Im delighted to be here. And I really wantto thank the Hartford HealthCare and the Office of Human Research Protections for inviting
me out. One of the things that Sherri didnt tell you is that no its really okay,
it was in another life I was at San Diego State University for close to 15 years. I
was hired by them to help them develop their human research protection program and so I
started I think I was affiliated with PRIMR back in 1995.
And really, I been an
IRB member for the past, gosh, 20 years now. So I have that side of my life going on and
concurrently with being in research administration, I was the director of research affairs at
San Diego state. And that included having oversight of the human research protection
program among with other things. But I got really involved in wanting to study research
ethics and was fortunate to get funding to do that.
So concurrent with my administration
position, I started to create an active research program. And about three years ago, I had
migrated from San Diego State over to UC San Diego. And Im going to tell you a little
bit about that journey and what kinds of things have kind of serendipitous in many ways have
led me to where I am today. So, because this happens every I have to
give a disclosure on where Im funded from.
So I have two main projects that Sherri mentioned.
One of them is the Building Research Integrity and Capacity program, that I will talk about
during the second part of my talk. And then the Connected and Open Research Ethics, which
is a really important part of what we are doing today that is creating a community
where we can all come together and start talking about research with emerging technologies
or what we call mobile health or digital health. So Im funded by the Robert Wood Johnson
Foundation presently and our funding with the Office of Research Integrity and National
Science Foundation and National Institutes of Health have help support the Building Research
Integrity and Capacity programs. So the title of my talk is Shaping Research
Ethics in the Digital Age.
What Id like to do is really focus on how research is changing
and what the past 15 years - 16 years of the 2000s have brought into the picture of how
research is conducted. What are the key challenges of using emerging technologies in research
today? Who are the stakeholders in how are we making decisions in shaping the ethics
of the research that we see? And what are the options for increasing community capacity,
so that our participants can be actual and authentic informed participants and partners?
So the research of today is much more complex than I would say it was 20 years ago,
when I first got involved Human Research Protections. The behavioral scientist and the social scientist
that Im working with are looking and you know, honestly biomedical research across
the board is involving clinical research as well as biomedical, behavioral, and social,
and they are starting to get integrated so people are looking at health from so many
different angles. We are looking at our social networks, our health behaviors.
Were looking
microbiome now, the genome, the environment and how we go about measuring those influences
on health have changed. So about three years ago, my colleagues and
behavioral medicine asked me if I could help them navigate the IRB, that they had an R01
from NIH that involved mobile, imaging, pervasive sensing, social media, and location tracking
technologies. So we created this acronym that I call MISST. And youre seeing more of
this now in your everyday research.
Im fairly certain that youre starting to see
this where people are using cell phones to collect personal health data in real time.
So its raising new challenges for how that data gets transmitted, how do we protect it,
how is it secured. The imaging technologies are wearable cameras that are being used to
see what people do in real time in their day to day lives without having to rely on self-report
or bringing somebody into a laboratory to watch how they behave. So now these technologies
can be used to see how people act in their everyday everyday. And all this is going to
lead to the ability to be very prescriptive about how we treat and prevent disease.
How
many of you in here have heard of the precision medicine initiative? Ok that looks like
maybe about 30%. So Ill talk a little bit about that while Im here as well.(5:17)
So the characteristics of 21rst century research is we are living in smart and connected environment
an increasingly smart and connected environment where we can monitor participants in real
time 24/7. Its not exclusively an academic venture anymore, so we now have Apple Research
kit, we have Google, who has a company called Verily thats involved in health research,
Microsoft Research. We have non-profits getting involved in research.
Its a different kind
of landscape. And the things we know now, we cannot guarantee that we can protect peoples
anonymity anymore. So these are the kinds of things happening with this new kind of
technology. So this is the case that got me started on
this path.
Its when my colleague said we cant get our studies approved, tell us
what we need to do. Knowing that I was in the IRB and also in their department, I went
in and sat with them in their lab and asked them, So, what are you doing? And they
said, Well, we want to see what people do in their everyday life. And so we recruited
people. We want to recruit people from Craigslist.
