Managing the Introduction of Biobanks to Potential Participants: Lessons from a Deliberative Public Forum

Abstract

Ongoing debate exists around how best to manage the issue of informed consent for research involving human tissue biobanks. However, the issue is well recognized and covered in the academic literature. A related and arguably equally important issue that to date has not received much attention is how best to manage the process of identifying and initially contacting individuals for their participation in a biobank. While many population-based biobanks strive for random sampling of healthy participants from the general population, disease-based biobanks usually need to rely on some sort of referral process to achieve specificity for type and subcategories of disease. There are thus numerous ethical implications regarding the way in which this referral process is managed. In this article we begin by providing a brief outline of the nature of the problems associated with the initial introduction between a biobank and potential research participants. We then consider data from a recent public deliberation on the topic of human tissue biobanking. In these discussions, participants were posed questions regarding their views pertaining to the introduction of potential donors to biobanks, and asked to make recommendations to be considered by policy makers in British Columbia, Canada. Based on these data we conclude that there is general agreement that introduction of research biobanks to potential donors should be conducted face to face, and by a medical professional known to the donor, and depending on donor circumstances, is acceptable during either pre- or postoperative periods. The strong preference for the introduction to involve a family physician should be considered in the future design of biobank contact and consent processes.

Introduction

In recent years there has been increasing interest in the ethical considerations associated with biobanking and genomic research.^1,2 A substantial amount of scholarly work on the subject is concerned with informed consent and its possible limitations in the biobank context,^3–9 risks to privacy,¹⁰ and, to a lesser degree, benefit sharing and the governance of biobanks.^11–14 However, to date, little attention has been given to the practical and ethical challenges associated with the process of actually identifying and contacting potential biobank donors (before consent is sought), and optimal methods for managing this introduction.

The initial contact between biobank and potential donor is sensitive for a number of reasons. While population-based biobanks usually rely on random recruitment, disease-based biobanks require at least some identifying information before contacting a prospective donor. This process raises both logistical and ethical challenges. Once contacted and informed about the implications of donating to the biobank, individuals have the opportunity to give or refuse consent. However, for that person to be approached in the first place, the biobank must have been provided with certain confidential, identifying information prior to the consenting process. It thus seems unavoidable that a further preliminary consenting process must occur in which a referring person or institution gains permission from the potential donor to pass on certain confidential information and for the biobank to contact the individual. These considerations are not merely academic or logistical; there are important reasons why an individual may not be comfortable with a third party having knowledge of their disease status and identifying information, considerations of which are acknowledged in current healthcare and research ethics protocols. Moreover, because the nature of biobanking research is largely unfamiliar to the general public, and the relative novelty of genomic research, public support of and trust in biobanks has yet to be established.^15–17

These issues are further complicated by the fact that biospecimens are collected in a variety of situations, both prospectively and retrospectively. In some instances, biobanks are constructed from specimens obtained from pathology laboratories that have been stored primarily for clinical purposes over many years. Such archived collections have usually not been consented for research use. They also vary as to whether the samples are anonymized on transfer to the research biobank. Additionally, while the vast majority of the specimens that are left over from samples used for initial diagnostic tests or clinical procedures are never required for future tests, there are instances in which additional portions of specimens are needed years later for clinical purposes. For these and several other reasons,a it is increasingly common for research biobanks to operate through prospective specimen collection, where the biobanks intentionally seek out individuals from particular patient groups for the purpose of requesting donation of biospecimens.

Thus the processes involved in introducing a biobank to potential donors and obtaining informed consent differ depending on the circumstances under which the sample was or is to be obtained. This article focuses mainly on the prospective collection of samples for research and storage in a biobank. This focus aligns with a broader shift from reactive to proactive approaches to obtaining informed consent for biobanks aimed at ensuring the ethical sustainability of biobank research, and to ameliorate potential erosion of public trust.

Currently there is no standard approach to establishing the initial contact with potential biobank donors. In order for an appropriate standardized approach, or set of approaches, to be developed and implemented, the input of the public is crucial. The general public represents key stakeholders in this process, for several reasons: they are the source of biospecimens; public funding often provides some component of financial support to biobank development, maintenance, and research; and the future of members of the public will be directly shaped by the technology of biobanks and associated research. While initial contact protocols clearly need to be based on acceptable professional standards, members of the public can provide valuable insight regarding which approaches are most favorable to potential donors, and can help to identify the concerns that are most significant to them.

Recently, an increasing number of public engagements have been conducted on the subject of biobanks.^18–21 However, none of these has specifically addressed questions regarding the introduction between biobanks and potential donors. In this article we draw on data from a deliberative democracy event in which a random, demographically stratified sample of British Columbians (Canada) was asked to deliberate about the social and ethical implications of various biobanking practices.²² A particular aim of this public engagement was to inform the protocols and standard operating procedures of the British Columbia (BC) BioLibrary, a program sponsored by a government health research agency that acts as a facilitator for the initial steps of biobanking for many biobanks in BC, Canada.²³ These initial steps revolve around the appropriate and efficient connection of donors and their biospecimens with relevant biobanks. In this article we provide an analysis of the conclusions and the deliberations of this public forum on the issue of managing introductions of biobanks to potential donors, with the ultimate aim of better informing practice in this area.

