00:01
It's important when
we're thinking about
responsible conduct
of research to also
consider times where
there is misconduct.
00:08
So misconduct is
significant departure from
accepted practices in
the research community.
00:13
And you know that the
person has committed
the misconduct intentionally,
knowingly or recklessly.
00:21
So it's any kind of scientifically
unsound clinical research.
00:24
When that happens, it exposes not
only the research subjects to risks,
but there's also going
to be the inconvenience
they've participated
in research.
00:33
And now there's been misconduct,
it's all for naught,
there's no purpose for having
had these human subjects,
you know,
participate in research that
then you can't have
valid results with.
00:45
And also with misconduct,
there's going to be concerns
about particular detrimental
research practices
that violate the traditional
values of science.
00:53
And let me talk to you
about a few examples
of detrimental
research practices.
00:59
So for instance,
you have your hypothesis,
you've created a
design for your study.
01:06
But you do not follow
the investigational plan.
01:08
you deviate from that,
that would be considered
a detrimental clinical
research practice.
01:14
You don't store your data well.
01:17
You have inadequate
or inaccurate records
of what you've actually
been doing in the research,
that would also be detrimental
to ultimately having valid results.
01:29
When you're talking about the
involvement of a human participant,
you fail to obtain or
appropriately document
their consent to be a
participant in the research.
01:40
Another example might be failure
to report adverse drug reactions.
01:44
So you've given an investigational
drug to a research participant,
they've had an adverse reaction,
you don't report that.
01:53
So that, you know, wherever the
oversight body is, isn't aware of that.
01:58
It might jeopardize future
participants in the research.
02:04
When you're actually
have collected
the data and now
are analyzing it,
you know, another detrimental
research practice would be,
you know,
not using statistics appropriately,
either misusing them
or using the wrong
statistical technique,
in order to analyze the data.
02:21
When you're
going to publication,
things that are forbidden or
things like honorary authorship.
02:26
So just putting a famous
person's name on or person's,
you know,
scientific stature on your publication,
even if they have not
provided that intellectual
contribution to the research
or to the manuscript.
02:38
Or even, you know,
so far as ghost authorship.
02:40
So somebody else has written it,
and then you're just
putting your name on it,
that's also something
that's forbidden,
a detrimental research practice.
02:51
There are also concerns
and we will talk about this in
future lectures about
issues of conflicts of interest.
02:57
So where you have a
personal interest in impeding
or, you know,
altering your primary obligation
to conduct sound research
and when you fail to report
that you might have
conflicts of interest,
that might bias how
you interpret results.
03:14
And making that
known to the public,
you're not being transparent,
that's also going to be
a detrimental clinical
research practice.
03:22
And then,
at least in the United States,
we have an Office of
Research Integrity that will
investigate when there are
allegations of misconduct.
03:30
And the three kinds of
misconduct that they will,
you know, try to make
a decision on are something
called fabrication,
falsification, and plagiarism.
03:39
So fabrication,
just making up data,
you haven't even done the
experiment and you're making up results.
03:45
Falsification,
perhaps you've done the research,
but you alter the results,
you don't accurately report them.
03:51
Or plagiarism, taking someone
else's intellectual contribution,
and not giving them
appropriate credit for that work.