Logo of amjphAmerican Journal of Public Health Web SiteAmerican Public Health Association Web SiteSubmissionsSubscriptionsAbout Us
Am J Public Health. 2009 December; 99(12): 2128–2134.
PMCID: PMC2775766

Public Perspectives on Informed Consent for Biobanking

Juli Murphy, MS,corresponding author Joan Scott, MS, CGC, David Kaufman, PhD, Gail Geller, MHS, ScD, Lisa LeRoy, PhD, MBA, and Kathy Hudson, PhD


The National Institutes of Health and other federal health agencies are considering establishing a national biobank to study the roles of genes and environment in health.

We assessed the public's attitudes toward the proposed biobank, including preferences for providing informed consent. Sixteen focus groups were conducted, and themes arising from the focus groups were tested in a large, representative survey (n = 4659) of the general population.

Our research demonstrates that when considering participating in a genomic biobank, individuals want ongoing choices and control over access to their samples and information.

INFORMED CONSENT IS THE cornerstone of ethical conduct in human subjects research.15 This concept is highlighted in a 2001 report of the National Bioethics Advisory Commission, according to which engaging in the consent process is “one of the best ways researchers can demonstrate their concern and respect for those who enroll in a study.”1 The emergence of biobanks, large collections of biological samples to be used for research purposes, has challenged traditional notions of how to protect and respect those who provide samples and information. Biobanks compile heath, environment, and lifestyle information and collect biological specimens from large numbers of individuals, who are often followed for long periods of time.

Biobanks can support an unlimited number of future research studies and provide the vast amount of annotated data necessary to tease apart important contributors to complex diseases. However, the open and evolving nature of genomic biobanks calls into question whether individuals who provide samples and information to a biobank can give truly “informed” consent to participate in a study.6

Guidelines for the protection of human research subjects are based on the assumption that individuals are participating in a discrete project designed to answer specific questions and not the creation of a tool for an unlimited number of future studies on yet-to-be-determined topics.6 Unlike clinical research, in which the risks primarily involve physical harm, the risks in biobank research are principally those that may follow from a loss of privacy.7

Many biobanks ask participants to provide broad or “blanket” consent at enrollment.811 This approach has been adopted because requesting consent each time a research project seeks to obtain access to samples or information from a biobank poses financial and logistical barriers to researchers and may be overly burdensome to participants. According to the World Health Organization, “blanket informed consent … is the most efficient and economical approach, avoiding costly re-contact before each new research project.”4 The UK Human Genetics commission argues that “the difficulties involved in tracing and securing re-consent for different forms of medical research would be … impractical and would seriously limit the usefulness of large scale population databases.”12

Until 2004, the United States considered coded samples—those in which a code links the sample to a donor—as identifiable because a key must exist linking the code to the donor's sample and information. In research projects involving identifiable information, reconsent would be required before any additional research involving coded samples could be performed.13 However, in 2004, the US Office for Human Research Protections expanded the definition of nonidentifiable samples to include cases in which a code exists linking the sample to the donor but the link to the code is not available to the investigator using the sample.5,13 Under this new definition, research involving coded samples does not meet the definition of human subjects research under the Common Rule (Federal Policy for the Protection of Human Subjects), and informed consent is not required.

However, not all human subjects research requires informed consent. The Common Rule allows institutional review boards to waive the requirement to obtain informed consent if (1) the research involves no more than minimal risk to the participants, (2) the waiver or alteration will not adversely affect the rights and welfare of the participants, (3) the research could not practicably be carried out without the waiver or alteration, and (4) the participants are provided, when appropriate, with additional pertinent information after participation.1315 Researchers who wish to use previously collected specimens may argue that the process of obtaining informed consent from the original donors cannot be practicably carried out.

Currently, many large US population biobanks request broad consent for unlimited future research studies as a condition of enrollment.911 Other biobanks do not seek individual consent to participate according to the view that use of deidentified information does not constitute human subjects research. In these cases, consent to participate in the biobank and to authorize unlimited future research studies is presumed unless the individual specifically opts out of the program.10,16

There is a paucity of literature describing public opinion on the type of consent that should be offered to individuals participating in genomic biobanks. In a qualitative interview study of 40 individuals presented with a broad consent template for the Duke Biorepository, 85% of the respondents reported that they would, if asked, allow their blood and information to be stored indefinitely for use in future research.17 In a 2004 survey of potential tissue donors in Sweden, 48% of donors indicated that being asked for consent for each research project involving collected biobank material would make them feel “respected and involved.” In contrast, 28% believed that such a process would be “a waste of money” or that it would make them feel “worried.”18 These limited data demonstrate that there is a wide range of opinions about the type of consent that should be offered to biobank participants.

