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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.

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Presentation on theme: "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."— Presentation transcript:

1 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

2 YESNO Do you intend to publish or present your research outside of Lindenwood University?

3 YESNO Is your research a teacher, student, or program evaluation for internal use, or marketing research designed to market Lindenwood University as a product?

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

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 As such, your research may not be published or presented, nor may you use any data collected in later published or presented works.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

6 CONTINUE Because your research is not designed to contribute to generalizable knowledge, IRB approval is… NOT REQUIRED

7 CONTINUE CONGRATULATIONS! Your research will contribute to generalizable knowledge

8 YESNO Does your research collect data from living individuals?

9 YESNO Does the collection of your data from living individuals involve physical procedures (e.g. drawing blood)?

10 YESNO Does the collection of your data from living individuals involve manipulations of the subject(s) or their environment(s)?

11 YESNO Does the collection of your data from living individuals involve interacting with those individuals in any way?

12 YESNO 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?

13 YESNO 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)?

14 YESNO Will the identities of the subjects be readily ascertainable by the investigator, or in any way associated with the information?

15 CONTINUE Your proposed research does not involve human subjects; accordingly, IRB approval is… NOT REQUIRED

16 CONTINUE Your proposal involves human subject research, and as such will require… IRB APPROVAL

17 YESNO Are you an employee of Lindenwood University?

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

19 YESNO Are you a currently enrolled student at Lindenwood University?

20 YESNO Is your planned research to be conducted as a part of your coursework at Lindenwood University?

21 YESNO Will you be using Lindenwood University facilities or resources to complete your planned research?

22 YESNO Will some or all of your planned research be conducted on Lindenwood University’s campus?

23 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

24 CONTINUE Your research protocol requires… LINDENWOOD UNIVERSITY IRB APPROVAL

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

26 YESNO Does your research involve gathering data from persons with diminished autonomy (e.g. seniors, medical patients, persons in correctional facilities, etc.)?

27 YESNO Does your research involve potential risks to participants in the study (i.e. physical, psychological, social, economic, legal, etc.)?

28 YESNO Does your research involve any deception of the participants?

29 YESNO 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

30 YESNO 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?

31 YESNO 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?

32 YESNO 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?

33 YESNO 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?

34 CONTINUE Your research protocol requires… FULL IRB REVIEW

35 CONTINUE Your research protocol qualifies for… EXPEDITED IRB REVIEW

36 YESNO Have your completed the NIH Protecting Human Research Participants training?

37 Continue and please visit http://phrp.nihtraining.com/users/login.php to complete the NIH training before you

38 studentfaculty Are you a Lindenwood University student or faculty member?

39 YESNO Has your protocol been approved by your departmental pre-IRB review process?

40 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.

41 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!

42 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.

43 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.

44 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.

45 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 IRB@lindenwood.edu


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