Materials and Methods

The BC BioLibrary Deliberation was conducted over 2 weekends in March 2009 in Vancouver, BC, based on collaboration between researchers at the W. Maurice Young Centre for Applied Ethics at the University of British Columbia, and the BC BioLibrary.b The aim of this public deliberation event was to (1) build on previous work^24–26 on eliciting views of members of the public to inform ethical governance of biobanks and (2) inform the specific protocols and governance structures of the BC BioLibrary. An important criterion in the study design involved recognition that most members of the general public have not heard about biobanking and do not have substantive or informed opinions on the subject. There is thus a risk of input being characterized, on the one hand, by a largely uninformed public and, on the other, by those with strong vested interests. The sampling and study design outlined in the following paragraph were aimed at overcoming these problems. The design and implementation of this study were informed by principles of deliberative democracy.²⁷ As such the goal was to foster civic dialogue and attempt to formulate collective statements that could be passed on to BioLibrary managers as recommendations for the governance of the BioLibrary. The ultimate aim was to implement a public input mechanism to increase the trustworthiness and ethical sustainability of this public resource for health research.¹⁴

Sampling and recruitment

The participants of the public deliberation consisted of a random demographically stratified sample of 25 residents of BC. Though a sample of this size cannot be genetically, politically, or statistically representative of the entire population of the Province, the recruitment process was designed to minimize selection bias and maximize diversity of perspectives.²⁸ In particular, drawing on the theoretical construct of a mini public,²⁹ even a small sample of sufficiently diverse participants can add an important set of perspectives to policy making processes that would otherwise be ignored. Moreover, random selection of participants ensured that selection bias was reduced and recruitment of all but excluded individuals with strong vested interests in the subject. Letters of invitation were mailed to 5000 households that were randomly selected by postal code. This initial mail-out resulted in 224 individuals responding to express their interest in participating. The final sample of participants was randomly drawn from these 224 individuals to fill demographic stratification for: Health Region (to account for potential systematic variation in people's healthcare experiences), age, and gender. At this point other demographic variables were documented, including religion, ethnicity, First Nationsc membership, and experience of disability, to ensure that the final sample was sufficiently diverse. A minimum of 2 individuals from First Nations communities, and a minimum of 2 individuals with experience of disability were selected to ensure that these groups were represented as both were seen as potentially subject to disproportional effects from biobanks. A total of 28 individuals were invited to the deliberation to account for attrition. Participants were compensated for their travel expenses and time at a rate of $100 per day for a total of 4 days.

Although no recruitment strategy is completely immune to the risk of systematic bias, our adopted recruitment strategy had the advantage of reducing the risk of recruiting those with strong vested interests. Because participation was by (random) targeted invitation only, as opposed to advertisements or open invitations, access for particular interest groups was minimized and representation of diversity was maximized. Moreover, demographic stratification and random selection from a larger pool of individuals expressing an interest in participating further reduced the risk of systematic recruitment biases.

Structure of the deliberation

Prior to the event, participants received a detailed information booklet (available at: http://biobanktalk.ca/), which described key issues and perspectives pertaining to the social and ethical implications of biobanks. The purpose of the booklet and first day of the event was to provide participants with information about the process of deliberation, biobanks, and 5 specific topics of interestd to be addressed during the deliberation. Printed materials and speakers included critical perspectives that challenged what might be taken for granted, such as the view that health research dependably produces more benefits than harms. To facilitate successful deliberation, participants were also encouraged to follow the components of deliberative discussions and conclusions, as outlined in Table 1.

Table 1.

Components of Successful Deliberative Discussions

1. Consideration of all the relevant information and perspectives on a topic (eg, the general public, researchers, and patients)

2. Respectful and inclusive discussion of issues and articulation of areas of disagreement

3. Commitment toward developing and articulating civic solutions that are implementable and acceptable on a societal level, recognizing that these may prevail over individual interests and perspectives

4. The product of the deliberation represents, as far as possible, a collective statement of the group of deliberants

It is important to note that while consensus was the stipulated aim of discussions, it was not presented as a requirement, thus allowing persistent disagreements and opinions to be voiced and recognized.

