Certificate Of Confidentiality Research Articles

Increasing socioeconomically disadvantaged patients’ engagement in breast cancer surgery decision-making through a shared decision-making intervention (A231701CD): protocol for a cluster randomised clinical trial

IntroductionSocioeconomic disparities for breast cancer surgical care exist. Although the aetiology of the observed socioeconomic disparities is likely multifactorial, patient engagement during the surgical consult is critical. Shared decision-making may...

Certificates of confidentiality and unexpected complications for pragmatic clinical trials.

IntroductionThe need to protect the confidentiality of research data has long been recognized. One means to help protect research data from use in civil or criminal matters in the United States is a Certificate of Confidentiality (CoC). Until recently, investigators applied for a CoC when conducting research that was sensitive, stigmatizing or where the disclosure of private information could possibly result in civil or criminal liability. However, effective October 1, 2017, CoCs are automatically issued for much research supported by the National Institutes of Health (NIH). While automatic issuance reduces administrative burden, it also poses some surprising unanticipated challenges for research in general and pragmatic clinical trials (PCTs) in particular, which are key elements of learning health systems.MethodsWe reviewed the new policy on CoCs to identify and analyze issues related to it that are potentially problematic for PCTs.ResultsWe identified three relevant issues: (1) whether the EHR may be populated with research data that may be sensitive or stigmatizing without explicit consent from subjects; (2) incomplete protections for sensitive data in the EHR; and (3) requirements for notifying subjects about the CoC provisions.ConclusionFormal guidance from the NIH is needed to address the application of CoCs to the setting of PCTs. In the meantime, it is essential for researchers designing and conducting PCTs, as well as health care systems in which this research is conducted, to be aware of the nuances inherent in CoCs so they can best adhere to their legal obligations regarding them. In the absence of guidance, special attention should be paid to pragmatic research that populates the electronic health record with research data as well as research conducted without explicit consent. Given the large amount of pragmatic research precipitated by the Coronavirus Disease 2019 pandemic, which has been accompanied by major efforts to share data, the need for such guidance is especially urgent.

40. Using Respondent Driven Sampling To Estimate Homicide And Motor Vehicle Crash Risk Among Adolescents And Young Adults In A Latino Community

Young people at highest risk of injury are often excluded when school or household based sampling methods are used. Respondent Driven Sampling (RDS), a variant of chain referral sampling, has been used to recruit probability samples of populations who are hard to reach or recruit into studies. In this study, RDS was used to ensure the inclusion of youth who do not attend school regularly or lack residential stability. RDS analysis estimated the proportion of young people in a Latino community who are at risk for homicide and being in a motor vehicle crash (MVC). Four initial participants (“seeds”) were selected based on desired inclusion characteristics. “Seeds” completed questionnaires and were given coupons to recruit up to three additional participants from their social networks. Seed-recruited participants then completed questionnaires and became recruiters for the next wave. The process continued for 30 days. Questionnaires were self-administered at a local public library in either Spanish or English on a computer tablet using REDCap. A Certificate of Confidentiality was obtained prior to data collection. Adolescents who lived within the defined geographic area; were between the ages of 14-21; and were “seeds” or recruited by prior study participants were eligible to participate in the study. The sampling frame was constructed based on questions that each participant answered about their network size and relationship to their recruiter. To obtain unbiased population estimates, all analyses were weighted to accommodate the RDS design. Weighted means and 95% confidence intervals were calculated using Stata/SE (version 15). With four “seeds” and a maximum of 10 waves, 129 participants were recruited. 88% were Latino, 57% male, 54% 14-18 years old, and 46% 18-21 years old. All variables reached equilibrium by four waves. RDS population estimates (95% CI) indicate that 34.1% (26.4-42.7%) of youth in the area do not regularly attend school and 9.8% (6.1-15.1%) are unstably housed. 48.4% (39.8-57.1%) recently used alcohol, 47.2% (38.5-56.1%) have significant depression symptoms, and 20.7% (13.9-29.8%) binge drink. Based on responses to a Violence Perpetration and Injury Scale, 29.4% (22.1-38.1%) are at risk for homicide. 16.7% (11.4-23.7%) got into a serious physical fight, 12.2% (7.7-18.7%) took part in a group fight, and 9.6% (5.9-15.3%) hurt someone badly enough that they needed bandages or care from a doctor. The most prevalent MVC injury risk behaviors were riding in a car where the driver was: talking on a cell phone 72.8% (64.5-79.7%), texting 62.3% (53.3-70.6%), upset or stressed 60.9% (51.9-69.1%); and not wearing a seatbelt 59.9% (51.2-67.9%). An alarming number of young people in this community are at risk for homicide and a MVC. RDS was an effective recruitment strategy to include youth who do not regularly attend school or lack residential stability. Their life experiences need to be included as we try to understand and prevent homicide and MVCs in urban Latino communities.

