Managing the Unimaginable: Biobank Participant Views on Reconsent for Whole Genome Sequencing of Stored Biospecimens

Abstract

Background:

DNA biobanks frequently obtain broad permissions from sample donors, who agree to allow their biospecimens to be used for a variety of future purposes. A limitation of this approach is that it may not be possible to discuss or anticipate all potential uses of biospecimens at the time patient consent is obtained. We surveyed biobank participants to clarify their views regarding the need to be informed about research involving whole genome sequencing (WGS).

Methods:

We invited 1200 participants in the Mayo Clinic Biobank to complete a survey inquiring about their support for WGS; their interest in being recontacted before WGS of their biospecimens; whether they would consent to WGS if asked; and the acceptability of proceeding with WGS if sample donors could not be reached.

Results:

Six hundred eighty-seven biobank participants returned completed surveys (57% response). More than 96% of biobank participants were supportive of WGS and would give permission for WGS of their sample, if asked. Nonetheless, 61% of biobank participants felt they should be recontacted before WGS was done. Participants were divided regarding the permissibility of conducting WGS if efforts to recontact sample donors were unsuccessful.

Discussion:

Our findings highlight a potential discrepancy between the broad permissions granted by biobank participants at the time they donated biospecimens and their views about the application of WGS to their samples. Biobank participants appear to value the ability to confirm their commitment to genetic research when the studies in question involve WGS, a technological capacity they may not have anticipated at the time they donated their biospecimens. Efforts to reevaluate biobank participants' views about the acceptability of new technologies may help to ensure alignment of participants' current beliefs and research applications that would have been difficult to anticipate at the time biospecimens were collected.

Introduction

DNA biobanks play a critical role in biomedical research, especially research that seeks to identify new disease associations or biological targets for additional study. To maximize the value of these resources, many biobanks rely on some form of “broad consent,” wherein sample donors agree to allow their biospecimens to be used for a variety of future research purposes.^1,2 Many of these future studies would be difficult, if not impossible, to anticipate and describe in sufficient detail at the time sample donors provide their consent.^3,4 As a result, “broad consent” has been viewed by some as ethically controversial.⁵

In response to the inherent limitations of broad consent for biomedical research, some have advocated for periodic renewals of participant support for new research applications. This approach, which is sometimes described as “dynamic consent,” would query sample donors to ascertain their willingness to have donated biospecimens analyzed for specific purposes that were either not anticipated at the time their samples were collected and stored or were not discussed due to concerns about the amount of time required to review a lengthy list of future research possibilities.⁶ Although this strategy has the potential to protect biobank participants' values, dynamic consent is not without its challenges. These include increased financial costs, loss of participants over time, and potential burdens on sample donors.^1,7 Several studies have found that their research subjects approve of broad consent for future research,^8–10 and some would even prefer one-time broad consent over dynamic consent, maintaining that renewals of willingness to participate in research is an unnecessary waste of resources.^11–13 These findings are not consistent across studies, however, as others have found that some research participants would welcome some form of recontact and reconsent.^1,12–16

As DNA biobanks expand and seek to recruit larger numbers of participants,¹⁷ it will be critical to understand which approaches to informed consent align most closely with sample donors' values and authentic preferences regarding the use of stored biospecimens. In this article, we describe biobank participants' perspectives on reconsent in the context of whole genome sequencing (WGS) research. To the extent that WGS research is a relatively new form of research that would not have been explicitly described at the time many biospecimens were collected for future research purposes, this context can provide insights into biobank donor understandings of the scope of broad consent and the importance of renewing donor consent for unexpected research applications of stored biospecimens.

Methods

Study population

Study participants were identified through the Mayo Clinic Biobank. This research biorepository was established in April 2009 and currently contains more than 55,000 unique patient samples.¹⁸ To participate in the biobank, individuals had to be current or former patients at Mayo Clinic or the Mayo Clinic Health System, reside in the United States, be at least 18 years of age, and be capable of providing informed consent. Biobank participants were recruited through information booths, mailings, and community outreach events. When the biobank was launched in 2009, study coordinators recruited potential participants using a face-to-face process. Based on feedback from participants, this process was subsequently modified to allow for mailed recruitment and consent. Biobank participants received a $20 thank-you gift for their participation and biannual newsletters to keep them abreast of some of the research studies being conducted with donated biospecimens.