To ensure that deliberants were well informed about the diverse range of perspectives and issues in biobanking, the beginning of the event involved a range of presentations from key experts and stakeholders offering different views on biobanks and related research. Presentations included an introduction to biobanks and the BC BioLibrary; an overview of ethical issues in biobanks such as privacy, consent, and legal considerations; a First Nations perspective; a presentation regarding the potential for genetic discrimination; and a report from an individual who participated in a previous deliberative engagement on biobanks. Examples, scenarios, and physical models were used to clarify the issues and ground the discussion. Participants were later divided into 3 small groups where, through the help of a facilitator, they discussed the topics under consideration. The small groups were designed to further familiarize participants with the issues and to enable all participants to speak freely and comfortably in a more intimate setting. Large-group sessions were held after each small-group discussion and were designed to crystallize perspectives developed in the small groups and ultimately to finalize the whole group's positions. Large-group discussions were more structured than small-group discussions in that they were explicitly geared toward developing collective statements that could be passed on to BioLibrary management and other policy makers as recommendations. This small-group/large-group model not only enabled the perspectives of each deliberant to be voiced and captured, but it also allowed efficient yet full exploration of each of the deliberation topics.

The final step in the deliberation was a ratification process whereby the group rearticulated (and occasionally modified) their positions on each topic after having discussed and considered the issues over the course of the 4 days. An important purpose of the ratification step was to overcome potential order effects that might have resulted from discussing the 5 topics of the deliberation in the order they were presented. The ratification step allowed the participants to consider their recommendations on all 5 topics in a more holistic manner. This process involved revisiting each topic, voting as to whether individuals in the group agreed or disagreed with a certain proposition or position, and collectively finalizing the deliberative recommendations. Throughout the entire process the facilitator worked toward a clear articulation of the nature of any disagreements, with a full documentation of each position. The deliberative recommendations produced at the end of the event represent the official, ratified collective statements and recommendations of the group. In addition, all proceedings, including small- and large-group discussions, were recorded and transcribed for further analysis. This analysis provides additional insight into the reasoning supporting the deliberative outputs, and ensures that viewpoints articulated by individuals only in small-group discussions are also considered (in presenting our results, below, we consider both ratified conclusions of the deliberation as well as analysis of the discussions).

Provision and framing of information

Owing to the complexity of the issue involved, deliberation was guided with the help of a workbook (available at http://biobanktalk.ca/) prepared for the event.²² Whereas the information booklet (see above, Structure of the Deliberation) was geared more generally toward biobanking, the workbook was tailored more specifically to the context of the BC BioLibrary. It is important to reiterate that our specific interest here pertains to questions regarding the introduction of biobanking and initial contact between the biobank and potential participants and not to questions regarding the best time and place to obtain informed consent (this was discussed as a separate topic later in the deliberation). Rather, the aim of the “introduction” topic was to elicit views about suitable ways to lay the groundwork for informed consent by appropriately identifying potential donors. To better illustrate the issues involved in the initial contact and help to inform the discussion, participants were presented with 3 scenarios that outlined different situations in which patients might be introduced to a biobank (see Table 2).

Table 2.

Scenarios Illustrating Different Contexts in Which a Biobank Is Introduced to Potential Donors

Scenario 1

A patient is told about the possibility of donating to a biobank during a preoperative consultation with her surgeon. The patient may or may not recall discussing the topic with her surgeon. If she expresses interest in donating, the surgeon forwards her information to the biobank personnel, who contact her shortly after to remind her that she had been referred by her surgeon and to schedule a meeting to explain in more detail and go through the consenting process.

Scenario 2

A patient arrives at the hospital ER with abdominal pain. She is admitted and scheduled for an emergency surgery 3 days later. The following morning, once she is in stable condition, she is visited by a surgeon she has not met before. This surgeon discusses the details of the surgery, to which the patient agrees. The surgeon returns the following day to inform her that the surgery will occur that afternoon. At this time, the surgeon asks if she wants to donate her unused tissue for research. The patient agrees. No consent form is signed before the surgery, but the surgeon says that the tissue will be collected and that the patient will be contacted at a later time by the research personnel.

Scenario 3

A patient is admitted to hospital, recovering from surgery. A nurse who has been caring for the patient asks the patient if she wants to be visited by biobank personnel to discuss using the tissue removed during surgery for research purposes.

After presentation of each of these scenarios, deliberants were prompted to consider the various practical and ethical trade-offs associated with each option (eg, time and resource constraints), as well as factors relevant to different kinds of patients, such as those who may lack capacity to provide fully informed consent. During the subsequent deliberations, participants were asked to consider the best time to introduce potential donors to the idea of biobanking, the various ways in which the biobank might identify potential donors, and how the introduction should differ for those with special circumstances (see Table 3). Although every attempt was made to include all relevant options for participants to consider in the framing of questions, it was recognized that participants might identify other options or feel that the particular framing of questions was not appropriate to the issue. Consequently, participants were free to reformulate questions to best express their conclusions.

Table 3.

