IRB On Demand Video- IRB On Demand: Does My Study Need IRB Review? Part 2

Audio Transcript Auto-generated

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  Mhm. Hello, my name is Heather Park May.

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  I'm the I.

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  R. B.

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  Training coordinator at Wayne State University.

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  Um I'm going to present now and on demand video

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  of Part two of the series determining whether your study

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  needs. Irby review and understanding the definition of human subject

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  research or human participant research.

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  Uh If you have not seen part one, please stop

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  and go back to Part one.

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  Um and watch that brief video before continuing on with

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  this Part two video or recording um Part one.

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  We talked about understanding the definitions and the regulations of

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  human participants and the definition of research and identifiable information

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  and um and so that information that background information is

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  really going to be important to understanding what what part

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  two is about which is which is focused on how

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  to complete the human participant research determination tool.

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  What the tool is used for.

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  Some tips for for getting that tool completed and submitting

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  it to the I.

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  R. B.

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  If that is.

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  Uh if that's something you're looking for looking into doing

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  so, the human participant research determination tool is to be

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  used for determining when a project requires Irby review and

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  approval. You would use this tool to determine if the

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  project meets the death, the regulatory definition of research requiring

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  I. R.

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  B. Review, which is determined in um question number one

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  and number two in the determination tool to receive the

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  RBS concurrence or documentation of your determination, uh send the

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  completed tool to Irby questions at wayne dot E.

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  D. U.

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  The tool will be processed, it will be sent to

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  a designated reviewer who will look it over, look over

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  the information you've provided and make a formal determination which

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  will be returned to you with either a memo that

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  documents uh documents that the study does not require Irby

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  oversight, which is going to be important for you to

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  keep on file.

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  In some cases, if the project ever leads to publication,

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  uh there are some cases where the journal that you're

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  submitting a manuscript to will ask for Irby documentation um

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  for that determination.

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  So it's important to keep that on file.

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  Um If the the I.

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  R. B.

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  Determines that the study does fall under the regulatory definition

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  of human participant research and I.

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  R. B.

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  Review is required, what you what you will return back

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  to you is that determination, along with instructions on how

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  to move forward with the I.

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  R. B.

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  Review specific to the type of review type of research

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  that's being done.

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  So you'll have real specific instructions for the type of

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  review, the review category that your study is going to

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  fall under.

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  So in either either way it's a beneficial.

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  It's a good place to start if you're just not

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  sure. Um, and uh, having that documentation is really helpful.

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  So I'm going to break down um, the tool by

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  section. So, um, describing the project you'll find on page

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  two of the determination tool.

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  This section includes several open ended questions that provides the

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  reviewer with the information that needed about the project in

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  order to make that determination.

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  So we're going to look more closely break down these

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  questions on page two of the determination tool.

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  So, um, the first question here is asking to propose,

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  describe the purpose of the study, question the objectives and

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  the aims for the study for the project here.

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  The reviewers really wanting to know what, why are you

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  doing the project and what are you hoping to learn

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  by completing the project.

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  Then you're asked to describe how the results will be

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  used, including any plans for presentation or publication.

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  So, here, what's the primary intent of the project?

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  If the primary intent is to is to understand or

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  fill a gap in the literature, um, that that could

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  contribute to general Izabal knowledge.

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  And your primary intent is to then publish a manuscript

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  that's going to be considered general Izabal knowledge.

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  And if you remember that definition, go back, go back

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  to part one of this series of on demand um,

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  training recordings, you'll you'll see that generalized well, knowledge is

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  the key for a project involving research.

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  So what are you going to do with the results

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  of the project?

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  When you learn what you're hoping to learn, what is

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  then, what's the next step and what is your primary

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  intent of the project, then you're asked to state the

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  locations where the activity will be taking place.

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  Um, make sure that you only include the locations that

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  Wayne State University researchers are going to be involved in.

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  If this project is being done someplace else, you only

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  want to stick to what your investigators are going to

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  be doing here, describe the participants.

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  If this applies for the project, who are you going

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  to be asking to participate Or and or whose data

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  will be collected?

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  If you're going to be doing a survey or focus

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  group or interview of some sort for this project, who

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  are you going to be asking to provide that information?

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  Complete that activity.

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  And if there is only going to be data collection

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  with no intervention or interaction with an individual whose data

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  are you looking to collect?

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  And so that information should be described here in this

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  question that asks to describe the participants.

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  If there are no participants, if you're not collecting data

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  that falls on, if you're collecting information that does not

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  meet the description of a human participant that we covered

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  in part one then you could just type N.

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  A. And and summarise the source of the data.

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  Then you're asked to describe the data that would be

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  collected for the study and the sources of that data.

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  So here we want to be real specific.

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  When you're answering this question um give details about where

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  the data is coming from.

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  What kind of databases that a medical medical record that

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  you're collecting the data from?

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  Or are you obtaining this data from a our data

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  repository of registry or a bio repository?

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  If you're getting bio specimens be specific about where the

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  data is coming from?

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  Who's providing it to you and and what is the

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  data that's being collected?

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  What kind of data are you looking at and then

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  described how the data is going to be obtained?

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  Is it going to be through a survey?

