Discovery

A Case for Progressive Institutional Review Boards

by Luna

Innovation is a constant topic in the biomedical research space. The pace of new tools, new techniques, and new discoveries is often hard to keep up with. Researchers and study participants expect innovation to deliver improvements as well as compatibility with new science, new methodologies, and new priorities, all in a constantly changing, complex environment for study participants.

This progress is almost always seen in the insights and outcomes of the research, but not in how the research is designed, begins, progresses, and is managed. Anyone who has done work in the biomedical research space knows that ethical oversight – whether by internal reviewers, external Institutional Review Boards (IRBs), or Ethics Review Boards (ERBs), collectively known as “reviewing bodies” – constitutes a significant part of all study construction and, therefore, is a significant part of all new science and discoveries. Shouldn’t the processes that enable study construction also be innovative and capable of adapting to new science, new methods, and new priorities?

A careful balance must always be maintained between ensuring protection of individuals participating in research and supporting innovative methods and processes to drive more efficient and cost-effective reviews and research.

The often broad, non-specific nature of regulations that govern “human research protections”, as they are called in the US, leave reviewing bodies somewhat adrift in what amounts to a vacuum. This vacuum forces them to make their own interpretation and implementation of the exact protections to uphold and leaves them without a mechanism to cross-communicate new processes for reviews or validations of new methods for research. At their core, reviewing bodies are simply a group of people working together to determine if a research study meets certain requirements and thresholds as interpreted from these regulations. The social psychology of how people interact on a larger social scale, how people make decisions in isolation and in aggregate, and how the context of their engagements changes their behavior in those different settings is sufficiently understood today. Yet, there is a large gap in transforming that understanding into the application of how reviewing bodies function. These factors have created a space that is prone to stagnation rather than innovation, languishing as a relatively static space for decades. The same study reviews are taking place, and the same study constructions are expected, with few changes permitted, let alone the ability to include entirely new methods. How do we inject innovation into such an environment to create what amounts to an adaptive or progressive IRB?

A careful balance must always be maintained between ensuring protection of individuals participating in research and supporting innovative methods and processes to drive more efficient and cost-effective reviews and research.

“At the Genetic Alliance IRB, we’ve found that an open dialogue between the IRB members, researchers, and technology providers is essential to understand pain points and inefficiencies in our process, and incorporate new techniques that improve both our processes and the research being done. We cannot limit ourselves to past methodologies, given the pace with which new technology is developing worldwide,” says Chris Carter, chair of the Genetic Alliance IRB.

IRBs and ERBs typically do not interact with service providers on the underlying technology by which data is collected for a study. Instead, their focus is on the burden of participation, the ethical considerations of what is being asked, and the privacy, burden, and safety risks to participants. However, we have seen a marked increase in the efficiency of designing and reviewing new studies when the IRB works in conjunction with the technical service provider to understand and approve the underlying mechanisms and processes first. By utilizing standard IRB practices to review and approve new processes and methodologies leveraging newly established technology supporting the research, we can increase the speed of research by reducing the complexity of new study design. Working with the Genetic Alliance IRB, we set out to find ways where an IRB and technology provider could work together to innovate reviews and research. Here’s what we did.

Case Study #1: Luna Platform – Simplifying the IRB Process for New Studies

“For several decades, standing in the shoes of research participants, I have been outraged at the delays and extra work some IRBs cause in the name of protecting the participants. From my perspective, many IRBs act to protect an institution rather than the people. In the case of advocacy organizations and communities working to accelerate research on their condition, making this as simple as possible and ensuring conduct of the best research for their communities is paramount,” said Sharon Terry, CEO of Genetic Alliance. “Working with LunaPBC, we did a first-of-its-kind submission to the Genetic Alliance IRB to approve an entire platform based on the methods it encompasses for participant engagement and retention, data collection, and analysis. This paves the way for a streamlined review process for any study being executed using the platform. There is no need for redundant approvals or long timelines.”

The Luna platform is a tool for researchers to establish new communities or cohorts to collect data and perform analyses for their studies in a continuously participant-connected environment. The platform has IRB approval, which includes a consent individuals e-sign to share de-identified data for research purposes on the platform. This allows CDI to be deployed on Luna by groups for the benefit of their community through a simple Organization-Specific CDI Addendum. Then study-specific consents are only needed for those studies that go beyond the standard methods described above for the platform and enables the IRB to focus on specific goals of and populations included in the research, since the underlying mechanics are the same from study to study. Examples of protocols that are not covered by the approval are 1) the collection of personally identifiable information instead of de-identified data, and 2) use of bespoke instruments on topics not prioritized by the community through Community Driven Innovation.

