Evolving Uses of Data:

Interviewees contrasted traditional informed consent, in which participants agree to a specific study purpose, to consent in a health data repository context, in which participants consent for use of their data for evolving purposes. While broad consent has been described as allowing future, unspecified, or indeterminant uses of data, we call these uses of data ‘evolving’ to reflect interviewees' emphases on data being relinquished to researchers' emergent choices about study questions. Interviewee 14 (NP) said, “Essentially, an individual consents at the outset that their data can be used for purposes that are not yet established.” Another (ID23; U+) agreed that participants must know “that their data is going to be used for research and available to researchers for all kinds of research.” According to interviewee 26 (H+), participants are giving up their right to disallow particular uses of their data: “we make it clear if you're not comfortable with having your samples and data used for [a] specific kind of research, then you should consider not participating because literally it could be used for any and all research.” Interviewee 41 (U+) agreed that participants needed to know that they were giving up rights: “let's just really be absolutely clear that you are donating your data and your blood and your information, and we do not know what researchers are going to do with it.” These interviewees emphasized that participants relinquish their right to prevent data from being used. Interviewee 50 (U+) said that the consent “needs to cover … the future assay that can be done on the specimen.”

Other interviewees emphasized that consent to participation in a health data repository entails an agreement that their data will be put to use. Interviewee 43 (NP+) said that consent is an agreement to share data with “someone out there [who] will hopefully be using it…to help us understand illnesses and diseases better.” Interviewee 19 (U+) said that the purpose of a repository is discovery, which necessitates an exploratory use of the data: “You are telling them that the data will be used for every discovery that will happen in the future.” Interviewee 17 (PR) called the lack of specificity of the study purpose “part of the transparency” of a data repository study since “we're moving into a discovery phase, so we won't know everything that we're going to learn.” These interviewees framed consent not so much as an agreement to any subsequent use of data but to a purpose dictated by the imperative of scientific discovery.

Institution and Infrastructure:

Rather than describing consent as an agreement to complete specific study procedures, interviewees described participants as agreeing to be a part of a broader research process. They described consent as conferring decision-making authority on the institution or infrastructure that manages the health data repository. As interviewee 26 (H+) explained, “They're consenting to be part of a large longitudinal study that will engage with them multiple times” over an extended period. When asked to clarify what participants are consenting to, interviewee 25 (U+) said they “are volunteering to be a part of [a study] and contribute information…that could be used for any type of research for years and years to come.” Interviewee 13 (U) said participants agree to a method of collecting and storing data, including “how the study will operate,” or “the infrastructure of the study and how the study is set up,” which comprises “a process by which their samples and data are going to be collected, how they are going to be stored, what sort of confidentiality protections…and then this process by which decisions will be made about who can use data and for what purpose.” Interviewee 31 (H+) summarized that the consent “has to accurately describe… the rules of engagement” of the study. Interviewee 27 (H+) described a requirement that researchers “be up front with folks that … these are the way your materials will be used, these are the protections that are in place, and we're going to do our best to make sure that it's being used as wisely as possible.” Interviewee 14 (NP) agreed that consent processes entail “making sure that at the outset participants understand that if they participate, this is the framework that they are participating in.”

Informed Enough:

Interviewees consistently deemphasized the importance of information exchange and understanding at the time of consent to a data repository. As interviewee 26 (H+) said, for example, the recruitment process “is actually about getting people jazzed up and excited” about a long-term relationship with the study. Interviewee 50 (U+) said that a “constant information loop with participants” is a goal, rather than one-time conveyance of information, a procedure this interviewee called “really looking at consent in a different light.” Interviewee 50 (U+) said that while traditional consent consists of “’I'm explaining something to you, I'm going to ask you some questions, making sure that you understand, and I'm going to ask you to sign this piece of paper,’” in consent for a health data repository “the engagement of participants … has to be continuous.” Interviewee 50 (U+) continued that, “engagement is part of the consent, you know, a more modern, and better at that, consent process.”

Interviewees considered this kind of consent to be informed enough: they acknowledged that initial information might be incomplete yet sufficient to protect participant autonomy. Interviewee 14 (NP) felt that complete information about a study was not needed to achieve an adequate consent process: “the idea of knowing everything in order to be able to make an informed decision is a naive concept. We never know everything when we make a decision and that doesn't impede us in making autonomous decisions.” Interviewee 13 (U) said that study purpose, procedures, and risks and benefits could be communicated “in enough detail that people can make an informed decision about whether they are willing to agree to that.” Interviewee 38 (U+) described a reasonable compromise between feasibility and the need to inform. The consent process must “weigh the balances between protecting human subjects, but also the balance between making a consent form that's like 40 pages long that no one's going to sign or be a part of.” Interviewee 38 (U+) said, “I don't think there's anything wrong with a consent that…is probably more feasible and practical” than a comprehensive informed process. While these comments reflect a ubiquitous need to balance feasibility and information provision during consent, we note interviewees' consistent dismissal of the need to completely inform potential participants. What we here call an informed enough consent is, according to interviewee 38 (U+), “still protecting a human subject, rather than something that is so detailed or so far into the weeds.”

Despite overall endorsement of the informed enough approach, the most common concern expressed by interviewees was the risk of inadequately informing individuals during consent. Interviewee 21 (H+) agreed that “just conceptually it's hard for people to understand,” and as a result “our biggest hurdle is…feeling like our patients are truly consenting to the process.” Interviewee 54 (H+) called “the lack of specificity” in the consent a major source of “negative feedback.” Five interviewees said that inadequate information provided at the time of consent decreased participation rates. Each aspect of the broad consent requirement for sufficient information-exchange — study purpose, procedures, risks and benefits, plans for use of data, and information sharing — was mentioned as a potential source of inadequate comprehension.

