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. Author manuscript; available in PMC: 2021 Sep 1.
Published in final edited form as: Health Commun. 2019 Jun 5;35(10):1219–1228. doi: 10.1080/10410236.2019.1623644

Race, Trust in Doctors, Privacy Concerns, and Consent Preferences for Biobanks

Soo Jung Hong 1, Bettina Drake 2, Melody Goodman 3, Kimberly A Kaphingst 4,5
PMCID: PMC6893100  NIHMSID: NIHMS1530744  PMID: 31167570

Abstract

This study investigates how patients’ privacy concerns about research uses of biospecimen and trust in doctors are associated with their preferences for informed consent and need for control over biospecimens in a biobank. Particularly, this study focuses on the perspectives of Communication Privacy Management theory, precision medicine, and racial health disparities. We recruited 358 women aged 40 and older stratified by race (56% African American and 44% European American). Multivariable linear regression models examined hypothesis and research questions. Individuals’ privacy concerns and trust in doctors were significantly associated with their need for control. Although participants’ privacy concerns were positively associated with their preference for study-specific model, trust in doctors had no effect on the preference. African American participants needed more control over their sample, and were more likely to prefer study-specific model compared to European American participants. Significant interactions by race on the associations between trust and need for control and between privacy concerns and preference for study-specific model were found. These findings suggest that when developing large diverse biobanks for future studies it is important to consider privacy concerns, trust, and need for control with an understanding that there are differences in preferences by race.

Keywords: biobank, need for control, informed consent, trust in doctors, communication privacy management theory, racial disparity

The National Cancer Institute’s dictionary of cancer terms (2016) defines genomics as “the study of the complete set of DNA (including all of its genes) in a person or other organism.” The potential for genomics to contribute to clinical care has long been recognized, and many optimistic scenarios for clinical use of information about a patient’s genome have been proposed (Dulbecco, 1986; Manolio et al., 2013). According to the National Research Council (2011), the term precision medicine is used to convey a broader concept related to precisely tailoring therapies to subcategories of disease, often defined by genomics (Ashley, 2015). The recent development of large-scale biologic databases as well as computational tools and methods for analyzing the data may dramatically improve the broad application of precision medicine (Collins & Varmus, 2015). Accordingly, one major focus of recent precision medicine is the assembly of a large cohort of individuals who are willing to donate their biospecimens to a biobank (Ashley, 2015). In the recruitment process for this cohort, race is a key issue because it is important to have a diverse cohort and biobank so that the advances of precision medicine are available for all populations (National Institutes of Health, 2018).

Although biobanks provide important opportunities for researchers to advance medical science and contribute to the collective good (O’Doherty & Hawkins, 2010), patients’ donation of biospecimens and associated health data for secondary research purposes raises several ethical issues. Specifically, donors of biospecimens used in multiple biobank studies are vulnerable to disclosure of protected health information (PHI), loss of control over their biospecimens, and risk of exploitation by medical researchers (Pentz, Billet, & Wendler, 2006). Prior research has shown that the public and biobank participants have privacy concerns about sharing genetic data and commercialization of biobanks, and have a need for transparency and more information about genetic research (Lemke, Wolf, Hebert-Beirne, & Smith, 2010; Nicol, Critchley, McWhirter, & Whitton, 2016), which could influence their decisions regarding research participation. Therefore, safeguarding participants’ privacy, which is essential in the informed consent process, may affect patients’ willingness to participate in studies that collect biospecimens for the viability of precision medicine research (Bussey-Jones, et al., 2010).

Therefore, in this study, we investigate the relationships of privacy concerns, trust in doctors, preferences for informed consent, and need for control over biospecimens in a diverse sample of women from the perspectives of Communication Privacy Management theory (Petronio, 2002), precision medicine, and racial health disparities.

Literature Review

Relationships of Trust in Doctors, Privacy Concerns, and Need for Control over Biospecimens

Petronio’s (2002) Communication Privacy Management (CPM) theory attempts to explain how individuals manage private information in the context of relational process. According to CPM, individuals believe that they own their private information, and as owners they can have the right to control it (Petronio, 2002). Accordingly, individuals restrict access to their private information or share it with trusted others. These “authorized” co-owners are expected to protect the private information with the owners. Decisions regarding the regulation as well as the flow of private information are predicated on the context where protection or disclosure occurs (Petronio, 2002). Since privacy rules depend on assessments of risks and benefits, orientations toward privacy, motivation, and situational demands, patients’ trust in medical providers is essential to reveal private health information (Petronio, DiCorcia, Duggan, 2012). It is because for patients, granting access tends to include judging risks and benefits of allowing access to their private information (Petronio et al., 2012). From the perspective of CPM, patients develop a confidentiality pledge by considering several parameters, and discern ways in which they define the disclosed medical information as confidential (Petronio et al., 2012). This process helps patients judge the level of needed control that they want over their information (Petronio et al., 2012). Therefore, patients’ trust and concerns about their privacy may be important factors that predict their need for control over private health information.