When participants enrolled in the Mayo Clinic Biobank, they were informed that their samples might be used for a variety of unknown, future research purposes (Box 1). The possibility that donated materials might be used in future genetics research was underscored in several portions of the informed consent document. In addition to authorizing the long-term storage and analysis of their blood sample, including genetic analysis, sample donors also agreed to allow the biobank to access past, present, and future medical records at Mayo Clinic.

Recruitment

A sample of 1200 participants from the Mayo Clinic Biobank was created and recruited for this study. To identify these 1200 individuals, biobank participants were stratified by age (18–30, 31–40, 41–50, 51–60, 61–70, and 71 and older), sex, and education (high school or less, at least some college). This stratification scheme produced 24 subgroups, and from each of these 24 subgroups, 50 biobank participants were randomly selected. Since there were only 40 men between 18 and 30 years of age, with an education of “high school or less,” all 40 of these individuals were included in the sample (and 60 men between 18 and 30 years of age with “at least some college” education were included).

Before recruitment, this study was approved by the Mayo Clinic Institutional Review Board (IRB # 08-007049). Each of the 1200 participants in our sample was mailed a study invitation packet that included a cover letter, a survey, and a prepaid return postal envelope. Eligible participants who did not respond to our initial invitation within 30 days received a second recruitment packet. Study recruitment was closed 30 days after this follow-up mailing.

Data collection

The survey assessed biobank participants' knowledge of genetics and views regarding participation in genetics research, including research involving WGS. The survey also examined participants' knowledge of genetics; the value assigned to genetic information, for both themselves and their children; concerns about privacy and confidentiality of genetic information; preferences regarding posthumous access to their genetic information; preferred mechanisms for the return of genetic results (e.g., telephone and in-person reporting); and personal use of Mayo Clinic's online patient portal.

Box 1. Excerpts from the Consent Form Used by the Mayo Clinic Biobank

“You are being asked to give samples and information to the Mayo Clinic Biobank, which will be used by many different researchers for many different studies. Most of the researchers who use the samples and information in the Biobank will be studying DNA. DNA is found in every cell in your body, and contains all of your genetic information. Researchers know that genetic information determines things like hair and eye color, and are trying to figure out how it affects what diseases people get.”

“Your blood contains DNA, which has all of your genetic information. Researchers are especially interested in studying DNA, although many types of studies will be done using the samples in the Biobank.”

“The Biobank will be used for many years, so we cannot predict all the ways that your sample(s) and information might be used.”

“You will not be told exactly which studies are using your samples and information. However, we will tell you how to get general information about all the studies that are using the Biobank.”

Box 2. Description of Whole Genome Sequencing Provided to Survey Respondents

“The next part of the survey is about a new medical test that doctors and scientists have recently developed called “whole genome sequencing.” This test can provide information about your chances of developing hundreds of different diseases over the course of your lifetime. Some of these are common diseases that you may be familiar with, like cancer, heart disease, and diabetes. This test also includes other less common diseases that you may not have heard about before.”

“Some patients are choosing to have this testing done by their doctors to help with their medical care. A video about this was designed for patients considering whole genome sequencing (WGS) and can be found on YouTube if you would like to see it. Keep in mind that having WGS done for research reasons is not exactly the same [YouTube link].”

Respondents were introduced to WGS research through a text box that included a basic explanation of the technology and its potential uses (Box 2). Respondents were also provided with a link to a 10 ½ minute YouTube video entitled, Whole Genome Sequencing and You.¹⁹ A series of four items was used to assess biobank participants' views regarding WGS research and the need to confirm participant consent before conducting such research (Table 1). Responses to these four items were positioned on a four-point Likert scale, with response categories of strongly disagree; somewhat disagree; somewhat agree; and strongly agree.

Table 1.

Survey Items Examining Patient Views Regarding Whole Genome Sequencing Research and the Need to Obtain Participant Consent Before Proceeding

For each of the following statements, please indicate your degree of disagreement or agreement.

1. I approve of the Mayo Clinic Biobank applying this new technology (WGS) on stored participant DNA samples…………………………………………………………..

2. I would want the Mayo Clinic Biobank to recontact me so I can give my permission for this particular project before they apply this new technology on my stored DNA sample………………………………………………………………………………….…..