For instance, regarding study purpose and procedures, interviewee 46 (H+) said that “people really don't know potentially what could be done with their data.” Interviewee 31 (H+) described that a consent for research on ‘health related’ topics is not well-understood by participants: “a lot of them…have [sic] very narrow understanding,” and may think that “health-related has to do with disease and not wellness, for example.” Interviewee 18 (U), noting that “it's one of the few things I am struggling with,” was worried that “the data can get sent out and studies that could be done on things that may not be compatible with someone's beliefs.” Interviewee 15 (NP) agreed that “I could see people not wanting the data to be used for a topic that they felt very strongly about.” Interviewee 13 (U) anticipated that if studies “are not in keeping with what people thought was going to happen, that that will be a major problem with trust in research and with people's willingness to continue.”

Interviewee 54 (H+) empathized with participants' wish for information: “I think they literally just want to know more specifics. They want more specificity of exactly, okay, well, you're taking six tubes of blood from me, what are you doing with six tubes of blood? What tests are you running?” Citing concerns that procedures were inadequately explained, interviewee 53 (U+) recommended “[r]ather than say, ‘Oh, we don't know what yet we can use your information for,’” the consent process should express “possible potential uses; list them all out and categorize them,” and afterward return to the participant to ask, “’Did I make myself clear?’”

Re-consent:

For interviewees, options for re-consent presented ambiguous solutions to the informational deficiencies of consent for health data repositories. On the one hand, re-consent procedures might mitigate limitations in information exchange at the time of consent, strengthening participants' link to and trust in the project. On the other hand, re-consent procedures could undermine participants' commitment to a study by suggesting initial consent was insufficient. In this way, interviewees had mixed views of whether re-consent was a form of engagement or an impediment to it.

For example, a minority of interviewees were confident that no additional permissions for use of data would need to be gathered from participants. The eight interviewees who said that there would be no situations where additional consent would be necessary described re-consent as undermining participants' ongoing relationship with the study. For instance, one said that a requirement for re-consent “would mean that there's a huge barrier to doing research … with data from communities that are already underserved by biomedical research” (ID36; NP+); that “you've consented people under this broad framework”; and that any re-consent “changes the terms that you agreed to initially” (ID14; NP). Three interviewees said that a re-consent process could heighten participant anxiety. It may, interviewee 17 (PR) said, attenuate engagement because it is a form of “bothering them about consenting and re-consenting” and “makes them feel like somehow everyone else is trying to protect themselves from something.” Interviewee 16 (U) agreed that “it's going to prompt people to say, ‘wait, what are they doing with my medical records?’” By going back to participants, interviewee 32 (U+) said, “you really run the risk of having people not want to continue” to participate.

Yet 23 of 44 of interviewees felt that some additional process of consent should be a part of participant follow up. Nine interviewees said that further consent would be necessary if new types of data were to be collected or analyzed in the future, for instance for study procedures that are “more high risk” (ID38; U+), in which “a different type of procedure … carries more risk than a blood draw” (ID25; U+), or that use a “brand new technology” (ID18; U) or “an additional questionnaire” (ID39; C). Some of these nine interviewees suggested re-consent should be used as the data analytic plan becomes clearer even if no additional data is collected. For instance, interviewee 34 (PR+) mentioned circumstances that should trigger “some sort of re-consent” including “anytime there's a major programmatic change” or “halfway through at the five-year mark, just to remind people,” or, as interviewee 40 (PR+) described it, as a study “gets more in-depth and things change.”

Three other interviewees considered additional consent to be important when topics for study were identified. Interviewee 15 (NP) recommended “more specific consents down the road” when the study is “easier to understand.” For interviewee 15, additional consent would be needed because, “when there is a specific topic, I think participants should be allowed to have” more information. Interviewee 24 (U+) said any topic should require re-consent “if the scope is not included in what the participant consent,” and interviewee 53 (U+) assumed “that down the road” a health data repository should include “very specific…follow-up consent process[es]…when other studies that are very specific then take place.” Two interviewees mentioned that using data for profit should require additional consent, and two others mentioned the need for special procedures for Native American participants whose “samples [have] to be completely segregated from everyone else's so that they have greater control over what can be done with it” (ID30; U+) or for participants with brain injuries or reduced capacity to consent (ID47; H+).

Four other interviewees said consent would be important if the data were to be used to study sensitive topics. As interviewee 13 (U) said, “if…a researcher comes along in and wants to collect a very particular information [sic] on a topic that is -- could be considered sensitive…then I think that we either have to make the criteria for wavier or exemption or you know, get consent, hopefully simple. Hopefully simple consent.” Interviewee 43 (NP+) agreed that the question of “when to go back and ask people if they're okay with certain kinds of things” would be important as researchers “are getting information about what they want to study [and] say, ‘Oh, this is kind of a sketchy topic or maybe we need to go back and ask.’” Interviewee 43 (NP+) mentioned the difference between “making a good drug…for…an illness that I care about that I want to be solved” or a “lifesaving drug” versus “if it's for, like, Viagra” or something “more cosmetic” in which going back to the participant for re-consent may be important.

Interviewees who felt confident that re-consent was needed could not always name what should trigger it: as interviewee 22 (U+) said, “I don't have a good example in mind, but I just can foresee if something is more sensitive.” Others described re-consent as a form of engagement: a means of “asking people if they're okay” (ID43; NP+) with study procedures or a strategy “just to remind people” (ID34; PR+) of their participation in the study.