreflected the particular expertise of the interviewee, andincluded the subject areas described in the discussionbelow. Where possible, the discussion that follows isbased on peer-reviewed published literature, often sug-gested by interviewees. Where research is novel or inprogress, we rely on anonymized statements of ourexpert informants to illustrate specific arguments madein the discussion. It is important to note that some ofthe ethical issues we raise here are relevant to researchother than biobank studies. Conversely, there are manyother ethical issues related to human microbiomeresearch that are beyond the scope of this paper. Wetherefore limit our discussion to those ethical issuesraised by human microbiome research that intersectwith biobank related issues.Biobank discussions gravitate toward four issues thatare now well recognized in the ELSI literature on bio-banks: privacy, consent, ownership, and return ofresearch results. Below, we discuss each of these issuesin turn, beginning with a brief outline of the problem ascurrently recognised in the ELSI literature on biobanks,followed by a discussion of the potential implications ofhuman microbiome research on the problem. In thisdiscussion, we pay particular attention to how the socialand ethical aspects of biobanks may change or becomefurther compounded as a consequence of microbiomeresearch being conducted using biobank type platforms(see Table 1 for a summary of the issues and concernsraised by biobanks relative to new issues introduce byhuman microbiome research). We conclude with somerecommendations for policy and a consideration ofimplications for benefit sharing and governance in thisevolving field.DiscussionPrivacyThe ability to protect both clinical and genetic datastored in biobanks has been pivotal to biobank discus-sion since such research was conceived[24]. Due to thepotentially sensitive nature of such data, there has beenHawkins and O’Doherty BMC Medical Genomics 2011, 4:72http://www.biomedcentral.com/1755-8794/4/72Page 2 of 9considerable anxiety regarding the possibility of privacybreaches, resulting in personal information being mis-used[25]. This is of particular relevance in the contextof genetic data, as access to an individual’s biologicalspecimens and DNA may reveal sensitive informationsuch as predispositions to certain diseases, as well asidentity and ethnic background[26]. In spite of increas-ing recognition that absolute guarantees of privacy pro-tection can no longer be made[27,28], biobanks thathave been constructed in ethically sustainable ways goto considerable effort to ensure that personal data isadequately protected to avoid potential discriminationor other adverse events[29].These concerns are further compounded given recentadvances in human microbiome research such as that‘microbial fingerprints’ have been found to be poten-tially as individual as DNA or actual fingerprints. Morespecifically, the composition of bacterial communitiesassociated with human skin have been found to beunique to each individual, allowing for identification ofindividuals through analysis of residual skin bacteriarecovered from an object (e.g. keyboard or mouse)touched by that person[21]. The identification of anindividual by their microbial fingerprint potentiallyraises privacy concerns similar to those already recog-nised in genetic and biobank related research. How-ever, the privacy concerns in microbiome research maybe somewhat more complex, primarily due to our lim-ited understanding of the relevance of such informa-tion at the current time. For example, microbiometechnology may allow access to information such aspast exposures, or locations an individual has visited inthe past (interview 132). As such information is notavailable from analysis of human DNA alone, this mayconstitute a very powerful new analytical dimensionfor use in forensic investigations or by law enforce-ment or homeland security agencies. Such possibilitiespromise to be highly controversial given the tensionsthat already exist between safe-guarding the integrityof health research databases versus pressure from lawenforcement agencies to permit greater powers in theuse of DNA technologies and databases. Further con-founding this, in contrast to DNA, the stability ofmicrobial fingerprints over time is unknown, so it isnot possible to say whether such information may belinked to a specific individual for an indefinite periodof time (interview 142 & 131).From a clinical perspective, human microbiomeresearch is still in its infancy, and it will take some timeto fully understand the meaning of microbiome findingsboth on their own, and in the context of other relevantgenetic and health information. Similar to concerns withthe clinical validity of genome wide association studies[30], there is concern that microbiome