We explored the attitudes of US residents toward the creation of a national genomic biobank proposed by the National Institutes of Health and other federal health agencies, including their preferences regarding informed consent to participate in the biobank.1922 The proposed National Institutes of Health large-cohort study assessing the feasibility of the biobank would recruit 500 000 individuals representative of the US population.

Participants in that study would undergo a baseline health examination, donate samples for laboratory testing, and grant researchers access to their medical records. Participants could be asked to monitor their diet, physical activity, and environmental exposures. Data and samples would be coded, and a link to participants would be retained to allow follow-up of health outcomes. Coded study data would be made available to the broader scientific community for analyses of gene–environment interactions.


We used qualitative as well as quantitative methods to assess the public's attitudes toward the development and implementation of the proposed study. Sixteen focus groups were conducted, and themes arising from the focus groups were tested in a large, representative survey of the general population.

Focus Groups

In January 2007, we received approval from the institutional review boards of both Johns Hopkins University and Abt Associates to conduct 16 focus groups (including a pilot) in 6 locations across the United States. A moderator guide and a short video description of the proposed National Institutes of Health large-cohort study were developed for the focus groups.23 After the video, focus group participants were asked questions on a wide array of related topics, including their preferences about the type of consent that should be offered at enrollment. They were also asked whether broad permission for unlimited studies should be sought or whether they believed biobank participants would want to be asked to consent each time a new study involving their samples and information was proposed.

After a pilot focus group meeting in January 2007 and minor modifications to the moderator guide, 15 focus groups were conducted in March, April, and May 2007, at 5 sites selected to achieve regional representation: Philadelphia and Middletown, Pennsylvania; Phoenix, Arizona; Kansas City, Missouri; Jackson, Mississippi; and Portland, Oregon. Focus group members were recruited to represent a diverse range in terms of demographic characteristics such as age, educational level, race, ethnicity, gender, and socioeconomic status (Table 1). In addition, one group's members had a prevalent health risk behavior (smoking), and another group's members had been subject to a known environmental exposure (these individuals had resided for a long period near the Three Mile Island nuclear power plant in Middletown, Pennsylvania).

Characteristics of Focus Group Participants: 6 US Locations, 2007

With the exception of the Three Mile Island group, local focus group vendors in each city recruited 12 participants for each group, with a goal of seating 8 to 10 per group. Recruits were sent a reminder letter and telephoned the day before the group meeting. In the case of the Three Mile Island group, a snowball sampling technique was used in which names of potential participants were gathered from recruited focus group participants who had lived in the area during the Three Mile Island accident.24

Each focus group was made up of individuals who were homogeneous with respect to the characteristics shown in Table 1. Focus group members signed a consent form, provided demographic information, and received a $75 cash incentive. Each focus group was 2 hours in duration.

Each group was audio recorded, and the transcripts were read into the NVivo software package.25 NVivo was used to assign primary text codes corresponding to the organizational section headings of the focus group guide. Three project investigators independently generated a list of secondary codes based on 3 transcripts. Three additional investigators then applied the secondary codes to a fourth transcript and compared their coding decisions, developing rules to make the coding more consistent. All 16 transcripts (including the pilot transcript) were coded with the secondary codes in an NVivo database. Text related to consent was analyzed for common themes. Findings on consent preferences are summarized here, with direct quotations to illustrate focus group members' opinions. Detailed methods for the focus groups have been described previously.24,26


On the basis of the focus group findings, a 177-item online survey was drafted to collect data on public opinions regarding the proposed cohort study. A large pilot survey was fielded to evaluate survey length, skip patterns, and wording.

