By Erica Wright
The Birmingham Times
The goal of the All of Us Research Program is to help researchers understand more about why people get sick or stay healthy. People who join will give information about their health, habits, and what it’s like where they live. By looking for patterns, researchers may learn more about what affects people’s health.
Dr. Stephen Olufemi Sodeke, Ph.D., is a bioethicist and professor of Allied Health Sciences at Tuskegee University. Here, Sodeke discusses the program.
How would you describe the All of Us Research program?
A: The All of Us Research program is a nationwide research effort seeking to obtain health information from about one million people, reflecting the diversity of the U.S. population, diversity in age, race, ethnicity, geographic locations and health conditions so we can gather data and put it in a huge database where researchers can have controlled access and use it to accelerate the scientific breakthroughs we’ve all been waiting for.
What makes this program different from other research programs?
A: The attempt to reach out to a diversity of people and request them to participate in this research study has never been done like this before. The Program is committed to giving back information regarding the health status of people, something we sometimes don’t take care of enough. This Program will make possible a very rich database that researchers can actually access to do all kinds of studies. This is not like clinical trials that are focused on particular health or health conditions. It is nothing of the sort. The Program is an attempt to assist researchers in studying patterns of diseases and how to better prevent, treat, or manage those diseases.
Talk about the need for the program and possible benefits.
A: There are several reasons why we need to be involved in All of Us Research program. The reasons might include the fact that there are things about health we simply don’t know enough about yet. For example, understanding personal genomic variants or genetic predisposition to a disease condition is important. For example, I did not know the genetic variants that I have that makes me incapable of producing antibodies to Hepatitis B. I just found that out accidentally that I could not produce that antibody; and if I had been challenged with Hepatitis B infection, it would have been deadly for me. So, we are the same for the most part, but we are all different.
We have differences in our genes, in our environment, in our exposures that can be quite profound just as I found out in the example that I gave. To better understand which one of these or environment is better for our health, is also a very important reason why we should participate in the All of Us Research program. What works for a middle class white male may not work for people of color or other groups; so in order to best advance our medical care for All of Us, we need to contribute to the database what is unique about us.
Additionally, the All of Us Research program database can make it possible for researchers to figure out how or why I respond differently to different therapies in order to get the best one for me or people like me. We realize that a segment of our population that has high reservation about seeing the doctor have been left out or left behind, and that’s why they’re not represented in research populations; so we need to join so that we are not continuously left behind. It is important that we capture the diversity of people in the United States to ensure the best care for all of us.
What happens with all of the data collected?
A: All of the data collected is going to be stored. The identity of that piece is given a unique identification number with names removed, it will be encrypted so it can be stored in a secure facility and only authorized access with justify the reasons will be allowed. There are ongoing works by the best minds in the country that suggest that there needs to be tiers of data access as well. We’re going to have a general tier which allows us to know, for example, the demographics of where this data is coming from. If anyone wants to know what this data looks like, that will be one tier that one could have access to after you identify yourself and give some reasons why you need to look at this. The registered access is where one goes into to get more in-depth information, but also one has to demonstrate vigorously the reason why one wants that type of access. And, there is the controlled access. It requires the most rigorous demonstration of identity, the need, and the reasons for why one may want that type of access. Anyone that wants to access the data would have to sign a use agreement. We have put together ethics training that people will have to take, and there is a Resource Access Board which will provide some sort of oversight to make certain that these data are not only private but secured as well.
Have you found out anything that has surprised you so far and what have been your “takeaways”?
A: I’m just simply fascinated by the fact that so many people have, and are continuing to join in large numbers almost every week. In about eight months now, we have a total of 447,000 registered participants as of December 1. They have joined for a number of reasons, some say to help find a cure for chronic diseases like diabetes, cancer, depression; others say in order to help others or give back something to society; and yet some others say, ‘I want to better understand the disease conditions,’ so I am just fascinated by all of these. The takeaway message or messages from all of these is that as more people get to know about the program, the initiative, more than likely, they will want to join. Some people, of course, we know will undoubtedly be hesitant to participate because of the mistrust stemming from research abuse experiences in the past. This is understandable. They should not be dismissed at all because such fears are legitimate. They are not unfounded fears. Some have been burned, and we should respect that choice if people make the choice not to participate. Another takeaway message is that learning how to persuade people for whom trusting can be dangerous would be critical to the expected success of the initiative; so, we are constantly working on that. Those are my takeaway messages as of now.
There are a number of partners in the project. How would you describe your role in relationship to the other community partners?