research datamay be prematurely or incorrectly interpreted. Similarto human genetic information, microbial data may beused, correctly or incorrectly, to reveal an individual’spredisposition to certain conditions such as obesity[31].One can conjecture that human microbiome data evenhas the potential to reveal an individual’s socioeconomicbackground. Perhaps more significantly, microbiomeinformation, when used in conjunction with geneticinformation, may tell us a significant amount about acertain individual’s susceptibility and predispositions andwould be more personally identifying than genetic dataalone[11]. For example, asthma is known to be aTable 1 ELSI Issues Raised by Microbiome Research relative to Biobank and Related StudiesELSI Consideration Nature of concern New issues introduced by HMB researchPrivacy andConfidentiality- Discrimination and stigmatisation - Increased scope of disease predispositiontesting- Microbial fingerprints- Potential knowledge of past exposures• For example, predisposition and susceptibility testingConsent - Respecting autonomy- Invasiveness of sample collection- Cultural and personal acceptability of research• E.g., research participation of minors (e.g. newborn blood spot collection) - E.g., Vaginal and fecal sample collectionOwnership - Human dignity- Benefit sharing- Samples traditionally considered waste, suchas fecal matter• E.g., ownership of blood/tissue samples and cell lines - E.g., fecal transplantReturn of Results - Clinical validity- ‘right to know’ versus ‘right not to know’- Additional treatment and screeningpossibilitiesBiobank Governance - Public trust and consideration of societal viewpoints - Infectious disease• E.g., ensuring minority viewpoints are consideredJustice - Resource allocation - Global health• For example, payment and health insurance coverage of genetic testsand pharmacogenomicsHawkins and O’Doherty BMC Medical Genomics 2011, 4:72http://www.biomedcentral.com/1755-8794/4/72Page 3 of 9multifactorial condition, with both genetic and environ-mental causative factors[32]. Similarly, a typical micro-bial signature has been identified for inflammatorybowel disease (albeit with a non specific association)(interview 135). A future doctor’s visit might thereforeconceivably involve both analysis of an individual’shuman genomic and microbial genomic profile[33].Knowledge of both would potentially enable greater pre-dictive value than genetics alone of what conditions maydevelop in an individual’s lifetime. Just as with geneticdata there are fears of discrimination based on lifeexpectancy or job prospects, for example by employersor insurance companies, and one can conjecture thatsuch microbiome-based discrimination may be moredisturbing, as there is potential for discrimination orstigmatisation based on socio economic status, where anindividual was born and raised, and which countries anindividual has visited[23]. More worrying still, given thatwe do not know what degree and depth of personalinformation might be revealed through human microbialanalysis, it has been suggested that in some societiessuch discrimination may even occur on supposed classor caste basis (interview 132). On the other hand, it isalso possible that microbiome research may help tocounter stigma in some groups. For example, the identi-fication of a microbial predisposition to obesity[34] maylead to greater acceptance and understanding of indivi-duals with obesity. However, it is quite unclear at thispoint in time in which direction broader public andinstitutional understandings will develop.ConsentThe issue of consent in biobank research has been wellcharacterized and discussed. The crux of the concernrelates to the ability of a potential research participantto give truly informed consent for a research project inwhich potential outcomes and effects are unknown,and when the precise nature of future research to beconducted may not yet be conceived[35-39]. Many ofthese concerns remain similar in the context of micro-biome research, where individuals may be asked togive specimens to be deposited in research banks foran indefinite period of time and for an undefined orloosely defined purpose. This raises questions regard-ing the integrity of the informed consent procedure,potentially leading to the erosion of research subjects’protection and an individual’s autonomy in decisionmaking about research participation[6,40]. Biobankdebates have suggested a number of proposed solu-tions to this issue, including broad consent, requiringre-consenting on a regular basis, and adaptive govern-ance mechanisms that allow for representative deci-sion-making on behalf of large numbers of biobankresearch participants [41,42].Concerns about consent, as they relate to biobanks,have important implications for microbiome research,both in terms of