Sample selection for and online administration of the main survey were managed by the survey firm Knowledge Networks.27 A total of 8735 potential participants aged 18 years or older were randomly sampled from Knowledge Networks' Web-enabled master panel of US residents; non-Hispanic Blacks, Hispanics, and people living outside of metropolitan statistical areas were oversampled. The main survey was conducted online between December 14, 2007, and January 31, 2008. Potential participants were e-mailed an invitation to participate and were sent up to 3 e-mail reminders. After survey data had been collected, prebanked information previously collected by Knowledge Networks on panel members' demographic and background characteristics was added to the data set. A detailed description of the survey methods has been published elsewhere.28

SPSS software was used in recoding the survey data for analysis.29 Support for the study and willingness to participate were measured via 4-point Likert scales; 2 binary variables were created for analysis from these scales. The SUDAAN software package was used in analyzing data, allowing correction for the survey sampling scheme in judgments of hypothesis test results.30

We used multiple logistic regression to examine demographic factors associated with support and participation and to assess associations between the study design factors and willingness to participate after adjustment for demographic characteristics. All descriptive analyses and cross tabs that included the entire sample were weighted to US census demographic benchmarks. In analyses conducted within or between different racial and ethnic groups or groups of urban and rural participants, the alternate weights calculated for oversampled groups were used.


Focus group members expressed a range of preferences regarding type of consent: broad or blanket consent at the beginning of the study, categorical or menu-based consent, and consent for each research project in which biobank samples and information would be used (see the box on this page). Several focus group members supported giving broad consent to use their samples and information for any research involving the proposed biobank. They reported that this no-strings-attached approach might ultimately help more people by giving researchers both unlimited access to samples and information and the flexibility to address new research questions that develop in the future.

Focus Group Participants' Consent Preferences and Comments: 6 US Locations, 2007

Broad/blanket consent
 • If I agree to do the study, I'm going to agree to just give my information and be done with it—however you want to use it. (Middle-SES White man, Phoenix, AZ)
 • If you are going to participate, you have to be willing to let the system do whatever it wants to do with the data. (Male pilot focus group participant, Hagerstown, MD)
 • I don't want to be contacted each time because there's going to be millions and millions of people wanting my DNA. (Lower-SES White woman, Kansas City, MO)
Menu/categorical consent
 • To call me every single time a researcher wants to do a study—I would rather have a list of things I don't want to be involved with. (African American woman, Philadelphia, PA)
 • You could make a list and I could just check them off. (Asian man, Portland, OR)
Study-specific/narrow consent
 • It would be nice knowing every time someone is going to get your permission. (Asian man, Portland, OR)
 • I would rather sign a piece of paper than you just take it upon yourself to do whatever. (Female smoker, Jackson, MS)

Some focus group members saw broad consent as a reasonable condition of enrollment. Supporters of this type of consent believed that if individuals started picking and choosing the types of research they would consent to, it would undermine the power of the study and “there would be no point” in doing the study. Broad consent also appealed to some focus group members because it would be a simpler and less costly process that would allow more studies to be done.

Drawbacks to granting broad consent were also noted. One focus group member was concerned that there would be no way for participants to “really know what you're involved with.” Another was uncomfortable with “the idea that they are doing research on something I might find objectionable.”

Many focus group members supported a consent model that provided options regarding the types of research in which an individual's information could or could not be used. Many suggested that the consent provide a “menu” of possible diseases or research topics, and participants could select the types of research for which their samples and data could be used (e.g., “Make a list and I [can] just check them off.”). Supporters of this approach believed that they would have much more knowledge of and control over the research studies in which they were participating.

Some supporters of menu consent noted that it would allow participants to place specific limitations on research involving their samples and information. According to one focus group member, “a hit list of things [I] don't want to be involved with” could be drawn up. Menu consent supporters believed that researchers would benefit from wide access to samples and information, and participants would be reassured that their samples and information would not be used in studies that violated their religious or moral beliefs.

One of the reported pitfalls of menu consent was that it would limit the samples and information available for research, particularly in areas that are controversial (e.g., mental health and behavior issues). Some worried that if the consent included limitations, it might preclude research on topics subsequently found to be critically important.

Some respondents wanted to be asked for their consent each time a study making use of their samples and information was proposed. This model would allow them to maintain control over how their samples were used rather than, in the words of one focus group member, researchers “tak[ing] it upon [themselves] to do whatever.” Some reported that having the opportunity to consent to each study would allow participants' views on acceptable and unacceptable types of research to change over the course of their participation.

