data privacy

June 14, 2023: IMPACt-LBP and INSPIRE Have Updated Study Snapshots, Ethics and Regulatory Documentation

Posted on by Damon Seils

Updated study snapshots and ethics and regulatory documentation are now available for the IMPACt-LBP and INSPIRE trials, both NIH Pragmatic Trials Collaboratory Trials.

Logo for the IMPACt-LBP NIH Collaboratory TrialIMPACt-LBP transitioned from the planning phase to the implementation phase in August. As part of the transition, the study team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core. The study is a cluster randomized trial evaluating the effect of first-contact patient referral to physical therapists and doctors of chiropractic for the treatment of low back pain. IMPACt-LBP is supported within the NIH Collaboratory under an award from the National Center for Complementary and Integrative Health.

Logo for the INSPIRE NIH Collaboratory TrialINSPIRE joined the NIH Collaboratory at the beginning of its implementation phase. The study team held its initial consultation with the Ethics Regulatory Core to review their approach their approach to consent, data privacy, and the applicability of recent FDA guidance regarding clinical decision support software functions. INSPIRE consists of 2 cluster randomized trials that are using personalized clinical decision support to improve judicious antibiotic prescribing for non–critically ill patients hospitalized with abdominal infections or skin and soft tissue infections. The project is supported within the NIH Collaboratory under an award from the National Institute of Allergy and Infectious Diseases.

May 11, 2023: Article Outlines Key Stakeholder Insights Related to Participant Data Sharing in Pragmatic Trials

Posted on by Hannah Webster

Headshot of Dr. Stepanie Morain

A new article from the NIH Pragmatic Trials Collaboratory outlines stakeholder insights and ethical considerations related to sharing deidentified, participant-level data in pragmatic clinical trials. While there are numerous arguments for and against data sharing in the context of pragmatic trials, the report aims to address the gap in documented stakeholder perspectives.

The article was published this month in Learning Health Systems.

The authors, including members of the NIH Collaboratory’s Ethics and Regulatory Core, recruited stakeholders who represented a range of experiences. They then conducted 40 semistructured interviews focused on ethical considerations. The team identified 5 overarching themes after analyzing the interviews: (1) challenges in sharing data collected under a waiver or alteration of consent; (2) conflicting views regarding patient-subject preferences for data sharing; (3) identification of respect-promoting practices beyond consent; (4) concerns about elevated risks or burdens from sharing data; and (5) diverse views about the likely benefits resulting from sharing data.

A key insight was that a “one size fits all” model for promoting broader sharing of data from pragmatic trials is not feasible, and policies must be sensitive to the unique challenges that pragmatic trials present, such as variation among trials.

“Our data indicate unresolved tensions in how to fulfill this expectation for [pragmatic clinical trials],” the authors wrote. “Future work could inform efforts to tailor data-sharing policy and practice to reflect these and other challenges, including sharing experiences from trials that have successfully navigated these tensions.”

Lead author Stephanie Morain and co-authors Juli Bollinger, Kevin Weinfurt, and Jeremy Sugarman are members of the NIH Collaboratory’s Ethics and Regulatory Core. This work was supported within the NIH Pragmatic Trials Collaboratory by a supplemental grant award from the National Center for Complementary and Integrative Health.

Read the full report.

Grand Rounds October 21, 2022: Disinformation, Cyberthreat, and Choice: Protecting Patients and Clinical Research From the Digital Triple Threat (Eric Perakslis, PhD; Andrea Downing)

Posted on by Elizabeth Mccamic

Speakers

Eric Perakslis, PhD
Chief Science & Digital Officer
Duke Clinical Research Institute
Professor, Department of Population Health Sciences
Chief Research Technology Strategist
Duke University School of Medicine 

Andrea Downing
ePatient and Security Researcher
Co-Founder – The Light Collective

 

 

Keywords

Data Security, Disinformation, Cyberthreat

 

