Consent For Research Research Articles

Using smart supportive technology to explore nighttime rest in persons living with dementia

AbstractBackgroundSleep disturbances affect 60‐70% of persons living with dementia (PLWD) affecting prognosis and care burden. Sleep studies typically employ actigraphy, however, it is intrusive and lacks information on location. This study explores the use of ambient sensors, to compare nighttime rest patterns of higher and lower functioning PLWD.MethodStudy participants were recruited in a 16‐bed residential care setting for PLWD. Research ethics and consent were obtained. Pressure‐sensing bed mats, motion and door sensors were installed. The sensors were connected to a hub and the cloud.Participants were divided into lower‐ and higher‐functioning groups based on interRAI Home Care scores.An AI program created nightly summaries for each resident using the sensor: evening rest start / end time, number / duration of in room movements (iRM), and actual resting time (aRT) per night.ResultThe higher functioning residents (n = 7) had a mean age of 83.1 ± 11.0 years, as compared to the lower functioning group (n = 5): 85.0 ± 6.7 years. The lower functioning group had consistently higher mean interRAI scores and tended to have a greater number of medications.Preliminary data from 407 nights suggest that the total rest time was longer for the lower functioning group (12.3+/‐0.97 hr) than the higher functioning group (11.9 +/‐ 1.24 hrs). The lower functioning group had 1.83 +/‐ 1.86 iRMs per night, with an average duration of 13.8 +/‐ 11.0 mins. The higher functioning group had 3.34 +/‐ 2.12 iRMs per night, with an average duration of 15.2 +/‐ 9.3 mins. This resulted in an aRT of 11.8 +/‐ 1.04 hrs for the lower functioning group and 11.1 +/‐ 1.25 hrs for the higher functioning group.ConclusionAmbient sensors were used to collect longitudinal data on nighttime activities in PLWD within a communal living setting. The findings suggest evening rest differences between higher‐ and lower‐functioning PLWD. Residents with more advanced dementia appear to be resting more, and those with less impairment seem to have more and longer rest interruptions. This technology could be used to explore the usefulness of various interventions on rest quality.

Effectiveness and safety outcomes in patients with EBV+ PTLD treated with allogeneic EBV-specific T-cell immunotherapy (tabelecleucel) under an expanded access program (EAP) in Europe.

7521 Background: Pts with relapsed or refractory (r/r) EBV+ post-transplant lymphoproliferative disease (PTLD) in Europe have had historically poor overall response rates and median overall survival (OS) with no approved treatment options. Tabelecleucel, an off-the-shelf, allogeneic EBV-specific T-cell immunotherapy has shown clinical benefit and favorable safety profile in the treatment of EBV+ PTLD failing rituximab ± chemotherapy (Prockop EBMT 2021, ATC 2021, ASH 2022). Its recent European marketing authorization (EMA) represents the first approval of an allogenic T-cell immunotherapy globally. Methods: Atara Bio supported expanded access requests for tabelecleucel in Europe. Here we report updated effectiveness and safety data for r/r EBV+ PTLD pts who provided consent for research between Sep 2020 and Dec 2022. Results: 74 EAP requests were received from 10 countries for pts with r/r EBV+ diseases. 27 EBV+ PTLD pts consented to secondary use of data and 24 pts had received ≥1 dose of tabelecleucel, including 4 pts with primary central nervous system (PCNS) PTLD. 16 of 24 (66.7%) PTLD pts achieved a partial (PR) (33.3%) or complete (CR) (33.3%) response, with median time to response (TTR) of 1.0 mo (0.8–2.2). Response rate for PCNS PTLD pts was 75% (1 CR, 2 PR). 1-yr OS Kaplan–Meier (KM) estimate rates were 73.7% (95% CI: 47.3, 88.3) overall, 87.5% in allogeneic hematopoietic stem cell transplant (HCT) and 66.5% in solid organ transplant (SOT), with a median follow-up time of 9.9 (2.4–13.9) and 6.0 (0.7–18.0) mo, respectively. Serious treatment-emergent adverse events (TESAEs) were reported in 7 (29.2%) pts, including 1 fatal event of disease progression. Predefined risks for tabelecleucel were reported in 3 pts; 1 (4.2%) SOT pt had a TESAE of liver transplant rejection (grade 2) and 2 (8.3%) HCT pts had non-serious TEAEs of chronic graft-versus-host disease (grade 1 and 2). No cases of cytokine release syndrome or tumor flare reaction were reported. No AEs were reported as related to tabelecleucel by the treating physician. Conclusions: These updated real-world results for pts with r/r EBV+ PTLD post-HCT or post-SOT treated in the European EAP continue to reinforce the favorable risk:benefit profile of tabelecleucel and are in line with clinical study data supporting its recent EMA approval. [Table: see text]

