Should You Sign up for the All of Us Massive Medical Study?

Posted on May 10, 2018 by resourcefulman

The National Institutes of Health is trying to recruit one million people to share their health data for long-term, large-scale research. “The next great breakthrough will be found in all of us,” advertising will flood to potential participants , “and what we find there will reveal secrets, heal the sick and eradicate disease.”

In truth, no one knows what the study will find; that’s the whole point. For researchers to draw firm conclusions, health research requires a large number of participants. In the past, studies have been conducted using over a million data points, but often they were medical records or census data. In this case, the NIH wants a million people to consent to participate in a research database and be available for various types of data collection: you may be asked to donate blood, urine or saliva samples and provide access to your database. medical records. The project also hopes to sequence the complete genomes of the participants.

A study involving one million people is not literally “all of us,” but it is a third of one percent of the country’s population, which is quite a lot. Researchers try to collect as diverse a sample as possible, although it is likely that the database will end up biased towards people who know about the research, want to participate, and feel safe to participate, which may not be completely representative of the country like everyone else. But they struggle to reach out to people who are underrepresented in medical research. If they succeed, this is a big step forward for the industry.

How will you win

The website where you join the study does not mention paying people to participate, as is sometimes the case with small studies. Instead, you simply benefit from knowing that your data is helping researchers. (Hence the melodramatic commercial, which reads: “When Americans are called upon to give from within, they come together and discover that our ability to help others is limitless.”)

You also have access to data that the study collects about you, which seems to include your genome sequence, or at least some of your genetic data. And they will let you know about published results, such as scientific articles that came from the All of Us research.

Researchers hope to unravel all sorts of health mysteries over time, but that doesn’t mean the benefits will go straight to you. In other words, this is not medical care, and researchers are not trying to find a solution to your personal health problems. They just want you to be one of the data sources that will help researchers know what types of health care they should try to personalize.

Who can participate

In order to get a sample of data that truly represents the entire country, the researchers want to involve everyone . They speak to us in several languages and want to attract people of every possible nationality, health status, and so on. Right now, the only people they can’t take are people under the age of 18 who are in jail or unable to consent on their own. They also say, “In the future, we hope to attract this population.”

You don’t need health insurance or money (the study pays for all necessary visits or labs, but not transportation or childcare). You don’t need a computer or mobile device, although it does help. And you don’t have to speak English; they currently have translators and materials in Spanish and plans to add support for other languages shortly.

What do they want from me?

We all get your name when you sign the research consent form and agree to participate. (Before doing this, you must create an account so they already know your email address and whatever password you choose.)

Here is the data that they ask for through the website or app in accordance with the privacy policy. Some of them are optional; you can opt out of providing this data, but still participate in the research.

Answers to the questions of the questionnaire. “We will ask you questions about your health, family, home and work. You don’t have to answer any question you don’t want to answer. ” When you sign up, you will spend 30 to 60 minutes filling out the survey, but they may also ask you to answer other questions later.
Fitness tracker data. “For example, we might ask you to take a short walk. We’re importing how far you go from your smartphone or fitness tracker into the All of Us app. ” It’s not obligatory.
Location data. “This will help us understand how active you are. We do not collect your actual location, we only collect the distance you travel. ” It’s not obligatory.

This is not mentioned in the privacy policy , but the website also asks security questions upon registration. These range from questions that could potentially compromise your identity, such as “What house number and street name did you live in as a child?” to … really questionable questions such as “What are the last five digits of your driver’s license number?” They also ask for information when you prepare to sign the consent form, including the state in which you live and the state in which you receive most of your health care.

Fortunately, the consent process is more than just a large sheet of small print. It includes a series of short video tutorials explaining each type of data researchers want to collect and why. These include:

Your contact information , as well as a phone number or email address of a close friend or relative who can help track you down if needed. They also say they “may use social media or public databases to help us keep your contact information up to date.”
Records of your previous doctor visits , which may include procedures you have had, medical conditions you contracted, test results, medications, and more. (“Your medical records may contain sensitive information. For example, they may tell us about your mental health, alcohol or drug use. They may also indicate sexual or other infections, including HIV status.”) If you do not contact Due to you may not be invited to participate in other parts of the study, such as donating blood samples or taking body measurements.
Your blood, urine and saliva . The samples will be kept in a dedicated room where researchers can request access to them. They may take so many samples that your little vials of blood, urine, or saliva are used up. You may then be asked to donate more.
Your DNA extracted from samples.
Body measurements including height, weight, blood pressure and waist. (This will be done in a 15-minute face-to-face meeting.)
Data they collect from other sources . For example, they might find pollution data for the city you live in, or ask the pharmacy to turn in your records.

What happens to your data

If 2018 had a topic, it would probably be “Your data is never safe”, so now is a bad time for research that aims to collect a ton of data from a lot of people and expects us to be patriotic and generously.

Fortunately, the researchers thought about it and even got some protections, Wired reports . The safest way is to never share anything with anyone, but if you choose to participate, All of Us promises to try to protect your data in several ways.

First, the website separates your data from information that makes it easy to identify you, such as your name and email address. Your data will be available to researchers under a code number instead of your name. However, they have very detailed information even without your name. “Even without your name, there is a chance that someone will be able to find out who you are,” the privacy policy correctly warns. “They may misuse your information. We believe that the risk is very small, but it is not zero. “

The research website also uses end-to-end encryption in the transmission of your data, making it difficult for hackers to eavesdrop. And they say they have thoroughly vetted a behind-the-scenes tech team that has access to sensitive data.

According to Wired, here’s how the data will be made available to researchers and the public:

Anyone can access information from the project, but the access levels will be multi-level. General questions about the general demographic characteristics of the All of Us cohort – data with a low risk of re-identification – will be open to the public. More sensitive data will be under tighter scrutiny – some will be available to civilian scientists collaborating with research organizations, and some will only be available to researchers trained in human research who have vowed not to collate unidentified health data with names, addresses and social security numbers.

Thanks to the 21st Century Cures Act clause, this study (and several others) has a Confidentiality Certificate that protects participant data from disclosure, including in most cases of law enforcement use:

Disclosures are permitted only when: … Required by federal, state, or local law (for example, pursuant to Federal Food, Drug, and Cosmetic Act or state laws requiring reporting of infectious diseases to state and local health authorities), for except in cases of disclosure of information in the framework of any federal, state or local civil, criminal, administrative, legislative or other proceeding;

The bottom line is that you give us all a lot more data than 23andMe or even Facebook, but they also protect it much better.

What if I change my mind?

You can opt out or opt out of participation at any time; it is the standard in scientific research. For example, if you came for body measurements, but then decided that you do not want to be weighed, no one will force you to get on the scale.

Since the study will last at least 10 years, it is possible that someone has invented a new way to study DNA or use data in research that we cannot currently predict or understand. So, unlike most research, you may not fully know what you are agreeing to. You simply transfer your data and believe that it will be used for good, not for evil.

Once registered, you can opt out of the study at any time and the study will not collect more information from you. But if some of your data has been shared with researchers, it will never be returned. In the study, you can find answers to questions, including about privacy, at [email protected] or 1-844-842-2855.

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