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Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
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4

Informed Consent

This chapter summarizes the presentations and discussion in two sessions on September 28 that focused on informed consent. Vetta Sanders Thompson chaired both sessions, the first on the complexity of informed consent, and the second on ethical considerations for obtaining informed consent. Questions and discussion for both sessions followed the end of the second session.

THE COMPLEXITY OF INFORMED CONSENT

Understanding Consent to Data Linkage

Annette Jäckle is professor for survey methodology at the Institute for Social and Economic Research at the University of Essex and associate director for innovations for Understanding Society. Jäckle explained this study, Understanding Society, is a longitudinal household panel and the UK equivalent to the Panel Study of Income Dynamics. Data are collected using a combination of web, face-to-face, and telephone interviewing, and they request respondents’ consent to link data to different government administrative records and financial data. A study observation is that respondents who complete the survey online are much less likely to consent to linkages than when they complete the survey with a face-to-face interviewer, and the gap is 30 percentage points. Jäckle said they are trying to solve this problem and increase informed consent by web respondents.

Jäckle briefly reviewed the key findings from the survey methods research literature on data linkage consent. She pointed to the variation in

Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×

consent rates depending on the topic, with consent rates to link financial data tending to be lower than to link health or education data. There are also differences in consent rates between interviewers, and very little consistency in the predictors of who consents between studies, within studies over time, or within studies for different consents. A surprising number of experimental studies have tried different ways of asking the consent question and have not been very successful at increasing consent, she commented. Her conclusion is that consent decisions can be influenced, but it is not yet known how. Several studies have shown that many respondents do not fully understand the request for consent to data linkage, which suggests an opportunity to improve understanding.

Both the Understanding Society and the Health and Retirement Study have documented that when asking people who did not give consent in one wave if they will consent in a later wave, half of the nonconsenters provide consent the next time they are asked, she reported. She said that this finding suggests it is not a fixed decision and can potentially be influenced. Research looking at multiple consents asked in one interview appeared to show a latent willingness to consent, she continued, but this willingness to consent does not seem to hold over time. It does not seem to be a stable characteristic, which suggests situational factors are important. She concluded that the research question is how respondents make the decision whether or not to consent.

Jäckle described her group’s research project to examine how respondents decide whether to consent or not and why respondents are less likely to consent when they are completing the survey online than with a face-to-face interviewer. The project started with qualitative, in-depth interviews, drawing participants from a separate Innovation Panel, which is a sample of 1,500 households that are interviewed in the same manner as the main sample. She explained the findings from these qualitative interviews were used to develop a conceptual framework about how people make the consent decision, generate hypotheses, and then experimentally test some of the hypotheses using both the Innovation Panel and an additional online access panel to increase their sample size.

As Jäckle discussed, their conceptual framework for consent draws upon the cognitive model of the survey response process, which states that in order to answer a survey question, respondents have to understand the question, retrieve relevant information from memory, form a judgment, and then decide what they are actually going to say; however, respondents do not necessarily execute this process optimally. The study drew upon the rational versus heuristic decision-making literature or System 1 versus System 2 processing, which has shown that people make the bulk of their decisions using System 1 processing, which means they are making quick, top-of-the-head decisions, but that they can also override those quick

Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×

decisions and make much more effortful, deliberate decisions. They also drew upon the literature in psychology about how people make decisions in real life, noting that people reduce the amount of information that they use to base their decision on.

Jäckle described the conceptual framework for how respondents decide to consent (Figure 4-1). The green box on the right-hand side contains the outcomes of interest: whether the participant provides consent, how well they understand the request, and how confident they are in their consent decision. The red box on the left includes the characteristics of each respondent, their prior experiences and knowledge, their cognitive capacity, and their attitudes and behaviors. In addition, she noted that the trust the respondents have in the organizations involved and the survey team may affect the decision. For example, some government departments may be perceived as more trusted than others. She noted that elements of the survey design, such as the content and the format of the consent request, and the mode for the request are also relevant. These factors might have direct influences on the outcomes, she suggested.

Jäckle said that the blue box in the middle of Figure 4-1 represents what goes on in the respondents’ minds, and how they are making this decision, which is the focus of the study. The study assumes a continuum of decision processes, with some respondents making the decision in a more reflective way and others in a less reflective way. She noted that respondents are not directly observed in this decision process, but are asked to self-report how they made the decision. They also measure other indicators. For

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FIGURE 4-1 How respondents decide whether to consent.
SOURCE: Annette Jäckle workshop presentation, September 28, 2021, and Burton et al. (2021).
Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×

example, they look at how long people take to answer the consent question, which should vary depending on whether the respondent is making more rather than less reflective decisions. They can look at whether respondents are reading additional information, and ask them to self-report how much effort they consider that they put into answering the consent question.

The focus of the study was on a single consent question about linking tax records, which asked if the participant gave permission for the researchers to pass their name, address, sex, and date of birth to Her Majesty’s Revenue and Customs for the purpose of linking their tax records to their survey responses. Participants were not asked for their unique national identity insurance number, but they were asked background and follow-up questions about how they made this decision. Jäckle noted that they replicated this research design in several samples, including the Innovation Panel and an online access panel, and included both web and face-to-face respondents.