Consenting in the time of the COVID-19 pandemic

Consenting in the time of the COVID-19 pandemic

Get this thing out of my body! Factors determining consent for translational oncology research: a qualitative research

BackgroundDepending on the needs of scientific research at a given time, biobanks make biological samples and data available to researchers. In this article, we aim to describe the reasons and underlying logic that determine the decision to grant or deny consent to the conservation of tumour samples in a biological resource platform for research purposes. We make use of the CARPEM biological resource platform model, where broad consent is required.MethodsThe results are based on semi-structured interviews, conducted between 2019 and 2021, with 25 individuals having various profiles.ResultsAll the people interviewed readily accepted the principle of conserving a tumour sample for research purposes. They explained their decision by citing the desire to participate in research dedicated to improving therapeutic medicine. Their trust in research institutions or in doctors was an important factor in their consent. The tumorous nature of the samples also played an important role, as did the absence of constraints. Finally, the high level of consent was also based on the difficulty they had in conceiving what the future risks might be once the sample had been taken, whereas the fact that they did not know the nature or purpose of the research to be carried out when they signed the consent form posed some problems. These results stem from a lack of a culture of ethics among the people interviewed.ConclusionThe information provided in the context of consent at the CARPEM tumour bank seems inadequate for consent to be considered 'informed', given the low level of knowledge that people have of the risks and issues. Information is missing even though we feel it would not change consent or only marginally. This raises questions, since part of the act of granting consent is based on the implicit trust French people have in the hospital that collects the data and in research practices in general. In the minds of those who participate, transparency is the ground on which trust rests. Lack of transparency could be deleterious for future research practices. However, it is not by striving to improve information leaflets that the consent-related information will improve but, rather, by more effectively helping future patients to assimilate that information.

Research recruitment and consent methods in a pandemic: a qualitative study of COVID-19 patients’ perspectives

BackgroundVirtual data collection methods and consent procedures adopted in response to the COVID-19 pandemic enabled continued research activities, but also introduced concerns about equity, inclusivity, representation, and privacy. Recent studies have explored these issues from institutional and researcher perspectives, but there is a need to explore patient perspectives and preferences. This study aims to explore COVID-19 patients’ perspectives about research recruitment and consent for research studies about COVID-19.MethodsWe conducted an exploratory qualitative focus group and interview study among British Columbian adults who self-identified as having had COVID-19. We recruited participants through personal contacts, social media, and REACH BC, an online platform that connects researchers and patients in British Columbia. We analyzed transcripts inductively and developed thematic summaries of each coding element.ResultsOf the 22 individuals recruited, 16 attended a focus group or interview. We found that autonomy and the feasibility of participation, attitudes toward research about COVID-19, and privacy concerns are key factors that influence participants’ willingness to participate in research. We also found that participants preferred remote and virtual approaches for contact, consent, and delivery of research on COVID-19.ConclusionsIndividuals who had COVID-19 are motivated to participate in research studies and value autonomy in their decision to participate, but researchers must be sensitive and considerate toward patient preferences and concerns, particularly as researchers adopt virtual recruitment and data collection methods. Such awareness may increase research participation and engagement.