outlining potential challenges, and insuggesting possible resolutions such as those outlinedabove. An area in which this is particularly notable isthat of child involvement in health research, with ques-tions being raised as to the ethics of children becomingresearch subjects when they cannot give informed con-sent[43-46]; for example, infant stool sample collectionfor microbial research raises similar concerns to newborn blood spot collection in genetic biobank research.Moreover, concerns regarding data-sharing may be simi-lar for both microbial and human specimens, in thatonce samples are shared with other researchers itbecomes difficult to regulate or withdraw consent. How-ever, it is important to note that it is possible thatmicrobial research may not be any more ethically pro-blematic than genetic research if microbial data are notstable over time. There is currently scientific uncertaintyand disagreement as to the relative stability of an indivi-dual’s microbiome over time and the degree to whichan individual’s human genome predetermines theirmicrobiome. If it turns out that there is significant varia-tion over a life-span, and/or a low degree of genetic pre-determination then, for example, a child whose micro-bial sample was collected in neonatal life may not beidentifiable from the specimen over the long term.In considering current biobanking practices and thepotential compounding of ethical implications owing tomicrobiome research, an important factor that needs tobe considered relates to the individual subjective andcultural acceptability of the actual research. For exam-ple, biobank research often involves use of a point intime biological specimen, such as a pathology relatedtissue sample, blood draw or buccal swab. Such samplecollection is usually relatively benign, painless and maynot require any additional procedures other than whatis clinically required. However, microbial research maybe considered more invasive, or less culturally accepta-ble by some groups. Most notably, collection of stoolsamples or vaginal swabs may not be acceptable tosome individuals, or in some countries or ethnic groups(interview 139). This is further exacerbated by the possi-ble need for collection from multiple orifices, and multi-ple collections over time. Certainly the nature of theresearch needs to be clearly outlined for an individual togive informed consent for a research study. However itis not unreasonable to conjecture that if some types ofresearch are not acceptable to certain groups, thesegroups may not participate in research studies, resultingin research findings that are relevant to only certainsub-sectors of society. While this concern is not uniqueto microbial research, it seems that biobank studies thatalso investigate aspects of the human microbiomeHawkins and O’Doherty BMC Medical Genomics 2011, 4:72http://www.biomedcentral.com/1755-8794/4/72Page 4 of 9require additional sensitivity to maintain publicapproval, trust and commitment to the researchenterprise.OwnershipAs alluded to above, microbial specimens may be col-lected from a number of different collection sites includ-ing the nose, mouth, gastrointestinal tract, skin, andurogenital tract (http://nihroadmap.nih.gov/hmp/). Aswith human biological specimen collection, microbialsample collection may be more or less invasive. How-ever, microbiome research differs somewhat in thatsome microbial samples are generally considered waste(such as dead skin or feces). Interestingly, the questionof ownership arises, a topic that has already led to con-siderable debate within the biobank literature. In parti-cular, there is debate as to whether a biologicalspecimen, such as tissue, a tumour or blood in someway ‘belongs’ to the individual it came from, at least fora defined period of time. Irrespective of whether oneconsiders tissue that has been removed from an indivi-dual to be owned by them at any given time in thefuture, at the very least current thinking tends towardsinformed consent being required not only for removalof a biological specimen, but also for its use in research.A case illustrative of the controversy in this context isthat of Henrietta Lacks, an African American womanwhose tumour cells were used in medical research tocreate profitable immortal cell lines without her knowl-edge or consent[47]. This case raises questions not justabout the extent of ownership, but also the potential forfuture benefit sharing. In particular, discrepancies havebeen pointed out between the large profits made bycompanies using Lacks’ cell lines and the family anddescendants of Henrietta Lacks, who in many cases can-not afford health insurance.The question of ownership may become even morecomplex with microbial research. This is particularly thecase with research on the gastro intestinal microbiome,which