We want to have them wear different kinds
of sensors so we can see what they are doing. So this case, is Brittany one of the lab assistants.
And she is wearing a camera around her neck, so its an outwardly facing camera. She
has around her hip an accelerometer and a GPS device thats keeping track of where
she is and when shes active. Shes also got accelerometers on both wrists, so that
they can look to see if accelerometers around the wrist are measuring things differently
than an accelerometer worn on the hip.
Ive mentioned this before at a PRIMR meeting,
its one of the things that they learned is that when youre riding a bike, the accelerometer
thinks that you are sitting down. So it is not accurately measuring movement and activity.
So, this was a study to see whether or not these devices could have objectively measured
everyday behavior. So that they didnt have to rely on self-report. So you can kind of
see and this is an observation study they just wanted to see, would this work.
But the
IRB had a problem with it. The problem had to do with the wearable camera. Ill just
ask you really quick. Does anyone notice that I am wearing a wearable camera? How many of
you in here would wanted me to disclose that before I started talking? So there is some
consent concerns right.
So you guys - Im the human subject, lets just say. I am
the participant in the research, and I have agreed to wear this. You cant really tell
that it is a camera, can you? It doesnt make noise or take pictures, but its telling
the researcher an awful lot about that person, and how they move through their lives. Where
they are when they are active, what it looks like, and you happen to be the byproduct or
bycatch.
So under what circumstances should you have the right to consent to be in my
research record. So this is a new kind of challenge. It is not what that is not insurmountable,
its something that we can deal with. But it was a challenge at the time that it went
through the IRB and caused delays.
So these are the delays that happen when things are
introduced to us as IRB people that are not familiar. And also the reason that things
take a long time. And one of the reasons that I received funding from the Robert Wood Johnson
Foundation is that they have so many concerns about new technologies being used in research
and their grantees cannot get approval to start their work. So they said if you could
help us bridge that gap, we need solutions.
We know that these things are new and different.
Lets figure out how to help IRBs so that they can work better with these new technologies.
So this is not on by the way. Im not taking anyones picture. This is just a
prop so that you can kind of get a sense of what kinds of things were talking about.
So youre here in a public room, what if I was coming to your house for dinner? What
if Im going to work? What if Im going to a meeting? What if Im going to a clinic?
So theres all these different places, where theres different considerations that we
need to think about. But we also need to think about them and be consistent, so that we dont
create inconsistencies across all the IRBs that are starting to struggle with how do
we do this.
So social media is also introducing a lot
of new opportunities for health research. So RunKeeper has tons of data that researchers
are using to learn about how people are active or inactive. We have all kinds of opportunities
through amazon through Twitter, Facebook. People are using Facebook and twitter not
only to recruit participants but actually to conduct interventions.
And they can also
analyze this kind of data, which much of it is public data and available to anyone of
us. We can download data right now from twitter and its geotagged, and we can start figuring
out what people are doing. I just gave Dr. Pritchard an article that my co-investigator
wrote that identifies he can identify HIV hotspots based on peoples tweets.
So,this
can be really important health information, but its also really important that we think
about what is private, what isnt, and how do we handle that kind of information because
most of the people that are tweeting arent thinking about these things when they set
their settings. They kind of go on this auto-pilot and dont realize that this data is public,
or maybe they do. We really dont know the answers to this.
This is a sensor that a colleague of mine in bioengineering has created. This is about
the size, maybe a little bit bigger, of a postage stamp.
Its sitting on somebodys
skin right now. So that is skin. And you can see it has ECG sensor, temperature sensor,
it has a wireless power coil, it does EEG. Photo detector, wireless antenna, wireless
communication.
He is using this to monitor fetal heart rate and contractions remotely
so that they can let the mom know when she actually needs to come into the hospital,
instead of having somebody come into the hospital and be sent home and back and forth. Or being
stuck in a bed with the big belt and having only that as an option for monitoring health
behavior. So theres a lot of really interesting new
things. These commercial products that we have seen over the past three years.