Patient and researcher stakeholder preferences for use of electronic health record data: a qualitative study to guide the design and development of a platform to honor patient preferences.

This qualitative study aimed to understand patient and researcher perspectives regarding consent and data-sharing preferences for research and a patient-centered system to manage consent and data-sharing preferences. We conducted focus groups with patient and researcher participants recruited from three academic health centers via snowball sampling. Discussions focused on perspectives on the use of electronic health record (EHR) data for research. Themes were identified through consensus coding, starting from an exploratory framework. We held two focus groups with patients (n = 12 patients) and two with researchers (n = 8 researchers). We identified two patient themes (1-2), one theme common to patients and researchers (3), and two researcher themes (4-5). Themes included (1) motivations for sharing EHR data, (2) perspectives on the importance of data-sharing transparency, (3) individual control of personal EHR data sharing, (4) how EHR data benefits research, and (5) challenges researchers face using EHR data. Patients expressed a tension between the benefits of their data being used in studies to benefit themselves/others and avoiding risk by limiting data access. Patients resolved this tension by acknowledging they would often share their data but wanted greater transparency on its use. Researchers expressed concern about incorporating bias into datasets if patients opted out. A research consent and data-sharing platform must consider two competing goals: empowering patients to have more control over their data and maintaining the integrity of secondary data sources. Health systems and researchers should increase trust-building efforts with patients to engender trust in data access and use.

Co-designing and pilot testing an infographic to support patients/families through the REMAP-CAP consent process: a mixed-methods study protocol

BackgroundInformed consent is critical to the ethical conduct of clinical research and requires understanding of a trial including its purpose, process, potential risks and benefits, and alternatives to participation. This can be challenging for complex trials, such as platform trials, and in high-stress environments, such as the intensive care unit (ICU). REMAP-CAP (randomized, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia) is a platform trial which studies treatments for ICU patients with community-acquired pneumonia, including COVID-19. Patient/family partners (PFP) identified challenges during the REMAP-CAP consent process.MethodsThis is a patient-centred co-design study to refine and test an infographic to supplement current REMAP-CAP consent documents. Infographic prototypes were developed by patients, substitute decision-makers (SDMs), and researchers with lived experience in the ICU or with ICU research. We will apply a two-phase exploratory sequential, mixed-methods research design. In phase 1, we will conduct focus groups with ICU patients, SDMs, and research coordinators (RCs). We will use inductive content analysis to inform infographic refinement, to be pilot tested in phase 2. Phase 2 is a prospective study within a trial (SWAT) at ≤ 5 REMAP-CAP sites. We will collect self-reported data from patients/SDMs and RCs. The primary outcome is feasibility (eligible consent encounters, receipt of infographic, consent to follow-up, completion of follow-up surveys). Data will be integrated to understand if/how quantitative results build upon the qualitatively informed infographic.DiscussionPhase 1 results will be used to co-design an infographic, directly informed by the perspectives of patients, SDMs, and RCs involved in ICU research consent discussions. Results from phase 2 will determine the feasibility of infographic implementation in REMAP-CAP consent encounters. These feasibility data will inform a larger SWAT to evaluate our consent infographic. If successful, use of a co-designed infographic to support REMAP-CAP consent documents may improve the experience of consent for patients, SDMs, and RCs.Trial registrationThe Northern Ireland Hub for Trials Methodology Research SWAT Repository (SWAT no. 176)

Expanding the boundaries of previously obtained informed consent in research: Views from participants in the Personalised Risk-based Mammascreening study.

