Institutional REVIEW BOARD
description
Transcript of Institutional REVIEW BOARD
A step-by-step guide to help you determine if your research protocol is required to be reviewed by the
Lindenwood University IRB
INSTITUTIONAL REVIEW BOARD
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YES NO
Do you intend to publish or present your research outside of
Lindenwood University?
YES NO
Is your research a teacher, student, orprogram evaluation for internal use, ormarketing research designed to market
Lindenwood University as a product?
YES NO
Is your research best described as the gathering and preservation of oral history?
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Your research is defined as a class project,
and does not require IRB approval.
As such, your research may not be published or presented, nor may you use any data collected in later published or
presented works.
NO IRB APPROVAL REQUIRED
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Because your research is not designed to contribute
to generalizable knowledge, IRB approval is…
NOT REQUIRED
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CONGRATULATIONS!Your research will contribute to
generalizable knowledge
YES NO
Does your research collect data fromliving individuals?
YES NO
Does the collection of your data from living individuals involve physical procedures
(e.g. drawing blood)?
YES NO
Does the collection of your data from livingindividuals involve manipulations of the
subject(s) or their environment(s)?
YES NO
Does the collection of your data from living individuals involve interacting with those
individuals in any way?
YES NO
Do you intend to collect information about behavior that occurs in a context in which an
individual can reasonably expect that no observation or recording is taking place?
YES NO
Do you intend to collect information which has been provided for specific purposes by an
individual and which the individual can reasonably expect will
not be made public (e.g. medical records)?
YES NO
Will the identities of the subjects be readily ascertainable by the investigator, or in any
way associated with the information?
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Your proposed research does not involve human subjects; accordingly, IRB approval is…
NOT REQUIRED
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Your proposal involves human subject research, and as such will require…
IRB APPROVAL
YES NO
Are you an employee of Lindenwood University?
YES NO
Is your planned research to be conducted in the regular course of your employment?
YES NO
Are you a currently enrolled student atLindenwood University?
YES NO
Is your planned research to be conducted as a part of your coursework at Lindenwood
University?
YES NO
Will you be using Lindenwood University facilities
or resources to complete your planned research?
YES NO
Will some or all of your planned research be conducted on Lindenwood University’s
campus?
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While your proposed research will require approval by an institutional review board, your
research does not, however, fall under the jurisdiction of the Lindenwood University IRB.
Accordingly…
NO SUBMISSION IS REQUIRED
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Your research protocol requires…
LINDENWOOD UNIVERSITY IRB APPROVAL
YES NO
Does your research involve gather data from anyone under the age of 18?
YES NO
Does your research involve gathering data from persons with diminished autonomy
(e.g. seniors, medical patients, persons incorrectional facilities, etc.)?
YES NO
Does your research involve potential risks to participants in the study (i.e. physical,
psychological, social, economic, legal, etc.)?
YES NO
Does your research involve any deception of the participants?
YES NO
Does your research involve gathering information about sensitive topics*?
*Defined as: political affiliations; psychological disorders of participants or their families; sexual behavior or attitudes;
illegal, antisocial, self-incriminating or demeaning behavior; critical appraisals of participants’ families or employers;
legally recognized privileged relationships (lawyers, doctors, ministers); income; religious belief and practices
YES NO
Will your research be conducted in established or commonly accepted educational settings, involving normal educational practices, such
as…
(1) research on regular and special education instructional strategies, or
(2) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management
methods?
YES NO
Will your research involve the use of educational tests (cognitive, diagnostic, aptitude, or
achievement), survey procedures, interview procedures, or observation of public behavior,
unless…(1) Information obtained is recorded in such a manner that
human subjects can be identified, directly or through identifiers linked to the subjects; AND
(2) Any disclosure of the human subjects’ responses outside the research reasonably could place the subjects at risk of criminal or
civil liability or could be damaging to the subjects’ financial standing, employability, or reputation?
YES NO
Will your research involve the use of educational tests (cognitive, diagnostic, aptitude, or
achievement), survey procedures, interview procedures, or observation of public behavior
that were not exempt under (B) above, where…(1) the human subjects are elected or appointed public officials
or candidates for public office; or(2) federal status requires, without exception, that the
confidentiality of the personally identifiable information will be maintained throughout the research and thereafter?
YES NO
Will your research involve the collection or study of existing data documents, records,
pathological specimens, or diagnostic specimens, if these sources are publicly
available or if the information is recorded by the investigator in such a manner that subjects
cannot be identified directly or through identifiers linked to the subjects?
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Your research protocol requires…
FULL IRB REVIEW
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Your research protocol qualifies for…
EXPEDITED IRB REVIEW
YES NO
Have your completed the NIH Protecting Human Research Participants training?
Continue
and please visithttp://phrp.nihtraining.com/users/
login.phpto complete the NIH training before you
student
faculty
Are you a Lindenwood University student or faculty member?
YES NO
Has your protocol been approved by yourdepartmental pre-IRB review process?
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Your research protocol must receive approval from your department’s pre-review process
before it may be submitted to the full IRB for approval.
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Your faculty advisor (e.g. thesis/dissertation chair) must electronically sign your package through IRBNet to verify that the student PI
has passed departmental pre-review.*
*Student submissions without a faculty advisor's electronic signature will not be
accepted!
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As a faculty member, you are not required to submit to a pre-IRB review process.* You may submit your protocol through IRBNet with only your own electronic signature.
*However, the IRB strongly recommends seeking feedback from your department’s IRB representative before submitting your
completed protocol for review.
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Primary investigators who already have an approved IRB application, but need to slightly modify the procedure, or extend the dates of
data collection, should submit the completion/amendment form as a new package
on IRBNet.
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Upon completion of your research, or within one year from receiving IRB approval (whichever
comes first), Primary Investigators who received Lindenwood University IRB approval should fill
out the completion/amendment form and submit the form as a new package on IRBNet to
notify the IRB that their research has finished or needs more time.
The Lindenwood University Institutional Review Board would like to thank all Primary
Investigators for taking the time and care to ensure that their applications meet all
guidelines set forth for submissions to the IRB.
THANK YOU.If you have any further questions, please contact the IRB chair at