ASSESSING THE IMPACT OF DISCLOSING AMYLOID IMAGING RESULTS TO COGNITIVELY NORMAL OLDER ADULTS: THE REVEAL-SCAN STUDY

Large-scale clinical trials now use PET neuroimaging and genetic testing to identify high-risk populations in which to test potential preventive therapies for Alzheimer's disease (AD). Many practical and ethical issues are involved in decisions about if, when, and how to communicate such biomarker information to cognitively normal individuals. Our multi-site, interdisciplinary group has conducted a series of randomized trials known as the REVEAL Study, examining the psychological and behavioral impact of disclosing APOE genotype information to asymptomatic adults with a family history of AD. This presentation describes protocol development for a newly launched REVEAL trial assessing effects of disclosing amyloid neuroimaging results to a diverse sample of at-risk older adults. A four-site randomized trial will enroll 270 adults aged 65–80 (at least 25% African American) with a first-degree relative diagnosed with AD or related dementia. APOE genotyping will enrich the study sample for increased likelihood of elevated amyloid PET scan results, but APOE results will not be shared with participants. Trial participants will be educated about amyloid neuroimaging and then randomized to receive either immediate or delayed disclosure of scan results. A series of longitudinal surveys and neuropsychological assessments will assess study outcomes of interest. Study protocol development has generated: 1) in-depth education materials and counseling aids focused on explaining the process, purpose, and limitations of amyloid neuroimaging; describing the implications of test results for future risk of AD; and providing resources and recommendations for AD risk modification; 2) a battery of validated and newly created measures that assess participants’ cognitive functioning, understanding of test results, psychological reactions, health behavior changes, and health utilization; and 3) mechanisms for addressing human subjects protection issues (e.g., external study advisory board, Certificate of Confidentiality, mental health resources in case of catastrophic reactions). This project is designed to yield information on the benefits, risks, and limitations of disclosing amyloid neuroimaging results to cognitively normal older adults across diverse cultural backgrounds. Study results will show the effects of amyloid imaging on cognition, social relationships, and behavior: findings that will help inform best practices for disclosure of AD biomarker information in research and clinical contexts.

Navigating high-risk surgery: protocol for a multisite, stepped wedge, cluster-randomised trial of a question prompt list intervention to empower older adults to ask questions that inform treatment decisions

IntroductionOlder patients frequently undergo operations that carry high risk for postoperative complications and death. Poor preoperative communication between patients and surgeons can lead to uninformed decisions and result in unexpected...

Exploring the Lived Experience of Trauma Among Obstetric Registered Nurses

Paper Presentation Objective To describe and analyze the lived experiences of obstetric registered nurses (RNs) encountering trauma while providing direct care. Design Hermeneutic phenomenology. Setting New York City. Sample Ten eligible obstetric nurses were recruited in using convenient, purposive, and snowball sampling. We also collected other data, including etymological history of the words, idiomatic phrases related to the phenomenon, and experiential descriptions in literature, biographies, diaries, art, and phenomenological literature. Methods Institutional review board approval and a Certificate of Confidentiality from the National Institute of Nursing Research were obtained prior to collecting data. Interviews were recorded, transcribed, and analyzed based on van Manen's stages of reflective analysis to arrive at the essential meaning of the phenomenon. Results Though experiences with trauma varied, the most common experiences included maternal death, intrauterine fetal demise (IUFDs), and emergency cesarean. Seven essential themes were uncovered as follows: (a) an internal process , (b) being faced with the unexpected , (c) going through the motions , (d) feeling helpless , (e) engaging others , (f) a visceral imprint , and (g) a damaged person. Conclusion/Implications for Nursing Practice Trauma is the emotional or psychological state of discomfort or stress resulting from an overwhelming event or series of events while providing direct care. Exposure to trauma has negative consequences for nurses, including mental, physical, and/or emotional health issues leading to problems such as posttraumatic stress disorder (PTSD), burnout, poor nursing care, and patient safety risk. For participants, trauma was an unforgettable, deeply personal, and complex experience. It is important that obstetric RNs and outsiders recognize that trauma is ever present in the obstetric specialty. The critical insight gained from this study provides valuable information to enrich our awareness about the vulnerability of obstetric nurses to trauma, to begin a conversation about how to improve the work environment for nurses, and to enhance the care they provide to their patients. We provide recommendations for practice, education, and research.