Advocates of study-specific consent noted that this type of consent would prohibit researchers from abusing study resources and from using participants' samples in studies that violated their moral or religious beliefs. Furthermore, proponents of this approach indicated that it would make participants feel respected and involved in the study. According to one such proponent, “It would be nice knowing every time that someone was going to get my permission.” Others noted that, by consenting to each research study, participants would be able to keep abreast of the study's progress.

The primary drawback voiced about providing consent for each study was the enormous burden on participants of having to interact with study staff each time a new study came up. One of the focus group members noted that it would be a “nuisance every day,” and another noted that it would be “too time consuming.” Furthermore, opponents of this approach stated that the logistical and financial burden of obtaining consent for each study, combined with the risk that large numbers of biobank participants may not provide consent for a given study, could threaten the overall effectiveness of the biobank.

Many focus group members suggested providing cohort study participants a choice between the different types of consent at enrollment. Focus group participants expressed their own personal views about consent while also recognizing the spectrum of individual preferences, and they suggested that participants be given a choice of broad or study-specific consent at the beginning of the study. For example, according to one participant, “Why not offer both? Because I know it would annoy me, but maybe someone else would want to know that.” Some focus group members suggested that participants should be able to “set their preferences” for the use of their samples and information.

Survey participants were also divided with respect to their preferences. Forty-eight percent reported that they would prefer to give blanket consent at the beginning of the study, whereas 42% favored being asked at the initiation of each research project. Only 10% favored categorical or menu consent.

When survey participants were asked about their views toward project-specific consent, a majority indicated that this method of consent would lead them to feel they have control, to have more trust in the study, and to feel respected and involved (Figure 1). Approximately 25% believed that project-specific consent would be a waste of time and money (27%) or that it would make them feel bothered (26%).

Focus group participants' opinions about providing study-specific consent.

White respondents (51%) were significantly more likely than Black respondents (38%) or Hispanics (40%) to favor blanket consent (P < .05). Conversely, 81% of Blacks and Hispanics and 73% of Whites indicated that they would have more trust in a study if they were asked to provide consent for each individual research project.

With respect to study participation, the term “contract” arose repeatedly and spontaneously among focus group participants in every city. Focus group members viewed a contract as a binding agreement between participants and researchers and did not view it simply as participants' agreement to participate. According to one of the focus group members, “Researchers would have to sign it [the contract] too.” In the words of another, the “signed contract … would detail what will be researched, what will be studied, and what participants have the right to.”

Some focus group members believed that a contract would help make the study trustworthy or ethical. Reviewing the contract would allow participants to represent their own interests; some focus group respondents mentioned that they might like to show it to a lawyer before signing. Focus group members thought that a contract might offer participants greater protection than an institutional review board or study oversight committee and provide participants with some level of recourse if researchers strayed from the agreed-upon terms. In the words of one respondent, “If they break the contract and you find out about it, that is a lawsuit.”

Focus group members identified elements that they believed should be outlined in the contract between researchers and participants, including specifics on what samples would be collected, how samples would and would not be used during the study, who would and would not have access to the study data, what would happen to the samples and data if and when the study closed, and what would happen if there were a breach in the contract. In addition, focus group members wanted the contract to state whether and how research findings would be returned and to include statements detailing how privacy and confidentiality would be maintained. Some noted that a contract might motivate study personnel to be vigilant about ensuring participant confidentiality, given that failure to do so, in the words of one respondent, “would be putting at risk a career.”

Despite support for contracts across all focus groups, some members questioned whether a contract would actually be enforced or violators punished. It was also noted that participants might change their minds and want to modify the terms of the contract, for example, if a relative developed cancer.

A large majority of the survey respondents (94%) indicated that if they participated in a study, a “contract signed by researchers and participants” would be very important or somewhat important. Similarly, nearly all of the respondents (94%) believed that there should be “consequences for researchers who violate my research agreement.”


Our research demonstrates that when considering participating in a genomic biobank, individuals want ongoing choices and control over access to their samples and information. Focus group participants recognized the wide spectrum of preferences about the nature and scope of the consent that could be offered and advocated giving potential biobank participants a choice of broad or limited consent at enrollment. Differing opinions regarding consent options were also seen among survey respondents. When asked to choose between broad, menu, or study-specific consent, respondents were split between those wanting to provide broad consent and those wanting to give consent for each study involving the biobank samples and data.

