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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 CONTINUE

Institutional REVIEW BOARD

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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. CONTINUE. Do you intend to publish or present your research outside of Lindenwood University?. YES. NO. - PowerPoint PPT Presentation

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Page 1: 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

CONTINUE

Page 2: Institutional  REVIEW BOARD

YES NO

Do you intend to publish or present your research outside of

Lindenwood University?

Page 3: Institutional  REVIEW BOARD

YES NO

Is your research a teacher, student, orprogram evaluation for internal use, ormarketing research designed to market

Lindenwood University as a product?

Page 4: Institutional  REVIEW BOARD

YES NO

Is your research best described as the gathering and preservation of oral history?

Page 5: Institutional  REVIEW BOARD

CONTINUE

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As such, your research may not be published or presented, nor may you use any data collected in later published or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

Page 6: Institutional  REVIEW BOARD

CONTINUE

Because your research is not designed to contribute

to generalizable knowledge, IRB approval is…

NOT REQUIRED

Page 7: Institutional  REVIEW BOARD

CONTINUE

CONGRATULATIONS!Your research will contribute to

generalizable knowledge

Page 8: Institutional  REVIEW BOARD

YES NO

Does your research collect data fromliving individuals?

Page 9: Institutional  REVIEW BOARD

YES NO

Does the collection of your data from living individuals involve physical procedures

(e.g. drawing blood)?

Page 10: Institutional  REVIEW BOARD

YES NO

Does the collection of your data from livingindividuals involve manipulations of the

subject(s) or their environment(s)?

Page 11: Institutional  REVIEW BOARD

YES NO

Does the collection of your data from living individuals involve interacting with those

individuals in any way?

Page 12: Institutional  REVIEW BOARD

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?

Page 13: Institutional  REVIEW BOARD

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)?

Page 14: Institutional  REVIEW BOARD

YES NO

Will the identities of the subjects be readily ascertainable by the investigator, or in any

way associated with the information?

Page 15: Institutional  REVIEW BOARD

CONTINUE

Your proposed research does not involve human subjects; accordingly, IRB approval is…

NOT REQUIRED

Page 16: Institutional  REVIEW BOARD

CONTINUE

Your proposal involves human subject research, and as such will require…

IRB APPROVAL

Page 17: Institutional  REVIEW BOARD

YES NO

Are you an employee of Lindenwood University?

Page 18: Institutional  REVIEW BOARD

YES NO

Is your planned research to be conducted in the regular course of your employment?

Page 19: Institutional  REVIEW BOARD

YES NO

Are you a currently enrolled student atLindenwood University?

Page 20: Institutional  REVIEW BOARD

YES NO

Is your planned research to be conducted as a part of your coursework at Lindenwood

University?

Page 21: Institutional  REVIEW BOARD

YES NO

Will you be using Lindenwood University facilities

or resources to complete your planned research?

Page 22: Institutional  REVIEW BOARD

YES NO

Will some or all of your planned research be conducted on Lindenwood University’s

campus?

Page 23: Institutional  REVIEW BOARD

CONTINUE

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

Page 24: Institutional  REVIEW BOARD

CONTINUE

Your research protocol requires…

LINDENWOOD UNIVERSITY IRB APPROVAL

Page 25: Institutional  REVIEW BOARD

YES NO

Does your research involve gather data from anyone under the age of 18?

Page 26: Institutional  REVIEW BOARD

YES NO

Does your research involve gathering data from persons with diminished autonomy

(e.g. seniors, medical patients, persons incorrectional facilities, etc.)?

Page 27: Institutional  REVIEW BOARD

YES NO

Does your research involve potential risks to participants in the study (i.e. physical,

psychological, social, economic, legal, etc.)?

Page 28: Institutional  REVIEW BOARD

YES NO

Does your research involve any deception of the participants?

Page 29: Institutional  REVIEW BOARD

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

Page 30: Institutional  REVIEW BOARD

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?

Page 31: Institutional  REVIEW BOARD

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?

Page 32: Institutional  REVIEW BOARD

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?

Page 33: Institutional  REVIEW BOARD

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?

Page 34: Institutional  REVIEW BOARD

CONTINUE

Your research protocol requires…

FULL IRB REVIEW

Page 35: Institutional  REVIEW BOARD

CONTINUE

Your research protocol qualifies for…

EXPEDITED IRB REVIEW

Page 36: Institutional  REVIEW BOARD

YES NO

Have your completed the NIH Protecting Human Research Participants training?

Page 37: Institutional  REVIEW BOARD

Continue

and please visithttp://phrp.nihtraining.com/users/

login.phpto complete the NIH training before you

Page 38: Institutional  REVIEW BOARD

student

faculty

Are you a Lindenwood University student or faculty member?

Page 39: Institutional  REVIEW BOARD

YES NO

Has your protocol been approved by yourdepartmental pre-IRB review process?

Page 40: Institutional  REVIEW BOARD

Continue

Your research protocol must receive approval from your department’s pre-review process

before it may be submitted to the full IRB for approval.

Page 41: Institutional  REVIEW BOARD

Continue

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!

Page 42: Institutional  REVIEW BOARD

Continue

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.

Page 43: Institutional  REVIEW BOARD

Continue

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.

Page 44: Institutional  REVIEW BOARD

Continue

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.

Page 45: Institutional  REVIEW BOARD

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

[email protected]