Participants had several options to indicate how they made their decision to consent, Jäckle reported. Just over one-third said that they made a reflective decision on whether or not to consent. They based their decision on thinking about the consequences of what would happen if they consented or on thinking about how much they trust the organizations involved. The rest predominantly used heuristic decision processes, for example basing their decision on gut feeling or habit, and were simplifying the decision and basing it on just some aspects rather than all the information available.

Jäckle described additional indicators to validate the self-reported measure of how respondents said they made their decision. Respondents who were less reflective and made decisions based on habit or gut feeling spent less time answering the question than those who made more reflective decisions. More reflective decision makers were more likely to look at additional information, and they also said that they used more different types of information in their decision than those who were less reflective. Jäckle said that the self-reported decision process measures real differences between respondents and that the decision process that people use is related to the outcomes, with more reflective decision makers having higher consent rates and better understanding of the consent request; however, that is not necessarily a causal effect.

In terms of why respondents are less likely to consent in web than face-to-face encounters, Jäckle said the 30-percentage-point difference in consent rates between modes is causal: Respondents are less likely to consent when they answer online than face-to-face, and they also understand the request less well. Respondents online are more concerned about privacy and data security, and they answer the consent questions less thoroughly, more quickly, and are less likely to read additional information than those in person. Online respondents are more likely to make habit-based decisions

Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×

and less likely to make reflective decisions than those in person, she added. She pointed out that the interviewers are not providing additional information or reassurance.

In conclusion, Jäckle said that there are clear differences in how people make the consent decision. The majority of respondents do not use a reflective process, are unlikely to read additional information, and make the decision very quickly. Just providing more information is unlikely to increase informed consent, she said, but the researchers do not know how they can get more people to make a reflective decision and whether it is possible to shift people’s decision-making style and thereby increase informed consent.

Biomeasures: Gaining Cooperation and Informed Consent

Katie O’Doherty is senior research director in the Health Sciences Department at NORC at the University of Chicago. O’Doherty focused on gaining cooperation and informed consent for a variety of different biomeasures across several different projects. These measures included sensory measurements, body measurements, performance of physical activities, and biosamples, such as blood and urine.

O’Doherty first described gaining cooperation and consent in interviewer-administered studies. Advance materials are provided with high-level information about biomeasure collection, but not extensive detail. Next, a field interviewer provides additional information at the doorstep to gain cooperation for the interview. Once the interviewer gains cooperation, they do a written informed consent for the interview, which includes an overview of the biomeasures, the risks, the benefits, the results, and confidentiality. Interviewers answer the respondents’ questions and address any concerns. The interviewers tell respondents that they can still participate in an interview even if they are unsure about a biomeasure, and that the interviewer will explain it in detail at the appropriate point.

The biomeasure collection takes place in the middle of the interview, O’Doherty said, which allows the interviewer to establish rapport and gain some trust with the respondent before asking for these measures. Verbal consent is obtained for the individual measures and the interviewer provides detailed explanation of these measures at the time of collection. Respondents receive a single incentive for the interview, including the questionnaire and biomeasures, rather than separate incentives, and the researchers try to share results from these measures with respondents. O’Doherty said that pretesting was helpful to make the process go more smoothly, and to address respondent questions and concerns.

O’Doherty shared biomeasure cooperation rates from the National Social Life, Health and Aging Project (NSHAP) from three in-person rounds of data collection (Table 4-1). The rates shown in the table are the

Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×

TABLE 4-1 NSHAP In-Person Biomeasure Cooperation Rates

Biomeasure Round 1 Round 2 Round 3
Weight 98% 98% 98%
Waist 97% 98% 97%
Height 99% 98% 99%
BP and Pulse 98% 98% 98%
Balance 99%
Timed Walk 96% 98%
Chair Stands 94% 98%
Smell 98% 96% 96%
Saliva 89% 95% 91%
Vaginal Swabs 68% 73%
Blood Spots 85% 92% 92%
Accelerometry 78% 84%

SOURCE: Adapted from Katie O’Doherty workshop presentation, September 28, 2021.

percentage of respondents who agreed to the measure out of the number asked in the interview. Many of the measures have very high cooperation rates, but rates are a little lower for saliva and blood spots, and are the lowest for vaginal swabs and accelerometry, which involves wearing a device for 8 days.

O’Doherty next described self-administered biomeasure collection. She began by showing a picture of the NSHAP BioBox (Figure 4-2), which was developed for remote data collection in Round 4 of the study. The box contains a BioBooklet with a yellow cover, which has the step-by-step instructions that respondents would follow to collect their own health measures. The supply box includes all the supplies needed to collect these measures and a place for specimen storage. O’Doherty noted that they simplified the collection instructions greatly for respondents. Field interviewers helped organize the supplies and the presentation of the instructions, and a lab pilot and two pretests of the BioBox were conducted. She said that they will not obtain all of the same biomeasures collected during in-person interviews, because the BioBox does not contain blood pressure monitors or scales.