Understanding participants' concerns and information needs regarding broadened consent is crucial to ensure transparency and participant autonomy. Our study qualitatively examined these issues in women participating in the Personalized RISk-based MAmmascreening study (PRISMA). The original PRISMA informed consent was project-specific (i.e., breast cancer research), limiting the scope of secondary research. We explored participants' needs for broadened consent to preserve informed decision-making while maximising the potential re-use of data. Focus groups (FGs) were performed following a semistructured discussion guide. Two independent researchers analysed the data thematically using an inductive approach. Twenty-three asymptomatic women and 13 women diagnosed with breast cancer were randomly divided into six FGs. Four superordinate themes were identified: (1) Normalization, (2) Attitude towards the pharmaceutical industry, (3) Privacy and (4) Knowledge. Our participants viewed data sharing as an important conduit for advancing medical science. Perceived integrity was more often attributed to noncommercial than commercial parties, with a marked mistrust towards the pharmaceutical industry. Most requested information needs related to data protection. Participants' ideal consent process would confer a range of options; for example, they would be able to choose with whom data can be shared, whether data will be de-identified or anonymous, the expiration date of their consent and how, if requested, general and personal study results would be disclosed. Our participants expressed clear information needs and a strong desire to be actively engaged in future data sharing decisions. Given that many researchers collaborate with commercial parties, building public confidence in these institutions would be beneficial. Illustrative examples addressing privacy concerns and clarifying difficult terms would aid consent decision-making. Although our participants displayed great altruism in sharing their data and accepted that broad consent would ultimately facilitate future research, broad consent did not reflect their ideal situation. Dynamic consent may be an option but warrants further feasibility research. Women were recruited from the general breast cancer screening population. Their perceptions and information needs, as reported in this study, will not only inform broadened consent for PRISMA but ideally guide other consent templates and decisions regarding consent processes.

5613401 SICKLE CELL DISEASE GENOMICS OF AFRICA (SICKLEGENAFRICA) NETWORK: QUALITATIVE INTERVIEW FINDINGS ON REASONS FOR REFUSAL OF BROAD CONSENT

Background: Sickle Cell Disease Genomics of Africa (SickleGenAfrica) Network is a collaborative project to examine the overarching premise that genetic variation affects the body’s defence against intravascular haemolysis and the development of organ damage in sickle cell disease. In addition, SickleGenAfrica employs community engagement to address fundamental ethical issues relating to genomics research, and this study focussed on broad consent incorporated in the process of informed consent. Objectives: To identify the reasons why some SickleGenAfrica participants refused to provide broad consent for future use of their biological samples and information for other genomics research. Methods: Qualitative research using one-on-one telephone interviews Setting: SickleGenAfrica study sites in Nigeria and Tanzania Participants: SickleGenAfrica site investigators based in Abuja, Kano, Lagos and Dar es Salaam study sites Analysis: Inductive thematic analysis Results: Overall, findings from the SickleGenAfrica project revealed that broad consent for future genomics research was obtained from all participants at two study sites in Accra and Kumasi (Ghana). Nonetheless, a small number of participants at four study sites in Nigeria and Tanzania refused broad consent stating reasons including concerns about confidentiality, unavailable updated information for future research, and lack of immediate benefits from genomic research. In addition, psychosocial factors such as gender differences, family dynamics with autonomous decision-making, and beliefs about possible spiritual uses of blood samples. Furthermore, insufficient information and limited understanding about genomics research emerged as reasons for refusal of broad consent. Conclusions: Continuous education to address ethical issues in genomics research, culturally sensitive psychosocial interventions for participants, and recommendations from beneficiaries of genomics research are required to help obtain broad consent in Africa.

Contextual Vulnerability Should Guide Fair Subject Selection in Xenotransplantation Clinical Trials

Contextual Vulnerability Should Guide Fair Subject Selection in Xenotransplantation Clinical Trials

Waivers of informed consent in research with competent participants and the Declaration of Helsinki.

Waivers of informed consent in research with competent participants and the Declaration of Helsinki.

Refusal to participate in research among hard-to-reach populations: The case of detained persons.