These
didnt exist when I first started on this pathway. So Fitbit didnt exist, and now
we have all of these commercial products that are being used as research tools. How many
of you in here have looked at a study that involves the Fitbit device? Whoa, ok theres
a lot of you in here. So theres new challenges that are introduced when we are using commercials
products as research tools because there is a terms and conditions document that has to
be agreed to in order to participate in the study.
Fitbit has a work around so you dont
actually have to accept the terms and conditions, but those are new kinds of things that actually
conflict with the federal regulations. So new things to think about with the commercial
products. This is just an example of the different kind
of data thats collected. So in the GPS.
You can see somebody thats been traveling
up and down and across the California-Mexico border. You can see an example of an image
that the camera takes. This is a person inside an office building. So you can see that his
is a kind of a fish eyed lens.
Social media data, just the volume and granularity. Whats
interesting about lot of this data is not protect health information. Its not being
collected as part of the patients activity or being put in an electronic health record.
But it is sensitive health information. So how do we store it? What are the standards?
What should they be? So, the kind of questions we are asking and
the things that we are interested in looking at are how do we obtain informed consent?
How can we make sure that the people who are participating in the studies actually understand
what kind of data is being collected about them? Do they understand what real time is?
Do they understand what storing in the cloud means? We want to know about how to evaluate
the probability and magnitude of harm, so that we can help IRBs understand how to think
about these things.
We want to know what the rights of bystanders should be. We dont
know a lot. We have a framework actually that we recently validated and published in Translational
Behavioral Medicine that gives some guidance on how you can think about bystanders who
were captured by a camera and under what circumstances you can consent them. An even then, you are
actually putting more burden possibly on a research participant, have to be thinking
about all these things.
And then data management, as I just mentioned. A lot of the data we
are collecting isnt covered by HIPPA. So under what circumstances, should you have
standards in place and know what those standards are?
And all of this is happening at a time where the landscape is even getting more complicated.
So we have the NPRM thats still kind of out there. We have the Quantified Self Movement.
How many of you in here have heard of the Quantified Self Movement? Ok, just a handful.
So these are citizen scientist, these are people who are capturing their own data and
making sense of themselves, capturing all kinds of their own data.
And they are a movement
and are growing and they are their own scientist. So what do we do with that? The Precision
Medicine Initiative is starting up in January. They just released the names I guess it
was just last week of the different centers who were going to be involved in capturing
data enrolling a million people. Enrolling a million people who may not have direct contact
during the consent process.
So times are changing, and I think what we really need to pay attention
to is that we need to change with the times and be nimble and be thoughtful. But how do
we go about doing that? This just came out in the paper yesterday.
And I just thought it would be interesting to add it. So Science 37, is a technology-enabled
clinical research company that is planning to bring clinical trials to peoples homes.
So theyre kind of reimagining what a clinical trial looks like, how people will have access
to it. And I would love for you guys to look at their site.
I just glance at it, but it
doesnt really it sounds like a good thing. It could easily lead to this what
is that called? Let me think, itll come to me it in a minute. Just the idea though,
its not real obvious that this is experimental, therapeutic misconception. Thats what I
was thinking of.
Its not going to be real obvious to people that this isnt going
to be something that helps them. These are the kinds of things that I dont even
know who Science 37 is, but its a new way of doing business.
We really wanted to start looking at how do we make sense of what is going on. So one
of the studies that we did, I call it the iWatch Exit Survey. So you saw Brittany all
wired up with these different gadgets.
They enrolled 280 something odd people in that
study. By the time that we deiced to find out what those participants experienced, we
were able to recruit 82 of them to complete an exit survey. And we asked them about their
experiences; we ask them about whether or not the informed consent process and content
reflected their experience. We asked them if they you know what their major complaints
where, if any.
We asked them about their preferences for privacy. We asked them about whether or
not looking at the images like they were allowed to look at the images they captured
on their camera. Thats about 30,000 images. We wanted to know whether or not the control
over their data mattered.
We wanted to know if the transparency was important to them.
We also wanted to know if whether coaching them on how to respond to somebody who asked
about the camera while they were wearing it was useful. So thats a paper we just published
in Translational Behavior Medicine. And what we learned is that the informed consent process
was exactly what they anticipated. Some people thought the images were blurrier than expected,
others thought they were more clear.