Identifying Potential Biobank Donors: Timing and Personnel Options

1. Under which conditions is it acceptable to introduce the biobank to a potential donor?

a) During a visit to the doctor

b) Booking admission to hospital

c) During admission to hospital

d) Preoperatively in hospital

e) Postoperatively in hospital

f) At home before surgery

g) At home after surgery

h) Other

2. Which of the following are acceptable ways for the biobank to identify potential donors?

a) The physician/surgeon/nurse identifies potential donors during a routine visit, a preoperative consult, or after a procedure

b) The hospital admitting clerk identifies potential donors when they are admitted to hospital, knowing that they are planned to have a surgical procedure

c) The pathologist identifies potential donors upon completion of review and clinical diagnosis, knowing that excess biospecimen exists

d) Donors identify themselves to the biobank after being made aware of its existence through public awareness campaigns

e) Other

3. Should contact and introduction of the biobank be managed differently for any of the following people with special circumstances?

a) Minors

b) People with mental disabilities

c) Elderly with guardians

d) Ethnic minorities

e) People with language barriers

f) People living in isolated areas

g) Tourists or temporary residents

Analysis

All small- and large-group discussions were recorded and transcribed verbatim in preparation for analysis. Participants were given pseudonyms to ensure anonymity. Transcripts were then coded using NVivo8 (qualitative analysis software) into both emergent and analytical categories. For the purposes of this analysis, we consider only the discussions pertaining to the issue of initial introduction and contact between potential donor and biobank. All relevant conversations from the deliberative proceedings were grouped into a single category during the coding process. The content of this single coding category was then subjected to a thematic analysis according to the 5 analytical categories.

1. How should prospective donors be identified and approached?

2. Who should broker the contact?

3. When should prospective donors be approached?

4. How should the biobank be presented?

5. What needs to be considered when introducing the biobank to potential donors with special circumstances?

Texts within each theme were then divided into subcategories based on the ideas being expressed; for example, within category 2 (who should broker the contact) subcategories included physicians and public awareness campaigns. This coding scheme made it possible to identify the reasoning behind statements and positions regarding specific practices, and also to ascertain the relative prominence of the various concerns and perspectives expressed over the course of the 2 weekends.

Results and Discussion

As described previously, throughout the 4 days of deliberation, participants worked toward generating recommendations on key issues pertaining to biobank governance. During the final day of the deliberative event, participants collectively reviewed, revised as necessary, and ratified their recommendations and conclusions. This allowed for documentation of which recommendations and principles were supported by all deliberants and, where consensus was not reached, enabled a clear articulation of areas of disagreement and concern. These recommendations, presented in the form of a poster at the end of the deliberation, constitute the deliberative conclusions (see O'Doherty and Burgess, 2009,²⁵ for a more theoretical discussion on deliberative outputs) of this forum. In addition, as noted earlier, in-depth analysis allows for additional insights to be gained regarding the reasoning, values, and perspectives supporting the deliberative conclusions. The discussion that follows outlines first the ratified deliberative conclusions reached by deliberants relevant to the issues discussed in this article, followed by a more detailed analysis and discussion of the 4 days of deliberation on the subject.

Deliberative conclusions

Managing the initial contact between the biobank and potential donors was the second (of 5) topic discussed during the deliberation event (see Hawkins and O'Doherty,³⁰ for deliberants' conclusion on other issues). Presentation of the issues to be considered in this introduction, coupled with scenarios and follow-up by small- and large-group discussions, allowed deliberants to thoroughly consider the issue and make recommendations during the final process of ratification. The specific question addressed by participants on this topic was, “under what conditions is it acceptable to introduce the biobank to a potential donor (if at all)?”e

In answer to this, 21 (of 23) deliberants collectively formulated and agreed upon the following response: “Face to face, by a known medical professional or other member of healthcare team who is already involved in the patient's care introduces concept of biobank to the patient and how the patient can:

(a) seek further information, or

(b) give permission for biobank to contact them.”

The 2 individuals who did not fully endorse this statement explained their position that the healthcare provider should not only have a close connection with the potential subject, but the healthcare provider should also have intimate knowledge of the actual research, particularly in the case of disease-specific biobanks (as they may warrant additional privacy considerations).

Deliberants also discussed the method of introduction of potential donors to the biobank and stated that face-to-face methods are strongly preferred. Web sites, posters, brochures, documentaries, and Public Service Announcements were all thought to be acceptable methods of introduction. However, telephone or junk mail was not deemed acceptable as these methods were perceived as unprofessional, inefficient, a waste of resources, and an annoyance.

Transcript analysis

While the deliberative conclusions just outlined constitute the “official” results of this deliberative democratic forum on the issue of introducing biobanks to potential donors, the discussions of deliberants across the 4 days of the event constitute a further rich source of data regarding perspectives of members of the public. Analysis of these discussions also provides a degree of nuance in addressing complex ethical issues that are not available from consideration of the deliberative conclusions alone. Further, this analysis allows us to understand not only those arguments that held sway and were ultimately supported by the group, but also those arguments that were presented without gaining support over the course of the deliberation. The results that follow are based on a detailed analysis of all large- and small-group discussions.

How should prospective donors be identified and approached?f

Most participants reported that they would feel uncomfortable being contacted “out of the blue” by a biobank representative. For a stranger who is not involved in the patient's care to know the particulars of their condition would, according to a majority of participants, constitute a violation of privacy. Ideally, the task of identifying potential donors would be done by someone who already knows the patient's identity and has access to their personal details.