According to Hall et al. (2001), trust is “a core, defining characteristic that gives the doctor-patient relationship meaning, importance, and substance” (p. 613). In the context of biomedical research, trust can take the form of personal trust between medical researchers and research participants (Kerasidou, 2017). Patients’ trust in doctors doing medical research (hereafter, trust in doctors) may play a significant role in recruiting biobank participants, and their desire or need for control over their donated biospecimens. Prior research has shown low trust in research in the public, which threatens the biomedical research enterprise by reducing willingness to participate in research (DeAngelis, 2000, Kerasidou, 2017). Indeed, prior studies have demonstrated that mistrust regarding potential outcomes of genetic research have been linked to lower rates of and less willingness to participate in a biobank (Bussey-Jones et al., 2010). Moreover, Lemke and colleagues’ (2009) study suggests that biobank participants have privacy concerns about sharing genetic research data, and thus need more transparency and control. Therefore, participants’ trust as well as their privacy concerns regarding medical research may impact their need for control over biospecimens. More specifically, participants’ mistrust and privacy concerns can increase their need for control. Therefore, participants’ trust in doctors may be inversely related to their need for control, while their privacy concerns may significantly increase their need for control.

H1–1: Trust in doctors is negatively associated with need for control over biospecimens.

H1–2: Privacy concerns about research uses of biospecimens are positively associated with need for control over biospecimens.

Factors Predicting Preferences for Study-specific Model of Consent

Informed consent is a complex procedure of information exchange between physicians and patients that occurs through both interpersonal and mediated communication (Wanzer et al., 2010). In legal terms, informed consent involves the specific guidelines and/or standards that manage health professionals’ interactions with patients. Through this means, health care providers inform their patients about the diagnosis, and several aspects concerning the proposed treatment/procedure, its purpose, possible risks/benefits, and other alternatives (Bottrell, Alpert, Fischback, & Emanuel, 2000). Ultimately, the goal of informed consent is to support and facilitate patient autonomy in making informed decisions about medical procedures (Kagarise & Sheldon, 2000). While informed consent to treatment is designed to protect patient autonomy by guaranteeing patient choice and consent based on physician disclosure and recommendation, informed consent to research is to secure research participants’ consent for activities planned to generate knowledge (Olufowote, 2011). Research participants’ informed consent is a key requirement of assembling a biobank as well (Code of Federal Regulations, 2009). What constitutes adequate informed consent in this context, however, remains to be defined. Although according to federal regulations, informed consent is required when identifiable biospecimens are collected for research purposes, the regulations provide little guidance, particularly about informed consent for research on stored samples (Mello & Wolf, 2010).

As the CPM theory (2002) suggests, private information is reflective of issues including a certain level of perceived vulnerability, such as private medical information. Medical providers receive disclosures from patients that they solicit or are told without being requested. However, to protect patient privacy, responsibility for ensuring the appropriate management of the private information is often expected, and health care professionals serve a stakeholder role as co-owners of patient information (Petronio & Sargent, 2011). In order to protect patient privacy, the Health Insurance Portability and Accountability Act (HIPAA) was implemented in 1996. According to HIPAA, to protect patient privacy, information discussed by the patient and information attained in the healthcare services should not be shared without the patient’s permission (Brann, 2006). Individuals’ biospecimens can be considered private medical information to be further investigated and clarified via the process of medical research. In addition, the process of informed consent can be understood as clinical staffs’ legal recognition that they have the rights of ownership on behalf of the patient (see Petronio, 2002). In the context of genetics and research participation, the purpose of informed consent is to empower prospective research participants by providing the information they need for an informed decision regarding whether or not to take part in a study by providing their biospecimens (Drake et al., 2016A). Via the process, individuals’ biospecimens are shared with the authorized co-owners or guardians, medical researchers, with which comes an expectation that the physician will care for the information related to their biospecimens in the way they expect based on the informed consent (see Petronio et al., 2012).