Key Points

  • Health care and the internet are intertwined. Patients use the internet to search for answers, and researchers use the internet to search for new solutions. The questions are how are you going to play online and how are you going to conduct your research in a way that is most effective and will keep everyone safe? Researchers need to overcome the risks of online tools and increase the benefits.
  • Perakslis said his definition of digital health is any time you mix medical information and the internet. There are 5 forces that drive the internet, including surveillance capitalism, attention economy, connectivity, social networks, and personification.
  • Case study: The U.K. coroner in the case of Molly Russell, a teenager who committed suicide, determined that she was suffering from a depressive condition, and, based on the sites she was visiting, the algorithms were feeding her very negative images without her request. Should social media for teenagers be regulated like a digital therapeutic, given how addictive they are and the behavior modification.
  • The Light Collective is an organization that represents collective rights, interests, and voices of patient communities in healthcare technology. It was started when Andrea discovered a vulnerability in Facebook’s group platform that allowed data to be scraped outside of the group. There should be no aggregation without representation.
  • Patients often turn to social media to find support and knowledge from peers due to the network effects of the platforms. The problem is patients can’t predict benefit or harm based on how their data is used.
  • In a recent paper, Health advertising on Facebook: Privacy and Policy Considerations, patients download their raw data, and found who was tracking them across the internet. Three out of 5 companies included in the study were not adhering to their privacy policies. The manuscript was shared with a news organization called The Markup, and they looked at the Meta Pixel installed by various hospital systems and found 30 out of the top 100 hospitals were using custom fields to share information with Facebook, which constitutes a data breech
  • There are doable ways to increase cybersecurity in health care. Researchers can be thoughtful about devices used in studies and how to keep patient information safe. Having a tech person on the study design team to advise on which devices are secure will allow as many people as possible to participate.

Learn more

Beyond privacy: A deeper understanding of the internet is required to protect digital trial participants

Health advertising on Facebook: Privacy and policy considerations

Discussion Themes

-What is the path forward? We need a new skill set or team member who studies cyber interaction, who can make sure your trial is safe. You need to involve them from the design phase. They can ask questions like who should I use for my digital campaign? Are you building the right tool? One of the things we are doing with the Light Collective is community members can shine a light on potential issues early on but we need a formalized path, training, a new role in research and clinical trials.

-How can we do research in states that are restricting access to reproductive health and keep patients safe? If we eliminate all the states where reproductive rights data could be harmful, is that going to impact site selection? We don’t want to create a disparity like that and have these women lose access to research. We need to think about how we are consenting and securing the data, and have a thoughtful approach to how we consent in these states. How do we maintain research access when health care access is limited in some of these states.

Tags

#pctGR, @Collaboratory1

February 11, 2022: Great Power and Great Responsibility: Machine Learning in Clinical Research (E. Hope Weissler, MD, MHS; Erich Huang, MD, PhD)

Posted on by terren.green@duke.edu

Speakers

E. Hope Weissler, MD, MHS
Resident, Vascular and Endovascular Surgery
Duke University School of Medicine

Erich Huang, MD, PhD
Chief Science and Innovation Officer, Onduo

Topic

Great Power and Great Responsibility: Machine Learning in Clinical Research

Keywords

Machine Learning; Artificial Intelligence; Data Liquidity; Data Storage; HL7FHIR

Key Points

  • Machine learning may address issues that have reduced the efficiency and effectiveness of clinical research and help clinical research projects reach their full potential.
  • Machine learning may improve the pragmatism of research, decreasing costs and time it takes to conduct a research study.
  • Machine learning can be used to canvas the literature, hypothesize drug-target interactions, propose new therapeutics, and analyze highly dimensional research output.
  • Effects of machine learning are up to us and could potentially reduce the pragmatism of research if applied indiscriminately. Machine learning could produce overly selected study participant groups, too closely managing adherence, and using ultra-high-touch follow-up methods.
  • Data Liquidity refers to the ease with which data can be transferred or exchanged. This depends largely on the manner in which the data is stored.
  • Some forms of data are liquid than others due to privacy, security, and ethical concerns.

Discussion Themes

A lot of emphasis is currently being placed on the mobile/wearable device area, but an equally important area to develop in machine learning is patient identification and recruitment.

Is data ever really de-identified? Should data be owned by the patient? Why is health data treated differently than consumer data? Privacy regulation is difficult and needs to be addressed further by Congress in the future.

 

Read more about Dr. Weissler and Dr. Huang’s machine learning in clinical research.