Participants unanimously agreed that it would be appropriate for a pathologist to identify and flag the patient as a possible biobank donor during routine reporting of results to the ordering physician. The physician could then introduce the biobank to that potential donor and, if the individual was interested, put him/her in contact with biobank personnel. There was, however, clear opposition to the idea of having the pathologist notify the biobank directly. Similarly, there was very little support for the option of having healthcare workers, such as hospital admitting clerks or other hospital staff, identify donors during the scheduling process. The group emphasized the preference of having someone known to the patient, almost exclusively described as their physician,g acting in the role of an intermediary between researchers and patients. Deliberants also agreed that it would be appropriate if physicians identified potential donors themselves, make the initial introduction, and refer interested patients to the biobank personnel.

Who should broker the contact?

Indeed, general practitioners (GPs) or specialists were unanimously preferred by deliberants as the first point of contact between patients and the biobank. Deliberants felt that because physicians are known to and generally trusted by the patient, coupled with the fact that physicians already have access to their personal and medical information, there would be no additional concerns about privacy. Though some participants expressed the concern that the inherent power differential may lead patients to feel pressured to participate in biobank research, particularly if a surgeon introduces the biobank, it was ultimately agreed that physicians are best suited to broker contact between the potential donor and biobank research.

The possible role of nurses and other hospital staff in the introduction and recruitment process elicited very little discussion. Some participants drew parallels between the processes of tissue donation and organ donation, in spite of evident differences between the 2. One participant shared her experiences working as a hospital clerk and witnessing responses to the recruitment process of an organ bank. She described patients being approached in the hospital setting and asked to donate either their own organs or consent on behalf of their relatives. Drawing an analogy between this and tissue donation, participants expressed significant disapproval of this method of introduction.

When should prospective donors be approached?

For both practical and ethical reasons, the majority of the group felt that the actual timing of the introduction was important (indeed, this issue elicited by far the most discussion and disagreement during the small- and large-group deliberations). A minority of deliberants expressed that there were no ethical problems with introducing the biobank at any time. These deliberants felt that as long as patients were not being asked to provide consent at the time of introduction, the introduction itself posed no foreseeable harm. Though they felt that it would perhaps be unwise to introduce biobanks to potential donors at times of stress or duress, this was because it would be “bad marketing,” not because it would be unethical.

There was unanimous agreement that the most appropriate time and place to introduce the idea of biobanking to a potential donor is during a visit to a family physician/GP or a specialist, or during a preoperative consultation. Deliberants felt that during these scheduled visits, biobanks could be discussed alongside a range of other issues and concerns.

Participants acknowledged that GPs and other physicians are normally quite busy and so may not have the time to discuss biobanks at length and answer questions. To address this issue, deliberants suggested that physicians could present the issue briefly and offer reading materials containing further information. From there, the physician could refer the patient to the biobank if permission was granted. If the patient indicated a need for more time to consider the decision, the patient could be provided with the relevant contact information so that the power to initiate contact with the biobank was located with the patient.

There was somewhat more disagreement about whether or not it is appropriate to introduce biobanks to potential donors either at the time of booking admission to the hospital or at the time of admission. For both options, some participants felt that it was appropriate to bring up biobanking at these times. A similar number of deliberants felt that neither of these options was acceptable because they felt that introduction at these times would pose an undue burden on patients, or they felt that it would be impractical given time and resource constraints. The remaining deliberants (approximately one-third of the group) felt that introducing the biobank during booking or admission would be permissible if certain conditions were met.h Specifically, these conditions were that (1) the admission is for nonemergency reasons and (2) the patient must be demonstrably comfortable and at ease. If it could reasonably be ascertained that the patient is not under any form of distress, it would be acceptable to introduce the issue at these times. However, if this could not be ensured, these deliberants felt that it would be unethical to overwhelm the patient or their families at a time when they are already worried or in pain.

Indeed, the most widely cited concern was that patients would be bombarded with information during times of stress, pain, under the influence of pain medication, or when otherwise incapacitated. Deliberants felt that if patients were approached in a busy hospital setting, possibly in pain, they might be unable to fully comprehend what they were being asked to agree to and to consider possible implications. There were also concerns that being asked during such times may lead patients to question whether their care and wellbeing was being sufficiently prioritized. Deliberants expressed that this may lead patients to feel distrustful of people around them at a time when they are already in a vulnerable and uncomfortable state. One deliberant described this as being analogous to a patient feeling like a “guinea pig.”

Concerns about patients' mental state and comfort level were also behind some deliberants' opposition to introducing biobanks in nonemergency situations, either preoperatively or postoperatively in hospital, or even postoperatively at home. On the question of whether or not it would be acceptable to introduce the idea of donating to a biobank at these times, deliberants' perspectives again coalesced into 3 positions. Approximately a third did not feel this was appropriate, for the reasons specified previously, while another third of the group felt it was appropriate. The remaining third expressed that it was acceptable to introduce the biobank in nonemergent pre- or postoperative situations on the condition that it could be ensured that the patient is under no distress and is given plenty of time to consider the information.