The amount of control individuals may have, as well as the expectations they have toward medical researchers, differ according to the types of informed consent model. Various models of consent have been suggested and utilized for the research uses of biospecimens collected in a biobank (Drake et al., 2016A; Mello & Wolf, 2010). A notice model of consent has been used by many biobanks in the past. In this model, individuals are notified at the time of consent to collect biospecimens that these biospecimens may be used in the future for secondary research purposes (Brown et al., 2016). A broad model of consent asks for participants’ permission to allow storage and future use of their biospecimens for all secondary research purposes at the time of collection. A study-specific model of consent asks participants to give consent for each research study in which their biospecimen would be used (Brown et al., 2016; Simon et al. 2011). Therefore, the amount of control an individual can have over their biospecimens is highest in the study-specific model of consent, and lowest in the notice model of consent. Previous empirical studies have shown inconsistent findings related to individuals’ preferences for models of consent (Platt et al. 2013; Simon et al. 2011), thereby suggesting that participants’ preferences for models of consent may vary across contexts and populations.

In one medical sequencing study, participating individuals indicated that genetic research data should not be shared without specific consent (McGuire et al., 2008). Participants’ trust as well as their privacy concerns regarding medical research may impact their need for control over biospecimens (see Lemke et al., 2009) and how they perceive the informed consent process. More specifically, participants’ mistrust and privacy concerns can increase their preference for a model of consent that gives them greater control over their biospecimens. Therefore, participants’ trust in doctors may be inversely related to their preferences for the study-specific model of consent, while their privacy concerns may significantly increase their preferences for the model.

H2–1: Trust in doctors is negatively associated with preference for the study-specific model of consent.

H2–2: Privacy concerns about research uses are positively associated with preference for the study-specific model of consent.

Potential Influences of Race on the Associations among Trust, Privacy Concerns, Need for Control, and Preferences for Model of Consent

According to CPM, privacy rules develop using core and catalyst criteria (Petronio & Durham, 2015). Core criteria involve individuals’ consistent privacy management behaviors such as durable rules based on culture, gender, and family privacy orientation (Petronio, 2002). According to previous research studies, family norms and traditional gender expectations affect privacy management as a type of core criteria used for controlling private information (Campbell-Salome, 2018; Petronio, 2002). Considering the history and experiences of African American populations, race may be one factor that affects their privacy rules/concerns used to control over the use of their biospecimens.

Scholars have argued that patients from racial and ethnic minority groups may experience less trust in their doctors compared to European American patients (Stepanikova et al., 2006), in part because racial discrimination in medicine has contributed to minority patients’ mistrust (Koenig et al., 2003). In fact, experiences and perceptions of discrimination and mistrust in the healthcare system are higher among patients from racial and ethnic minority groups compared with European American patients (LaViest, Nickerson, & Bowie 2000). Racial discrimination toward African American patients in medical research and clinical settings has been historically pervasive in the United States (Koenig et al., 2003). The most notable and striking example of this legacy might be the 1932 U.S. Public Health Service Tuskegee Syphilis Study of Untreated Syphilis in the Negro Male in which federally funded researchers intentionally withheld syphilis medications from African American men with the disease (Boulware et al., 2016). Another important example related to biobanks is the Henrietta Lacks case. In The Immortal Life of Henrietta Lacks (2011), Rebecca Skloot investigates an African American woman Henrietta Lacks’s life and death and whose cancerous cells (i.e., HeLa cell line) revolutionized medical research and facilitated many of today’s lifesaving treatments. However, Skloot (2011) highlighted the dark side of this success and raised significant ethical, legal, and policy questions regarding patient privacy and informed consent. First, her cells have been used in research without her or her family’s informed consent for decades. In addition, others made profits on the use of her cells while her family has received no compensation and lives with meager financial resources. Moreover, although the nomenclature used to identify the cell line was not illegal at that time, it meant that the cells’ source was identifiable, and patient privacy was not protected at all. The story has contributed to African Americans’ mistrust toward medical research particularly at major research institutions (Luebbert & Perez, 2015).

Recent literature has shown that African American individuals’ knowledge of both legacies is associated with reluctance to participate in medical research (George, Duran, & Norris, 2014). More specifically, compared to European American individuals, African American individuals have had more concerns about research participation such as a lack of knowledge about research, concerns about potential harms related to hospital experimentation, and a fear of side effects in prior research (Boulware et al., 2003; Hughes, Varma, Pettigrew, & Albert, 2017). Studies that have explored the association between trust and research participation suggest that (mis)trust is indeed an important determinant of willingness to participate in research (Corbie-Smith, Thomas, & George, 2002; Hughes et al., 2017). In addition, among those who refuse participation, African American individuals may be less trusting compared to European American individuals (see Mouton, Harris, Rovi, Solorzano, & Johnson, 1997). According to a systematic review about barriers and facilitators of research participation by individuals from racial and ethnic minority groups (George et al., 2014), African American individuals’ perceptions of mistrust regarding medical research are composed of three factors: (1) fear of purposeful mistreatment, (2) fear of unknown research procedures, and (3) fear of unintended consequences. Accordingly, in this review African American individuals wanted follow-up and study results reported to individual participants.