Round 4 remote data collection is currently in the field, O’Doherty said. Advanced materials are sent first, with an invitation letter that contains high-level information about the questionnaire and the BioBox, along with a brochure. Participants can complete the questionnaire by web, phone, or paper and pencil, which are offered sequentially as options.

Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×
Image
FIGURE 4-2 NSHAP BioBox for remote collection in Round 4.
SOURCE: Katie O’Doherty workshop presentation, September 28, 2021.

Regardless of mode, the questionnaire ends with an invitation to participate in the BioBox. To gain cooperation, the information provides an overview of why participation is important, what they are being asked to do, what measures would be collected, how long it would take, and the incentive that they would receive, which an interviewer would normally explain for gaining cooperation. People who are interested then receive much more detailed additional consent language, which includes the risks and benefits and how their data will be protected. If they consent to receive the BioBox, it is mailed to them along with a copy of their consent form and a prepaid incentive.

O’Doherty shared results from a pretest conducted last year that involved comparing six different BioBox types to assess consent with each approach. Three different types of boxes varied by what measures were included and the length of time required to do them, with two taking about an hour and another about an hour and a half. Three included collecting blood, and three did not. Not asking for blood yielded slightly higher return rates than asking for blood, and the boxes that took less time for respondents to complete also had slightly higher return rates than the boxes

Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×

that took longer. Based on these results, O’Doherty related, they decided to go with a one-hour box for Round 4 and to collect blood because of its importance to the study aims.

O’Doherty briefly described the health visits with a phlebotomist in the High School and Beyond (HS&B) study, which Eric Grodsky and Rachel Canas discussed earlier in the workshop (see Chapter 3). The procedures were similar to those for the NSHAP BioBox, she pointed out. In addition, a web video was created to try to increase consent because a pretest showed that web consent was lower than phone consent. As this study is still in the field, results are not available to share.

In conclusion, O’Doherty touched on refusal conversion for both the NSHAP BioBox and HS&B health visit. Because gaining cooperation and informed consent are attempted without an in-person interviewer to explain things in more detail, experienced interviewers call respondents to revisit the biomeasure collection consent and answer questions about a month after a remote interview. She said they are also offering a higher incentive, and preliminary results are showing success in converting some biomeasure nonrespondents.

The Complexity of Informed Consent

Christine Grady is a nurse, bioethicist, and senior investigator and chief of the Department of Bioethics at the National Institutes of Health Clinical Center. Grady spoke in general terms about the complexity of informed consent, drawing upon her research and experience as well as the literature. She first described the components of informed consent: Consent for people who have the capacity involves giving them study information in a relevant way, determining that they can understand the information and can use it to make a voluntary choice about whether or not to participate, and then authorizing participation in some way. She acknowledged the process is much harder than it theoretically sounds like it should be.

Informed consent is complex because of enduring challenges in making decisions about disclosure and understanding voluntary choice, she continued. It is also complicated by differences in individuals’ motivations and expectations, their capacity to understand and to make decisions, their tolerance for and perception of inconvenience and burden, their trust, and their responses to incentives.

With respect to disclosure of information, Grady opined the hardest decision to make is what information should be disclosed in a way that is accessible, relevant, and understandable to participants. She stressed the importance of how the information is presented, whether it is on the web or in person, beyond its amount and complexity. Not enough is known about how different groups accept different presentations of information,

Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×

but acceptance probably varies by age, socioeconomic circumstances, and culture. Considerations in terms of how information should be presented for the purposes of consent depend on the setting and the population. For example, presenting information about treatment to a very sick patient in the intensive care unit with COVID-19 is very different than presenting information to somebody in the outpatient setting for a blood sample.

In terms of understanding information, Grady referred to a meta-analysis that looked at how well people understand information about participation in research and found that it is not very good.1 Specifically, no particular part of the study information was understood by more than 75 percent of the people. Some key features of studies like placebo use and randomization are understood by 50 percent or less, which means that one in every two people who are participating in a placebo-controlled study do not really understand what that means. Grady said that a number of factors affect understanding, including age, education, and features like pain, cognitive impairment, and literacy, as well as expectations and familiarity. She noted that a large percentage of research participants in cancer clinical trials say they trust their providers and do not need to pay attention to the details of the study or the benefits and risks.

In her research on understanding and consent, Grady reported a fairly large percentage of people in surveys admit that they do not really read the information provided to them. A number of studies have tried to show that changing the length of a consent form or adding videos or other enhancements to the consent process may improve understanding, but the results show that no one approach, other than person-to-person discussion, seems to consistently increase understanding in the process of informed consent. Less is known about what information people really want. Although people say they are satisfied with the information received, asking them specific questions shows the limits to their understanding. Perhaps, she suggested, people do not want or feel they need some of the information that researchers think is necessary.

Grady discussed several implications of understanding and consent for longitudinal studies. Some evidence suggests that people forget information that was provided to them at an earlier point in time, she said. When asked at a later point in time what they remember, they remember much less, and say that they want more information, especially about things that they have determined over time have become meaningful to them. Questions remain about the right way to ensure that people are consenting over time, noting some studies might call for a legitimate reason to reconsent people. Other models, such as dynamic consent, sometimes used for biobanks, give participants a fair amount of control over how much they are sharing in a

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1 See https://www.who.int/bulletin/volumes/93/3/14-141390.pdf.

Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×

specific time, and they can pull their data or decide to be in one study but not another.

Consent understanding is complicated because science is complicated, Grady commented, and trying to explain to people what researchers are doing and why is challenging because health literacy and science literacy in general are quite low. A constant debate in the bioethics world centers on how much participants should understand in order to give consent, she related. Most people believe it depends on the kind of study; as risks or novelty increase, then maybe the threshold of understanding should be higher, but there are also different kinds of misunderstanding, some of which are probably more problematic ethically than others.

Turning to the next component of informed consent, voluntary decision about participating or continuing to participate, Grady explained this involves whether people feel like they can say no, whether they feel any pressure, and if so, from whom. Family and friends may apply pressure, but it could also come from the research team or a doctor. She said that some bioethicists think incentives place pressure on people, but others disagree.

Research examining why people continue to participate in longitudinal studies has identified three primary reasons, Grady reported. The most important reason is perceived benefit, that people either find medical benefit in terms of access to an experimental intervention, personal benefit like money or attention, or feeling good about what they are doing. The second reason is people feel good about making contributions to science and to others. The third is that many people say that they want to continue their commitment to the study. She noted that studies where people are asked if they were willing to participate in different kinds of studies have a similar pattern of findings: high levels of willingness, with decreased willingness when there is more risk or invasiveness, or when more time or burden is involved. She concluded by calling for a better understanding about why people want or do not want to participate in longitudinal studies, how to make them as convenient and low burden as possible, how to earn trust, and how incentives play a role.

ETHICAL CONSIDERATIONS FOR OBTAINING INFORMED CONSENT

Vetta Sanders Thompson commented that Grady’s presentation provides a good transition to a discussion of ethical issues encountered in longitudinal study consent, particularly variability over time and what participants are asked to consent to.

Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×

Consent as a Long-Term Relationship: Lessons for Longitudinal Studies

Stephanie Cargill is an associate professor of health care ethics at St. Louis University. She took a theoretical approach to question assumptions and frameworks in order to better achieve the goals of longitudinal research, especially with aging populations. She related that her work in the ethics of biobanking, biobanking consent, biobanking in communities, as well as challenges to traditional informed consent paradigms, apply to longitudinal studies in aging populations.

Cargill identified two central challenges unique to longitudinal studies: even if people understand the complex information about consent, the informational landscape very likely will change, meaning what the study will be doing and the risks might shift. In addition to the fact that the participants will probably change location over time, their values, priorities, and identities in a deeper sense might be different, which is problematic if the ethical onus rests on information and choice provided at the very beginning. Another challenge of consent in longitudinal studies is the issue of withdrawal and retention, she explained, which is a tension between the right and the ability for people to withdraw and the scientific validity of longitudinal studies that requires retention over periods of time.

As Cargill related, historically there have been many critiques of the traditional notion of consent, in which most of the ethical work of consent happens at a discrete event where someone is given information and then makes a choice. Consent is usually assumed to be unidirectional, meaning that the researchers or members of the research team provide information actively and have the responsibility for the information and context being appropriate, and the participants are seen as somewhat passive receivers. Even though the participants need to understand and choose, the responsibilities lay primarily on the givers of the information. Barriers to consent are often participants’ understanding or environmental factors, such as whether there is sufficient time or participants feel safe in that environment.

Cargill noted that for longitudinal studies, this model of the ethics of consent is problematic because researchers cannot provide enough information at the outset since neither they nor the participants know for sure what will happen in the future. To her, framing people as passive receivers of an intervention does not work if they are to be active in their consent and participation over time. Other models, such as broad consent, do not solve these problems because they do not provide an informed choice nor are people more active participants.

Cargill briefly reviewed alternative models of consent, emphasizing that the ongoing process of informed consent is more than checking back in with people. Rather, it means that consent is ethically valid over time and part of an ongoing relationship between the researchers and their participants

Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×

in terms of information and choice (Lidz et al., 1988). She cited Miller and Wertheimer (2010), who made an even deeper point that not only should consent be a process, but also it is a bidirectional process. Rather than the researchers holding all the responsibility for consent and making sure all the information is provided, there are responsibilities on both sides so participants make the choice that is appropriate to them.

Cargill’s work draws on the health communication literature, she said, making the argument that consent is a communication process. She argued that a very antiquated notion of how communication works is used by many researchers seeking consent. Known as the transmission model of communication, where there is a sender and a receiver and noise, this model of communication was rejected by scholars and researchers long ago, she said. Modern communication theories are much more complex and involve the relationship, the trust, the deferral of authority, the shaping of identities, and other concerns. She challenged workshop participants to think about what it means to be in an ethical relationship with people in longitudinal studies, and what it means for information and choice. Cargill said that for people to continue to participate ethically in longitudinal studies, they need to continue to make the choice to be in it. Both sides need to forge a relationship. She called for knowing what makes people want to be in, and continue to want to be in, these studies.