 

Tags

#pctGR, @Collaboratory1

December 17, 2021: Cyberthreat, Cybersecurity and Cyber Compliance in Clinical Research and Healthcare: One Size Fits None (Eric Perakslis, PhD)

Posted on by terren.green@duke.edu

Speaker

Eric Perakslis, PhD
Chief Science & Digital Officer
Duke Clinical Research Institute
Professor
Department of Population Health Sciences
Chief Research Technology Strategist
Duke University School of Medicine

Topic

Cyberthreat, Cybersecurity and Cyber Compliance in Clinical Research and Healthcare: One Size Fits None

Keywords

Cybersecurity; Attack Surface; Cyber-Compliance; FISMA; InfoSec

Key Points

  • Over 40 million medical records are compromised each year.
  • Electronic Health Information is targeted due to its high value with respect to improper medical payments. Medicare estimates over $25 billion in improper payments each year.
  • The focus for cybersecurity should be on the most vulnerable groups. Women, BIPOC, and elderly populations experience cyberattack and identity theft more often than other populations.
  • Security objectives should focus on confidentiality, integrity, and availability.
  • The Cyber Risk Equation: Risk = Threat*Vulnerability*Impact*Likelihood
  • When starting a study, design with cybersecurity in mind, minimize attack surface, know your weakest link, add InfoSec expertise to the design team, and lean-in to innovation.

Discussion Themes

Researchers should take some responsibility for learning how to secure patient information. Training programs to make researchers more aware of cybersecurity concerns would increase researcher comfort in working with electronic health data.

A research network consisting on multiple sites may have differing needs and capacity to secure data. Treating each research site individually could allow greater representation in research, but those sites may be more vulnerable to cyberattack.

 

Read more about cybersecurity by Dr. Perakslis in A cybersecurity primer for translational research.

 

Tags

#pctGR, @Collaboratory1, @eperakslis

December 15, 2021: This Friday in PCT Grand Rounds, Cybersecurity and Compliance in Clinical Research and Healthcare

Posted on by Damon Seils

Headshot of Dr. Eric Perakslis
Dr. Eric Perakslis

In this Friday’s PCT Grand Rounds, Dr. Eric Perakslis of Duke University will present “Cyberthreat, Cybersecurity and Cyber Compliance in Clinical Research and Healthcare: One Size Fits None.” The Grand Rounds session will be held on Friday, December 17, at 1:00 pm eastern.

Dr. Perakslis is the chief science and digital officer for the Duke Clinical Research Institute and the chief research technology strategist in the Duke University School of Medicine. Join the online meeting.

April 16, 2021: Minnesota EHR Consortium COVID-19 Project: A Statewide Collaboration to Inform Vaccine Equity (Paul E. Drawz, MD, MHS, MS; Tyler Winkelman, MD, MSc)

Posted on by Gina Uhlenbrauck

Speakers

Paul E. Drawz, MD, MHS, MS
Associate Professor
Division of Renal Disease and Hypertension
University of Minnesota

Tyler N.A. Winkelman, MD, MSc
Co-Director, Health, Homelessness, and Criminal Justice Lab
Associate Director, Virtual Data Warehouse
Hennepin Healthcare Research Institute

Topic

Minnesota EHR Consortium COVID-19 Project: A Statewide Collaboration to Inform Vaccine Equity

Keywords

COVID-19; Electronic health records (EHRs); Data analysis; Research consortium; Healthcare systems; Population health; Distributed data network; Vaccine equity

Key Points

  • The EHR Consortium’s COVID-19 vaccine project aims to inform policy and practice through data-driven collaboration among members of Minnesota’s health care community.
  • The collaborative network can monitor population-level health metrics and analyze changes over time using aggregations of data to inform public health policy. Sources of data include EHRs, census data, state-wide electronic immunization records, and population data.
  • The COVID-19 vaccine dashboard is updated weekly and provides data at the ZIP level by age categories and race/ethnicity.
  • Minnesotans who have received a COVID-19 vaccine (any source) and had a visit at a consortium site in the last 10 years (~90 percent of the state population) are reflected in the dashboard.

Discussion Themes

How were you able to convene this consortium during a pandemic year?

Was your hashing algorithm home-grown or did you have an outside partner?

In the future, this infrastructure will be expanded to incorporate smaller health systems and additional content expertise around comorbidities, disease prevalence, and identification of disparities in near real-time.

Read more about the MN EHR Consortium at Hennepin Healthcare and the University of Minnesota Clinical & Translational Science Institute.

Tags

#pctGR, @Collaboratory1

September 1, 2020: New Publication Explores Stakeholder Perspectives on Collateral Findings in Pragmatic Clinical Trials

Posted on by Gina Uhlenbrauck

A recent article in Learning Health Systems from members of the NIH Collaboratory’s Ethics and Regulatory Core and colleagues describes key themes from stakeholder interviews about collateral findings in pragmatic clinical trials (PCTs). A collateral finding is information that emerges in a PCT that is unrelated to the primary research question but which may have implications for patients, clinicians, and health systems.