Case Study #2: Community Driven Innovation – Innovative Methods for Research
Luna established the Community Driven Innovation™ (CDI) method for uncovering and validating the top priorities of a community or cohort, similar to methods like the Delphi technique, but without the disadvantage of inherent groupthink or expert bias those other techniques often introduce. By working collaboratively with the Genetic Alliance IRB and several researchers using CDI for their research goals, we were able to identify new ways to not only improve the research being done, but also simplify certain aspects of the IRB process itself.

 “The Genetic Alliance IRB immediately understood the value of the CDI method, not only in reducing burden on study participants, but also in reducing costs and time for their own reviews for both new studies using CDI and new data collection, typically surveys, being designed based on the insights from CDI,” shared Ian Terry, senior user experience research at Luna.

Together, we established two concepts that were integrated into the Luna platform protocol with the Genetic Alliance IRB: (1) A CDI “meta-study” design, and (2) “Related Topics” surveys.

CDI Meta-Study Design

We established a protocol that defines the CDI method leveraging the mechanisms on the Luna platform for consent, recruitment, data collection, and data analysis. New deployment of CDI can be added via an addendum to this protocol defining the specific populations and key personnel involved in recruitment since nothing else changes from CDI to CDI. This streamlines the time for review and cost to review by the IRB, and enables researchers with less scientific experience to take advantage of deploying a CDI to their communities or cohorts.

Related Topic Surveys

Building off of the CDI method protocol, we worked with the Genetic Alliance IRB to design a process to eliminate the need for researchers to submit all research questions during the initial study design and instead enable evolving content based on the insights generated from the CDI itself. Together, we established thresholds for specific topics and priorities uncovered by the CDI that could be turned into questions in follow-on surveys without requiring additional IRB reviews. We’ve now opened up the research such that the involved patient population can select the research topics using several well-documented methods from Computational Social Choice theory. By doing this, we don’t have to pre-decide what a specific population may need; we can build the very task of asking that question into the study design. This allows us to remove many steps that would have been spent attempting to figure out what the population wants and thereby speed up the time it takes to establish this study in the first place. But also gives the research population – versus the experts or researcher – the autonomy to decide where the research should be headed, a power that has been missing in the medical world for a long time.

These are only a couple of examples of how collaborative exploration of new processes, methods, and technologies can create an innovative and efficient environment for safe, ethical research. By focusing on technology and method innovation in our external and internal ethical reviews, we can explore new frontiers in the research that empower participants to help drive study design. Subsequently, elevating the participant to drive the study design ensures that the new inventions and products developed meet their needs and pain points directly, thereby expediting answers, time- to-market, and ultimately better health. We’ve turned a top-down study process into a dynamic ecosystem of iterative listening, accessible to non-scientists, that supports the privacy and safety of its members.

Learn more about Community Driven Innovation at www.lunadna.com/cdi

About Luna

Luna’s suite of tools and services connects communities with researchers to accelerate health discoveries. With participation from more than 180 countries and communities advancing causes including disease-specific, public health, environmental, and emerging interests, Luna empowers these collectives to gather a wide range of data—health records, lived experience, disease history, genomics, and more—for research.

Luna gives academia and industry everything they need from engagement with study participants to data analysis across multiple modalities using a common data model. The platform is compliant with clinical regulatory requirements and international consumer data privacy laws.

By providing privacy-protected individuals a way to continually engage, Luna transforms the traditional patient-disconnected database into a dynamic, longitudinal discovery environment where researchers, industry, and community leaders can leverage a range of tools to surface insights and trends, study disease natural history and biomarkers, and enroll in clinical studies and trials.

Privacy and Security

Privacy-Preserving Technologies and Rights-Based Privacy Regulation Compliance

by Luna

There has been increased interest over the past decade over what to do with the growing volume of digital information collected on individuals that are potentially used or sold by companies and governments. This interest is even more heightened when health data is involved and how this data might be used in ways contrary to the interests or values of individuals. In parallel, new data protection laws have passed in many parts of the world and increasingly in several states within the United States that express the control of data privacy as a human right.

It is commonplace to merge the concepts of data privacy and security, even though each has a unique role. Data security is the step taken to prevent unauthorized access to data. A common security approach involves data encryption that requires user-specific information to decrypt the data back to its original form. Privacy-preserving technologies, or PPTs, are a newer class of technologies that support the distribution of encrypted data that can be selectively decrypted to reveal some or all of the data that is encapsulated. PPTs are especially exciting for the sharing of genomic data so that only some of the data is made available to a researcher, which presents a lower risk to the individual for subsequent data misuse.

