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Documents and Instructions to Prepare for an IRB Review
 

Contact: Tracey Wheeler Pangborn
Phone:   215.898.4318
Email:     traceywh@nursing.upenn.edu

1. IRB Guidance for IRB and Protocol Submission: http://www.upenn.edu/regulatoryaffairs/human/IRBGuides.html

http://www.upenn.edu/regulatoryaffairs/human/forms.html

2. You will need to complete a Face Sheet (Section I) for every IRB submission regardless
of the level of review:

sbsapplicationsection1.doc – for social and behavioral science applications

http://www.upenn.edu/regulatoryaffairs/human/forms/
biomedapplicationsection1.doc -
for biomedical science applications

3. You will need to write a Protocol Summary (Section II) for every IRB submission regardless
of the level of review. Typically, a protocol summary for a full board study
equires more information than is required of an exempt study. However, the
necessary elements must be included in any protocol summary:

sbsapplicationsection2.doc – for social and behavioral science applications

http://www.upenn.edu/regulatoryaffairs/human/forms/
biomedapplicationsection2.doc - for biomedical science applications

4.  You will need to complete the IRB Required Documents (Section III) which is a checklist
that will ensure you have submitted all of the necessary documents depending on the level of review.

http://www.upenn.edu/regulatoryaffairs/human/forms/
sbsapplicationsection3.doc –
for social and behavioral science applications

http://www.upenn.edu/regulatoryaffairs/human/forms/
biomedapplicationsection3.doc -
for biomedical science applications

4. As necessary, you will need to write a consent document or request a waiver of written voluntary consent:

Consent Form Templates:

5. If you need to: Request for Waiver of HIPAA Authorization to Use of Disclose Documents, Records or Data Sources Containing for Research Involving Protected Health Information for Research Purposes: hipaawaiver.doc

6. Claim of Exemption Form: claimofexemptionform.doc

7. To ascertain if your study is exempt use the following form: ExemptScreeningQuestions.doc

8. To submit a Continuing Review Form: crform.doc

9. Research proposals should meet the spirit of the Code of Federal Regulations (CFR) and the policies and procedures set forth by the University of Pennsylvania ORA.


 


 



 

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