This course presents critical concepts and practical methods to support planning, collection, storage, and dissemination of data in clinical research. Understanding and implementing solid data management principles is critical for any scientific domain. Regardless of your current (or anticipated) role in the research enterprise, a strong working knowledge and skill set in data management principles and practice will increase your productivity and improve your science. Our goal is to use these modules to help you learn and practice this skill set. This course assumes very little current knowledge of technology other than how to operate a web browser. We will focus on practical lessons, short quizzes, and hands-on exercises as we explore together best practices for data management.
Data Privacy in Global Research
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From the course by Vanderbilt University
Data Management for Clinical Research
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From the lesson
Post-Study Activities and Other Considerations
In this week, we cover activities to wrap up your study and share data and results, as well as two lectures on other electronic sources of data that can be used in research. In response to learner requests, we've also added several lectures on clinical data management in resource-limited settings, in collaboration with research colleagues from Indiana University. This is a long week of videos, but next week will be short on videos in exchange!
Meet the Instructors
Stephany Duda, PhDAssociate Professor
Department of Biomedical Informatics
Paul Harris, PhDProfessor
Biomedical Informatics and Biomedical Engineering
In this segment, we will talk about the role of data use agreements in
global clinical research, my name is Constantin Yiannoutsos.
I come from Indiana University Fairbanks School of Public Health and
the Department of Biostatistics.
My personal area of research is HIV epidemiological
research particularly focused in low and middle income countries.
And thus, as a caveat the epicenter of
this work is going to focus on and
be on the use of data sharing.
And agreements in low and middle income countries and
particularly between developed and developing world countries.
But I will cover a few subjects and point out some differences in data transfers.
And in particular, the role of data use agreements and
ancillary issues surrounding them.
In cases where data are shared between where both
parties rather that share data are within developed world nations.
Let's start out by reviewing the themes of this segment.
And today we will cover the following issues surrounding the transfer and
the sharing of data.
First of all, we'll talk about privacy and
we will be very clear about what we mean by that.
In general though and in broad terms,
we're going to be talking about privacy about of the data source.
We're going to talk about ethics in sharing of clinical data and
I stress that we will be talking only about sharing and
use of clinical data today.
We will touch on informed consent both for
the collection and for the sharing of clinical data.
And then we will go into our main theme and our main subject for
today which is the role of data use agreements or DUAs.
Why they are needed and some of the elements of that
comprise and appropriate data use agreement.
This slide just shows that there
are a number of privacy concerns that
both inform and are relevant to this.
The parts that are outlined in this slide do not necessarily have to do with
privacy regarding data sharing and especially in the developed world.
However, they do have potential indirect effects on
data sharing among various developed world nations.
Both in the way of the sensitivity and how individuals
in the developed world rather understand privacy.
And also because certain recent situations,
some of which I have put in this slide.
May adversely impact collaboration and data sharing.
Particularly from countries in Europe with the United States, as well
as other developed world nations with the US distrust or mistrust or sensitivity.
With the way the US sometimes may be perceived to handle or
use data shared by other groups may also be informed by
these high profile cases outlined in this slide.
Privacy on the other hand, may be a concept which is
both different and perhaps alien in other cultures.
I like this expression privacy for the other 5 billion which
has to do with privacy concerns of the non, quote unquote,
developed world part of the Earth's population.
This is from a paper of a commission and
study commission by the Office of the Privacy Commissioner of Canada.
And addresses a number of issues that may not be clear or
may not be immediately accessible to someone living in a developed world.
Country and who is potentially aspiring to
start a collaboration in a developed world nation.
One of the questions that we can ask is whether privacy,
individual privacy in this way.
The way people in the west understand and
in the north, let's say understand the concept of privacy.
Whether this is a universal human right or
imposing our understanding of individual privacy.
Is a form of a quote, cultural imperialism.
In other words, where we are actually imposing
a concept which is foreign and is not understood well by other cultures.
The opposite of course, argument is that there is a certain universal nature or
quality about privacy which has to be respected.
However in many countries and many cultures,
particularly those in the developing world.
There are greater concerns about group and community, rather than individual privacy.
For example, in Africa where I work, there are major concerns about
the reputation of tribal groups rather than the reputation or
privacy of an individual person.
So, the question that arises from this simple
couple of questions that we addressed is how does one properly define privacy?
We will not give an answer to this question but
rather urge the audience of this segment.
To think about thoughtfully what constitutes privacy and how people
may understand the concept of privacy with whom we would like to collaborate.
Finally, the question that should be asked is how
our research data properly be identified.
We are talking about the identification of data to maintain privacy but if privacy
has to do with groups or tribes or communities.
Then the identification may have also a different context
versus what we in the west may understand as the identified data.
Which is the removal of personal information from a database.
Just as a recent example,
in a collaboration that I had personally been involved in.
We had to clear and
discuss various findings from a study in terms of the communities involved.
And we had to be very sensitive about the way that we would communicate these
results.
And publish the names of the communities
involved from which these results emanated.
Rather than of course, the individuals from which the data were obtained.
So privacy may be defined differently in other cultures and
we have to be very sensitive about that.
Especially privacy can be defined differently with respect to genetic data.
I have here a quote from a study by de Vries and others
with the poignant title Knowing and knowing whom to trust.
Exploring the role of ethical metadata and mediating risk of harm in collaboration
in collaborative genomics research in Africa.
Which was published in BMC Medical ethics.
And it says any information in ethnic group, geographical location or
country linked to individual level genetic data could potentially provide
a wealth of information about the people in that ethnic group.
The greater the detail of ethnic or
other demographic data that is linked to the genetic data released.
The greater the need to protect the ethnic groups or
communities involved potentially through restrictions on the use of the data.
Also, one has to be aware of the changes that are happening
in global research and in fact, in global research collaborations.
Here is a study from the National Bioethics Advisory Commission
report from 2001.
Which says the change in landscape of international research is also relevant.
Increasingly scientists from developing countries are becoming more
involved in research.
As many of the countries from which these investigators come
have developed the capacity.
For technical contributions for research projects and for
appropriate ethical review of research protocols.
Although the source of funding for such collaborative research is likely to
continue to be the wealthier, developed countries.
Collaborators from developing countries are seeking justifiably
to become fuller and more equal partners in the research enterprise.
Emphasis added on the funding source which will continue
coming from the wealthier and developed countries.
And this fact may create inequities which may
result in either real or perceived course of nature of collaboration.
And data sharing between an investigator or a group in a developed country and
another group or an investigator in a developing country.
So there is a significant ethical dimension of research in LMIC or
low and middle income countries.
I put here a quote from the Nuffield Council on Bioethics which says that
researchers from developed countries.
May not be fully aware of prospective participants' considerable trust and
respect for medical doctors and other health care practitioners.
Even those with modest qualifications.
And it goes on to say, this may be especially true if the health care
practitioners have been trained in western countries.
And it is questionable whether researchers from developed countries are well prepared
for the enormous responsibility that's added to of respect and
trust places upon them.
And this is an area where a great deal of people from and
researchers from the developed world are not aware of.
Or have not thought of their perception of
themselves by their colleagues in the developing countries.
And how hard it is to strike a balance between
being aware of this perception.
But also not appear presumptuous by assuming that this
exaggerated sentiment exist in among their collaborators.
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