Throughout the deliberation, disagreement persisted about whether it is generally best to introduce the biobank and obtain consent before the specimen is collected, or whether it is acceptable to do this afterward and explain that tissues have been stored pending the patient's consent. The majority of deliberants agreed that obtaining consent prior to collection is preferable, if possible. The rationale for this preference, for many, was that completing the recruitment and consenting process before the sample is collected seems more professional, avoids the process appearing “loosey-goosey,” and does not make the consent of the participant appear to be an “afterthought.”

Although no deliberants were in principle opposed to the notion of making the initial contact when patients are awaiting a nonemergency procedure at home, and though this time was widely preferred over approaching patients in the hospital setting, there were still concerns about bothering patients when unwell. In addition, contacting patients at home implies the use of telephone or letter communication and these were not preferred means of introduction. (This is discussed further below in How should the biobank be presented.)

The majority of the group was unwilling to offer unconditional support to most introduction options because they emphasized that the timing of the initial introduction must be determined on a case-by-case basis, and should be contingent upon the individual patient's condition and state of mind. In order for the person making the initial contact to be able to assess whether it is an appropriate time to approach the patient, direct face-to-face contact was thought to be ideal.

How should the biobank be presented?

All deliberants felt that face-to-face interactions were the preferred mode for being introduced to the biobank. Because the initial introduction has the potential to be sensitive and confusing, some participants felt that it is important to have a personal connection at this point in the recruitment process and to take the time to ensure that patients feel comfortable, understand what they are being told, and assess their receptivity to the idea of donating. Further, face-to-face communication was preferred as this makes it possible to assess the patients' condition and mental state and decide whether it is an appropriate time to discuss issues of this level of complexity.

In contrast, phone communication was unanimously deemed undesirable; in part because it was thought unlikely that physicians (the preferred introducers) would have time to call patients at home to discuss biobanks, and in part because it is difficult to ascertain an appropriate time to have the conversation. Moreover, deliberants pointed out that phone solicitations are associated with telemarketers and would therefore be unsuccessful in gaining trust and cooperation.

Similarly, because of the association with commercial solicitations and “junk” mail, there was little support for sending materials to private homes through the postal service or via e-mail. Nonetheless, there was repeated emphasis on the importance of providing accessibly written materials such as brochures and pamphlets. Because the group acknowledged the feasibility problems associated with involving physicians in the introduction and recruitment process, some participants emphasized that the introduction could involve little more than offering reading materials detailing the relevant information.

Though current biobanking practices sometimes necessitate the active, targeted recruitment of donors with particular conditions, some participants felt that, in the future, it may be appropriate to institute a system whereby patients can be introduced to the idea of biobanking during a routine visit to a physician when they are in good health and are not coping with a serious condition.

Many deliberants also felt that the challenges associated with the initial contact could be addressed by increasing overall public awareness of biobanking. If patients already knew about biobanking, perhaps from a television documentary, posters on the walls of their doctor's office, through a news broadcast, newspaper article, commercial, or from science courses in high school, the recruitment process could be simplified and fewer resources would be required to explain and answer questions about the nature of biobanking and the issues involved with donating. Providing such public education would help individual patients to be “ready” and to find it easier to provide an answer when actually approached about the prospect of donating tissue to a biobank.

What needs to be considered when introducing the biobank to potential donors with special circumstances?

Participants did not feel that the process of introducing biobanks should differ significantly for individuals with “special circumstances.” There was agreement that for minors or elderly persons who lack capacity, a caregiver (such as a parent or an adult family member) should be present at the time of introduction and that their perspective should be a factor in whether or not the consenting process would go forward. For patients with limited proficiency in English, it was agreed that reading materials in a wide variety of different languages should be made available. Additionally, there was support for the provision of materials in Braille or in audio format for the visually impaired. Participants also felt that cultural norms and values should be respected and considered, where appropriate. For example, participants acknowledged that for some groups, such as First Nations groups, it may be appropriate to approach group leaders first to obtain “community consent” (ie, permission from group leaders to approach individuals in the group) prior to approaching individuals for consent. All in all, deliberants expressed that the recommendations specified with regards to when, how, and by whom the introduction should take place are relevant to as broad a range of potential donors as possible.

Conclusion

The previous discussion outlines both the deliberative conclusions—those that were agreed on and ratified by the majority of the deliberants at the end of the event—as well as the discussions and outcomes of the small and large groups during the entire event. While the deliberative conclusions provide important guidance for biobank researchers and managers, the extent of variance within each issue is reflected in the more detailed transcript analysis and is important to consider. Specifically, the deliberative conclusions reached by participants regarding managing the introduction of biobanks to potential donors express a preference for face-to-face introductions, by a medical professional known to the donor, preferably a physician. A further key finding is that participants do not want the circle of those who know about their medical information expanded unnecessarily or without their permission in the process of recruitment. Transcript analysis also provides more nuanced guidance on how this might be done appropriately and acceptably.

