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IRB Guidance

 Topic  IRB Guidance
 Questions?
Human Research

Is IRB Review Required?
The first question one should consider when assessing the requirement for IRB review is whether the activity meets the regulatory definition of human researchAnyone unsure about IRB review requirements and whether their proposed activity constitutes “human research” requiring IRB review should contact the Office of Regulatory Affairs. The IRB staff will determine if the activity is human research. If an activity does not meet the regulatory definition of human research, the IRB will, upon request, issue a letter stating that the project does not require IRB review or approval. Download  guidance.

 

Biomedical:

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Social and Behavioral:

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Claim of Exemption

Is your study exempt for further IRB review?
If you think your study is exempt, refer to the Instructions for the Claim of Exemption Form

 

Biomedical:

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Social and Behavioral:

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Clinical Trials Registration

 

ClinicalTrials.gov Registration  All US drug or device clinical trials must be registered on ClinicalTrials.govin accordance with the FDA Amendment Act of 2007.  If you have questions or require a login please contact our office at This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

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Confidentiality Certificates of Confidentiality allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding.  See the NIH Certificate Kiosk for additional information.

http://grants2.nih.gov/grants/policy/coc/

 
Conflicts of Interest
Please see the Office of the Vice Provost for Research, COI Policies and the COI submission system

 

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Cooperative Agreement: CHOP/Penn

Investigators are encourages are encouraged to review the CHOP/Penn IRB Cooperative Agreement to determine if their study is eligible for consideration under the agreement.  Download guidance.

 

Tracy Ziolek

or 

Meghan Blair

Data & Safety Monitoring

 

Download guidance.

 

 
Emergency Use of a Test Article

Physician request for an individual patient IND under expanded access for emergency or nonemergency use 

 

Requests for emergency uses of investigational drugs or devices:  Call 215.746.6272 or 215.868.3114.  

 

 

 

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NIH Genome Wide Association Study (GWAS) Registry

Any request to submit data into the NIH Genome-Wide Association Studies repository must include certification that the submission has been approved by the responsible Institutional Official. At Penn the IRB serves that function and this guidance document details (i) how to submit requests for GWAS certification to the IRB, (ii) how the IRB will consider these requests and (iii) how studies can be drafted to ensure that IRB Certification can be granted.

 

Guidance Document

Patrick Stanko

Track Ziolek

 

HIPAA

The NIH provides detailed information to the research community on the HIPAA privacy rule

http://privacyruleandresearch.nih.gov/

 

Investigational Devices

IDE Requirements

Significant & Nonsignificant Risk Device Determinations

under construction

 

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Investigational Devices: Early & Expanded Access  Download guidance. This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
Investigational Drugs

Sponsor-Investigator held Investigational New Drug Applications

under construction

 

 
Payment to Research Subjects

The Penn IRB is responsible for reviewing the rates, forms and schedules of remunerations to subjects participating in research at the university. It is the IRB’s charge to ensure that the amount of remuneration and the proposed method and timing of disbursement do not present undue influence to subjects. Download guidance.

 

 

 
Payment for Recuitment of Subjects

The University of Pennsylvania IRB believes that finder’s fees and bonus payments to investigators and study staff create a potential conflict of interest.  The Institutional Review Boards do not approve of finder’s fees being paid to University of Pennsylvania or UPHS investigators, physicians, nurses, and others who have a treating and/or counseling relationship to a subject being referred for enrollment in a clinical trial. 

 

The Institutional Review Boards do not approve of finder’s fees or bonus payments being paid to any, house staff or University of Pennsylvania Health System (UPHS), or University of Pennsylvania employee for referring or recruiting prospective subjects.  The IRB may review and approve small, nominal value gifts to staff organizations as long as such gifts are not based on any indicator of trial enrollment. Download guidance.

 

 

 

Community Research Partners

Guidance to foster community engagement in the research process, patients and other community stakeholders are involved in various levels of research design and conduct. Download guidance.

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Pennsylvania Law

This guidance document describes Pennsylvania laws on surrogate consent and mandatory reporting requirements that may be applicable to human research. Download guidance.

 

 
Recruitment Materials

The Institutional Review Board is responsible for reviewing study recruitment procedures and materials to ensure protection of the rights and welfare of human subjects and equitable subject selection into research [21 CFR 56.107(a), 56.111(a)(3)]. Any method of advertisement must be approved by the IRB before it is implemented.  All advertisements must comply with informed consent and subject selection regulations pursuant to 21 CFR 50.20, 50.25, and 56.11(a)(3) as well as the institutional policy described in this document. Download guidance.

 

 
Repositories

under construction

 

 
Research results and the electronic Medical record
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Scientific & Scholarly Validity
Download guidance.
 
Short Form

under construction

 

 

 
   Copyright 2008 University of Pennsylvania Office of Regulatory Affairs | 3624 Market Street, Suite 301 S., Philadelphia, PA 19104-6006
   Phone: 215.573.2540    Fax 215-573-9438.
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