Alternative consent models lessen the ethical pressure to make sure at the beginning that all the information is given, it is understood, and consent is completely voluntary, all in that one discrete moment in time, Cargill said. These models lessen the pressure because information will continue to be disclosed, and choices will continue to be made. However, she cautioned that these models also require that researchers pay attention to the communities and populations with whom they are working and invest in a relationship with them. Trust needs to be built at the outset with access to desired information over time, she emphasized. Ways are needed to motivate people to continue, whether incentives or other types of services, but withdrawal has to be accessible as well.

Cargill provided some implications for studies on aging populations and emphasized that researchers should do their “homework” and think carefully about aging populations in different contexts with different capacities. She urged researchers to consider what people would want to know to make their initial decisions, what would motivate them to continue or to stop, and what is the best way to communicate. The bidirectional aspect of consent means that information needs to be gathered and given on both sides, she emphasized; not only are researchers giving information to participants, but also participants need to give information to researchers so the study can be designed in a way that accommodates and forges the correct relationship.

Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×

Cargill concluded that from an Institutional Review Board perspective, this type of consent is not so radically different that it does not satisfy the regulations. Researchers need to understand the risk level to argue for the nature of the initial consent in the process and for revisiting consent with funding built in. She suggested researchers can justify this consent by citing evidence that it increases retention.

Ethical Considerations for Obtaining Informed Consent in Longitudinal Studies of Aging

Emily Largent is the Emanuel and Robert Hart Assistant Professor of Medical Ethics and Health Policy at the University of Pennsylvania, and she holds a secondary appointment at the Penn Law School. Her research focuses on Alzheimer’s disease, and she said she has been keenly aware of the ethical challenges that arise when participants have or—as can occur in longitudinal studies of aging—may be expected to experience cognitive or functional impairment. Because it is important to include cognitively impaired older adults in studies, she said it is necessary to identify strategies to approach the consent process thoughtfully.

Largent noted that obtaining consent for research participation is a way of demonstrating respect for people, and it allows them to decide for themselves whether participating in research is consistent with their values, preferences, and interests. But, she said, individuals experiencing cognitive impairment typically experience an erosion of their ability to self-determine, i.e., to make choices about what they do and what happens to them. Largent pointed out this potential mismatch between the goals of informed consent for research and participants’ abilities to grant consent.

Largent highlighted three ethical considerations arising from this mismatch. First, researchers need a clear plan for assessing decision-making capacity and, in the event they discover that an older adult they are seeking to enroll lacks capacity, for ensuring the individual’s voice is still heard in the consent process. Second, researchers need to appreciate the challenges that arise from recruiting dyads that are comprised of a research participant and the research participant’s study partner. Third, researchers need to think about the importance of using the consent process to set participants’ expectations regarding the return of results.

In longitudinal studies of aging, some individuals will reasonably be expected to experience cognitive changes, she pointed out, and a goal of the research may be to examine how cognition changes over time. She noted that capacity is task and context specific and can fluctuate, waxing and waning over time, so a diagnosis of dementia does not necessarily mean that an individual lacks capacity. Tests of cognitive abilities may be predictive of decisional abilities, she explained, but typically are not appropriate for

Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×

gauging capacity. She also warned researchers not to rely on staff, such as those in a long-term care facility, to tell them who or who does not have the capacity to consent to research participation.

Largent said that for all of these reasons, investigators need to go into a study with a robust plan for how to assess prospective participants’ capacity to consent to research. She encourages them to engage in a dialog that includes opportunities for prospective participants to repeat back key concepts about the research, including what it involves and how participation might affect them. The investigator’s assessment of those answers, whether adequate or inadequate, helps inform a final determination of capacity. If the participant does not have capacity, the investigator typically needs to identify an appropriate surrogate decision maker, which can be a challenge and can constitute an obstacle to recruiting a representative sample.

Largent also noted that even if a surrogate provides permission for an older adult to participate in research, the investigator’s job, from an ethical perspective, is still not done because decision-making capacity requires understanding, appreciation, reasoning, and the ability to evidence a choice. Individuals who do not have capacity still may have one or more of these constituent abilities to a meaningful extent, she said. So, she continued, individuals with diminished capacity should generally be asked for their assent or they should be given an opportunity to dissent from participation in research, even if the researcher has already obtained permission from a surrogate decision maker. Because assent and dissent are big concepts, she urges investigators to plan not just for a capacity assessment, but how they will operationalize the idea of assent and dissent in practice or in the field.

Largent went on to note that in longitudinal studies, participants might experience cognitive decline and therefore diminished capacity as the study continues. In these instances, study visits should be seen as ongoing opportunities to check in with participants and ensure that continued participation is something that they are interested in and willing to do. In her view, formal reconsent to participation is not necessary unless there is a material change in information, such as changes in the risk-benefit balance, burdens, or if other material information becomes available. When additional consents are requested, such as a physical exam or biospecimen collection, Largent said a new capacity assessment may be necessary.