Peoples interaction with them, some people said that
this is really creepy. Other people said that is really cool. Let me know if you want to
see the paper. Because I think its really a good starting point for engaging participants
in the process of assessing risk and not having us imagine it for them.
Because I worry about
us over protecting people and not giving them the option of getting into research studies
that would probably would be kind of fun and interesting for them. The participants really
enjoyed their involvement in the study. What I found interesting was that they rated themselves
as very very private. Like, who does that while wearing a camera? So, then we wanted
to see about in San Diego its a very diverse, culturally diverse community.
We
wanted to see whether or not that mattered. Whether people in diverse communities thought
about these kinds technologies differently. So weve done, little small studies with
the Latino population who worry about the GPS tracking. They worry about their legal
status.
We talked about with the people who in the native Hawaiian Pacific Islander community
who again had concerns about being tracked passively. We also went to the refugee - Somali
community in San Diego. This was an interesting one because they had agreed to wear an accelerometer,
which is not really a new device. Its been around for a while.
But it was something the
investigator asked them to wear around their wrist. They were in a physical activity and
nutrition study and they explained it, showed them pictures of it, they said this what it
does, this is what the data looks like. The women agreed to participate. And when the
investigator when back to get the device to download the data, there was no data.
There
was no data. And they did not wear their devices even though they said, Yup, absolutely
going to wear it, no problem. But they did not wear it. So they did not wear it because
it was something they had to wear around their wrist.
It caused unwanted attention. It conflicted
with their culture in that they pray five times a day, and they have to wash their hands.
So they had to take things off. They said if you had given us a waist one, we would
have worn it, no problem. But something happened in that translation and so these kinds of
things are important for us to be paying attention too.
And really engaging people in the process
of designing these studies. I also was so fortunate to have Anthony Maget involved.
Hes one of our advisors on the CORE project. Hes the Director of Human Research Protections
programs at UC San Diego. And I told him I.
Really wanted to understand how the IRBs were
thinking about this. We have five IRBs at UC San Diego. And so, I instead of asking
IRB if I could see their records, I went to the investigators who were using these kinds
of technologies. And I said, Can I see your protocols? And eight of the investigators
shared their entire protocols with me.
So I could look at what they were doing, what
they submitted to the IRB, what the IRB said back to them, what they said back to the IRB,
how that the back and forth went. And in one institution with five IRBs four different
IRBs reviewed these studies, and found different things to be concerned about, different ways
of managing risk, different sometimes completely ignoring things that another committees
said absolutely not. So if were seeing that in one institution, then lets multiply
that by the 6,000 that are out in the U.S. And how do we stop this from moving forward
in chaotic way and think about it in how do we move it forward in a cohesive manner, where
we communicate with each other.
So the last piece of this, is the ecosystem.
Whats happening? Im seeing it at UC. San Diego. Is it happening anywhere else?
So we did a search through the NIH reporter using keywords that have come up and our group
kind of generated to find out whats happening in the mobile health ecosystem. Whose doing
this kind of research? Whose funding this kind of research? Where is that happening?
And, so we are just finishing writing this paper.
This is a speck of dust still. This
is like 1% of the NIH budget, but its grown 1200% in the last 10 years. And its continuing
to grow. So were going to continue to see this kind of research.
We need to get ahead
of it so thats what were trying to do. We had focus groups last year at the PRIM&R
meeting. And four focus groups with people who were IRB Administrators, Analyst, Directors,
Members, Chairs, Leadership, PRIM&R Board of Directors. So we analyze that data, and
we found that people were concerned about capacity overload.
They couldnt keep up
with the volume that they have already. How are they are supposed to keep up with this
new emerging kind of research. They didnt feel like theyhave the expertise. They did
not want to be inconsistent.
So they worried about that. They dont have the evidence
they need to make decisions. And they are not familiar with technologies. And they are
concerned that their IT person isnt going to be available every time they need to go
ask a question.