3. If the Mayo Clinic Biobank asked for my permission to allow my stored DNA sample to be used in a whole genome sequencing project, I would approve the request…

4. If the Mayo Clinic Biobank asked a participant to give permission to allow their stored DNA sample to be used in a whole genome sequencing project, but they did not respond, is it acceptable to use their stored sample in the project…….….….….….….….……

Data analysis

Response frequencies were calculated for all demographic variables and the four items pertaining to WGS research. Chi-square and Fisher's exact tests were used to compare differences across demographic and other variables. Kruskal-Wallis tests were used to compare means.

Results

Of the 1200 biobank participants invited to participate in this study, 687 returned completed surveys (response rate = 57%). Participants were predominantly white, 51 years of age or older, and with at least some postsecondary education (Table 2). The vast majority of these biobank participants (96.8%) were supportive of scientists using WGS to study stored biospecimens in the Mayo Clinic Biobank. In addition, 97.7% of respondents indicated that they would agree to allow their personal sample to be used in a WGS study if asked. Fewer non-white participants endorsed the use of WGS technology on stored biobank samples compared to white participants (89.3% vs. 97.2%; p < 0.0198), and fewer non-white participants would allow researchers to apply WGS to their personal samples if asked (89.3% vs. 98.0%; p < 0.0021). In addition, respondents who indicated that they would not authorize their personal sample being used in WGS research were, on average, younger than those who would allow such use (46.9 years vs. 55.3 years; p < 0.0465).

Table 2.

Demographic Characteristics of 687 Survey Respondents Drawn from the Mayo Clinic Biobank

	N (%)
Age
18–30	68 (9.9)
31–40	94 (13.7)
41–50	101 (14.7)
51–60	136 (19.9)
61–70	149 (21.8)
70+	137 (20.0)
Sex
Female	359 (52.3)
Male	328 (47.7)
Education
HS or Less	304 (44.3)
Some college	147 (21.4)
BA or advanced degree	236 (34.4)
Race
White	658 (95.8)
Other	29 (4.2)
Marital status
Married	484 (70.9)
Living with someone as if married	37 (5.4)
Separated	6 (0.9)
Divorced	35 (5.1)
Widowed	22 (3.2)
Never married	76 (11.1)
Unknown	25 (3.4)
	Mean (SD)
Years enrolled in the Biobank	2.6 (1.1)
Age (Years)	55 (17.1)

When asked if researchers should recontact biobank participants and seek their permission before conducting WGS research on stored biospecimens, most biobank participants (61.4%) indicated that they would want to be recontacted and given the opportunity to approve or disapprove the use of their personal sample for this purpose (Table 3). Nonetheless, nearly all of the individuals who wanted to be recontacted (97.0%), indicated that they would consent to the application of WGS to their personal sample. Participants' level of education was associated with a preference for reconsent, with more educated biobank participants expressing lower levels of interest in being recontacted before their personal sample being used for WGS research (p < 0.0227).

Table 3.

Biobank Participants' Interest in Being Recontacted to Authorize Whole Genome Sequencing Research Involving Their Personal Biospecimen

	Reconsent necessary (N = 405)	Reconsent not necessary (N = 255)	p value
Age			0.1738¹
Mean (SD)	55.7 (17.4)	54.0 (16.2)
Sex			0.3313²
Female	219 (63.1%)	128 (36.9%)
Male	186 (59.4%)	127 (40.6%)
Education			0.0227²
HS or less	188 (66.2%)	96 (33.8%)
Some college	90 (62.9%)	53 (37.1%)
BA or advanced degree	127 (54.4%)	106 (45.5%)
Race			0.7456²
Other	18 (64.3%)	10 (35.7%)
White	387 (61.2%)	245 (38.8%)
Time in biobank (months)			0.4253¹
Mean (SD)	31.5 (13.1)	30.5 (13.7)

Kruskal–Wallis.

Chi-Square.

Despite strong support for WGS research, 46.8% of study participants did not approve of researchers proceeding with WGS research if efforts to recontact biobank participants and obtain their permission were unsuccessful (Table 4). More educated respondents were less supportive of researchers proceeding with WGS research in situations where efforts to recontact sample donors were unsuccessful (p < 0.0335). Respondents who did not support proceeding with WGS research if attempts at recontact were unsuccessful were also younger than those who would endorse proceeding with the sequencing in the absence of explicit authorization from the sample donor (53.6 years vs. 56.5 years; p < 0.0311).

Table 4.

