00:01
Now let us talk about Research Ethics Boards.
The Research Ethics Board is the group of
people who assess whether or not your research
project is ethical. You require the stamp
of their approval before you can probably
start collecting data under the auspices of
whatever institution you work for. So the
Research Ethics Boards, they protect the rights
and welfare of human subjects. They review
the protocols that scientists like you and
I submit to make sure that they fall under
certain ethical standards. So they are responsible
for ensuring that the risks to participants
are as low as possible. They want to make
sure that the risks are acceptable in light
of the possible benefits. So it's not just
about the absolute risk, it's about the risks
relative to what you can get out of it.
00:45
They are also in charge of making sure that the
document, the informed consent document that
you have your subjects sign, is accurate and
complete, in that it has to express all the
potential risks and benefits that your study
offers. In general they are going to oversee
the methodology of your study to make sure
it is conducted in an ethical manner, meaning
the methodology is protective of the rights
and safety of your subjects. Important thing
to remember about Research Ethics Boards is
they don't have the force of law, much like
all the agreements we talked about. They are
guidelines, however, most ethical institutions,
like universities and hospitals, will employ
Research Ethics Boards to make sure that any
research conducted under their roof is ethical
and very often the funding of those institutions
depends on whether or not they conform to
these ethical standards. So getting board
approval is essential for conducting proper
ethical research in the modern environment.
01:42
So two kinds of epidemiological research or
medical research in general that you would
probably submit to an ethics board and first
is primary data collection, that's when you're
going out as a researcher to collect new data
from human subjects and the second kind is
secondary data analysis, that's when somebody
else has already collected some data and you're
analyzing it. Now the second type is very,
very common in epidemiological study. That's
when we can look through huge data sets or
maybe even government data sets, like large-scale
epidemiological surveys, in the USA there is
one call NHANES, the National Health and Nutritional
Examinations Study, that one is quite well
studied and is extensive and that's a classic
case of secondary data analysis. In both scenarios,
primary and secondary data you are required
to submit a protocol to a Research Ethics
Board. Research Ethics Boards come in a variety
of flavors, sometimes they are called Institutional
Review Boards, IRBs. Sometimes they are called,
Independent Ethics Committees, IECs. Sometimes
they are called, Ethical Review Boards, ERBs
or sometimes just Research Ethics Boards, REBs.
It doesn't matter what they are called,
they're doing essentially the same kinds of
work. They are assessing your application
to make sure it meets a certain ethical standard.
So again, they provide the oversight for ethical
conduct in all research involving human subjects,
there is a parallel board that deals with
animal subjects and most boards as well have
subcommittees that deal with either health
sciences research or social sciences research
or etiological research, so long as it involves
human subjects, they are going to examine
your protocol to make sure it is as ethical
as possible.
03:24
So the things that research ethics boards
look for in submissions. First and foremost
they are looking for a proper informed consent,
how are you going to acquire informed consent,
how are you going to communicate those risks,
do you have a document that is defensible
in the legal environment. If you're looking
at vulnerable groups, can you justify the
targeting of those groups. Vulnerable groups
include children, the mentally impaired, aboriginal
groups perhaps or socially or economically
depressed groups, groups who have historically
or traditionally been coerced into behaviors
or participation. So if you're going to be
studying a vulnerable group, your ethics application
has to be especially well-written and clear
in justifying why it's important. Have you
expressed the fullness of the extent of risks
that your subjects will be exposed to and
can you justify those risks, have you sought
to minimize those risks and again, risk can
be physical or psychological, or even social
or economic. Incentives have to be spelled
out as well. Sometimes we like to offer a
financial incentive or gift of some kind for
someone to participate in our study. Keep
in mind, offering an incentive can be seen
as coercion, so this is why it is a delicate
act of offering a gift, a thank you, some
expression of gratitude, as opposed to a direct
manipulation of a subject or coercion of a
subject to participate, so a balancing act
must be expressed. How many benefits does
your study offer the subject? Sometimes they
offer none at all, that's okay, but you have
to be clear about that. Now how is the data
going be taken care of. Every research project
involves a collection of data, usually it's
stored electronically these days, so how will
your data be stored? Will it be secure? Will
it be on a network computer? How long will
you keep it? Who will have access to it? Will
it be just you or you and your research assistant,
you and your employer? All these elements
have to be expressed in your protocol so that
the committee can decide whether or not your
data management strategies are ethical in
respecting the rights of confidentiality of
the subjects. Speaking of confidentiality,
how much of it do you offer your subjects.
05:43
For example, if your study involves asking
people's opinions on matters, it's a qualitative
research project and you're going to publish
their opinions and attribute their names to
those opinions. That's not a lot of confidentiality
being offered, on the other hand, if you're
going to decapitate your data and by decapitation
I mean, remove the heads, remove the identifying
features, remove the names or anything I could
use to identify who it is who gave me those
responses. Well that's a degree of anonymity
or confidentiality that is positive, it shows
that you are respecting your subjects' privacy.
And also, can the subjects withdraw, this is key.
06:24
Perhaps someone agrees to participate in your
project, but then finds it's far too much
of a problem or maybe the risks outweigh the
benefits and they want to leave. You have
to find a way to let them leave, without any
sort of penalty. They cannot be coerced into
staying in the research project if they don't
want to. Now if they do leave, you have to
explain what happens with their data. Will
it be deleted? Will it be kept? Will the subject
have the option of what happens to their data?