A common data privacy policy is the right to rescind one’s consent and to have the individual’s data deleted, also known as the “right to be forgotten.”

Data privacy, in contrast to data security measures, is a set of policies that are applied to secure data. These policies typically govern the data collected, the purpose for which the data is collected, and the informed consent granted to the researcher to study the data. A common data privacy policy is the right to rescind one’s consent and to have the individual’s data deleted. This is also known as the “right to be forgotten.”

Security-based protections such as PPTs and privacy-based protections are very different in how they are implemented. With security-based approaches, data are distributed to researchers that are approved to access the data. Once access is granted, the control of the data is lost. Over time there can be many copies of the data that have been granted to multiple researchers, as shown in Figure 1A.

Figure 1A. Once permission is granted data is distributed to uncontrolled environment(s)

In contrast, privacy-based approaches maintain control of each piece of data within an environment that supports the removal of the data if an individual’s consent is withdrawn. Under the privacy-based approach, an individual has a virtual string on their data that supports the pulling back of their data at any time, as shown in Figure 1B.

Figure 1B. Use of permissive data is used within an environment that enforces privacy policies.

The question of which approach is better rests largely on the regulatory environment in which the research is being performed. In Europe, compliance with the General Data Protection Regulation, or GDPR, requires that the data rights of individuals persist when they share their sensitive personal data, such as health data. In states such as California, the California Privacy Rights Act (CPRA) that has come into law in 2023 requires similar protections for individuals. For historic datasets, databases, and biobanks that include genomic data, the use of PPTs has provided a more secure way to distribute such sensitive personal data.

About Luna

Luna’s suite of tools and services connects communities with researchers to accelerate health discoveries. With participation from more than 180 countries and communities advancing causes including disease-specific, public health, environmental, and emerging interests, Luna empowers these collectives to gather a wide range of data—health records, lived experience, disease history, genomics, and more—for research.

Luna gives academia and industry everything they need from engagement with study participants to data analysis across multiple modalities using a common data model. The platform is compliant with clinical regulatory requirements and international consumer data privacy laws.

By providing privacy-protected individuals a way to continually engage, Luna transforms the traditional patient-disconnected database into a dynamic, longitudinal discovery environment where researchers, industry, and community leaders can leverage a range of tools to surface insights and trends, study disease natural history and biomarkers, and enroll in clinical studies and trials.

Privacy and Security

Something Exciting Happened on October 6, 2022, Concerning Your Medical Records

by Luna

Editor’s note: This article is jointly authored by Luna and Greenlight Health Data Solutions.

The Information Blocking Rule, now in effect, is a new federal regulation we should all celebrate as a big win for control over our health information, a right that we should always have had.

Let’s take a step back in time and then fast forward to today. In recognition of the importance of digital health information for advancing precision medicine, the Information Blocking Rule was a provision of the 21st Century Cures Act which aimed to modernize healthcare data interoperability and update a component of HIPAA that was oriented to paper-based medical records, not Electronic Health Records (EHRs). Part of the motivation to connect EHRs was to improve the portability of one’s health data to multiple healthcare providers and to give direct access to one’s health data using online patient portals. The Information Blocking Rule requires that all healthcare organizations give patients access to their full health records digitally (via a patient portal)–without delays or cost.

Why is this important? The new Information Blocking Rule unblocks access to Electronic Health Information (EHI), which Health and Human Services (HHS) defines as electronically Protected Health Information, or PHI. The significance of this rule has many threads–not least of which is bringing control and rights to the information much closer to the patient–the individual who the data is about, you! You can now review and research your own information to be a more informed patient. You can easily share your data with new healthcare providers if you relocate or change your insurance coverage. You can avoid time-consuming and costly duplication of diagnostic tests, which is commonplace whenever one engages with a new medical professional. You can also choose to share your data with a clinical research study or trial that is of interest to you to advance medical knowledge and health discoveries for society more broadly.

We’ve been advocates for individuals’ rights to access their health information for a long time. Greenlight Health was an early software platform specifically designed to offer patients online access to their health data. Luna has implemented Greenlight’s EHI data-sharing APIs which support connections to more than 90% of the U.S. provider market. This approach allows for the inclusion of EHR data, along with genomic and health survey data, for patient-centered research studies to understand and improve health outcomes. Gathering health information from multiple health systems, and across decades, provides convenience to individuals and their families while simultaneously providing a richness of data to researchers to unlock new insights for health improvements. Such patient-centered studies hold promise to enrich the standard of care more equally for individuals of all ethnic and racial backgrounds.