Largent suggested that researchers conducting longitudinal studies of aging may wish to consider alternative mechanisms, such as research advance directives, for participants to express their research-related wishes should they become incapacitated. Research advance directives are not widely used, she acknowledged, but they can be useful in sparking discussion among family members who may not otherwise have an opportunity to discuss an individual’s preferences regarding research participation. In

Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×

addition, completion of a research advance directive can be an opportunity to identify a surrogate to make decisions about research participation. To Largent, such a document might actually change the view or the kinds of research that can permissibly be conducted with individuals who lack decision-making capacity.

Turning to dyads, Largent explained aging research and Alzheimer’s disease research often require that individuals enroll with a study partner who is a knowledgeable informant and can provide information about the participant’s cognition and function. That information is sometimes used to determine study eligibility, but it can also be used to assess various outcome measures. Study partners can also play important roles in managing study logistics, providing transportation to an appointment, ensuring the participant has the appointment on their calendar, and monitoring the participant in between study visits. The partner is particularly important if there is an intervention, such as an investigational new drug, and the study is looking for side effects. A partner can also help ensure adherence to a study protocol. She noted that studies show that the decision to participate in research is often made collaboratively within a participant’s study partner dyad. Unsurprisingly, cognitively unimpaired older adults tend to make these decisions more independently, but they still talk about engaging with trusted others to discuss research participation.

Largent noted that dyads in which the research participant has either mild cognitive impairment or a dementia-level impairment may still engage in a highly collaborative process between the participant and the study partner, although the study partner takes on a more dominant role in decision making as the participant’s cognitive decline continues. This observation leads to an important consideration in recruitment and retention strategies that target the research participant as well as the study partner, she commented. She finds many study partners appreciate a call from the investigator to explain the study and its requirements so that they can see the value of the study and understand the value they are contributing to it. Flexible scheduling of appointments, telephone and video visits, and reimbursement and incentives for study partners should be considered, she added.

Largent cautioned that if having a study partner is an eligibility criterion, structural barriers, such as an adult child who is still in the workforce or taking care of their own family, make it harder to participate in research, leading to a lack of representativeness. Requiring a study partner would wholly exclude some populations, particularly unfriended older adults, an important population that has unmet needs and is worthy of research. She also said that triadic communication between a patient, family member, and a researcher can be a challenge for individuals with cognitive impairment because these individuals often feel like they are left out of a conversation—that people talk past them or about them,

Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×

instead of with them. Investigators need strategies for ensuring that they are talking with and receiving information from both members of a dyad, she urged.

Largent next highlighted the return of results, which may include genetic testing results, biomarker results, and cognitive testing results, among others. These results can provide insight into risk of cognitive and functional decline, reveal the presence of pathology, or illuminate changes over time, hinting perhaps at prognosis. Based on her research, Largent said older adults often value having this information and use it in different ways, including for their own health and health care decision making. For example, individuals who learn about their increased risk for Alzheimer’s disease report that they exercise more, eat fewer processed foods, and play brain games. Even when information is not viewed by older adults as being medically actionable, she continued, it may still have importance for life planning purposes. Participants may update wills and advance directives, make choices about working longer or retiring sooner, or engage in financial planning in anticipation of future care needs, she pointed out. Conversely, people who find that they are at less risk than they initially assumed for developing cognitive impairment due to Alzheimer’s disease talk about being reassured and feeling that they have a freer future in which to plan.

Largent said that information about risk diagnosis and prognosis is not just of interest to the older adult, but also to family members who might learn something about their own health. This is particularly clear when an older adult learns genetic information and shares it with genetic relatives. Family members might also learn something about their risk of caregiving, she added, which can change their own health behaviors and future plans.

With this background, Largent said that the consent process needs to be understood as an opportunity to set participants’ expectations about the return of results: Will results be shared at all? If so, which results, with whom, and under what conditions? An investigator’s offer to share clinically validated results can serve as a powerful incentive to participate in research. In addition, many participants feel the information is theirs and they are entitled to it, although others may prefer not to know. She emphasized making sure the consent process helps people understand what the results are and if results will be coming to them, and that information needs to be provided in the informed consent document.

Largent concluded that longitudinal studies of aging constitute an important means of understanding and addressing the needs of older adults and their family members; however, obtaining consent in such studies, particularly when individuals are at risk for or experiencing impaired decisional capacity, can be ethically challenging.

Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×

Ethical Considerations for Obtaining Informed Consent: Insights from Psychology

Sunita Sah is a professor and organizational psychologist at Cornell University. She shared insights from psychology, behavioral economics, and her own research to draw implications for longitudinal survey consent. She echoed the five elements for valid consent that Grady and other ethical and legal commentators have identified: consent should be voluntary, not coerced; people must have cognitive ability, the capacity to consent and not be impaired in any way; people should receive sufficient information on the risks, benefits, and the alternatives; and they should have an adequate understanding of the disclosed facts. Finally, they must either authorize, give informed consent, or decline by giving an informed refusal.

While it is necessary that the consent process provide disclosures of relevant information, Sah said her focus is on whether some disclosures have an impact on the other elements that are needed for valid consent, in particular the voluntary element. Her research has examined disclosures of potential risk, which can produce unintended burdens due to unexpected psychological effects that can occur.