Biobank Participants' Views on the Acceptability of Proceeding with Whole Genome Sequencing Research When Efforts to Recontact Sample Donors Are Unsuccessful

	Acceptable (N = 353)	Unacceptable (N = 310)	p value
Age			0.0311¹
Mean (SD)	56.5 (17.4)	53.6 (16.4)
Sex			0.0654²
Female	174 (49.9%)	175 (50.1%)
Male	179 (57.0%)	135 (43.0%)
Education			0.0335²
HS or Less	166 (58.2%)	119 (41.8%)
Some college	78 (53.8%)	67 (46.2%)
BA or advanced degree	109 (46.8%)	124 (53.2%)
Race			0.6726²
Other	16 (57.1%)	12 (42.9%)
White	337 (53.1%)	298 (46.9%)
Time in biobank (months)			0.4802¹
Mean (SD)	30.7 (13.4)	31.5 (13.3)

Kruskal–Wallis.

Chi-Square.

Discussion

The rapid pace of biomedical research can result in new technologies being applied to stored biospecimens in DNA biobanks. Our study sought to clarify the extent to which biobank participants are comfortable with their personal samples being used by researchers in ways that would have been difficult to anticipate or describe in detail at the time those biological materials were originally collected and informed consent was provided by sample donors.

Our results highlight a potential discrepancy between the broad consent provided by sample donors at the time biospecimens were collected and their preferences for recontact and reconsent to specific research applications. Despite having previously authorized a broad array of future research uses of their biospecimens, including future genetic analyses, a majority of our respondents (61.4%) wanted researchers to recontact them and obtain their permission before conducting WGS research with their personal sample. This potential inconsistency with the permissions that participants granted at the time of sample collection is even more striking, given that the overwhelming majority of our respondents supported WGS research in general (96.8%) and indicated that they would grant researchers permission to apply WGS to their personal sample if they were asked (97.7%). Importantly, this apparent inconsistency might not be a true inconsistency, but may reflect participant misunderstandings—either at the time they enrolled in the biobank or when they completed the survey. Or, some participants may have been open to notification about instances of sample use subsequent to biobank enrollment, but there was no opportunity to express this preference at the time they enrolled. While our data neither allow us to assess the extent to which this potential discrepancy may reflect a substantive change in participants' preferences over time nor indicate misunderstandings about the scope of the permissions provided at the time consent was initially obtained, the possibility of inconsistency between prior and current preferences concerning the use of stored biospecimens has implications for the stewardship of stored biological samples.

One interpretation of this apparent discrepancy is that many participants would simply like to know more about how their personal samples are being used and are interested in being recontacted as a way of learning more. From this perspective, participants' interest in recontact may stem from their curiosity about how donated materials are serving the common good rather than an interest in controlling how their personal biospecimens are used by researchers. Prior studies have found that many biobank participants are interested in learning more about how their DNA will be used in research.^12,15,20,21 For example, De Vries et al. found that many biobank participants are interested in learning more about the use of their samples, even when those uses may not pose any personal risk or have any direct implication for their medical care.²² This curiosity may explain a part of the motivation for wanting to be recontacted about unexpected research applications of stored biospecimens.

This interpretation is consistent with our finding that biobank participants' interest in being recontacted regarding WGS research was not tied to an intent to opt out of such studies. Of the 61% of participants who wanted to be recontacted and given an opportunity to reconsent before WGS of their samples, 97% indicated that they would allow their sample to be used, if they were asked. In addition to possibly desiring some degree of control over the use of their biospecimens or being simply curious about how their samples are helping to advance biomedical research, these individuals may also see the act of recontact as a form of recognition for their donation to the biobank.

Our data also suggest that education may explain some of the differences we observed with respect to participants' interest in recontact. Participants who did not feel that recontact was needed were generally more educated. These individuals may have had a better understanding of the scope of the permissions they granted at the time they enrolled in the biobank or may have appreciated the similarities between WGS research and other types of biomedical research more fully. However, we also found that participants with higher education levels did not feel comfortable moving forward with WGS research if efforts to recontact sample donors were unsuccessful. While these findings may appear to be in tension, they arguably point to the complex and multifaceted views held by biobank participants. For example, some participants may have felt that the scope of their original consent included studies involving WGS. Many of these same participants may have felt that, while reconsent is not required, an investigator who elects to seek additional authorizations, but is unable to recontact the sample donor has now created an obligation to obtain explicit consent before proceeding with the research. Future research should seek to assess the ways that biobank participants weigh these and other considerations related to the scope of their initial consent and view various circumstances that might establish a need for researchers to seek additional permissions regarding the use of stored biological materials.