Racial differences in privacy concerns and trust may affect the associations of these variables with need for control as well as preferences for models of consent. Existing literature has shown inconsistent results about racial differences in need for control over biospecimens as well as participation in biobank studies. Some studies showed that African American individuals were less likely to donate their biospecimens or enroll in a national cancer genetics research study compared with their European American counterparts (Bussey-Jones et al., 2010). However, other research has suggested that African American individuals have favorable attitudes about genetics research (Henderson et al., 2008). In addition, recent studies showed that African Americans wanted to be asked for permission before each biobank study (i.e., study-specific model), while European American participants wanted to be asked one time (i.e., preferring the broad consent model) (Brown et al., 2016).

These racial differences in preferences for control over biospecimens as well as preference for model of consent might be partially caused by level of trust toward medical research and privacy concerns. Therefore, given the potential differences in trust, privacy concerns, need for control, and preferences for informed consent, race may moderate the associations between these variables.

RQ 1: Do African American and European American participants differ in (a) the association between trust and need for control and (b) the association between privacy concerns and need for control?

RQ 2: Do African American and European American participants differ in (a) associations between trust and preference for study-specific model of consent and (b) privacy concerns and preference for study-specific model of consent?

METHODS

Participants and Procedures

We recruited 358 women aged 40 and older stratified by race (56% African American and 44% European American) as these two racial groups comprised 94% of the local region. Because of the stratified recruitment, those identifying as more than one race or as a race other than European American or African American were not eligible to participate in the study. To recruit participants, research assistants made in-person visits to multiple patient-care centers associated with a comprehensive cancer center and local hospital, attended several health fairs and distributed flyers at local libraries, grocery stores, laundromats, and food pantries. We also partnered with a program for community research and engagement managed by a Midwestern university’s Center for Community-Engaged Research. In addition, the study team utilized Craigslist and Facebook to create an online presence for the study. We posted study ads to the local area’s Craigslist page and established a ‘community’ page for the study on Facebook where we posted details about the study. We encouraged participants to share information about the study with others and welcomed referrals.

The purpose of the parent study was to develop plain language materials for the informed consent process for a breast cancer-related biobank through cognitive interviews and a randomized experiment. All participants in this study were female because they were the target audience for the biobank. All participants were English speaking adults 40 years of age or older. More information about participant characteristics is shown in Table 1. In the study, participants reviewed three informed consent materials that vary in the amount of control they can have over biospecimens, in a randomly determined order based on different models of consent: notice; broad; and study-specific, and were asked to select the model they most prefer. These three models have been used and tested in the previous studies related to biobanks. In a notice model, individuals are notified at the time of consent to collect biospecimens that these biospecimens may be used in the future for secondary research purposes. A broad model of consent asks for participants’ permission to allow storage and future use of their biospecimens for all secondary research purposes at the time of collection. A study-specific model of consent asks participants to give consent for each research study in which their biospecimen would be used (Brown et al., 2016; Simon et al. 2011).

Table 1.

Demographic Characteristics of Participants (n=358)

N (%)
Age 55 or less 198 (55.3)
56 or more 160 (44.7)
Education Elementary school, junior high or some high school 29 (8.1)
High school diploma or GED 79 (22.1)
Some college or Associate degree 122 (34.1)
College degree 76 (21.2)
Graduate degree 48 (13.4)
Did not attend school in the US or not answered 4 (1.1)
Income Less than $9,999 76 (21.2)
$10,000- $14,999 46 (12.8)
$15,000-$19,999 39 (10.9)
$20,000-$34,999 68 (19.0)
$35,000-$49,999 40 (11.2)
$50,000-$74,999 35 (9.8)
$75,000-$99,999 18 (5.0)
$100,000+ 19 (5.3)
Not answered 17 (4.7)
Race European American 157 (43.9)
African American 201 (56.1)
Insurance Yes 285 (79.6)
No 73 (20.4)
Total 358 (100)
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Measures

Trust in doctors doing medical research.