The degree of disagreement over the course of the entire deliberation and within each topic provides an indication of the variation in the extent to which different patients may be comfortable being approached about a biobank. The most variation occurred around the questions of timing of approach. This may reflect the fact that the deliberative group comprised people who may or may not have had prior experience as a patient, or that the variety of patient circumstances (eg, scale and intent of operations, implications, and additional therapies) was difficult to envisage. Indeed, participants repeatedly expressed that the timing of the introduction would have to be established on a case-by-case basis, depending on the nature of the individual patient's condition and their mental state. But inherent to the discussion and range of opinion, and also the unanimous support for the concept of a pathologist flagging possible donors, was the acknowledgement that contact might occur during either pre- or postoperative periods. Systems for approach that includes the patient's physicians were clearly preferred. However, given the fact that clinicians are often and increasingly under significant time constraints, strategies to include clinicians in limited time roles or to establish acceptable delegates will be important to consider. It should also be noted that the involvement of physicians in the recruitment of patients to participate in biobanks might be seen by some Institutional Review Boards (IRBs) (research ethics boards) as risking undue inducement because of the role of trust and authority the physician may hold relative to the patient. While this is clearly a circumstance that needs to be guarded against, the fact that physicians came out so strongly as the favored brokers between patients and biobanks suggests that on the whole the trust demonstrated toward them is perceived as justified, at least when compared with other possible brokers envisaged by the deliberants.

An important consideration in problems such as the ones considered here is that in many cases there is a conflict among different ethical perspectives such that reasonable people may disagree about what should be done. When reasonable people disagree about how to settle a pressing question, trade-offs between desired outcomes or values need to be recognized and taken into account in the formulation of policy. The most valuable public input for policy, in such cases, is therefore arguably the kind of input that also incorporates recognition of value trade-offs. In the present case, the deliberations of the participants illustrate recognition of a number of trade-offs that are critical to formulating appropriate policy. These trade-offs include the following:

• Recognition that, in spite of a preference for involvement of physicians, there are already heavy time constraints on clinicians, which need to be factored into any policy solutions.

• Tension between privacy protection and narrow informed consent protocols on one hand, and facilitation of health research on the other. The importance of both was emphasized and there was recognition that policy solutions needed to trade-off between the 2.

• Biospecimens left over from clinical use cannot be stored indefinitely. If they are not used for research, the most likely alternative is for them to be discarded as waste.

Since a key objective of the deliberation was to help inform the governance and operating procedures of the BC BioLibrary, some consideration of how the advice from the public was taken up by the BioLibrary is relevant. As described previously,²³ a biolibrary is a framework that assumes a part of the process of biobanking on behalf of individual biobanks and is focused on acquisition, cataloguing, and distribution of biospecimens to biobanks. To achieve this, the BC BioLibrary was initiated in 2007 with its initial priority to establish a network of “Biospecimen Collection Units” within clinical pathology departments supported by “inventory catalogues.”²³ The initial assumption was that the existence of these 2 elements of the framework alone would overcome the major barriers faced by many biobanks, including geographic and temporal gaps in the biospecimen acquisition process. It was also assumed that while the issues and logistical barriers related to the mechanisms for obtaining consent were clearly important and directly linked to biospecimen accrual by the BioLibrary, these mechanisms were best addressed by individual biobanks, and were also lesser barriers.

So in retrospect the initial BC BioLibrary design anticipated that the outcome from the deliberation would be general agreement that introduction of research biobanks is acceptable to donors either pre- or postoperatively. This principle was a major justification for establishing a dedicated collection framework that is independent of biobanks so that the timing of obtaining consent can be disconnected from timing of the harvesting of biospecimens. However, the initial BC BioLibrary design did not anticipate the strong preferences for face-to-face initial approach by a physician. This lesson, combined with early experience with the framework, clearly identified a key “rate limiting step” for the BioLibrary to achieve full value for biobanks, given the increasing constraints on engaging physician time in most health systems. As a direct result of these lessons learned from public deliberation, the BC BioLibrary has therefore developed and incorporated “permission to contact processes” as a new major element to its design and operations since 2010. These processes focus on obtaining initial permission from a potential donor to be contacted by a representative from a biobank (approved by both the BioLibrary and the research ethics board), to discuss the research biobank with the intention of obtaining biobank consent. This permission is only for contact, and in different BioLibrary sites it is obtained either by the physician or in most cases by a representative of the physician within the clinic at the time of a medical appointment. The incorporation of “permission to contact processes” to the BC BioLibrary framework has been very successful from the standpoints of both potential donor acceptance, biobank consent efficiency, and value of the BC BioLibrary to biobanks, and has clearly provided an acceptable method for biobanks to achieve an initial “face-to-face” approach that is not necessarily or directly dependent on physician time (manuscript in preparation). Regarding the broader ability to generalize these findings, it should be noted that while many of the issues debated by participants that are not discussed in this article (eg, protection of privacy and protocols for obtaining informed consent) have similar implications for recruitment to population-based biobanks or healthy controls for disease-based biobanks, the issue of the introduction between biobanks and potential donors as discussed here is rather specific to disease-based biobanks and pathology collections. Care should therefore be taken in extrapolating the findings emerging from discussions of biobanks in the present context to other types of biobanks.