So those are problems that we started to ask
the questions to other people. Weve not only been doing interviews and focus groups
with IRBs but also scientist that are using these tools. And so were asking the questions
like, how do we design a system that is responsive to the stakeholders as science starts to change
and morph? Do we keep the system we have? Do we transition to a new model? And how do
we have the conversation about where this is going?
So right now, I kind of think about our stakeholders as being the tools makers. But as you look
at the tool makers, these are the people that make the technologies.
They are actually morphing
into the researchers so you can see I. Have Google and Facebook and Apple up there.
But now there not just limited to that one task, there now getting involved in being
a researcher. We got the human subjects who participate in the studies, and we have IRBs.
We also have clinicians, and we also have patients, and we have people. This is a community
of community of people that we need to be thinking about.
So I had proposed we engage all of these stakeholders and conversations to see how do we intersect
this.
But I didnt have enough funding to do that, so my stakeholders are IRBs and Researchers
And this is a participatory process. So - Ill go back, CORE is Connected and Open Research
Ethics, thats what CORE stands for. And the people we have talked to through focus
groups, through interviews for the past year have told us what they wanted and we started
to build it. So, what we have now is a network of people who represent the stakeholders.
Almost 200 people now and we not have really started to advertise.
So the only reason Im
talking to you about it is that - we are now ready for you to come join this community
and help become active participants in moving it forward. Up until this point, weve been
building and beta testing, testing and reiterating, and now we think weve got a pretty good
program in place. We also have a Q&A forum. And I was talking to Elisa Hurley who was
the Executive Director of PRIM&R , whose also on our steering committee.
She said how is
this different from the IRB forum. I said thats a great question. First of all, we
are only focusing on MISST technologies; mobile, imaging, pervasive sensing, social media,
location tracking, and were not here for just the IRB people. We are here for all stakeholders
to come together so that we can answer questions that we dont know the answers to yet.
So,
if youre doing a study and you dont really know how to handle the data, I would
like a privacy person or a security person to come in and say you d need to be thinking
of these things. So thats community were building. If we have a researcher whose used
location tracking and has language that theyve used that has been a really useful tool in
their consent form, people get what they are explaining. They share that information in
the resource library.
Our resource library now has protocols language that has intellectual
property redacted, but it has protocol language talking about risks, talking about data management,
we have consent language, all of these entries are tagged so that you can easily find what
youre looking for. But the Q&A forum is a place you can go ask questions. And one
of the things Elizabeth Buchanan told me when she was trying to create something like this
for internet research is she said that the biggest mistake was that we didnt create
the option to be anonymous. And so if you have questions, and you arent confident
about having your name out there, you click I want to be anonymous.
That way you can put
out and can ask questions and not feel like youre embarrassing your institution or
yourself. You just show up and ask questions, and I would have shown you these, but Im
not sure I I dont know if I could have link to this. I think their Wi-Fi might be
working here. This is what the network looks like.
This
is 50% researchers at this point and time, 35% IRB people, and then we have people who
identify as ethical, social, legal, ELSI people. We have people who are identifying as regulators,
patients, we have yeah, its like really cool group of people. And I dont know a
lot of them, which is even more fun. Because I thought, Im on the bandwagon going out
to get people to show up and now Im getting people I got people in the U.K., Australia,
in Canada.
So this is becoming a global network. And I would really like you to show up and
be a part of it. So, take a picture of this, and I have cards
for you for later. This tells you how you can sign up for the network, whats on the
platform.
It has information about if you want to tweet about whether you like it or
not. All of that is there for you. And - ok. Oh no, I didnt get my camera out in time.
And again I do have cards and Ill be here.
So, one of the things we wanted to do though,
is that we need to bring participants into the conversation. We need to get deed back
from participants, if this is does the consent language, is it meaningful to you?
Do you like what its saying, do you get it? So we need to start engaging participants
in this process of our conversation. So, Im going to bridge the CORE project that Ive
just explained and why we did what we did. And where we are with the program that Ive
been working on for, gosh, close to 15 years called Building Research Integrity and Capacity.
So this is a program about community engagement and community education.