To Sah, disclosure’s great promise is that it provides potentially useful information so that recipients can make an informed choice. However, she has uncovered some unintended consequences from disclosure. She asked the workshop audience to imagine going to a doctor who recommends that they enter into a clinical trial, but the doctor says that under disclosure rules, the doctor is required to disclose stock ownership in the company of this drug. Sah asked the audience: How does that make you feel? What do you do with that information? How do you respond to the doctor? She noted the likelihood of feeling extremely uncomfortable about signaling distrust in this type of situation or insinuating that the doctor could be biased or corrupt in any way.

Without disclosure of the conflict of interest, Sah posited, patients could present a range of reasons for rejecting the trial, including it sounds too risky, it is too painful, or that it may have undesirable side effects. After the doctor has disclosed a conflict of interest, it becomes salient that the refusal is more likely to be interpreted as being due to the disclosure, and this signals distrust in the doctor.

Sah described two psychological processes that increase pressure to comply with others, even when there is a decrease in trust. Insinuation anxiety is the reluctance to signal distrust due to the fear of insinuating that the other person is untrustworthy. She described it as an aversive, emotional state that occurs when people become concerned about offending the other person and implying they are something different than what they appear to be. She said that insinuation anxiety can have a great impact on behavior.

Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×

Another psychological process, called the panhandler effect, arises from pressure to help someone out and not wanting to appear unhelpful.

Sah said that both insinuation anxiety and the panhandler effect could appear in the same situation or sometimes only one is present. Both are tied to relationship concerns and pressures to not signal distrust or unhelpfulness, and both processes contribute to what she refers to as the burden-of-disclosure effect. The two forces work in opposing directions as to whether the person will take the advice or not. A person is placed in an effective bind about whether or not to follow advice or a recommendation. Sah said that the person is stuck between a rock and a hard place. Instead of being the warning that it is supposed to be, disclosure of potential risk can put a burden on those that it is supposed to protect, increasing the pressure to comply with recommendations.

Sah described a study where she tested these two hypotheses. Study participants, asked to take the perspective of patients, read about a common situation that they might encounter at a doctor’s office and they listened to their doctor give two options. The doctor gives the same recommendations in all the conditions. She introduced one situation as follows:

Imagine you are a patient suffering from early onset arthritis, and you’ve been seeing your rheumatologist, Dr. McLane, who you have known for the last three years. You are currently suffering from an acute attack which has left some of your joints aching and swollen. You decide to pay a visit to your doctor. After examining you and reviewing some of your test results, Dr. McLane says…

Sah said that participants then listen to a voice recording where the doctor recommends either entering a clinical trial or using a standard drug. There are two options, and the doctor always recommends entering the trial. In the disclosure condition, one more sentence is added to the voice recording, which is when the doctor discloses the financial conflict of interest. In this option, the doctor says, “I do think it is important, however, to let you know I will receive a referral fee from the manufacturer of the drug if I refer you for the clinical trial.”

Sah said that in the disclosure condition she saw a significantly decreased amount of trust in the doctor, but at the same time, reports of increased insinuation anxiety. She noted that both trust and insinuation anxiety matter when making a decision about whether or not to follow the advice. She also drew a distinction between compliance and consent; compliance is not valid consent, and it is unreliable and short lived. She referred to other studies that showed once people have an opportunity to change their mind in private, compliance drops immediately, and they reverse their decision. She said that this suggests an element of feeling

Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×

coerced, which decreases the aspect of voluntariness, a critical element of valid consent.

In another study, Sah and colleagues sought to increase consent but reduce insinuation anxiety. They added two additional conditions, one in which the doctor states that the disclosure is legally required and one in which a written disclosure is given to the patient by someone else before seeing the doctor. Her results showed that any disclosure decreased trust, regardless of whether it was voluntary, required by law, or given by someone else. However, insinuation anxiety is much higher if the disclosure is given face-to-face by the doctor, regardless whether it is seen as voluntary or required by law, and insinuation anxiety decreases when the disclosure is given by someone else.

Sah next described a large randomized preregistered field study conducted at Cleveland Clinic, taking advantage of a policy change about to be introduced that required physicians who received $20,000 or more from industry to disclose this information to patients. The researchers manipulated the policy change in a large field study of over 1,900 patients at two different outpatient clinics through a letter that either just scheduled an appointment (control condition) or included a disclosure of a financial conflict, with a detailed explanation on the second page about which companies the doctor had conflicts. The letter also manipulated whether patients received information on the risks, the benefits, or both of their physician having a financial relationship with the company.

Sah said that they were interested in whether, after receiving this letter, patients would go to their appointment, cancel it, or just not show up. Those patients who did see their physician were sent a survey within a week of their appointment. They obtained a 68 percent response rate for the survey, which tested patients’ knowledge and understanding of the information in the disclosure letter, as well as trust in the physician and the hospital. Seventy-two percent of the patients remembered receiving the letter, and 57 percent of people in the disclosure condition said they knew their physician had a conflict of interest. They found no effects on trust in the physician and the hospital in any of the conditions, or on appointment attendance.

Sah concluded by noting the implications of research to improve consent and retention and to reduce insinuation anxiety. To decrease the pressure, external disclosure works well. Giving the disclosure ahead of time, making sure it is salient, and making sure people understand that they can deliberate would help reduce insinuation anxiety, she said.