A randomized study of the effect of anonymity, quasi-anonymity, and Certificates of Confidentiality on postpartum women's disclosure of sensitive information

BackgroundUnder-reporting of substance use and other sensitive information is a substantial threat to internal study validity, particularly during the perinatal period. Anonymous approaches are associated with greater disclosure but are incompatible with longitudinal follow-up. Alternative approaches include use of a U.S. Federal Certificate of Confidentiality (CoC) and quasi-anonymous methods, in which there is no link between name and data. However, the relative effect of these procedures on disclosure is unknown. This randomized study was designed to evaluate the effects of consent condition (anonymous, quasi-anonymous, CoC, and traditional confidentiality) on disclosure of sensitive information among postpartum women. MethodsParticipants were 200 postpartum, primarily African-American women who were randomly assigned to one of the four consent conditions and completed a brief computer-delivered assessment of alcohol and drug use, sexual risk, intimate partner violence, and emotional distress. ResultsParticipants in the anonymous and quasi-anonymous conditions disclosed significantly more sensitive information than those in the traditional consent condition. In contrast, no advantage in overall disclosure was observed for the CoC condition. This result was largely consistent across specific content areas with the exception of emotional distress, disclosure of which was unrelated to consent condition. ConclusionsAlthough use of a CoC has limited impact on disclosure, the quasi-anonymous method may increase disclosure to a similar extent as full anonymity. Quasi-anonymous approaches should be considered when under-reporting is likely, a context in which the disadvantages of this approach must be balanced against its advantages.

Certificates of Confidentiality: Legal Counsels' Experiences with and Perspectives on Legal Demands for Research Data

The certificate of confidentiality (Certificate) is an important tool for protecting identifiable, sensitive human subjects research data in the United States. However, little is known about the Certificate's effectiveness in protecting identifiable data. We interviewed 24 legal counsel representing U.S. research institutions about their experiences with legal demands for research data. Our respondents reported few, if any, legal demands over the course of their tenure, but two-thirds had experience with legal demands for data protected by a Certificate. They reported such demands often were resolved without disclosure of identifiable research data, typically without court intervention. While our respondents reported similar success protecting identifiable data in court, they often did not rely on the Certificate to do so.

Certificates of Confidentiality and the Marshfield Clinic's Personalized Medicine Research Project

Enrollment in research studies is often limited by the fear that one’s personal information cannot be kept private. One way researchers can address this is by obtaining a certificate of confidentiality (CoC) for their study. This article briefly reviews what a certificate of confidentiality is, how to obtain one, and the Marshfield Clinic’s experience in recruiting for the Personalized Medicine Research Project.