relies heavily on the use of fecal samples. In otherwords, the question of ‘who owns your poop?’ nowbecomes relevant. The question is complex not onlybecause feces has traditionally been considered to bewaste, but because of the ambiguous relationshipbetween the genomes of commensal bacteria found infecal matter and human identity. One the one hand,these genomes are clearly not a part of the human gen-ome and so should not be considered in any way a com-ponent of ‘being human’. On the other hand, the notionthat the human genome has co-evolved to its presentstate with this multitude of bacterial genomes, and thatwe require this symbiotic relationship for the mainte-nance of our health, suggests that the particular collec-tion of microbial genomes each of us carries may bealmost as personal as our own genome. At present,there is still much scientific uncertainty about the stabi-lity of the microbiome over time, so it is unclearwhether a microbial ‘waste’ sample could still be linkedto the individual it came from after a certain number ofyears. It is thus pertinent to ask whether ownership isindeed a relevant consideration if a sample can nolonger be linked back to a certain individual, particularlyif this sample was considered waste in the first place. Toput it another way, if it turns out that a given indivi-dual’s microbiome changes and evolves over time, doesthis make the ownership claim more or less valid?The issue of ownership is important for two main rea-sons. The first can broadly be described as having to dowith human dignity, especially as it relates to culturalidentities, and the second with potential consequencesof ownership, particularly financial. Regarding the for-mer, several parallels can be drawn with biobankresearch utilising blood samples. For example, the Nuu-chah-nulth, an indigenous population on VancouverIsland, agreed to blood sample collection for geneticresearch on rheumatoid arthritis. However, these sam-ples were later used - without the Nuu-chah-nulth’sknowledge or consent - for research into their ancestralorigin. This incident was controversial not just becauseinformed consent was not obtained, but also because ofthe cultural importance of blood and sense of ownershipfor the Nuu-chah-nulth, who felt that their samples hadbeen stolen[48]. Although fecal matter can hardly bedescribed in the way blood has been as the ‘most sym-bolically precious of substances’[49], it is associated withdeep psychological and cultural significance in otherways. Collection of vaginal microbiome samples is simi-larly highly personal and associated with a range of cul-tural, social, and psychological sensitivities. In short,collection of microbial samples is potentially highly per-sonal in ways that are quite different from the sense ofownership individuals may experience in relation toother tissue samples. Precisely how this sense of owner-ship will manifest for research utilising microbial sam-ples is currently unknown and should itself be thesubject of research sensitive to cultural, religious, andother contexts.Regarding the issue of material consequences of own-ership, the commercial entitlements of ownershipbecome contentious particularly in discussions of tech-nology development (for example drug, software andbiotech development) which may lead to economic gainthrough intellectual property, sales and marketing,patenting and so on. Such concerns do have similaritieswith ethical issues raised in tissue biobank research,such as the potential for financial goals to drive researchdirection, patenting that either stimulates or stifles tech-nology and treatment development, and financial benefitHawkins and O’Doherty BMC Medical Genomics 2011, 4:72http://www.biomedcentral.com/1755-8794/4/72Page 5 of 9sharing (interview 109). Questions about what is pro-prietary, particularly when considering publicly fundedresearch, raise ethical issues such as justice, fairness andbenefit distribution. For example, as derivation of bene-fit, financial or otherwise, is one consequence of owner-ship, there is concern that benefits may only be madeavailable to those who can afford to pay. Benefits of theresearch, in the form of novel or improved treatmentmodalities or in the form of financial benefit sharing,may not actually reach those who contributed toresearch or those in greatest need. The issue is particu-larly relevant in a broader international context and thequestion of whether and how microbiome research ben-efits those in developing nations, will need to be consid-ered[50,51].These issues are not unique to microbiome studiesbut may manifest rather distinctly in this type ofresearch or its applications. For example, a controversialmethod for treating certain forms of bowel diseaseinvolves the use of fecal transplants, in which a slurry offeces from a