And I want you to
think in your mind, reflect on what does a researcher look like to you? Who are the PIs
that you work with? Well if youre working in biomedical science, you dont think of
these bench scientist. But most people think of someone working in a lab when they are
thinking who is a researcher. These actually happen to be my colleagues over at UC San
Diego, theyre real people. And these are the researchers that I work
with in San Diego.
And their community help workers in San Diego. They go by Promotora
and - in 2000 when the federal government came out with requirements for training key
personnel in Human Research Protections, we did a program for our graduate students and
we did for our faculty. We really tailored it to be for behavioral and social sciences
because thats what we did. And the investigator of Public Health came up to me and said you
know so many of our researchers are monolingual Spanish speakers, who have about an 8th grade
education and whatever you create for graduate students and faculty is going to be lost on
this group, even if you translate it.
So we were fortunate to get funding from the National
Institutes of Health; Heart, Lung and Blood to create a program that was tailored for
community health workers. And just for some background about who these
people are, how many of you in here have heard of community health workers? Oh, awesome!
So they are called different things, depending on where you are on the country, where you
are globally. They go by close to 150 names that I have seen through the World Health
Organization who was published papers on the role community health workers and global health.
But in the U.S. It is becoming a very important way, for research to happen in communities.
And so, they go by these different names.
Patient navigators, are really popular in
San Diego. Research promotora, community health advisor, outreach educator. And the American
Public Health association has a dedicated section for community health workers. Many
states are starting to certify them and they can actually be paid through the affordable
care act now, which is creating some tensions within the community, because many of them
do not have a bachelors degree.
And they dont do it because of their education,
they do it because of love for the community. They have become such an important part of
reaching hard to reach populations, where health disparities are most prevalent. That
they are now helping to shape the design of study, especially with the communities based
participatory research momentum gaining steam in community engaged research. It is that
they help people that are researchers, they tell them we have a problem with asthma, our
kids are getting sick.
Why is that? Well it happens to be that they live near a freeway,
well actually under a freeway. So the researcher work with them and see how do we study this
and figure out how to reduce the incidence of asthma in this population. So they co-design
the research, they implement the research, they disseminate results. And then they apply
these findings in practice.
What they have in common, is that they dont have any formal
research training. And when we got involved with promotoras, what we learned this because
they dont know what research is, they do things that compromise the protocols, inadvertently.
They may be asked to deliver a dose of something. The dose could be a cooking class, the dose
could be an exercise intervention. And they dont realize that they are part of a study,
because the PIs dont think they need to know.
One of our focus groups, we learned
that PI meant practically invisible. So its kind of telling you, that there is a disconnect
on the team, right? So, we have been focusing a lot of efforts on training promotoras. But
Im now moving over to training PIs because if they dont know what their people know
and dont know, whats the quality of the data, right? Were making a lot of important
decisions about public health based on data that may be compromised because the promotora
didnt get training that they needed. And its not malicious research misconduct.
Its inadvertently changing a protocol because what they think they are doing is going to
better serve their community.
And, Paul Applebom looked at this in a clinical setting, and
found the same that clinical nurses did in clinical trials protocols. When they saw their
patients care was potentially compromised, they would change up the protocol. But in
this case, you know, the promotora really didnt know that they were part of a research
study. And sometimes they cant really tell the difference between service delivery and
research activity because the interventions look like education, right?
So recently the C3 Report came out and its the first report on community health workers
has been published since 1998.
For the first time, its said that the community health
worker need to have training in research methods, had to design and implement program evaluation,
and theres a lot of movement on how to create professional training for community
health workers. Most of the training up until this point, has been very disease specific.
Ok were hiring you or your volunteering to deliver an intervention that focuses on
cardiovascular disease. Heres what that is, heres what youre doing. SO very
contained but now theyre saying, they are involved in research.
And this is not new.
Promotoras have been involved in research for 30 years. Its just now that they are
being recognized as an important part of that team that needs training.
Im pretty happy about that because were way ahead in that we have created the curriculum
that would meet that need. So we had gotten funding from the Office of Research Integrity,
so first funding was National Institutes of Health. We start doing focus groups with PIs,
project managers, and promotras to find out what you need to know about human research
protections in order to do your job.