Depression in a Random Sample of Incarcerated African-American Men

To the Editor: Approximately two million individuals are incarcerated in the United States. Correctional institutions currently house more individuals with serious and persistent mental illness than any other type of U.S. institution (1). Given the disproportionate incarceration of African-American men and the difficulty they experience in accessing mental health treatment services outside of correctional environments (2), insight into their mental health status is critical for informing novel treatment approaches for such a vulnerable population. This study was conducted between April and August 2008 in one of the largest maximum-security male correctional institutions in the U.S. The Beck Depression Inventory (BDI) (3) was administered to assess depressive symptoms among 134 randomly selected incarcerated African-American men. Pearson's correlation coefficients (r) were computed to examine relationships between interval and ratio variables; chi square tests evaluated differences between categorical variables. Logistic regression estimated odds ratios (ORs) and associated confidence intervals (CIs) for depression and the following participant characteristics: age, marital status (married or unmarried), education level, probation or parole status when arrested, previous incarceration, total time incarcerated, and sentence received. Each participant was required to read a non-signatory consent form; placing a check mark at the end of this form confirmed their verbal agreement to participate in the study. This study was approved by the institutional review boards of the research community and the Department of Corrections. A certificate of confidentiality was received to further protect participants' rights. Study participants' ages ranged from 25 to 74 years (mean±SD=42.1±10.8). A majority (80%, N=107) were not married. Eighty-four percent (N=113) possessed at least a high school diploma or GED. Half of the sample (50%, N=67) reported being previously incarcerated. Most (69%, N=92) were currently incarcerated for violent offenses. On average, participants had been incarcerated for 13.1 years. The mean sentence length was 37.5±25.4 years. Overall, the mean BDI score was 11.22±7.03, an indicator of mild clinical depression according to recommended standards (4). Forty-three percent of the participants (N=57) were classified as clinically depressed. Among the depressed participants, 29% (N=39) were considered moderately depressed, 11% (N=15) were moderately to severely depressed, and 2% (N=3) were severely depressed. There were several statistically significant differences between participants whose BDI scores were in the depressed range and those whose scores did not meet the depression criterion. [A table presenting data on these differences is available in an online supplement at ps.psychiatryonline.org.] Age was significantly correlated with depression (r=.18, p<.05); older participants were more likely to experience depression. Participants with at least a high school diploma or GED were more likely than those without a high school education to experience depression (χ2=3.82, df=1, p<.05). Participants on probation or parole when arrested were less likely to experience depression than those who were not on probation or parole when arrested (χ2=7.98, df=1, p<.05). Participants with at least a high school education were almost three times as likely as their less educated counterparts to experience depression (OR=2.88, 95% CI= .96–8.59) [see additional table in the online supplement for this analysis]. Being on probation or parole at the time of arrest was associated with lower levels of depressive symptoms (OR=.27, 95% CI=.11–.67). These findings suggest that corrections officials should consider age, education level, and probation-parole status when adopting treatment approaches. Helping prisoners implement a comprehensive treatment plan that could be used consistently after release could significantly improve the likelihood that they will not be reincarcerated (5), allowing them time to adjust to mainstream society after release.

Just Say “I Don't”: Lack of Concordance Between Teen Report and Biological Measures of Drug Use

Prevalence estimates of illicit drug use by teens are typically generated from confidential or anonymous self-report. While data comparing teen self-report with biological measures are limited, adult studies identify varying degrees of under-reporting. Hair analyses for cocaine, opiates and marijuana were compared to confidential teen self- and parent-reported teen drug use in a longitudinal cohort of >400 high-risk urban teens and parents. Both teens and parents substantially underreported recent teen cocaine and opiate use. However, compared with parents, teens were more likely to deny biomarker-verified cocaine use. Teen specimens (hair) were 52 times more likely to identify cocaine use compared with self-report. Parent hair analyses for cocaine and opiate use were 6.5 times and 5.5 times, respectively, more likely to indicate drug use than were parental self-report. The lack of concordance between self-report and bioassay occurred despite participant's knowledge that a "certificate of confidentiality" protected both teen and adult participants, and that the biological specimens would be tested for drugs. These findings confirm prior reports of adult under-reporting of their own drug use while extending our understanding of teen's self-admitted drug use. The lack of concordance between teen self- or parent-reported teen drug use and biomarkers confirm our concerns that both teen- and parent-reported teen drug use is limited, at least for youth in high-risk urban settings. Methods of ascertainment other than self- or parent-report must be considered when health care providers, researchers and public health agencies attempt to estimate teen drug-use prevalence.

Obtaining an NIH Certificate of Confidentiality to Protect the Identities of Research Participants

Certificates of Confidentiality (CoC) can be obtained from the National Institutes of Health (NIH) to protect researchers from forced disclosure of their participants’ personally identifiable information. We recently applied for an NIH CoC and it was approved. In this article, we describe an NIH CoC and why you might want one. Then we share our experiences in getting one, including one unexpected snag, and what we learned about CoCs that surprised us.