An essential aspect of inclusive clinical study participation requires that data shared by individuals is done with their informed consent and that the data is not used for other purposes outside the individual’s consent. Luna’s health data sharing and analysis platform uses rights-based data privacy measures to protect access to shared data so that a contributor (you) can remove their data from the platform and/or from any studies they joined with a simple click of a button. By implementing rigorous rights-based data protection and privacy that complies with all current privacy laws (such as GDPR in the EU), Luna provides a path to international clinical studies that can benefit from population diversity globally.

It’s no longer in the medical provider’s control to decide when to release a patient’s information. The Information Blocking Rule is really about information sharing and empowering the patient with ownership of their health data. Under HIPAA, healthcare providers are allowed 30 days to fulfill medical record requests; 60 days is permitted if the provider needs an extension. With this new rule and direct EHI access methods for patients, a healthcare provider cannot “interfere” with the flow of EHI, and it needs to flow without delay. When there are instances of interference, healthcare providers and EHR vendors are subject to financial penalties (up to $1 million per occurrence and/or reductions in Medicare and Medicaid reimbursement). Healthcare providers and vendors lobbied strongly against this rule being passed (in fact, the rule was held up for six years). Days before the rule became effective, 10 of the leading healthcare industry trade associations pushed HHS for a delay. As stated, the rule extends an individual’s right to access EHI through a patient portal. As the name implies, patient portals were designed to support functionality that allows individuals to connect to their medical records whenever needed. The intent of having immediate access to medical records through a patient portal is to provide a mechanism for sharing EHI with other healthcare providers, with family members, and for research.  

It’s no longer in the medical provider’s control to decide when to release a patient’s information.

This rule is one more step toward providing you with a comprehensive understanding of and access to your own healthcare information and, more importantly, control of how your health records are shared.

Taking the power of your health records to the next level, Greenlight Health and Luna combine capabilities to enable you to consolidate your records in one place and safely share your health records and other unique experiences in research studies that are of interest to you. You are in the driver’s seat now. The steps you take next could make a big difference in finding treatments and cures for those who need them most.

About Luna

Luna’s suite of tools and services connects communities with researchers to accelerate health discoveries. With participation from more than 180 countries and communities advancing causes including disease-specific, public health, environmental, and emerging interests, Luna empowers these collectives to gather a wide range of data—health records, lived experience, disease history, genomics, and more—for research.

Luna gives academia and industry everything they need from engagement with study participants to data analysis across multiple modalities using a common data model. The platform is compliant with clinical regulatory requirements and international consumer data privacy laws.

By providing privacy-protected individuals a way to continually engage, Luna transforms the traditional patient-disconnected database into a dynamic, longitudinal discovery environment where researchers, industry, and community leaders can leverage a range of tools to surface insights and trends, study disease natural history and biomarkers, and enroll in clinical studies and trials.

Technology

Celebrating Software Engineer Oscar Garcia During National Hispanic Heritage Month

by Luna

When Oscar Garcia was growing up in Tijuana, Mexico, his parents encouraged his interest in computers. Living on the border of Mexico and the United States gave Garcia a unique perspective of experiencing two melding cultures. Today, Garcia is a software engineer at Luna. In honor of National Hispanic Heritage Month, Garcia shared how he was inspired to join the STEM field of computer programming and how his heritage has shaped his career, personal life, and leadership philosophy.

Oscar Garcia developed his love of video games into a career as a software engineer.

What do you do at Luna?
I’m a software engineer. I work with the backend team to do everything on the backend of the Luna application. I work primarily with a lot of business logic, but more into why it’s happening behind the scenes. This October will mark one year for me at Luna.

Tell me about how you grew up.
I’m from Tijuana, Mexico. I was born and raised in Tijuana and have been living here for the past 27 years. Living on the border gave me the opportunity to get to know San Diego and experience both cultures. I had the unique advantage of seeing both worlds. I was very interested in pop culture and technology, including television, movies and video games.

My parents worked all day. So, as a kid, I spent a lot of time with my grandma. My parents worked hard to provide me with an education, and I was very grateful. I remember my father buying our first computer with Windows XP. That was when I started to get interested in computing. I took a computing lab in school, and my passion for computers just grew from there. Video games were a big factor in my decision to take the software development major since it was the spark that got me interested in how software was made. When I got to high school, I entered the world of programming with very simple console applications. Looking at colleges in Mexico, I looked for software development programs and decided on Cesun University. I graduated as a software engineer in 2017.