Some commentators have suggested a modified form of broad consent in which the initial research authorizations include a description of circumstances that would prompt the biobank to recontact participants to clarify their preferences regarding sample usage.²³ A variant of this approach is to establish regular time intervals for revisiting the scope of biobank participants' preferences regarding sample use. Sample donors might be recontacted every 5 years, for example, to confirm their willingness to allow biospecimens to continue to be used for research. Alternatively, biobank oversight committees or community advisory boards could be created and consulted when a need arises to clarify whether a technological advance or unanticipated study design should be viewed as a substantive departure from the types of research applications envisioned at the time biospecimens were collected.^1,24 Although each of these strategies has its limitations, our data highlight the possibility that oversight mechanisms and sample-use policies capable of managing discrepancies between the initial permissions granted by sample donors and their future preferences regarding sample use may be appropriate. Future studies should seek to identify the extent to which discrepancies like the one we observed are present in other biobank populations and whether those potential discrepancies could be minimized through innovative governance or policy solutions.

Finally, our results raise numerous practical questions that require further consideration. How can biobanks balance the practical demands and burdens of recontact and reconsent against the costs of sustaining large DNA collections? What types of research studies might prompt a need to renew sample donors' prior research authorizations? What other communication strategies might meet biobank participants' expectations about being informed about the uses of their biospecimens? Future research should examine these and other questions to assess biobank participants' views regarding other types of research studies that sample donors may view as sufficiently different from the types of studies described during their initial consent process to warrant recontact and confirmation of their permission to proceed.

Limitations

A limitation of our study is the homogenous sample, which was predominantly white, was well educated, and included a large proportion of individuals older than 50. In addition, our sample was from a single health system. A more diverse sample of biobank participants from a range of institutions might have generated a different set of preferences with respect to recontact and reconsent for WGS research. In addition, respondents may not have fully understood some of the more technical terms used in our survey items, which were not evaluated with cognitive testing before fielding the survey. We were not able to assess which participants viewed the online video explaining WGS. It is possible that the video could have clarified concepts for some individuals and created expectations for others (for example, an expectation that WGS would include clinical follow-up). Another potential limitation of this study is that the very act of soliciting biobank participant preferences regarding recontact and permission for future studies—and doing so in the context of a survey that also inquired about potential concerns for privacy and confidentiality—may have introduced an element of bias. We were not able to explore the extent to which these concerns were associated with participants' responses to the questions we report in this study. We also were not able to measure the intensity or stability of participants' opinions over time. Future research should examine these views in greater detail and seek to assess the diversity of opinions that may exist regarding the importance of seeking additional research authorizations in circumstances that may not have been fully described during the initial consent process.

Other limitations stem from our inability to assess the extent to which participants fully appreciated the nature of WGS research and its potential relationship to other types of genetics research described in their initial biobank consent form. We focused narrowly on WGS research and did not explore attitudes about other types of genetic evaluation. Although WGS was explained in the study questionnaire and a link to an online video was provided, we were not able to assess participants' understanding of these materials. In addition, participants were not asked to consider other types of biomedical research that did not involve the application of WGS. Consequently, we cannot assess the extent to which biobank participants view WGS sequencing as unique or whether these same participants would have expressed a preference for recontact for other research studies as well. We were also unable to assess the reasons participants preferred recontact and reconsent.

Conclusion

Our data provide important insights into the possibility that biobank participants' views regarding future research uses of their personal samples may not align with the scope of research uses that were authorized at the time they provided consent and donated biological materials to a DNA biobank. Despite having initially authorized a broad array of future research uses, and being generally very supportive of biomedical research, many biobank participants expressed an interest in being recontacted about the application of WGS to their biospecimens. These results suggest that biobank directors cannot assume that the broad research authorizations provided by sample donors at the time of their initial consent is unlikely to change over time and includes all future biomedical research uses of stored biospecimens. Although most biobank participants appear to endorse some form of broad consent, it remains unclear how best to manage research applications that were not discussed or may not have been imaginable at the time biospecimens were collected.

Footnotes

Acknowledgments

The authors wish to thank the patients who volunteered to participate in this study and shared their views about biomedical research. This study was funded by the Mayo Clinic Center for Individualized Medicine. The authors have no additional financial relationships to disclose.