Certificates Should Be Retired

In their thoughtful Policy Forum on research ethics, “Certificates of Confidentiality and compelled disclosure of data” (14 November 2008, p. [1054][1]), L. M. Beskow, L. Dame, and E. J. Costello describe a case where research records, despite having this Certificate, were not fully protected from a court-ordered subpoena. Considering this case and our Institutional Review Board (IRB) experiences, we wonder whether the Certificate, unevenly required by IRBs and time-consuming to obtain, provides any additional, substantive protections to research subjects. Currently, Informed Consent and HIPAA authorization documents explicitly state how research data will be secured, with whom data may be shared, and what monitoring agencies may have access. Furthermore, consent documents often state which information (e.g., child or elder abuse) will be disclosed to authorities. These explicit data-sharing permissions and protections appropriately cover all research records, regardless of their supposed “sensitive” or “nonsensitive” content. Obtaining a Certificate of Confidentiality from NIH places burdens on investigators and lengthens informed consent documents already laden with confusing legal language. If time is critical, investigators may choose to remove sensitive questions or instruments to achieve more rapid IRB approval. Hence, the value of the research may be compromised. With the goals of enhancing subject recruitment and obtaining honest research data on sensitive topics, one must weigh the purported benefits of the Certificate against their potential impedance of established legal and judicial system processes. As imperfect as those processes may be, we believe that the effectiveness of legal arguments and the privacy rights provided to all research subjects by covered entities should govern final judicial decisions, and not a Certificate selectively issued by NIH. [1]: /lookup/doi/10.1126/science.1164100

Research Participants' Perceptions of the Certificate of Confidentiality's Assurances and Limitations

THE CERTIFICATE OF CONFIDENTIALITY (COC) provides additional protections to personal and sensitive research data. COC guarantees are not absolute and investigators are obligated to inform potential participants of COC limitations. The present study utilized qualitative and partnership methodology to examine participants' (N = 24) perceptions of COC assurances and limitations in the context of a hypothetical study on depression. Although some participants were comforted by COC assurances, a majority of participants had confidentiality/privacy concerns specifically with COC passages concerning federal audits and legal reporting requirements. As one respondent noted, "Why is it that you guys don't have to turn the records over to the court unless I say so . . . but you have to give them over to the government? . . . I don't know about what is goin' on." Our findings underscore the need for larger quantitative investigations to examine the negative and positive impact of COCs on research participation and response bias.

Human subject protections in genetic research.

The Certificate of Confidentiality (COC) is a voluntary tool to protect researchers from being compelled to release identifying information about their subjects. Institutional review board (IRB) review and informed consent (IC) procedures are mandatory tools to protect human subjects. Although many studies reveal poor documentation of IRB and IC procurement, most published research undergoes IRB review and has appropriate IC procedures. There are no empirical data about the use of COCs. We examined the procurement and documentation of all these human subject protections in the genetics literature. A total of 112 (55%) articles documented IRB review, 108 (53%) document IC, and 82 (41%) documented both. None documented the procurement of a COC. Returned surveys provided additional information that confirmed that at least 74% (n = 150) of research had received appropriate IRB review, at least 71% (n = 143) had procured IC, and at least 10% (n = 21) had obtained a COC. An additional 22 respondents had procured COCs for other research, whereas 17 respondents were unaware of them and their purpose. In this era of public scrutiny of medical research, we recommend greater familiarity with and documentation of all human subject protections.

Human Subject Protections in Genetic Research

The Certificate of Confidentiality (COC) is a voluntary tool to protect researchers from being compelled to release identifying information about their subjects. Institutional review board (IRB) review and informed consent (IC) procedures are mandatory tools to protect human subjects. Although many studies reveal poor documentation of IRB and IC procurement, most published research undergoes IRB review and has appropriate IC procedures. There are no empirical data about the use of COCs. We examined the procurement and documentation of all these human subject protections in the genetics literature. A total of 112 (55%) articles documented IRB review, 108 (53%) document IC, and 82 (41%) documented both. None documented the procurement of a COC. Returned surveys provided additional information that confirmed that at least 74% (n = 150) of research had received appropriate IRB review, at least 71% (n = 143) had procured IC, and at least 10% (n = 21) had obtained a COC. An additional 22 respondents had procured COCs for other research, whereas 17 respondents were unaware of them and their purpose. In this era of public scrutiny of medical research, we recommend greater familiarity with and documentation of all human subject protections.