Trust in doctors was assessed with a scale from Hall et al. (2006). More specifically, we used the following items: 1) I completely trust doctors who do medical research; 2) Doctors tell their patients everything they need to know about being in a research study; and 3) Doctors who do medical research only care about what is best for each patient. Participants responded to these items on a 5-point scale from Strongly disagree to Strongly agree. Items were averaged (α = .67; M = 3.68, SD = .85). The average score was treated as continuous in analysis.

Family and personal history of cancer.

Previous research has shown that patients with personal or family history of cancer were more likely to donate their biospecimens to a biobank or participate in medical research (Drake et al. 2016B; Lee, Bassett, Leng, & Maliski, 2012). Therefore, family and personal history of cancer were assessed using items from the Behavioral Risk Factor Surveillance System (BRFSS) (Centers for Disease Control and Prevention, 2012). Specifically, the following two questions were asked: 1) As far as you know, does cancer run in your family? and 2) Has a doctor (or other health professional) ever told you that you have cancer? Participants responded to these items by choosing between two options: Yes or No.

Privacy concerns about research uses of biospecimens.

Privacy concerns about research uses of biospecimens were measured at baseline with items from Pentz et al. (2006). Specifically, the following three items were used: 1) My insurer would find out my health information; 2) My employer would find out my health information; and 3) Genetic information about my ethnic or racial group would be discovered. Participants responded to these items on a 4-point scale from No concern to Large concern. A composite, averaged scale formed from these items had a reliability of α = .70 (M = 1.79, SD = .81).

Need for control over biospecimens.

Need for control over biospecimens was assessed at baseline with items from Kaufman et al. (2008). Specifically, the following two items were used: 1) I would like to have control over how my samples are used in each possible research study; and 2) I would like to be informed about how my samples are used in each possible research study. Participants responded to these items on a 4-point scale from Strongly agree to Strongly disagree. We averaged the items and used the mean score in analysis (M = 3.74, SD = .99; r = .57***).

Preference for study-specific model of consent.

Participants’ model preference was measured by using the following item: Thinking about only these three options, which process would you prefer? Please select only one. Preference for study-specific model of consent (vs. notice/broad) was assessed by dichotomizing preference for study-specific model as 1 (52.5%), and others (notice and broad models) as 0 (47.5%).

Control variables.

Several demographic and medical variables were controlled for. Education was measured with the categories described in Table 1. For other control variables (i.e., family history of cancer, personal history of cancer, and prior participation in medical research), the following items were asked: 1) As far as you know, does cancer run in your family?; 2) Has a doctor (or other health professional) ever told you that you have cancer?; and 3) Have you ever participated in a medical research study?.

Data Analysis

SPSS Version 24 was used for data analysis; statistical significance is assessed as p<0.05. To achieve study goals, multiple regression methods were employed. Specifically, in the multiple linear regression model with need for control over biospecimens as the dependent variable, demographic variables (education and race) and personal and family cancer history were entered in block 1, variables regarding participants’ privacy concerns and trust in doctors in block 2, and an interaction term (race*trust) in block 3. In the multiple logistic regression model predicting participants’ preference for study-specific model of consent (vs. notice/broad), the demographic variables and personal and family cancer history were entered in block 1, variables regarding participants’ privacy concerns and trust in doctors in block 2, need for control in block 3, and an interaction term (race*privacy concerns) in block 4. Then, to investigate the interaction effects, SPSS Macro for Probing Interactions in OLS and Logistic Regression (Hayes & Matthes, 2009) was employed. This study used a bootstrapping method to check the consistency of a beta coefficient generated by multiple-regression analysis by repeatedly sampling cases (5,000 times).

RESULTS

Age, education, income, race, and insurance were assessed. Descriptive statistics regarding these variables are in Table 1. Among these variables, given their significant influences in the literature on biomedical research, race and education were selected as control or modifying variables in this study. Table 2 shows correlations among Study Variables and Differences between African American and European American participants.

Table 2.