A: My role in the All of Us Research program is to truly strengthen the All of Us network to bring awareness of the research initiative to our communities; some things like forming and building relationships with community partners, and then encouraging people to check out the All of Us Research program, or sending the link: joinallofus.org, so that’s one of my primary roles. Another one is reassuring the communities who have a history of misfortune with researchers and medical research and institutions that there are in fact significant procedures and policies in place to protect their interests now. For example, the All of Us research program ensures that there is valid consent, so that if one were to go and try to look at what All of Us is, or go to joinallofus.org wanting to join, you will need to provide the valid consent to participate. We are trying to make sure there is no such thing as coercion, no exploitation, no stigmatizing research, and that the program itself takes very seriously the privacy and security of the data that we acquire; and it’s constantly working on this as well. I know this because I work with the committee on access, privacy and security by invitation. We have the best minds and knowledge in the nation working systematically and carefully on these issues.
As a bioethicist are you looking for anything specific?
A: As a bioethicist, I have the privilege of paying attention and counseling all those that I’m working with within the All of Us Research program, looking out and paying attention and asking them to pay attention to how to ensure respect for participants’ voices and choices, and how to pay attention to what is beneficial or concerning or troubling by the program itself. Paying attention to justice and fairness, and to the opportunities that are later available to make it easier to join the program and benefit from it. I am paying attention to how the program itself engages people because that’s very important. I am pay attention to how to make it easier for all types of people to join. I am paying attention to watching for appropriate communication of benefits of the research program in a transparent fashion without overpromising what is impossible to deliver.
I am paying attention to appropriate communication of risks for those participating in the program to be done in a transparent fashion. I am paying attention to voluntary participation with valid consent because this is very essential. I am paying attention to how the program protects the privacy and confidentiality of the data that will be entrusted to us. I am paying attention to ensuring that research findings are returned to participating persons in an ethical and responsible way. I am paying attention to ensuring that data does not fall into the hands of people who can use it for nefarious reasons. We actually have what is called a Certificate of Confidentiality which allows us to protect the data and not be bound in any way to give out information that is given to us.
What about the program appealed to you when you first heard about it?
A: It was the fact that All of Us Research program wants everyone represented. The fact that All of Us Research program wants diversity in geography, in health related information, environmental exposures. All of Us Research program wants to stop just one representation in medical research. I like those things. It is not only beneficial to, in fact, try and do those things, it is socially just to do so. In fact, I think it is the right thing to do. There are still so many things that we don’t know that are worth knowing about the common diseases that affect us. The idea with the All of Us Research program database is that we’re trying to do what we can to help in this area. If we can help researchers get good data to work with, this is very appealing to me. Researchers can use this database to help me or people like me understand predisposed genetic environmental risk factors to guide against chronic diseases and conditions before it’s too late to prevent those diseases or treat such health conditions. Those things are appealing to me, as so many diseases still remain undiagnosed; some are very rare, and perhaps using this kind of database, researchers can help identify what is wrong, and whether or not therapies directed at these diseases can be prepared and tested and cleared for use by the FDA (U.S. Food and Drug Administration).
There seems to be a focus here on tailoring needs to individual. Why is that important as we move forward?
A: That’s very important because for the most part, as I indicated earlier, we are the same. We have differences in profound ways for that matter when it comes to our genetic predisposition to how we process drugs or respond to our environment, yet, we have been used to the usual one size fits all kind of approach in medicine. This should not be so. One size does not fit all. So, the All of Us Research program will help identify what’s different so that we can benefit from using the right drug in the right place, for the right person, at the right time.
Would you like to add anything that should be stressed?
A: I would like to emphasize that joining the All of Us Research program can be individually and communally rewarding. If our data is not in the database, what can be known about us is reduced, hence, not much headway can be made by researchers to discover what is going on, and what to do about it for those who look like us. We can be empowered by knowing more about our own health. With access to robust data, information about therapy that works best for groups and individuals alike can be understood and solidified rather than be some sort of trial and error kind. By evidence, what does not work can be discarded or regrouped for better health for all of us; so, those things, I believe, should be stressed.
MORE ABOUT ALL OF US
The All of Us Research Program is a large research program. The goal is to help researchers understand more about why people get sick or stay healthy. People who join will give information about their health, habits, and what it’s like where they live. By looking for patterns, researchers may learn more about what affects people’s health.
The mission of All of Us is to speed up health research. One million people are being asked to share their unique health data. This information will be added to a database. Researchers can then access this data to conduct thousands of studies on health and disease.
The goal for the entire Southern Network of All of Us is 20,000 participants per year for five years, total of 100,000. The Southern Network is Alabama, Mississippi and Louisiana.
For more information call (855) 282-2863, email email@example.com, or visit JoinAllofUs.org.
Updated on 1/30/2019 at 12:57 p.m. to correct and clarify Dr. Sodeke’s quote about the access to robust data.
Updated on 2/10/2019 at 8:17 a.m. to make changes for clarity and corrections.