Understanding the impossibility of predicting the overall extent to which biobank samples and information would be used in future research, focus group participants wanted to set their preferences and described methods, mainly Internet based, for how this aim could be achieved. Obtaining consent for secondary research with stored samples and, more recently, for research involving genomic biobanks has been viewed as impractical largely because of the costs involved. However, recent technological advancements may enable participants to exert this type of control affordably.31 Further research would be useful as a means of determining to what extent, if any, describing biobank collections as a public good in trust for public benefit might influence participants' willingness to accept a broad consent model.

The repeated use of the term “contract” by focus group participants in each city and the overwhelming desire for a contract demonstrated by the survey data suggest that the public believes that there are or should be reciprocal obligations between researcher and participant. The desire for a contract not only underscores the demand for an individualized research agreement but also may reflect a lack of trust in the research enterprise. For example, focus group respondents mentioned fears of being used as “guinea pigs” and of research abuses such as those that occurred in the Tuskegee Syphilis Study.

Furthermore, the framing of research agreements as contracts in the focus groups and the strong support for contracts identified in the survey suggest several additional research questions. For instance, it would be useful to understand what aspects of a contract (e.g., mutual responsibility of researcher and participant, obligation to spell out exactly what the study will involve, opportunity for recourse) would be most important to potential participants, whether contracts differ from traditional informed consent models, and whether individuals' willingness to participate in a study would increase with the inclusion of contract language.

The traditional view of the relationship between researcher and participant established 40 years ago may address issues that are not a part of biobank research, such as risk of physical harm, while failing to address issues novel to biobanking. Given that the success of biobanks depends on the commitment and involvement of the public, it is crucial to engage the public in finding solutions to the ethical challenges posed by biobank research.


This project was supported by the National Human Genome Research Institute (grant UG1HGH004206).

We gratefully acknowledge the contributions of Rick Borchelt and Shawna Williams of the Genetics and Public Policy Center, Johns Hopkins University. BakedMedia Inc. of Owings, MD, developed audiovisual materials for the focus group participants, and Knowledge Networks of Menlo Park, CA, programmed and fielded the survey. We also thank the focus group participants and the citizen advisory panelists, as well as Sandy Hoffman of the George W. Comstock Center for Public Health Research and Prevention in Hagerstown, MD.

Note. The content of this article is solely the responsibility of the authors and does not necessarily represent the views of the National Human Genome Research Institute or the National Institutes of Health.

Human Participant Protection

This study satisfied all criteria for the ethical treatment of human participants. Focus group research was approved by the institutional review boards of both Johns Hopkins University and Abt Associates. Survey research was approved by the Johns Hopkins University institutional review board. All focus group participants provided written informed consent.