healthy donor (usually a close relative ofthe patient) is transplanted into the patient. These treat-ments seem to be extremely efficacious and are basedon the notion that the microbial populations within thestool of the healthy donor are able to repopulate andcolonise the abnormal gut of the patient and therebyaffect a cure. The treatment is controversial, however, asthe transplant may also introduce any number of patho-gens to the patient. It is thus only used in very extremecases of illness, and most hospitals are reluctant toallow the procedure at all (interview 140 & interview116). Work is currently underway to characterise theefficacious bacteria in a healthy gut on a genomic level,to isolate them and turn them into a probiotic treatmentthat does not require the transplant of fecal matter(interview 140). The point here is that (i) there is evi-dent value in the feces of (at least some) individuals,and that (ii) both the treatment, as well as research per-taining to the treatment, are likely to be associated withcultural sensitivities, awkwardness, and possibly embar-rassment on the part of patients and research partici-pants. This suggests that serious consideration be givento questions of ownership as they pertain to humanmicrobiome derived samples.Return of resultsThe issue of whether, how, and under what circum-stances to return research results to research partici-pants has been subject to considerable scrutiny bothfrom the public and research perspectives[26,52-55]. Inbiobank and genetic research the question of return ofresults usually relates to informing research participantsabout genetic predispositions, particularly where treat-ment options or preventative strategies may be of valueand individuals may act on this information[56]. Someargue that research participants have a right to knowsuch information[57,58], whilst others argue that thereis a right not to know[59,60]. Researchers voice con-cerns that requiring return of results places an unjustburden on them, making the research enterprise unten-able[5]. In addition, unless the clinical utility of researchresults is firmly established by evidence based studies,there is a risk of harm due to the premature or inade-quate translation of research results[61,62].These debates are equally relevant to microbialresearch, and similar questions are raised, includingwhether results should be returned on a public or indi-vidual level and who is responsible for result disclosureand explanation[23]. It is possible however that returnof microbial research results may actually have moreimpact, on an individual and public level, than geneticresearch results, if an individual is found to have apotentially harmful microbial profile that is easily trea-ted. There has been much debate about the utility ofgenetic information, particularly when there is little thatcan be done to mitigate such genetic risks[63]. Giventhat commensal microbial populations are likely to bemore malleable than human genes, knowledge of anindividual’s microbial profile may open up far moredecisions points for treatment, diagnosis, and risk man-agement than knowledge of one’s genome[64]. This haseven more profound implications if there is an infec-tious component to a microbial profile so that return ofresearch results may be of immediate public healthinterest.SummaryAs outlined in our introduction, although there are arange of ELSI issues raised by human microbiomeresearch, we have focussed primarily on the intersec-tion of human microbiome research and biobanking.Many of the ELSI issues raised by human microbiomeresearch in this context are not significantly differentfrom those already encountered in human tissue bio-bank research. However, there are some areas in whichthe already difficult considerations involving privacy,consent, ownership and return of results are furthercomplicated by the additional collection and study ofmicrobial DNA associated with humans. Identifyingthese challenges is not intended to hinder microbiomeresearch, but rather to assist researchers, clinicians,and patients to work together in ways that buildunderstanding and cooperation, while avoiding unne-cessary conflict. Engaging with these challenges at arelatively early stage of the science also allows mean-ingful and relevant policy guidelines to be formulatedfor human microbiome research and its applications ina proactive rather than reactive manner.Hawkins and O’Doherty BMC Medical Genomics 2011, 4:72http://www.biomedcentral.com/1755-8794/4/72Page 6 of 9Governance considerationsIn considering the rather specific issues of privacy, con-sent, return of results, and ownership in the context ofresearch ethics and biobanks, there has been growingrecognition first, that these issues cannot be resolved inisolation from each other and, second, that their