Author Disclosure Statement

No conflicting financial interests exist.

References

Dixon-Woods

, Kocman

, Brewster

, et al. A qualitative study of participants' views on re-consent in a longitudinal biobank. BMC Med Ethics, 2017; 18:22.

Garrison

, Sathe

, Antommaria

, et al. A systematic literature review of individuals' perspectives on broad consent and data sharing in the United States. Genet Med, 2016; 18:663–671.

Brothers

KB.

Informed consent in the era of biobanks. Genome Med, 2013; 5:4.

Platt

, Platt

, Thiel

, et al. ‘Cool! and creepy’: Engaging with college student stakeholders in Michigan's biobank. J Commun Genet, 2014; 5:349–362.

Hansson

, Dillner

, Bartram

, et al. Should donors be allowed to give broad consent to future biobank research?. Lancet Oncol, 2006; 7:266–269.

Kaye

, Whitley

, Lund

, et al. Dynamic consent: A patient interface for twenty-first century research networks. Eur J Hum Genet, 2015; 23:141–146.

Steinsbekk

, Kare Myskja

, Solberg

. Broad consent versus dynamic consent in biobank research: Is passive participation an ethical problem?. Eur J Hum Genet, 2013; 21:897–902.

Valle-Mansilla

, Ruiz-Canela

, Sulmasy

. Patients' attitudes to informed consent for genomic research with donated samples. Cancer Invest, 2010; 28:726–734.

Vermeulen

, Schmidt

, Aaronson

, et al. Obtaining ‘fresh’ consent for genetic research with biological samples archived 10 years ago. Eur J Cancer (Oxford, England: 1990), 2009; 45:1168–1174.

10.

Warner

, Weil

, Andry

, et al. Broad Consent for Research on Biospecimens: The Views of Actual Donors at Four U.S. Medical Centers. J Empir Res Hum Res Ethics, 2018; 13:115–124.

11.

Master

, Campo-Engelstein

, Caulfield

. Scientists' perspectives on consent in the context of biobanking research. Eur J Hum Genet, 2015; 23:569–574.

12.

Master

, Claudio

, Rachul

, et al. Cancer patient perceptions on the ethical and legal issues related to biobanking. BMC Med Genomics, 2013; 6:8.

13.

Simon

, L'Heureux

, Murray

, et al. Active choice but not too active: Public perspectives on biobank consent models. Genet Med, 2011; 13:821–831.

14.

Caulfield

, Rachul

, Nelson

. Biobanking, consent, and control: A survey of Albertans on key research ethics issues. Biopreserv Biobank, 2012; 10:433–438.

15.

Joly

, Dalpe

, So

, et al. Fair Shares and Sharing Fairly: A Survey of Public Views on Open Science, Informed Consent and Participatory Research in Biobanking. PLoS One, 2015; 10:e0129893.

16.

Ludman

, Fullerton

, Spangler

, et al. Glad you asked: Participants' opinions of re-consent for dbGap data submission. J Empir Res Hum Res Ethics, 2010; 5:9–16.

17.

De Souza

, Greenspan

. Biobanking past, present and future: Responsibilities and benefits. AIDS (London, England), 2013; 27:303–312.

18.

Olson

, Ryu

, Johnson

, et al. The Mayo Clinic Biobank: A building block for individualized medicine. Mayo Clin Proc, 2013; 88:952–962.

19.

Icahn School of Medicine. Whole Genome Sequencing and You. 2012; www.youtube.com/watch?v=IXamRS85hXU. Accessed September 21, 2018.

20.

Hull

, Sharp

, Botkin

, et al. Patients' views on identifiability of samples and informed consent for genetic research. Am J Bioeth, 2008; 8:62–70.

21.

Kaphingst

, Janoff

, Harris

, et al. Views of female breast cancer patients who donated biologic samples regarding storage and use of samples for genetic research. Clin Genet, 2006; 69:393–398.

22.

De Vries

, Tomlinson

, Kim

, et al. The moral concerns of biobank donors: The effect of non-welfare interests on willingness to donate. Life Sci Soc Policy, 2016; 12:3.

23.

Annas

GJ.

Privacy rules for DNA databanks. Protecting coded ‘future diaries’. JAMA, 1993; 270:2346–2350.

24.

Kaye

From single biobanks to international networks: Developing e-governance. Hum Genet, 2011; 130:377–382.