Correlation among Study Variables and Differences between African American and European Americans

Variables Both European
American		 African
American		 1. 2. 3. 4. 5. 6. 7.
1. Family history of cancerA 192 (53.6) 95 (26.5)a 97 (27.1)b 1
2. Personal history of cancerA 52 (14.5) 32 (8.9)a 20 (5.6)b .10 1
3. Participation in medical researchA 158 (44.1) 77 (21.5)a 81 (22.6)a −.02 .02 1
4. Trust in doctorsB 3.68 (.85) 3.79 (.83)a 3.59 (.87)b .03 .01 .05 1
5. Privacy concerns about research usesB 1.79 (.81) 1.62 (.71)a 1.92 (.86)b −.03 .04 −.06 −.16** 1
6. Need for controlB 3.74 (.99) 3.54 (.96)a 3.90 (.98)b −.02 −.12* −.17** −.08 .21*** 1
7. Preference for Study-specific modelA 188 (52.5) 72 (20.1)a 116 (32.4)b −.07 −.12* −.07 −.10 .21*** .29*** 1
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Note: European American (n) = 157; and African American (n) = 201

A:

N (%);

B:

Mean (SD); and

a or b

= significant mean/group difference

*

p < .05;

**

p < .01;

***

p < .001

Factors Predicting Need for Control over Biospecimens

Table 3 reports the results of multiple linear regression analysis with need for control over biospecimens as the dependent variable. In model 1, race was a significant predictor of need for control over biospecimens. That is, African American participants reported needing more control over their biospecimens than European American participants (β = .16, p <.01). In model 2, race remained significant (β = .12, p <.05), in addition, individuals with a personal cancer history (β = −.11. p <.05) and prior participation in medical research (β = −.14. p <.01) needed significantly less control than those without a personal cancer history or prior participation in medical research, respectively. Additionally, those with greater privacy concerns about research uses of biospecimens had greater need for control over biospecimens (β = .17. p <.01). In model 3, the associations of personal history of cancer (β = −.11. p <.05), prior participation in medical research (β = −.15. p <.01), and privacy concerns about research uses of biospecimens (β = .17. p <.01) were consistent with Model 2. Participants’ trust in doctors was negatively associated with their need for control (β = −.17. p <.05). Therefore, both hypotheses 1–1 and 1–2 were supported.

Table 3.

Factors Predicting Need for Control over Biospecimens

Need for control
Model 1 Model 2 Model 3
β (SE) β (SE) β (SE)
Race: African Americana .16 (.11)** .12 (.11)* −.39 (.46)+
Education: some college or moreb −.04 (.11) −.04 (.11) −.04 (.11)
Family history of cancer .01 (.10) .01 (.10) .01 (.10)
Personal history of cancer −.10 (.15)+ −.11 (.15)* −.11 (.14)*
Participation in medical research −.14 (.10)** −.15 (.10)**
Trust in doctors −.04 (.06) −.17 (.09)*
Privacy concerns about research uses .17 (.06)** .17 (.06)**
Race * Trust .52 (.12)*
R2 .045** .099*** .112***
Δ R2 .055*** .013*
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Note:

a:

comparison group – European American;

b:

comparison group - high school or less

+

p < .10,

*

p <. 05,

**

p <.01,

***

p <.001

An interaction of race and trust in doctors on need for control over biospecimens was found (β = .52. p <.05). This result (Model 3 in Table 3, Figure 1) suggests that while trust in doctors was significantly and negatively associated with need for control over biospecimens among European American participants (SD = .83, b = −.20, se = .09, p < .05), no association was found among African American participants (SD = .87, b = .07, se = .08, p = .37).

Figure 1.

Figure 1.

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Interaction by Race on the Effect of Trust in Medical Researchers on Need for Control over Biospecimens

Factors Predicting Preference for the Study-specific Model of Consent

Table 4 reports the results of logistic regression analysis predicting preference for the study-specific model of consent. In model 2, personal cancer history was a significant and negative predictor of preference for the study-specific model of consent. Specifically, participants with a personal cancer history were less likely to prefer the study-specific model of consent (OR= 0.50, p < .05, 95% CI = 0.27, 0.94) than those without this cancer history. In addition, participants’ privacy concerns about research uses of biospecimens were significantly and positively associated with their preference for the study-specific model (OR= 1.57, p < .001, 95% CI = 1.27, 2.24). In model 3, privacy concerns about research uses were still significantly associated (OR= 1.55, p < .01, 95% CI = 1.16, 2.08), and participants’ need for control over biospecimens was significantly and positively associated with their preference for the study-specific model (OR= 1.70, p < .001, 95% CI = 1.33, 2.16). In model 4, race was a significant predictor of participants’ preference for study-specific model. That is, African American participants were more likely to prefer the study-specific model of consent than European American participants (OR= 3.68, p < .05, 95% CI = 1.14, 11.87). The effects of privacy concerns about research uses (OR= 2.51, p < .01, 95% CI = 1.46, 4.33) and need for control (OR= 1.58, p < .001, 95% CI = 1.32, 2.14) were consistent with prior models. Therefore, Hypothesis 2–2 was supported. However, Hypothesis 2–1 was not supported, because trust in doctors was not significantly associated with preference for the study-specific model of consent (OR= .89, p = .381, 95% CI = .68, 1.17).

