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CITI Program Webinar Demo - IRB Review of Observational Research - YouTube
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welcome everyone thank you for joining
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us for today's citi program webinar
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today's topic is irb review of
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observational research and will be
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presented by dr eileen willetts from the
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icann school of medicine at mount sinai
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just a few quick notes this webinar will
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be recorded and the recording will be
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available on the citi programs website
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this webinar is for educational purposes
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only it's not designed to provide legal
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advice or legal guidance you should
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consult with your organization's
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attorneys if you have any questions or
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concerns about relevant laws and
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regulations that may be discussed in the
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webinar in addition the views expressed
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in the webinar are solely those of the
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presenter
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now let me tell you about today's
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presenter dr eileen willetts is a
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certified irb professional she's irb
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chair at with the icann school of
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medicine at mount sinai in new york
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she's an associate professor in the
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department of
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environmental medicine and public health
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an associate professor in the department
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of global health and health systems
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design at mount sinai and an adjunct
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associate professor with the clarkson
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university mount sinai program and
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bioethics
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as an irb chair dr willis provides
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extensive regulatory support and
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research ethics training to
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investigators study personnel and
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medical and graduate students
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she also works with irb leadership to
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develop institutional research policy
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informed consent citizen science and
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global health challenges rank at the
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forefront of her current research
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interests
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now we can move on to the learning
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objectives for this webinar they address
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a number of aspects of observational
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research studies and how irbs typically
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review such protocols
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this
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webinar will identify the key
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characteristics of the main types of
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observational research studies cohort
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studies cross-sectional and case control
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the webinar will enable you to recognize
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study risk in relation to the different
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types of observational studies as well
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as understand the kinds of study bias
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associated with each observational
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research design and apply the regulatory
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review criteria to observational studies
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for effective protocol review
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and also in addition to these four
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stated learning objectives as a result
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of developing this presentation we've
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decided to add two additional learning
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objectives in blue and these will expand
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and add depth to our discussion of irb
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review
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let's begin with an overview of
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observational research i'll briefly
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describe observational research study
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designs and touch upon their strengths
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and weaknesses including their
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susceptibility for bias i'll then
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discuss how irbs consider the primary
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types of observational studies with
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respect to the risk of subject harm
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this risk determination is what drives
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the type of irv review process whether a
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study can be determined exempt from irb
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review or be reviewed by the expedited
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review process these are the basic
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domains of observational study design
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cross-sectional studies case control
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studies retrospective cohort and
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prospective cohort studies
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each type of study has its own specific
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design elements related to the timing of
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assessments and sampling of study
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subjects as well as advantages to study
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conduct and the validity of research
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findings
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the rigor of each design and its
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strength of evidence is indicated in
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this pyramid
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it illustrates that the prospective
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cohort study is considered the most
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rigorous and definitive design in terms
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of the findings it can generate followed
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by the retrospective cohort study case
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control study and cross-sectional study
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design
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the reasons underlying the strength of
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evidence categorization are more fully
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explored in the city program course on
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observational research so i will not get
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into the weeds here and we'll keep the
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discussion more about what an irb
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reviewer should know regarding the
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different design types so as to
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effectively review an observational
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research protocol
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different observational study designs
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may be prone to different types of
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challenges or limitations
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these can impact how you approach your
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irb review and that is why it's
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important to understand which study
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design is being used within a given
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protocol
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for example
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depending on the outcome of interest a
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prospective cohort study can take years
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to conduct and may require a large
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sample size as some subjects will lose
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interest in the research and drop out
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some participants may be lost to
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follow-up for reasons related to their
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health status or their life circumstance
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for this reason irb professionals should
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question a seemingly small number of
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study participants in a longitudinal
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study
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other observational study challenges
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involve the inability to establish a
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temporal sequence of events
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this problem is specific to
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cross-sectional studies because all data
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are collected at a single point in time
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and it can be difficult to determine
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when a given variable precedes another
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in time
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lastly because observational studies are
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by definition
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non-experimental randomization or random
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assignment is not part of the design
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as it is in many clinical trials
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the lack of randomization can yield
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study groups that aren't
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at this time in the context of the
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aforementioned types of observational
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study was let's consider how the irb
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professional would approach protocol
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review
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one of the earliest assessments the irb
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makes when reviewing a study involving
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human subjects is whether the research
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poses minimal risk of harm to subjects
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or more than minimal risk of harm
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here we see the regulatory definition of
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minimal risk i'm sure most of you are
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familiar with this
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and many observational studies employ
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research methods that are considered
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minimal risk
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for example
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research involving focus groups surveys
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or structured interviews
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and studies in which data are collected
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using using non-invasive measures such
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as blood pressure venipuncture or mri
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while one might not consider
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observational research as having a high
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degree of physical risk given that by
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definition it does not involve an
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intervention the risk of other types of
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subject harm is possible and should be
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considered during the course of irb
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review
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if we consider the risk of psychological
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harm
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a cross-sectional study involving an
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in-depth interview in which study
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participants are asked to recall
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traumatic events for example domestic
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violence can potentially cause distress
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asking individuals to participate in
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research activating such memories should
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never be undertaken lightly
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when reviewing observational research
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involving sensitive lines of inquiry it
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is good practice for the irb to ask the
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investigator about the risk of
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psychological harm and how it might be
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deducted and addressed during the course
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of the study
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also
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consider that observational studies
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sometimes evaluate risky behaviors such
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as unsafe sexual practices or drug use
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the identification and disclosure
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when a study first presents to you a
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human research protection program the
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first order of business is to identify
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the appropriate level of review
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here you can see four options
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with respect to option one
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a not human subject's research
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determination
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an activity is research not involving
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human subjects if there is no
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interaction or intervention with living
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individuals and neither the provider of
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the specimens or data nor the recipient
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can link the specimens or data with
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identifiable information individuals
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either living or dead
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an observational study involving a fully
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de-identified publicly available data
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set with no investigator access to
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identifiers could conceivably be
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considered not human subjects research
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similarly should an investigator be
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provided with bio specimens with
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absolutely no links back to the subject
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this activity could fit an nhsr
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classification
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however
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more often than not there exists the
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potential to link data back to the
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individual and the irb professional will
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select exempt category 4 to best
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classify the research
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many observational research studies that
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present to the irb are no greater than
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minimal risk and will qualify for either
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an irb exemption or the expedited review
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process
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when might an observational study be
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deemed exempt
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exempt in summary there are three main
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types of observational study designs
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each is non-interventional and
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characterized by the direction and
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timing of data collection
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the irb may deem an observational study
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exempt or elect to review it by the
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expedited review process or by convened
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committee most but not all observational
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research is considered minimal risk and
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will undergo expedited review or will
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fit into an exempt category
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irbs can approve waivers of consent and
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hipaa authorization for observational
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research when certain criteria are met
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irbs apply the 111 criteria to the
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review of observational research
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i also invite everyone to review our
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content offerings regularly as we are
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continually adding new courses and
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webinars and various areas of research
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ethics compliance and professional
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development
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