What aspects of your Hispanic heritage do you think have impacted your work at Luna?
Fellowship. Growing up here on the U.S.–Mexico border, you can see how fellowship is such an important part of the community. It’s one of the core values I’m proud of. At Luna, I want to build a team and work with my team toward a common goal. In this case, it’s building complete software at the highest standards.

What does Hispanic Heritage Month mean to you personally?
Hispanic Heritage Month is a representation of what we value as a community; that we are part of a connected group and have an important role to play together. I’m proud of my heritage and where I grew up. For me, these four weeks are a reminder and chance to tell the world that as a group, we can do amazing things. We have done amazing things.

Growing up here on the U.S.–Mexico border, you can see how fellowship is such an important part of the community. It’s one of the core values I’m proud of. At Luna, I want to build a team and work with my team toward a common goal.”

Garcia says his mother is who has inspired him to be a better person and continue despite challenges.

Was there a particular person who inspired you growing up?
My mom. She’s the person who always inspired me to be a better person. She taught me to stay humble, and that no matter how hard things get, keep pushing. Those lessons she taught me got me to where I am today as a software developer.

Is there anyone in your field who served as a mentor in your field?
I had a professor at university who inspired me to continue to pursue programming. He also kept pushing me to continue to create new goals for myself, to step out of the box, and to approach new jobs or new technologies. Looking back, I can see that I was hesitant or unsure of myself, and he kept pushing me to be more confident and try new things. I admired the knowledge he had of software development, and I looked up to him as someone I wanted to emulate. I strive to be that person who wants to mentor people and share their knowledge with others in the field.

What advice would you give to a young professional in the STEM field?
Keep working hard. Keep innovating. Don’t doubt yourself, and don’t be afraid of failing. It’s where you will learn the most. Another important piece of advice is always to keep an open mind—that’s where the greatest ideas come from. When you have an open mind, you start seeing things in different ways.

About Luna

Luna’s suite of tools and services connects communities with researchers to accelerate health discoveries. With participation from more than 180 countries and communities advancing causes including disease-specific, public health, environmental, and emerging interests, Luna empowers these collectives to gather a wide range of data—health records, lived experience, disease history, genomics, and more—for research.

Luna gives academia and industry everything they need from engagement with study participants to data analysis across multiple modalities using a common data model. The platform is compliant with clinical regulatory requirements and international consumer data privacy laws.

By providing privacy-protected individuals a way to continually engage, Luna transforms the traditional patient-disconnected database into a dynamic, longitudinal discovery environment where researchers, industry, and community leaders can leverage a range of tools to surface insights and trends, study disease natural history and biomarkers, and enroll in clinical studies and trials.

Technology

Feature Spotlight: Member Accounts

by Luna

Making what’s important to you easier to find

We’ve made some changes to your member account. Now it’s easier for you to find your studies and see information from your communities and registries.

Member Dashboard

View tasks like “Contribute Data” ready for you to complete

Access studies you’ve joined. You can also access your studies by clicking on the “My Studies” tab

Find additional resources and information on conditions or diseases of interest to you using Disease InfoSearch

Review all the data you’ve shared and patient portal connections you’ve made by clicking on the “My Data” tab at the top of the dashboard

Access your notifications, settings, and logout from the side menu under the colored avatar in the top right of the dashboard

Community/Registry Pages

Your communities and registries each now have their own page devoted to their content. So you can easily find everything related to them all in one place.

View all the studies your community has available

Access special permissions you’ve granted your community organizers

Community/registry-specific messages on the community pages so you can see just the messages from your community or registry

Log in today to see what’s new on your dashboard

LOGIN

Coming Soon: More improvements to your member account are headed your way

A formal messaging center where you can more easily read all your notifications and important messages from study coordinators and community organizers

What’s Staying the Same

Luna remains focused on providing a regulatory compliant platform where you can feel good knowing your data is secure and confidential.

Log in today to see what’s new on your dashboard

LOGIN

About Luna

Luna’s suite of tools and services connects communities with researchers to accelerate health discoveries. With participation from more than 180 countries and communities advancing causes including disease-specific, public health, environmental, and emerging interests, Luna empowers these collectives to gather a wide range of data — health records, lived experience, disease history, genomics, and more – for research.

Luna gives academia and industry everything they need from engagement with study participants to data analysis across multiple modalities using a common data model. The platform is compliant with clinical regulatory requirements and international consumer data privacy laws.

By providing privacy-protected individuals a way to continually engage, Luna transforms the traditional patient-disconnected database into a dynamic, longitudinal discovery environment where researchers, industry, and community leaders can leverage a range of tools to surface insights and trends, study disease natural history and biomarkers, and enroll in clinical studies and trials.