Table 4.

Factors Predicting Preference for Study-specific Model

Preference for Study-specific model
Model 1 Model 2 Model 3 Model 4
OR 95% CI OR 95% CI OR 95% CI OR 95% CI
Race: African Americana 1.51+ .98-2.33 1.25 .80-1.96 1.12 .70-1.78 3.68* 1.14-11.87
Education: some college or moreb 1.10 .69-1.72 1.08 .67-1.74 1.14 .70-1.86 1.10 .67-1.80
Family history of cancer .84 .55-1.28 .84 .54-1.29 .82 .52-1.28 .82 .52-1.30
Personal history of cancer .57+ .31-1.05 .50* .27-.94 .56+ .29-1.09 .54+ .28-1.06
Participation in medical research .81 .52-1.27 .94 .59-1.49 .93 .59-1.48
Trust in doctors .87 .67-1.12 .87 .67-1.14 .89 .68-1.17
Privacy concerns about research uses 1.57*** 1.27-2.24 1.55** 1.16-2.08 2.51** 1.46-4.33
Need for control 1.70*** 1.33-2.16 1.68*** 1.32-2.14
Race * Privacy concerns .49* .26-.94
Nagelkerke R2 .035+ .096*** .162*** .178***
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Note:

a:

comparison group - European American;

b:

comparison group - high school or less

+

p < .10,

*

p <. 05,

**

p <.01,

***

p <.001

Additionally, an interaction effect of race and privacy concerns about research uses on preference for study-specific model was found (OR= .49, p < .05, 95% CI = .26, .94) This result (Model 4 in Table 4, Figure 2) suggests that although privacy concerns about research uses were significantly and positively associated with preference for the study-specific model of consent among European American participants (b = .92, se = .28, p < .001), no relationship was found among African American participants (b = .21, se = .18, p = .23).

Figure 2.

Figure 2.

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Interaction by Race on the Effect of Privacy Concerns about Research Uses on Preference for Study-specific Model

DISCUSSION

Ethical protections as well as patients’ willingness to participate in studies that collect biospecimens is essential for the viability of genetic research (Bussey-Jones, et al., 2010). In this study, we investigated the influences of privacy concerns about research uses and trust in doctors on preferences for informed consent and need for control over biospecimens in a biobank among a diverse sample of women from the perspective of CPM theory (Petronio, 2002), precision medicine, and racial health disparities. Given the fact that African American individuals may have higher levels of mistrust and privacy concerns, we also explored how these associations are different between African American and European American participants. The findings of this study have theoretical as well as practical implications for the assembly of large, diverse cohorts of participants in future biobank studies, especially with regard to trust, privacy concerns, need for control, and barriers/facilitators to participation by African American individuals.

First, as hypothesized, while individuals’ privacy concerns about research uses of biospecimens were significantly and positively associated with their need for control, their trust in doctors inversely predicted this outcome. These results support previous literature regarding CPM theory as well as genetic research participation. Several prior studies have suggested that mistrust of medical research (Bussey-Jones, et al., 2010) as well as privacy concerns about sharing genetic data (Lemke et al., 2009) exist among patients and the public and contribute to lower rates of participation in genetic research. Similarly, according to CPM, individuals believe they own their private information, and would like to control it by sharing it with authorized or trusted co-owners (Petronio, 2002). The results of this study suggest that patients may develop a confidentiality pledge by considering their trust in doctors and privacy concerns, and decide the level of control they need over their biospecimens (see Petronio et al., 2012). The results also suggest that both trust and privacy concerns may matter for patients’ decision-making about participation in a biobank, and more transparency is needed in the process of medical research.

Second, we hypothesized that both trust in doctors and privacy concerns would predict participants’ preference for the study-specific model of consent. However, although participants’ privacy concerns about research uses were significantly and positively associated with their preference for study-specific model, trust in doctors was not associated with this preference. Nevertheless, these results can be understood in the same vein of previous studies (e.g., McGuire et al., 2008), suggesting that informed consent is an essential process affected by privacy concerns. Individuals’ biospecimens include private medical information to be investigated via the process of medical research, and the process of informed consent can be regarded as a legal recognition that doctors have the rights of ownership of biospecimens on behalf of the patient (see Petronio, 2002). Therefore, the results suggest the process of informed consent cannot be separated from participants’ privacy concerns, and thus the varying amount of control over biospecimens in different types of consent might be an important factor for research participants to consider. We found that privacy concerns regarding research participation influence participants’ preference for model of consent, which may be because these models vary the amount of control participants have over the uses of their biospecimens and the information they receive. This result, which is consistent with prior findings (Hansson, 2009), highlights the fact that informed consent exists for patients’ autonomy and informed decision making (see Kagarise & Sheldon, 2000). Although trust negatively affected participants’ need for control, no relationship was found between trust and preference for the model of consent. This suggests that participants’ preference for the study-specific model may depend on factors other than mistrust in doctors. Future studies will need to investigate what these factors are.