Discussion

Thompson asked John Phillips to launch the discussion. He asked Sah about the context of her study on disclosure of financial conflicts of

Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×

interest. He asked about any comparable issue in recruiting participants for a longitudinal aging study where there does not seem to be any financial conflict that would arise. He inquired whether incentive payments might be equivalent to a financial conflict.

Sah suggested thinking about the issue in terms of how uncertainty and how risks are presented. In additional studies where it was clear that the person asking does not have any personal agenda, she posited that the direct application is the balance of risks and benefits that are being communicated and how they are communicated. For example, if risks are communicated face-to-face, people have other unintended burdens placed on them. They might want to ask more questions or feel very uncomfortable with the risks, but dismiss them because of relationship concerns. Having time to deliberate beforehand and providing information about risks and benefits in a balanced way would increase valid consent and retain participants, she suggested, rather than obtaining consent on the spot and then having participants change their mind later.

Grady pointed out people have different incentives for participating, and they react very differently. Some participants believe if a large financial incentive is offered, then there is more risk involved in taking part in the study. Others are very persuaded by financial incentives. Sah posited how risks are communicated, whether face-to-face or whether people have time to focus on them, would be the biggest takeaway.

Phillips asked whether giving people time to leave and think about participating means that they might not come back. Sah replied that it will increase valid consent. She noted Jäckle also had evidence that when people have more time to deliberate, the more reflective people will end up consenting as opposed to giving a kneejerk reaction on the spot to consent because they feel pressured and then decline later.

Thompson asked the panel of presenters what they saw as the most pressing research needs. Grady said for each population or each kind of study, a better understanding is needed about what would motivate people and why they would care about participating. She referred to Cargill’s community engagement work and suggested it provides an important homework assignment for any study.

Cargill said that they have done a number of studies on the quality of the decision at the time of consent, but people make those decisions at very different times. She said some studies show that people have already decided when they walk in the door about whether they will do the study. She noted that once people have decided they will do something, they are not open to different information, and getting them to listen to the pros and cons is very difficult. She urged more understanding about how people make decisions through time as opposed to just in the immediate moment.

Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×

Phillips told Largent the idea of a study partner is compelling, but some people will not be able to get a study partner for various reasons. He asked about research or experience with the ways in which that challenge has been overcome. Largent replied that she and colleagues do a lot of work with study partners and try to understand who can and cannot find a study partner. They have found almost everyone can identify one person who might be willing to be a study partner, but typically it is only one person. As soon as people encounter an obstacle to asking that person to be their partner, quite a few participants are lost; it is much easier for people who are married and have a retired spouse. It varies by study, she commented, but researchers need to consider whether a study partner is necessary and whether there are other ways to gather information.

Phillips asked Cargill about getting ongoing consent and whether repeatedly asking participants if they want to be in the study makes them more likely to drop out. He questioned the risk of this approach for longitudinal studies. Cargill identified two kinds of longitudinal studies: in some cases, people provide samples and data, and the researcher wants to be allowed to continue to use it. This case provides an incentive to stay under the radar, because as long as they are not reminded, they are not going to withdraw. If they are reminded, there is a higher chance that they will drop out. However, Cargill called for a paradigm shift for longitudinal studies that requires continuous participation to think about how to motivate people to continue. She said that this is where community engagement comes in: People continue because they are getting something out of it. The key question, she said, is lessening the burden for people to continue or making them want to continue because they get something out of it. She said those ways improve retention without a researcher simply hoping that participants will forget, because that is not ethical consent.

Phillips asked if there is any concern about panel effects, such as providing research findings on the impact of managing diet on health that may result in participants changing their diets as a result. He noted how much people change their behavior based on this kind of information is not known, but the question comes up often and raises concerns about whether a true random sample is maintained. Cargill said that it is worth thinking carefully about what type of information is provided to participants to not undermine the data. She pointed to many different ways to provide added value to participants besides narrowly telling them the results of the study. It could be information about other areas of their lives, for example, but said it is important to do the homework and ask people what would motivate them to continue and what they would like to gain from the study.

Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×

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Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
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Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×
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Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×
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Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×
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Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×
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Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×
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Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×
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Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×
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Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×
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Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×
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Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×
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Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×
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Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×
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Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×
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Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×
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Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×
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Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×
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Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×
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Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×
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Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×
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Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
×
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Suggested Citation:"4 Informed Consent." National Academies of Sciences, Engineering, and Medicine. 2022. Improving Consent and Response in Longitudinal Studies of Aging: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26481.
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This Proceedings of a Workshop summarizes the presentations and discussions at the Workshop on Improving Consent and Response in Longitudinal Studies of Aging, which was held virtually and live-streamed on September 27-28, 2021. The workshop was convened by the Committee on National Statistics of the National Academies of Science, Engineering, and Medicine to assist the National Institute on Aging (NIA) with its methodological research agenda and inform the different longitudinal survey programs sponsored by NIA about practices and research to improve response and consent in other survey programs. The workshop was structured to bring together scientists and researchers from multiple disciplines and countries to share their research and insights on how to improve response and consent in large, representative longitudinal studies on aging.

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