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  Is it going to be by scrubbing data from existing

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  records or are you going to be receiving all of

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  the data from a third party source like a data

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  repository or registry?

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  Explain how that data is going to be obtained here

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  and then describe whether or not the data will include

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  individually identifying information.

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  Examples given here, date of birth and medical record number,

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  email address, which is a piece of identifiable information.

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  So is this information going to be uh included?

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  And and so you want to explain that here And

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  then one thing that is often missed when people are

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  completing this tool is this bottom this last question within

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  this bottom box here could the identities of participants be

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  known to or be readily ascertained by the investigators?

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  So here you would check yes.

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  If you will have access to or will need to

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  use identifiable data, even if you're not going to be

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  collecting that data for analysis.

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  So if that happens to be the case, you will

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  need to check.

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  Yes. Now in part one, I promised that I would

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  explain more detailed information about programme evaluations and quality improvement

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  versus research.

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  So when you're describing how the results of the program

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  evaluation will be used in that, in one of those

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  questions that we just went over, it's really important in

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  your description of this type of activity to include information

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  about the changes that will be made or actions that

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  will be taken locally after reviewing the results of the

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  project and sharing that information with local stakeholders.

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  So if you're doing a program evaluation or quality improvement,

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  you learn about areas of the of the program that

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  need to be improved or you know, specifically identified um

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  ways or areas that are lacking.

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  Need more attention.

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  What are you going to do about that?

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  What kind of changes are going to be made?

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  What actions are going to be taken?

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  That's an important information that will help the reviewer determine

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  if this is research.

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  If it could be generalised, able or if this is

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  really just focused on improving a local project that can't

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  be um where the information just can't be applied outside

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  of that area.

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  The key difference between program evaluation and quality improvement projects

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  and research that contributes to general Izabal knowledge lies in

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  the purpose of the project and how the information gained

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  will be applied.

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  So will the knowledge be gained to modify?

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  Will the knowledge gained be used to modify?

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  Internal processes and programs to evaluate areas of concern that

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  the project identifies?

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  Or is the project designed in a way that will

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  provide data to be applied more broadly to fill a

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  known gap in the literature?

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  So if the latter is true, then the project will

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  contribute to general Izabal knowledge there.

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  You have the intent to create general Izabal knowledge and

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  therefore the research is requires I.

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  R. B.

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  It is research, right?

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  And so then if it's research and it involves a

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  human participant, it does require Irby review.

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  Yeah. So I'm going to jump into question number one,

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  question, number one of the determination tool is focused on

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  determining if the project involves human participants or human subjects.

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  And uh so this is focused centered around that definition

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  of the human human participant That we went over in

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  question part# one.

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  So here the question number one asks, uh does the

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  activity involve the prospective collection of information?

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  Our interaction with an individual.

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  Um And so if there is a prospective interaction with

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  the participant, then you would check yes here.

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  So this includes internet surveys, interviews, focus groups.

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  These are all prospective interactions.

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  So you would check yes.

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  In these cases you would also check yes if the

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  project involved the collection of information or bio specimens that

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  would be done specifically for the proposed project.

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  And then for question# one B.

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  If the project requires the event investigator to access or

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  use identifiable information to collect data, then you would check

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  yes here as well.

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  If you're going to have any if you will have

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  access to identifiable information or will require the use of

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  identifiable information but you're not going to include any identify

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  IRS in your data collection for your analysis, then you

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  do still need to check yes because if you remember

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  in part one when we talked about the the definition

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  of human participant, it involves the use of identifiable information

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  and not solely the collection of identifiable information.

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  Question number two is this will help us determine if

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  the project needs regulatory definition of research.

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  So question number two A is focused on determining if

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  it's a systematic investigation.

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  If it's going to involve development, testing, evaluation and data

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  collection Um this uh then it would include this would

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  be uh systematic investigation and you would check yes.

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  Again this description this definition was included and it was

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  covered in part one Question# two.

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  B. is this project going to contribute to general Izabal

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  knowledge? If it's going to draw conclusions general conclusions, uh

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  informed policies or could be universally are widely applicable, then

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  this um would contribute to general Izabal knowledge.

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  So you would check yes here Now, question# three.

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  This would be covered.

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  You would only answer question number three, if you've answered

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  yes to any response is the number one and number

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  two. So uh yes to number one A.

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  And or number one B.

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  And yes to number two A.

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  And or number to be.

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  Then you would complete this question.

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  And this will help us decide whether uh this project

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  requires Irby review under federal, the federal Drug Administration regulations.

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  So this is for research involved, clinical research involving drugs

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  or devices or biological products.

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  So in this case, if you check any of these

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  boxes in this section and your project requires Irby review

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  which is also subject to FDA regulations.

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  And the common rule that summarizes everything that I have

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  here. There's references, links to resources to provide additional information.

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  And the links will be available on our education page

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  in the on demand Training section, where in a in

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  a way where you can just access the resources um

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  without the video, without the audio recording, um any questions

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  that you have can be directed to to i r

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  b questions at wayne dot e d u and I

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  will be there available.

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  They're monitoring that inbox to answer those questions directly.

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  Thanks for your time.