Providing insights on refusal to participate in research is critical to achieve a better understanding of the non-response bias. Little is known on people who refused to participate, especially in hard-to-reach populations such as detained persons. This study investigated the potential non-response bias among detained persons, comparing participants who accepted or refused to sign a one-time general informed consent. We used data collected in a cross-sectional study primary designed to evaluate a one-time general informed consent for research. A total of 190 participants were included in the study (response rate = 84.7%). The main outcome was the acceptance to sign the informed consent, used as a proxy to evaluate non-response. We collected sociodemographic variables, health literacy, and self-reported clinical information. A total of 83.2% of the participants signed the informed consent. In the multivariable model after lasso selection and according to the relative bias, the most important predictors were the level of education (OR = 2.13, bias = 20.7%), health insurance status (OR = 2.04, bias = 7.8%), need of another study language (OR = 0.21, bias = 39.4%), health literacy (OR = 2.20, bias = 10.0%), and region of origin (not included in the lasso regression model, bias = 9.2%). Clinical characteristics were not significantly associated with the main outcome and had low relative biases (≤ 2.7%). Refusers were more likely to have social vulnerabilities than consenters, but clinical vulnerabilities were similar in both groups. The non-response bias probably occurred in this prison population. Therefore, efforts should be made to reach this vulnerable population, improve participation in research, and ensure a fair and equitable distribution of research benefits.

Association of poor perceived work ability and psychosocial work-related factors in health and social service worker age groups: a cross-sectional study

ObjectivePrevious work ability studies have primarily focused on old workers and physical health. This study investigated how poor perceived work ability (PPWA) is associated with work-related factors in different health...

Patient Information and Consent for Care in the Intensive Care Unit

In this paper, we review the ethical issues involved in providing information to, and obtaining consent (for treatment and/or research) from patients in the intensive care unit. We first review the ethical obligations of the physician in treating patients, who are by definition, vulnerable, and often unable to assert their autonomy during situations of critical illness. Providing clear and transparent information to the patient about treatment options or research opportunities is an ethical and, in some cases, legal obligation for the physicians, but may be rendered difficult, not to say impossible in the intensive care unit by the patient's health state. In this context, we review the specificities of intensive care with respect to information and consent. We discuss who the right contact person is in the ICU setting, with possible choices including a surrogate decision maker, or a member of the family, in the absence of an officially designated surrogate. We further review the specific considerations relating to the family of critically ill patients, and the amount and type of information that may be given to them without breaching the tenets of medical confidentiality. Finally, we discuss the specific cases of consent to research, and patients who refuse care.

Informing a European guidance framework on electronic informed consent in clinical research: a qualitative study

BackgroundElectronic informed consent (eIC) may offer various advantages compared to paper-based informed consent. However, the regulatory and legal landscape related to eIC provides a diffuse image. By drawing from the perspectives of key stakeholders in the field, this study aims to inform the creation of a European guidance framework on eIC in clinical research.MethodsFocus group discussions and semi-structured interviews were conducted with 20 participants from six stakeholder groups. The stakeholder groups included representatives of ethics committees, data infrastructure organizations, patient organizations, and the pharmaceutical industry as well as investigators and regulators. All were involved in or knowledgeable about clinical research and were active in one of the European Union Member States or at a pan-European or global level. The framework method was used for data analysis.ResultsStakeholders underwrote the need for a multi-stakeholder guidance framework addressing practical elements related to eIC. According to the stakeholders, a European guidance framework should describe consistent requirements and procedures for implementing eIC on a pan-European level. Generally, stakeholders agreed with the definitions of eIC issued by the European Medicines Agency and the US Food and Drug Administration. Nevertheless, it was raised that, in a European guidance framework, it should be emphasized that eIC aims to support rather than replace the personal interaction between research participants and the research team. In addition, it was believed that a European guidance framework should include details on the legality of eIC across European Union Member States and the responsibilities of an ethics committee in the eIC assessment process. Although stakeholders supported the idea to include detailed information on the type of eIC-related materials to be submitted to an ethics committee, opinions varied on this regard.ConclusionThe creation of a European guidance framework is a much needed factor to advance eIC implementation in clinical research. By collecting the views of multiple stakeholder groups, this study advances recommendations that may facilitate the development of such a framework. Particular consideration should go to harmonizing requirements and providing practical details related to eIC implementation on a European Union-wide level.

