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Irb Application Essay

3623 words - 15 pages

Internal Review Board

For The Protection
Of Human Subjects In Research

North Carolina Central University
Request for Review of Research Involving Human Subjects

| | (For Staff Use Only) | |
|1. School/Department/Unit:NCCU/Psychology |REQUEST #____________ |Today's Date February 3, 2005 |

2. Name of Principal Investigator (PI) ______________________________________________
...view middle of the document...

IRB Chair Recommendation
[ ] Exempt from further IRB Review, see Exempt Paragraph # _________
[ ] Full Review
8. Final Disposition: [ ] Exempted [ ] Approved [ ] With Conditions
[ ] Not Approved [ ] See Attachment [ ] Conditions Met ____________
(Chair's Initials)

Signature ___________________________________ __________________________
Chair, IRB Date

NOTE: Project will expire on ___________________. If Exempted, no further review is needed unless
the protocol changes. If approved as grant Proposal, PI must resubmit as Specific Project.

Protocol ____________________________ Investigator_Hope Sinclair________ Date_February 3, 2005_____
[ One (1) copy to be filled out by investigator; ALL items* must be submitted unless not applicable to your project.]
[X ] [ ] *1. Summary sheet - one page, in lay terms

[X ] [ ] *2. Informed Consent (For detailed description see IRB Handbook)

[X] [ ] a. Statement that study involves research/clinical investigation

[X] [ ] b. Purpose of research

[X] [ ] c. Duration of subjects' participation

[X] [ ] d. Procedures to be followed

[ ] [X] e. Risks [both foreseeable & unforeseeable]

[X] [ ] f. Anticipated benefits, or lack thereof

[ ] [X] g. Alternative procedures or treatment

[ ] [X] h. Additional cost(s) to subject

[ ] [X] i. Statement of compensation for injury

[X] [ ] j. Statement that participation is voluntary and subject may withdraw without penalty
[ ] [X] k. Financial interest statement, if applicable

[X] [ ] l. Statement of whom to contact for questions

[X] [ ] m. Confidentiality of records

[ ] [X] n. Statement regarding pregnancy, if applicable

[ ] [X] 3. Investigational drug data, if pertinent

[X] [ ] *4. Research Protocol [include amendments and sample consent]

[ ] [X] 5. Letters of support, if required

[X] [ ] *6. Six complete packet submitted to IRB Office (160 Alex-Dunn) four weeks before IRB meeting for preliminary review and revision

[ ] [X] 7. Financial Conflict of Interest

[X] [ ] *8. CV - one copy of Primary Investigator(s) for IRB file

[X] [ ] *9. Cover Sheet

[X] [ ] *10. Thesis Plan (Chapters 1 & 2)
To Principal Investigator: The Institutional Review Board for the Protection of Human Subjects will need 6 copies...

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