The authors conducted semi-structured interviews with 41 key stakeholders experienced in the conduct or oversight of PCTs and those in health system leadership. The interviews explored respondents’ experience with collateral findings in PCTs and their reactions to how such findings should be managed. The authors identified four themes that emerged from the responses:

  • Collateral findings are complicated by layers of ambiguity about the nature of PCTs and how to characterize unanticipated results.
  • No one-size-fits-all approach exists to managing collateral findings in PCTs, as such findings are context-specific.
  • There is a range of attitudes regarding the scope of research responsibilities and obligations in PCTs.
  • While prospective planning for collateral findings in PCTs is critical, such planning has not yet been widely undertaken.

The article provides additional details on each theme, including excerpts from stakeholder responses that show a range of insights for managing unanticipated findings in PCTs. A clear takeaway is that prospective planning is an essential step in addressing the ethical management of collateral findings to inform the future conduct of PCTs.

The expansion of PCTs makes it likely healthcare systems will increasingly encounter [collateral findings], yet little guidance exists regarding their appropriate management. – Morain et al. 2020

This work was supported within the National Institutes of Health (NIH) Health Care Systems Research Collaboratory by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director. Supplemental funding for this work was provided by the National Center for Complementary and Integrative Health. The aim of the supplement, Management of Trial Incidental Findings Study (MOTIFS), is to develop an empirically informed, ethically sound approach to managing incidental findings in PCTs.

August 26, 2020: New Publication on Patients’ Views About Disclosure of Collateral Findings in Pragmatic Clinical Trials

Posted on by Gina Uhlenbrauck

Members of the NIH Collaboratory’s Ethics and Regulatory Core, and colleagues, recently published an article in the Journal of General Internal Medicine highlighting potential challenges in managing collateral findings in pragmatic clinical trials (PCTs). A collateral finding is information that emerges in a PCT that is unrelated to the primary research question but which may have implications for patients, clinicians, and health systems.

In their study, the authors presented focus group participants with a hypothetical scenario, asking them to imagine they were a patient in a PCT wherein it was discovered incidentally that they were taking two contraindicated medications. The authors then explored participants’ reactions to the discovery and their preferences for whether or not they would want to be informed about the collateral finding, how it should be communicated and by whom, and the type and amount of information that should be communicated.

The article provides excerpts from participants’ reactions—which varied across the spectrum from fear and anger to gratitude. Their preferences for how to disclose collateral findings in PCTs also suggest several important considerations for clinicians, including the expectation that patients will question them about such findings, and how to develop approaches for disclosure that align with patients’ values.

Preferences for how such disclosures are made varied but were driven by several consistent desires, namely minimizing patient harm and anxiety and demonstrating trust and respect. – Bollinger et al 2020

This work was supported within the National Institutes of Health (NIH) Health Care Systems Research Collaboratory by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director. Supplemental funding for this work was provided by the National Center for Complementary and Integrative Health. The aim of the supplement, Management of Trial Incidental Findings Study (MOTIFS), is to develop an empirically informed, ethically sound approach to managing incidental findings in PCTs.

July 16, 2020: New Publication Describes Unexpected Complications of Certificates of Confidentiality for Pragmatic Clinical Trials

Posted on by Gina Uhlenbrauck

Judith Carrithers and Jeremy Sugarman, co-chairs of the NIH Collaboratory’s Ethics and Regulatory Core, recently published an article in the journal Learning Health Systems that examines the NIH’s Certificate of Confidentiality (CoC) policy for NIH-funded human subjects research. Since October 1, 2017, the CoC is issued automatically and applies to all biomedical, behavioral, clinical, and other research funded wholly or in part by the NIH that “collects or uses identifiable sensitive information.”

In their review of the CoC policy, the authors describe unanticipated challenges of applying the policy to pragmatic clinical trials, where the focus is on embedding research interventions in clinical care and which relies on existing data in electronic health records (EHRs). The authors identify 3 issues that are especially problematic in embedded pragmatic clinical trial (ePCT) settings and which may jeopardize the progress of learning health systems:

  • Whether the EHR may be populated with research data that may be sensitive or stigmatizing without explicit consent from subjects
  • Incomplete protections for sensitive data in the EHR
  • Requirements for notifying subjects about the policy’s provisions

The authors urge the NIH to provide formal guidance on the CoC policy as it pertains to ePCTs. Read the full publication online.

“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.” – Sugarman and Carrithers