Curiosity Killed the Cat's Privacy
The All of Us registration process: I did it for science...and myself.
In my last post, I noted that the National Institutes of Health All of Us research program conducts genetic testing as part of its research program. I have come to understand that one of the pillars of accurate autoimmune disease classification is molecular genetic analysis, best accomplished through the more cost-efficient Whole Exome Sequencing, and/or the more time-consuming and expensive Whole Genome Sequencing. When I found that All of Us operated in my geographic area, and conducted genetic testing, I was determined to learn more. I had a lot of questions about the type of DNA testing conducted, the scope and detail of the results provided to participants, and what the drawbacks are of participating in this kind of study. So, I set aside my reservations, and signed up.
What You Get: All of Us Genetic Analysis Information
If study participants opt in to DNA testing, it appears likely that their whole genome will be sequenced for free, along with other free services that could be informative (emphasis added in bold is mine):
We will use many methods to study your samples. For example, we might study your DNA using whole genome sequencing. Whole genome sequencing is a way of studying nearly all of a person’s DNA. Every person’s whole genome sequence is different. It is unique to them, like a fingerprint.
If you say yes to getting your DNA results, we will check your DNA for certain types of changes. We will do this by having a specially trained scientist look at your DNA.
It might take a few months or even a few years for All of Us to check your DNA. There are many types of DNA changes, and we may be able to give you some types of DNA results sooner than others. You will be able to follow our progress through your All of Us account.
You can choose to see any of the measurements from studies All of Us does on your samples, like your whole genome sequence. You may not be able to see all of the measurements from studies researchers do using your samples.
If you want to get your DNA results, you need to give the All of Us Research Program permission to check your DNA for changes. If you say no, we will not check your DNA for changes. But we will still use your DNA for research. You will still be part of All of Us.
If you say yes, you are telling us that you want to learn about some or all of your DNA results. When we are ready to check for a specific type of DNA change, we will tell you more about what the results may mean for you. Then you can decide whether you want your results for that type of DNA change. For example, you may want to learn about any health-related DNA changes you have. You might only want to learn results about where your ancestors may be from. Or you might want to learn about all of your DNA results. You get to choose.
If you give us permission, we will check for changes in your DNA that could affect your health. If we find a change in your DNA that increases your risk of a health condition, we will try to contact you directly. We will help you make an appointment with an All of Us genetic counselor. They will tell you your results and answer your questions. If you want, they will help you find a health care provider in your area.
If we find other types of health-related results, we will send you a note through your All of Us account. We will give you a report that you can share with your health care provider.
If we do not find any known health-related changes in your DNA, we will also send you a note through your All of Us account.
DNA can also give you information that is not about your health. DNA can tell you where your ancestors may be from, and it can help explain how your body works. You can decide if you want us to check for these kinds of DNA changes. If you say yes, we will send you a note through your All of Us account once we have your results. In the note, we will tell you how to see your DNA results.
Over time, we may learn more about DNA changes. We may learn new information that changes your results. As we learn more about DNA changes, we may go back and look at your DNA again. We will tell you if we find anything new. We will tell you if we find anything that changes your results. The list of what we will check for may change as researchers make new discoveries. You can find the most updated list of what we check for at www.joinallofus.org/what-participants-receive.
Your All of Us results will not tell you everything about your DNA. We will not check for every DNA change. Even if we do not find a DNA change, you could still have one. You could still be at risk for developing a health condition even if we don’t find any health-related changes in your DNA that increase your risk.
Your All of Us results are not the same as the results from clinical DNA tests. Your results would need to be confirmed with a clinical test for your health care provider to use them in your health care. Do not make changes to your medicines or care until you talk to a health care provider. If you don’t have a health care provider, we can help you find one.
Do I need to pay to get my DNA results?
You do not need to pay to have us check for DNA changes. You do not need to pay to find out your results. You do not need to pay to talk to an All of Us genetic counselor.
If you discuss your DNA results with your health care provider, it’s possible that they may be able to find a health condition earlier. It’s possible they may be able to help prevent a health condition. This could help you get better treatment. Your health care provider may be able to adjust the amount of medicine they give you or find a medicine or treatment that works better for your body.