1. National Bioethics Advisory Commission Research involving human biological materials: Ethical issues and policy guidance. Available at: http://www.bioethics.gov/reports/past_commissions/nbac_human_part.pdf. Accessed June 29, 2009
2. Berg JW, Appelbaum PS, Lidz CW, Parker LS. Informed Consent: Legal Theory and Clinical Practice 2nd ed New York, NY: Oxford University Press; 2001
3. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Belmont report: ethical principles and guidelines for the protection of human subjects of research. Available at: http://ohsr.od.nih.gov/guidelines/belmont.html. Accessed June 29, 2009
4. World Health Organization Proposed international guidelines on ethical issues in medical genetics and genetic services. Available at: http://www.who.int/genomics/publications/en/index1.html. Accessed June 29, 2009 [PubMed]
5. 45 CFR §46.116(a) (1991)
6. Greely HT. The uneasy ethical and legal underpinnings of large-scale genomic biobanks. Annu Rev Genomics Hum Genet 2007;8:343–364 [PubMed]
7. Ursin LO. Biobank research and the right to privacy. Theor Med Bioeth 2008;29:267–285 [PubMed]
8. UK Biobank Web site. Available at: http://www.ukbiobank.ac.uk. Accessed June 29, 2009
9. Northwestern University NUgene Project Web site. Available at: www.nugene.org. Accessed June 29, 2009
10. Frequently asked questions Center for Applied Genomics Web site. Available at: www.chop.edu/consumer/jsp/division/generic.jsp?id=84933. Accessed June 29, 2009
11. Kaiser Permanente Division of Research Research program on genes, environment, and health. Available at: http://www.dor.kaiser.org/external/Home_Default.aspx. Accessed June 29, 2009
12. UK Human Genetics Commission Inside information: balancing interests in the use of personal genetic data. Available at: http://www.hgc.gov.uk/client/document.asp?DocId=19. Accessed June 29, 2009
13. Elger BS, Caplan AL. Consent and anonymization in research involving biobanks: differing terms and norms present serious barriers to an international framework. EMBO Rep 2006;7:661–666 [PMC free article] [PubMed]
14. 45 CFR §46.102(f) (1991)
15. 45 CFR §46.116(c)(2) (1991)
16. Pulley JM, Brace MM, Bernard GR, Masys DR. Attitudes and perceptions of patients towards methods of establishing a DNA biobank. Cell Tissue Bank 2008;9:55–65 [PubMed]
17. Beskow LM, Dean E. Informed consent for biorepositories: assessing prospective participants' understanding and opinions. Cancer Epidemiol Biomarkers Prev 2008;17:1440–1451 [PubMed]
18. Hoeyer K, Olofsson BO, Mjorndal T, Lynoe N. Informed consent and biobanks: a population-based study of attitudes towards tissue donation for genetic research. Scand J Public Health 2004;32:224–229 [PubMed]
19. Design Considerations for a Potential United States Population-Based Cohort to Determine the Relationships Among Genes, Environment, and Health: Recommendations of an Expert Panel Bethesda, MD: National Human Genome Research Institute; 2004
20. Collins FS. The case for a US prospective cohort study of genes and environment. Nature 2004;429:475–477 [PubMed]
21. Manolio TA, Bailey-Wilson JE, Collins FS. Genes, environment and the value of prospective cohort studies. Nat Rev Genet 2006;7:812–820 [PubMed]
22. Collins FS, Manolio TA. Merging and emerging cohorts: necessary but not sufficient. Nature 2007;445:259. [PubMed]
23. Proposed study video Genetics and Public Policy Center Web site. Available at: http://www.youtube.com/user/DNApolicy. Accessed June 29, 2009
24. Murphy J, Scott J, Kaufman D, Geller G, LeRoy L, Hudson K. Public expectations for return of results from large-cohort genetic research. Am J Bioeth 2008;8:36–43 [PMC free article] [PubMed]
25. NVivo Qualitative Data Analysis Software [computer program]. Version 7. Doncaster, Victoria, Australia: QSR International; 2006
26. Kaufman DJ, Geller G, LeRoy L, Murphy JA, Scott J, Hudson K. Ethical implications of including children in a large biobank for genetic-epidemiologic research: a qualitative study of public opinion. Am J Med Genet C Semin Med 2008;148:31–39 [PubMed]
27. Baker LC, Bundorf MK, Singer S, Wagner TH. Validity of the Survey of Health and Internet and Knowledge Network's panel and sampling. Available at: http://www.knowledgenetworks.com/ganp/docs/Appendix%20Survey%20of%20Health%20and%20the%20Internet.pdf. Accessed June 29, 2009
28. Kaufman D, Murphy J, Scott J, Hudson K. Subjects matter: a survey of public opinions about a large cohort study. Genet Med 2008;10:831–839 [PubMed]
29. SPSS [computer program]. Version 16.0. Chicago, IL: SPSS Inc; 2008
30. Research Triangle Institute. SUDAAN Version 9.0 Online Reference Manual. Available at: http://www.rti.org/sudaan/onlinehelp/flashhelp/wf_njs.htm. Accessed June 29, 2009.
31. Kohane IS, Mandl KD, Taylor PL, Holm IA, Nigrin DJ, Kunkel LM. Medicine: reestablishing the researcher-patient compact. Science 2007;316:836–837 [PubMed]

Articles from American Journal of Public Health are provided here courtesy of American Public Health Association
PubReader format: click here to try


Related citations in PubMed

See reviews...See all...

Cited by other articles in PMC

See all...


  • PubMed
    PubMed citations for these articles

Recent Activity

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

See more...