Third, the results of this study showed significant interaction effects by racial group. This study examined whether racial differences in need for control over biospecimens as well as preference for the study-specific model of consent (Brown et al., 2016) may be the results of African American participants’ lower level of trust in doctors doing medical research and higher privacy concerns. While trust in doctors was significantly and negatively associated with need for control over biospecimens among European American participants, no association was found among African American participants. The difference in associations by race may be explained by the socio-cultural influence of the Lacks’s case and the CPM theory (Petronio, 2002). According to CPM, privacy rules develop over time, and core criteria involve individuals’ consistent privacy management behaviors such as durable rules based on culture and gender that are used for controlling private information (Campbell-Salome, 2018; Petronio, 2002). As discussed in the literature, race may be one factor that affects participants’ privacy rules to control over the use of their biospecimens. It is possible that Lacks’s case has influenced African Americans to have a high need for control even when their trust in doctor is high enough. Moreover, although privacy concerns about research uses of biospecimens were significantly and positively associated with preference for the study-specific model of consent among European American participants, no relationship was found among African American participants. There are a few possible explanations for this result. For example, it may be that privacy concerns about research uses may not assist African American participants in distinguishing between types of consent. As explained in Skloot’s (2011) book, it is possible that African Americans are less concerned with type of consent model because they are more concerned with the use of their biospecimen for financial profits that are not disclosed or not shared for the common good (see Javitt, 2010). In addition, African American participants’ personal experiences of discrimination in the healthcare setting may have affected the findings. Therefore, future studies should focus on African American participants’ knowledge of this legacy as well as experiences and perceptions of discrimination, which may function as the potential core criteria that affect their consistent need for control as well as preference for the study-specific model.

Lastly, our findings add to a growing body of knowledge about the roles of patients’ trust in doctors and privacy concerns about research uses of biospecimens in predicting their need for control over biospecimens as well as preference for model of consent. Particularly, the findings provide practical implications by examining the reasons of patients’ need for control in the consent process of biobank research. More specifically, the results suggest what issues researchers and practitioners should consider in the recruitment of African Americans into future genetic research by highlighting the importance of informed consent and the potential predictors of preference for the models of consent. Moreover, these findings highlight different roles of privacy concerns and trust across racial groups in predicting participants’ need for control over biospecimens as well as preference for model of consent. According to the final rules for the Federal Policy for the Protection of Human Subjects (or Common Rule) published by federal agencies in 2017, broad consent can be more frequently used in future studies instead of conducting the research on non-identified biospecimens, having an institutional review board (IRB) waive the requirement for informed consent, or obtaining consent for a specific study. This suggests that more privacy issues and concerns should be taken into consideration in future studies. Given that it is important for biobanks to reflect the rich diversity of the populations, our findings will be helpful for the initiative’s recruitment strategies as well as consent process related to minority populations’ privacy concerns.

Limitations and Conclusion

Although this study provides several novel findings, it is important to acknowledge its limitations. First, since the participants were African American or European American women living in the Midwest, the results might not be generalizable to other populations of women, and there may be differences by region and gender. Second, it is not clear how participants’ preference for informed consent relates to their actual donation decisions. Here, we intended to capture the consent preferences of diverse women who might or might not have been approached for participation in biobanks. It is critical to examine preferences among those who have not yet considered biospecimen donation in order to plan for population-based biobanks. However, future research should focus on whether these preferences are in aligned with actual donations.

Despite the limitations, our findings provide grounds for examining the reasons underlying patients’ need for control in the consent process of biobank research, especially when it comes to the recruitment of African Americans. Specifically, the findings highlight different roles of privacy concerns and trust across racial groups in predicting participants’ need for control over biospecimens as well as preference for model of consent. Our findings will be helpful for future biobanks to reflect the rich diversity of the populations.

Footnotes

Conflict of interest: The authors have no conflicts of interest to declare.

Human subjects and informed consent: All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000. Informed consent was obtained from all patients for being included in the study.

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