If you have a health-related DNA change, your blood relatives might have it too. If you choose to tell them about your DNA change, their health care providers might suggest different care that works better for them.
You may also think it’s interesting to learn information from your DNA that’s not about your health. For example, you may want to learn where your ancestors may be from.
So how does the service All of Us is offering help with understanding your particular autoimmune disease classification, diagnosis, and treatment?
It’s a question mark, for sure. Participants cross the hurdle of genetic testing, but the results they receive may not be relevant to what they need to know. Studies conducted on your genetic material may not relate to autoimmune disease. I was disappointed in the dearth of autoimmune diagnoses included in the All of Us questionnaire about personal and family health history. My first thought was, how in the world will autoimmune disease researchers, not specializing in the most common autoimmune diseases, identify All of Us patients for their studies? There is always the “other” categories that can be filled in, but these strike me as a shot in the dark. Also, a clinical diagnosis was requested as part of the All of Us questionnaire. Where would a participant with VEXAS, for example, which has no diagnostic criteria, no ICD-10 code for chart verification purposes, fit into this questionnaire? Of course, you could write it in the free text option, but are researchers looking for it, or looking for it in that location?
I still think this is the foundation for individuals and researchers to move forward. Your whole genome may not be used for autoimmune disease research, but what you have is the completed testing, access to your results, and the ability to stay up to date on the latest genetic research on autoimmune disease that you can compare to your whole genome results. It’s also a concrete result that you can use to talk to your doctor, which has the potential to inform your treatment and diagnoses.
What You Lose: Privacy Protection
The drawbacks of participation are significant. It’s a lengthy process, and it is purposefully written to a grade school reading level, which makes the process feel longer. As I was contemplating clicking “agree” to everything, I went down what felt like a paranoid rabbit hole. I cataloged the world history of governmental misuse of medical information to identify, exploit, oppress and kill the “other.” It’s a leap of faith to agree to this kind of study when considering that history, so I felt a little less paranoid when the consent process at least acknowledged that risk (emphasis added in bold is mine):
The main risk of taking part in All of Us is to your privacy. Your privacy is very important and we will take great care to protect it. But we cannot guarantee your privacy…A data breach is when someone sees or uses data without permission. If there is a data breach, someone could see or use the data we have about you. Even without your name, there is a chance someone could figure out who you are. They could misuse your data. We believe the chance of this is very small, but it is not zero…Researchers will use basic facts like your race, ethnic group, and sex in their studies. This data helps researchers learn if the things that affect health are the same in different groups of people. These studies could one day help people of the same race, ethnic group, or sex as you. However, there is a risk that others could use this data to support harmful ideas about groups…Taking part in All of Us may have risks that we don’t know about yet. We will tell you if we learn anything that might change your decision to take part.
Right now, I’m violating one of their tenets of privacy protection—sharing my participation on social media. The risks of this are clear to me, but the benefits of sharing more detailed information about the All of Us genetic analysis study component, as it relates to potential advancements in the genetic understanding of autoimmune disease, is more important to me.
Telling people you're part of All of Us could be a risk to your privacy. It could make it easier for someone to identify you in the All of Us scientific database and learn other information about you. They could misuse your information.
You can help protect your privacy. You may want to be careful about sharing that you are part of All of Us on social media or in other public areas. You may also want to be careful about posting your data or results.
I will not be posting my data or results. That’s a step too far, even for me. All of Us lists the privacy protections they offer, and even here, the potential for governmental misuse of medical data is present in the protections provided, but also the potential for the passage of harmful laws and regulations (emphasis in bold is mine). We do not know what future governments will look like, and this data has the potential to exist in perpetuity.
What will you do to protect my privacy?
Your privacy is very important to us. We will take great care to protect it. Here are a few of the steps we will take:
Data we have about you will be stored on protected computers. We will limit and keep track of who can see this data.
We will limit who is allowed to see information that could directly identify you, like your name or social security number.
In order to work with your health data researchers must sign a contract stating they will not try to find out who you are.
We will tell you if there is a data breach that we think could be harmful to you.