Variations in the Drainage Pattern of Testicular and Renal Veins, and Bilateral Duplication of Renal Arteries with Prehilar Divisions

The dissection of a 76-year-old male donor with a consent for research and publication, revealed variations of the renal and testicular vasculature where the right testicular vein joined a right accessory renal vein to form a common trunk that opened into the right renal vein. The left renal vein descended obliquely to the left ventral to the pair of left renal arteries, under crossed the prehilar branches of the arteries dorsally as it approaches the left kidney and entered the hilum posterior to the arterial branches. Both kidneys were supplied by two renal arteries (superior and inferior). The left superior renal artery followed the course of the left renal vein, crossed inferiorly ventral to the inferior renal artery, and then the last part of the left renal vein to enter the lower corner of the hilum of the left kidney. The bilaterally duplicated renal arteries broke up into anterior and posterior prehilar (early) divisions that entered the respective kidney. The co-occurrence of such multiple and complex a variation is of nephron-urological importance and can complicate nephro-surgeries, interventional radiologic procedures and the management of abdominal aortic aneurysm.

Disparities in germline testing by race/ethnicity and preferred language in patients with prostate cancer.

112 Background: A remote Genetic Testing Station (GTS) workflow was implemented at an academic medical institution to expand access to genetic testing for patients with prostate cancer. During a telephone appointment, a genetic counselor assistant collects family history and facilitates genetics education, research consent, and remote sample collection for multi-gene panel testing. We compared testing completion and patient loss from workflow based on race/ethnicity and preferred language to identify disparities. Methods: Metrics were collected prospectively and analyzed retrospectively for patients with metastatic or high-grade prostate cancer referred to genetics between 3/15/2020 – 6/30/2022. Self-reported race, ethnicity, and preferred language were collected by chart review. Testing completion was compared between groups using Fisher’s exact test, with White non-Hispanic (WNH) and Preferred Language English (PLE) cohorts as controls. Odds ratios and 95% confidence intervals were reported. Patient loss at workflow checkpoints (scheduling, consenting, sample collection, and results release) was summarized for each group. Results: 827 eligible patients were identified: 78 (9%) Asian /Pacific Islander (API), 51 (6%) Black non-Hispanic (BNH), 42 (5%) Hispanic, and 625 (76%) WNH. 31 patients reporting other non-Hispanic race were not included in the analysis. 30 patients (4%) self-reported Preferred Language non-English (PLNE) and 797 (96%) PLE. BNH patients were significantly less likely to complete testing compared to WNH patients (OR 0.320, 95%CI: 0.168, 0.632, p<0.001). There was no difference in testing completion in API (OR 0.918, 95%CI: 0.467, 1.944, p=0.797) or Hispanic (OR 0.743, 95%CI: 0.325, 1.918, p=0.466) compared to WNH patients. PLNE were significantly less likely to complete testing (OR 0.393, 95%CI: 0.171, 0.965, p=0.016) compared to PLE patients. Patient loss occurred primarily at consenting and sample collection. 14% of BNH, and 9% of Hispanic patients did not consent, compared to 4% of WNH. 17% of PLNE did not consent compared to 5% of PLE patients. 13% of BNH did not return a sample, compared to 3% of WNH patients. Conclusions: In remote GTS, BNH and PLNE patients were significantly less likely to complete germline testing than WNH and PLE patients respectively. Disparities in patient loss were most pronounced at consenting and sample collection. Measures to mitigate disparities include assisted consenting (with interpreter as needed) and video-assisted or in-clinic sample collection. [Table: see text]

Germline testing for men with prostate cancer: Need to broaden the indications in Europe?