resolu-tion must involve a strong focus on governance. Whileoperationalization of standardised approaches to bio-bank governance are only just beginning to emerge, cur-rent thinking on the subject tends to emphasise theneed to facilitate health research while enhancing thecapacity for participant and public involvement as wellas benefit sharing[44,65]. This trend is likely to continuewith research endeavours relating to the human micro-biome, but will inevitably require creative adaptation toapply to novel circumstances introduced by microbialresearch. Moreover, while many human genomeresearchers have become accustomed to thinking aboutthe social and ethical implications associated with theirresearch, microbial researchers may not have previouslyengaged with such issues as the need to protect researchparticipants’ privacy, and dealing with incidental findingssuch as disease predispositions and whether (and how)to communicate these results back to participants.Considerations about governance may become evenmore pressing and complex with the advent of humanmicrobiome research due to the public health implica-tions of such research. For instance, while already com-plicated, considerations about biobank governance havegenerally not had to take into account issues such asinfectious disease. This is clearly an important factor formicrobial research, and mechanisms for interfacingresearch platforms with public health agencies will likelyneed to be designed. Importantly, this link will need tobe made transparent to research participants to conformwith adequate informed consent criteria.Justice considerationsIn addition, as alluded to in our discussion on owner-ship and return of results, provisions for benefit sharingare relevant in this context[50]. The precise form thatbenefit sharing might take can vary, but involves ensur-ing that the results of research are distributed withsome sense of justice and fairness. Benefits of researchcan be conceptualised in terms of financial returns,medical technologies, or public health benefits, whileappropriate beneficiaries might include the researchers,research participants, funders, identifiable minorities andthe wider public, depending on context. Similar to thecharges of bioprospecting and biopiracy that have beenlevelled against some genetic researchers for exploitingindigenous groups without appropriate compensation,microbiome research may lend itself to exploitation ofgroups and individuals for the benefit of alreadyprivileged segments of the population. For example,given the importance that is attributed to commensalbacteria in human health, research is likely to focus onproducing probiotic interventions through studying cor-relations between particular health variables (e.g., cancerresistance, immunity, women’s health) and the microbialprofiles of certain individuals or groups. Without appro-priate governance, the primary health benefit of theseprobiotics will flow to those who can afford them, whilethe associated financial benefits will flow to researchersand developers. While there can be no a priori objectionto this, there is a sense of incongruity if the researchparticipants who contributed time, samples, and exposedthemselves to the potential risks of research involvementshare neither financial nor health benefits.RecommendationsIn conclusion, our consideration of the social and ethicaldimensions of the intersection of human microbiomeresearch and tissue biobanking suggest some recommen-dations for policy:1. We need to be mindful of, and protect against,novel and unanticipated forms of discrimination thatmay arise from microbiome research. Such discrimi-nation may come in many forms, and be based onany number of levels of categorization includingsocio-economic factors, and cultural or ethnic back-ground (interview 137). Marginalised sectors ofsociety who already suffer from discrimination, suchas minorities and those with obesity, may find thatmicrobiome research leads to a greater ‘scientific’basis for marginalisation - the results of which couldbe abhorrent. Also, association of diseases such ascancer with a microbial aetiology (whether corrector incorrect) may lead to stigmatisation of groupsreminiscent of those associated with certain infec-tious diseases.2. As with other forms of biomedical research,microbiome research needs to be sensitive towardthe socio-cultural and economic context of itsresearch participants. Given the nature of microbialresearch on samples sourced from humans, particu-lar attention should be given to respecting the sensi-tivities of participants. Success in this regard is likelyto be rewarded with strong research participation,and stronger relationships of trust between scientistsand the larger public. Failure will inevitably leadtowards further alienation between the