So we found out what it is theyre doing, how
theyre going it, where they are doing it. And thats when we found out they didnt
know what research was. And its really hard to build a foundation about Human Research
Protections when they dont know what research is. So we kind of go back to the drawing board,
and think we have to teach them what research is.
How are we going to do that? So we asked
the Office of Research Integrity, can you give us some funding so we can build these
other modules ? And I can tell you thats one of the hardest jobs Ive ever done,
is create a research methods course for somebody that were targeting at a 6-8th grade level.
You know, typically when youre in college you go through an entire semester of research
methods and you know that thats one of the more challenging courses. But we were
able to get this to a point to where we were talking about what is research, what is health
services, whats a research design, what is a variable, what are these things I
mean we have 5 modules in our amazing curriculum that focuses on building that foundation.
And then we have modules on the rest of it. But, the point of this is that I had Office
of Research Integrity I had money for these modules. I had NIH money, we built these modules
and they were existing in two different places and not very visible.
And so I went back to
the Office of Research Integrity a couple of years ago and I said we have these really
amazing programs that are over here and over here because of different funding sources.
I need to bring them together, and we need to evaluate them. So I went back out to the
researchers and I said are your promotoras still doing this kind of work, or are they
doing something different? How should we assess their research capacity? And then we wanted
to measure whether or not our BRIC program worked in increasing their knowledge about
research. This is what it looks like, and I brought
a copy in case anyone wants to see. This is a really cool book.
It has pretty pages and
you can its actually something you can study on your own, or you can do it in
a group, or we come train you or we come train them. So theres a lot of ways that you
can access to this. So, its on our website. These are the modules that I was just mentioning.
So an introduction: what is research? What is Research Design? What are the elements
of research? How do you collect information? How do you handle information? What is human
research ethics? How do we think about risks and benefits? What does that mean to think
about the magnitude and probability of harm? We break this down to really accessible chunks
that are translated in Spanish and English.
So we now have Spanish and English, and I
was fortunate enough to be on a Fogarty Award to Jordan and now we have it in Arabic. And
pretty soon well have it Portuguese. And again this is not something we are doing to
compete in anyway with CITI. Were really focusing on a completely different member
of the research team.
Paul Brunchwager and I talked already about how we can work together
to make sure that training that is for non-researchers is available because theyre an important
part of the time. And if you put one of our promotoras behind a computer to go through
CITI program, they are demoralized. They are embarrassed, they dont understand it, it
doesnt map to with what they are doing. Then the research manager has to explain what
this means, so its taking two peoples time to go through something that isnt really
helping.
And, so, were really focusing an entirely different demographic, whose doing
different kind of job in the research infrastructure. This is just an example of a Spanish slide.
Because we have this in slides that are narrated, audio-narration. Were building our web
based access. We, like I said, have it in hard copy.
But this is how a demonstrate what
random assignment is. And that concept is not really easy for people to get. You know
the whole concept of randomization is a challenge. So when we were teaching this course over
the summer last year, turned out that the idea of going through across the border, across
the Mexican border into California, some people get pulled over to secondary for inspection.
They thought of that as being random.
So when they gave us an example of what they random
meant, we can use something meaningful to them, when trying to explain what this concept
is. This is just an example of how we try to use really nice visuals combined with graphics
to demonstrate a point. And this is just a we created an instrument
that to measure their research capacity, knowledge, and skills. We had a self-assessment.
We also
had multiple choice questions, that were critical thinking about. And the questions that we
created mapped to our learning objects for each module. And we typically had three items
for each learning objective., I learned later after we started doing this. That when you
create an assessment, an educational program assessment, it typically takes $5,000 per
item to do it right.
We didnt have that many dollars per item. But I think we think
we did a really nice job for creating multiple choice questions, and so we did a pre and
a post. We did a lot of pilot testing of this instrument before we administered it. And
we did a pre - post and we found that even though we randomly assigned people to the
control group or to our experimental group, the control group ended up having more research
knowledge than our experimental group at the get-go.