383 Background: The clinical role of germline testing (GT) for prostate cancer (PC) is rapidly increasing due to the growing implications of precision medicine in metastatic disease, where genetic results can address eligibility for novel targeted treatments. Thus, ESMO and NCCN guidelines recommend GT for all metastatic PC individuals, whereas American testing criteria are more broad and include family history and other tumor features, such as high-risk disease, or intraductal or cribriform histology. Methods: We have retrospectively collected and analyzed clinical and genetic features of men with PC who underwent single-gene or multi-gene GT at some Swiss Institutions with expertise in hereditary cancers from July 2018 until October 2022. All patients (pts) have given written informed consent for research. Results: 109 men with PC underwent GT and received pre- and post-test counseling. Of these, 54 (50%) were metastatic, 34 (31%) had high-risk localized disease according to NCCN criteria, 7 (6%) presented cribriform or intraductal histology. A significant family history, as defined by current NCCN guidelines, was found in 79 (72%). 67 (61%) had no pathogenic (P) or likely pathogenic (LP) variants; 25 (23%) had a variant of unknown significance (VUS); 17 (16%) were found to have a P/LP variant in the following genes: BRCA2 (8), ATM (4), BRIP1 (1), FANCA (1), NBN (1), POT1 (1), TP53 (1). Among these 17 pts, the median age at diagnosis was 66 (45-80), 10 had metastatic disease, 5 had high-risk localized disease, 14 had a family history and 5 had a personal history of another cancer. Only 6 pts were <60 years old at the time of diagnosis. Cascade screening was offered to 16 families (94%). Conclusions: Our preliminary data support the increasing role of GT in PC and suggest the need to expand its indications. In this cohort, 7/17 (41%) of men with localized PC were found to carry P/LP variants and would not have met the criteria to undergo GT according to current European guidelines. GT may have treatment implications for metastatic PC pts whereas in early stage disease can inform cancer risk and screening for pts and their male and female relatives.

94. Implementing Online Public Deliberations on Minor Consent for Biomedical HIV Prevention Research in Diverse Cities

94. Implementing Online Public Deliberations on Minor Consent for Biomedical HIV Prevention Research in Diverse Cities

Patient Perspectives and Preferences for Consent in the Digital Health Context: State-of-the-art Literature Review.

The increasing integration of digital health tools into care may result in a greater flow of personal health information (PHI) between patients and providers. Although privacy legislation governs how entities may collect, use, or share PHI, such legislation has not kept pace with digital health innovations, resulting in a lack of guidance on implementing meaningful consent. Understanding patient perspectives when implementing meaningful consent is critical to ensure that it meets their needs. Consent for research in the context of digital health is limited. This state-of-the-art review aimed to understand the current state of research as it relates to patient perspectives on digital health consent. Its objectives were to explore what is known about the patient perspective and experience with digital health consent and provide recommendations on designing and implementing digital health consent based on the findings. A structured literature search was developed and deployed in 4 electronic databases-MEDLINE, IEEE Xplore, Scopus, and Web of Science-for articles published after January 2010. The initial literature search was conducted in March 2021 and updated in March 2022. Articles were eligible for inclusion if they discussed electronic consent or consent, focused on the patient perspective or preference, and were related to digital health or digital PHI. Data were extracted using an extraction template and analyzed using qualitative content analysis. In total, 75 articles were included for analysis. Most studies were published within the last 5 years (58/75, 77%) and conducted in a clinical care context (33/75, 44%) and in the United States (48/75, 64%). Most studies aimed to understand participants' willingness to share PHI (25/75, 33%) and participants' perceived usability and comprehension of an electronic consent notice (25/75, 33%). More than half (40/75, 53%) of the studies did not describe the type of consent model used. The broad open consent model was the most explored (11/75, 15%). Of the 75 studies, 68 (91%) found that participants were willing to provide consent; however, their consent behaviors and preferences were context-dependent. Common patient consent requirements included clear and digestible information detailing who can access PHI, for what purpose their PHI will be used, and how privacy will be ensured. There is growing interest in understanding the patient perspective on digital health consent in the context of providing clinical care. There is evidence suggesting that many patients are willing to consent for various purposes, especially when there is greater transparency on how the PHI is used and oversight mechanisms are in place. Providing this transparency is critical for fostering trust in digital health tools and the innovative uses of data to optimize health and system outcomes.