All of Us has Certificates of Confidentiality from the U.S. government. These will help us fight legal demands (such as a subpoena or a request from federal, state, or local law enforcement) to give out information that could identify you.
All of Us will only use information about DNA changes for research. We will not tell insurance companies about who has DNA changes. We will not tell employers. We will not tell banks. We will not tell any school, college, or university.
Will you ever give out my name or other information that identifies me?
There are a few times when we might need to give out your name or other information that identifies you.
We will give out information about you to protect your health or the health of others
If we learn or suspect that you are being abused.
If we learn or suspect you are abusing, neglecting, or have abandoned someone who depends on you for care, like a child or dependent adult.
If we learn that you plan to harm yourself or someone else.
If we learn that you have a disease that is a risk to public health, like measles.
We will give out any data needed to meet U.S. laws and regulations. This may include information that identifies you. For example, there is a regulation that says the Food and Drug Administration (FDA) may ask to look at the records for the All of Us Research Program. The FDA checks how programs like All of Us give people DNA results about their health. If the FDA asks to look at these records to do their checks, we will let them.
Once your information is shared with All of Us, it may no longer be protected by patient privacy rules (like HIPAA). However, it will still be protected by other privacy rules. These include the rules that researchers must follow to access the All of Us scientific database.
Through reading the All of Us privacy concerns and protections, it became clear that there’s a certain demographic that may have less risk from participation: people who are retired, and who, frankly, because of fewer years to live have less to fear from an oppressive U.S. government; those who are medicare/medicaid eligible; and/or those who already have disability, life and long-term care insurance.
Are there ways that DNA results cannot be used?
Employment
The Genetic Information Non-Discrimination Act (GINA) is a federal law that says employers can’t treat people differently because of their DNA information. This law does not apply to employers with fewer than 15 people.
Health insurance
GINA also says health insurers can’t use DNA information against people. Health insurers can’t use that information to change your coverage, cancel your coverage, or charge you more. This is different from life, disability, and long-term care insurance. Life, disability, and long-term care insurers may ask for your DNA information. They can use that information to decide if they will cover you and how much to charge.
All of Us will not tell employers about your DNA results. We will not tell insurance companies.
What are the risks of learning my DNA results?
There are different kinds of risks to learning about your DNA. When we are ready to check for certain types of DNA changes, we will tell you more about the results you would receive. You may have questions. Genetic counselors can help answer any questions you have about what results may mean for you. You may want to talk to a genetic counselor about these questions before signing this consent or after getting your DNA results. You can ask to talk to an All of Us genetic counselor at any time through the All of Us Support Center. They can also help you find support if you need it.
Health care and Insurance Risks
Changes in health care
Your All of Us DNA results must be confirmed by a clinical test to be used in your care. Your health care provider may recommend new or different care based on this clinical test. You may want to make some of these changes to your care and not others. You can decide what care is right for you. These changes in your care may cost more than regular care. Some of these changes in your care may not be covered by your insurance. Your health care provider may recommend care that makes you need to take time off of work, like surgery.Disability, life, and long-term care insurance
In most places, DNA information can be used by disability, life, and long-term care insurers. These insurers can ask you if you have information about your DNA and you have to tell them what you know. They can use that information to decide if they will cover you and how much they charge. If you find out that you have a health-related DNA change from All of Us, it could make it difficult or more expensive to get these types of insurance.Family Risks
Your blood relatives
Your DNA tells about you and people who are related to you by blood. If you have a certain DNA change, your blood relatives might have it too. They may or may not want to know this information. You may realize you are not related to some family members in the way you thought you were.Emotional Risks
If you decide to have your DNA checked, you may receive news that worries or scares you. You may be afraid of passing health-related DNA changes on to your children. Remember, you can ask to talk to an All of Us genetic counselor at any time. They can answer your questions and help you find support.
Why It Matters
The risks to individuals are serious, the results returned to individuals are uncertain. The broad direction that’s necessary for advancement in the knowledge of autoimmune disease is clear: high-quality and ethical research research research. Individual considerations of the risk to privacy and security are deeply personal. I hope the information that I have provided is generally helpful for individuals considering research participation.