But after the course, our BRIC students
scored 5 more questions correctly than the control group. So were still kind of teasing
that out, finding out exactly what that means. So were still working on that data for
this. But the assessment, like I said, its looking at research competencies, their knowledge.
And we used community examples that are contextualized.
We tested this now, not only with Latinos,
but Native Hawaiian Pacific Islanders and with, gosh, a group of 250 California folks
that were hired to help implement a $50 million randomized control trials with special needs
youth. The program hired 250 people that had no research background to implement a program.
So we had the opportunity to train a lot of different people.
All we do when we adapt our curriculum, we just use example and scenarios that resonate
with that groups culture, their experiences. So these are some of the early adopters that
weve engaged in working with the BRIC program. So the Department of Rehabilitation, again
thats the $50 million one in California, but its it about 265 million across the
U.S.
They have many different states involved in this. The study, and again, its special
needs youth with the idea that if they have a certain type of intervention, they may become
independent autonomous, employed people. So the U54 Morris Cancer Center, they have implement
our program with patient navigators. And we NCI study that is focusing on Native Hawaiian
Pacific Islanders, weve implemented the program on NCI study that was with the Somali
Refugee and City Heights.
Over the summer, a colleague of mine implemented our program
of promotoras that he hired in Ecuador to study the effects of pesticides exposer on
adolescent and child development. And a recent colleague, who is doing a global study to
eradicate kidney disease, is using our program right now in four different countries.
So,were starting to gain some ground, and we couldnt do it without an awful lot of
people. And Im sorry for the small letters up here. But this is has taken a lot
of time and effort to do it well and to do it right.
And weve engage the community
at every step of the way. And the promotoras have been instrumental in creating the documents
and testing them and telling us what graphics work and what graphics dont work. And what
words mean something different than what we thought they meant. And we have a bicultural,
bilingual team.
So this manual and this program have been vetted by the very best. We had
subject matter experts who are expert who are experts in Human Research Protections
reviewing it. We had experts in research methods review it. So we had content experts as well
as people who understood the culture and the language.
So weve been blessed by having
a lot of folks really supporting what were doing.
Here is the content information for the BRIC. Project, in case you want to look at that
and look us up online. Again, the curriculum is going to be available for download. Were
trying to figure out a model to make it sustainable because we need to have income in order to
continue to develop it.
Id love to be able to give it away. But the book I just showed
you here, it cost a lot to print. So we need to figure out to make it something we
dont expect a promotora buy it because they dont have the money. If we can get
PIs to start putting this on there grant as a line item, as a training cost, then that
might be a method of doing it.
And then were going to be doing different kinds of road
shows, where well be part of different conferences. So next year, well go to APHA
conference and do a pre-conference workshop for the community health workers. Were
going to partner with Campus Community Partnerships for health so that we can do that. But this
curriculum is really focused on community health workers.
But what I liked to say is
that it doesnt just have to be community health workers. If were going to create
participants who are partners this is the kind of curriculum that we need to be able
to reach out to people that are not research savvy citizens.
I say next steps; this is a mess of new things that we have going on. Its going to a lot
of education, so firs - next step is education. Its going to take some money; its going
to take patience.
We need to involve the community in that process. We cant be doing this
on our silos anymore. So,Id like to start thinking about democratization
of research so that we bring this community together and that we have these conversations
together. And as the Precision Medicine Movement moves forward and begins to recruit a million
people, I think everybody in this room has a role to play in helping to make sure that
we are checking with people who participate in studies make sure that they are on board
and understanding what they are doing.
So in closing, I just want to say you
know the more we can do to bridge the gap, I think our CORE platform is a place where
this can start happen. As the studies move forward with a million people, theyre going
to be using emerging technologies, wearable sensors, implantables, all kinds of new things.
Research is not only going to happen in peoples homes, Walgreens and CVS are going to be the
major hubs for where research happens. So, with that, I would just like to thank you
all for listening to me. And Ill be around the rest of the day and most of tomorrow.
So I do hope to talk to you one on one.
And if you have any questions, I do think that
I have a few minutes, right now. So thank you..
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