scientificestablishment and certain members and subgroupsof the public.3. As outlined above, microbial data may be aspowerful as genetic information in calculating pre-dispositions to disease. In addition, knowledge of theHawkins and O’Doherty BMC Medical Genomics 2011, 4:72http://www.biomedcentral.com/1755-8794/4/72Page 7 of 9interactions between human and microbial genomeswill certainly provide a far superior platform for cal-culating disease predispositions. Microbiomeresearch studies will need to take this into accountand make adequate provision for making decisionsto withhold or disseminate such information toresearch participants.4. Until there is evidence to the contrary, informa-tion about an individual’s microbiome should betreated with the same safeguards as human geneticinformation. This means that biobanks (whetherthey hold biological samples and/or information)need to make adequate provision for data storageprotection mechanisms to diminish potential privacybreaches. In this context, the concept of what istruly ‘personal’ information needs further explorationand definition. As with other forms of data, privacybreaches of microbial data have the potential forharmful effects, infringement of autonomy, stigmati-zation and discrimination, yet these need to bebalanced with public health considerations. Aware-ness of these potential outcomes should enable us tobuild in adequate privacy protections at the begin-ning of such research endeavours. Anonymization ofspecimens may be an option, however may be mean-ingless if the sample can be linked back to an identi-fiable sample elsewhere[27]. In addition,anonymization of specimens may be less fruitful forthe research endeavor[42].5. Given that many researchers working on the HMPhave not had previous experience with human sub-jects research, efforts might be made to increaseawareness among researchers about the social andethical implications associated with such research.6. Finally, the question of ‘who owns your poop?’will finally need to get the attention it reallydeserves. If only to avert costly court cases and mis-matched expectations between researchers and parti-cipants, a reconsideration of the categorisation ofhuman waste may be important.AcknowledgementsWe would like to thank Liz Wilcox, Jayme Taylor and Tamara Ibrahim forvaluable assistance in project and data management, as well as expertadvice from Petra Arck, Michael Burgess, and Steven Hallam. We alsogratefully acknowledge funding for this project from CIHR (competition200808CHM, Catalyst Grant: Human Mirobiome, application number 193095).Most importantly, we would like to thank the scientists who agreed to beinterviewed for this project for sharing their valuable time and expertise.Finally, we would like to thank two reviewers and participants at the HelexDatasharing Conference 2010 for valuable insights and comments.Author details1Centre for Applied Ethics, University of British Columbia, Vancouver, BC, V6T1Z2, Canada. 2Department of Psychology, University of Guelph, Guelph, ON,N1G 2W1, Canada.Authors’ contributionsKO conceived of the study, carried out the background research andconducted the interviews for the study. AH conducted interview analysis forthe study. AH and KO coordinated and drafted the manuscript. All authorsread and approved the final manuscript.Competing interestsThe authors declare that they have no competing interests.Received: 18 February 2011 Accepted: 7 October 2011Published: 7 October 2011References1. Cambon-Thomsen A, Rial-Sebbag E, Knoppers B: Trends in ethical andlegal frameworks for the use of human biobanks. Eur Respir J 2007,30:373-382.2. Haga SB, Beskow LM: Ethical, legal, and social implications of biobanksfor genetics research. Advances in Genetics 2008, 60:505-544.3. Greely HT: The Uneasy Ethical and Legal Underpinnings of Large-ScaleGenomic Biobanks. Annual Review of Genomics and Human Genetics 2007,8:343-364.4. Knoppers B: Biobanking: International Norms. J Law Med Ethics 2005,33:7-14.5. Hawkins A: Biobanks: Importance, Implications and Opportunities forGenetic Counselors. Journal of Genetic Counseling 2010, 1-7.6. Secko DM, Preto N, Niemeyer S, Burgess MM: Informed consent inbiobank research: A deliberative approach to the debate. 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PLoS Biology 2008,6:73.Pre-publication historyThe pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1755-8794/4/72/prepubdoi:10.1186/1755-8794-4-72Cite this article as: Hawkins and O’Doherty: “Who owns your poop?":insights regarding the intersection of human microbiome research andthe ELSI aspects of biobanking and related studies. BMC MedicalGenomics 2011 4:72.Hawkins and O’Doherty BMC Medical Genomics 2011, 4:72http://www.biomedcentral.com/1755-8794/4/72Page 9 of 9


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