There are theoretical and practical challenges with regards to moving public views and stated preferences into regulatory frameworks. For instance, such factors as existing laws and entrenched stances of research ethics boards may prove relatively rigid obstacles to translating public recommendations into policy. Also, members of the public in deliberative forums may have missed important information in developing their recommendations. In particular, this particular forum was constituted by members of the general public, rather than patient populations. Given that decision perspectives are known to change as a result of developing a disease and at point of care,³¹ the perspectives of patients may also need to be examined more specifically. Nevertheless, a patient population, while arguably representing a relevant affected group in this context, also represents a narrower set of interests relative to a more diverse public sample. The sample in this study included many participants who were simultaneously patients or past patients (this was ensured in having a recruitment filter of a minimum of 2 individuals with experience of disability, as well as being evident in discussion transcripts in which participants drew on their experience as patients to substantiate their arguments). In other words, the rationale of the study was to represent interests that are in principle broader than those of a patient population, while also ensuring that patient interests were incorporated in the deliberative process.

Importantly therefore, the data presented here reflect the considered conclusions of a forum characterized by diversity, deliberation that was inclusive of multiple perspectives, a relatively high degree of technical knowledge, and consideration of different scenarios and generic forms of biobanks (eg, cancer and noncancer, etc).i The informed and deliberative ratified conclusions thus provide an important source of considered democratic input for social policy. The forum also provides a good idea of what a contemporary and diverse population in BC thinks is reasonable in the management of ethical difficulties surrounding biobanks, and outlines a range of issues and public responses to different practices. Moreover, the conclusions might be able to be considered in terms of recommendations for changes to Tri-council policy documents or laws, and are certainly capable of being implemented within most current institutional and legal frameworks and may provide guidance to Research Ethics Review Boards and IRBs. This may of course require further legal analysis, but this is beyond the scope of this article and should remain as a suggestion, not a point of analysis. Finally, while appropriately translating public viewpoints into policy is certainly rife with challenges and inadequacies, the results of this deliberation do go further toward the goal of incorporating and respecting public viewpoints in the area of genomic research and beyond.

Footnotes

Acknowledgments

We would like to thank members of both the Face-to-Face research team and the BC BioLibrary for their efforts in making the BC BioLibrary Deliberation happen and their inputs into this article: Dan Badulescu, Jacqui Brinkman, Emma Cohen, Isaac Filate, Sara Giesz, Holly Longstaff, Michael Mackenzie, Ania Mizgalewicz, Jennifer Myers, Shauna Nep, and Janet Wilson-McManus. We also gratefully acknowledge funding for this project from Genome BC, the PROOF Centre of Excellence, the BC BioLibrary, and CIHR. Most importantly, we would like to thank all the participants at the BC BioLibrary Deliberation for sharing their views with us and for dedicating weekends of hard work to this project.

Author Disclosure Statement

Dr. Peter Watson is a member of the editorial board of Biopreservation and Biobanking. Kieran O'Doherty, Tamara Ibrahim, Alice Hawkins, Michael Burgess disclosed no conflicts.

a

For example, lower cost, acquire cases with current treatment protocols, apply specific study selection criteria, deploy more specific consent, obtain other nonsurgical specimens (such as a blood sample) to go with the tissue.

b

The BC BioLibrary is a network established to support and complement biobanks in BC by improving quality and access to human biospecimens for biobanks, research studies and clinical trials; developing and maintaining stakeholder trust; and building capacity for translational research in BC. For more information please see (downloaded February 28th, 2011).

c

The preferred designation for Native Canadians.

d

Topics in the order of discussion: (1) Collection of Biospecimens; (2) Initial contact/Introducing the Biobank; (3) Linking Samples to Personal Information; (4) Consent; and (5) Governance of Biospecimens and Associated Data. We consider here only the results for topic 2.

e

The original questions posed to participants, as outlined previously in the methods section (see and workbook), were reframed and simplified to the question presented during the actual event. This reframing was based on significant deliberant feedback that a general guidance statement is more appropriate for the topic at hand. The issue of the reframing of questions is peripheral to the purpose of this article, but readers interested in this methodological issue are referred to O'Doherty and Hawkins (2010).

f

Note that there is inevitable overlap between some of the issues and analytical categories. This is most evident between the issue of who should identify potential donors and who should act as broker between patients and the biobank. Some of the blurring evident in participants' statements here is indicative of how these roles would blur in real-life situations.

g

One deliberant suggested a nurse may also be acceptable.

h

Note that this is contrary to much common practice.

i

Although the recruitment to the event and the experience of deliberation may influence the participants toward recruitment to a biobank, the deliberation situated the discussion in the context of several scenarios aimed to guard against systematic bias.

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