USP Investigator Information

Instructions for Investigators

Any project involving human subjects, research, sponsored or non-sponsored, conducted by employees of the USP, or involving non-public information held by the University will be reviewed and approved by the Institutional Review Board for Research using criteria similar to those applied to federally-funded research and consistent with the principles outlined in the Belmont Report.

All "key personnel" are required to complete training in human subject research with regard to common concepts, principles, and issues related to protection of human participants, including principles of bioethics and basic legal standards. Proof of completion of such training is required prior to submission of a protocol for IRB review. See Resources for Investigators below.

Application for Human Subjects Research Project Review

• Certain research projects involving human subjects may be exempt from IRB review or may qualify for expedited review, in accordance with 45 CFR 46. The IRB is responsible for making this determination.
  
• All projects that access or use Protected Health Information (PHI) require HIPAA research subject authorization or an IRB request for waiver of HIPAA authorization. If the work is carried out at an outside institution where a HIPAA authorization form is available, no additional document is required for USP.
  
• The completed request for project review and the research protocol proposal should be forwarded to the Office of Sponsored Projects and Research, Mail Box 109 or k.mitche@usp.edu.
  

Download Request for Project Review document in Microsoft Word format

Research Project Progress Reports

All projects are reviewed periodically depending on degree of risk, but in no case less frequently than every 12 months. Investigators must submit a project report for IRB continuing project review and at the termination of the project.

Download Progress Report document in Microsoft Word format

Protocol Amendments

Any changes in the approved research protocol or consent form must be approved by the IRB prior to implementation. Submit a Project Reveiw Application, completing only the sections that will change and check the "Amendment Box" at the top of the form.

Download Request for Project Review document in Microsoft Word format

Health Insurance Portability and Accountability Act of 1996 (“HIPAA”)

The U.S. Department of Health and Human Services (“HHS”) issued the Privacy Rule to implement the requirement of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). A major goal of the Privacy Rule is to assure that individuals’ health information is properly protected while allowing the flow of health information needed to provide and promote high quality health care and to protect the public's health and well being.

Researchers are advised to review the HIPAA Privacy Rule for Research
to determine if protocol requires HIPAA.

USP Template for HIPAA Microsoft Word Format

Request for HIPAA Waiver Microsoft Word Format

Consent Form

Template for Human Subjects Consent Form
Microsoft Word format

Research Protocol

Template for Human Subjects Research Protocol
Microsoft Word format

USP Institutional Review Board

Policies & Procedures

USP IRB Policies & Procedures (last revised June 2004)

Scheduled IRB Committee Meetings

Protocols that require full IRB Committee review should be submitted at least 2 weeks prior to the scheduled meeting date. Investigators are encouraged to attend the meeting on the day when their protocol is being reviewed. All meetings are held in Wilson Hall room 205.

Protocol form due to OSPR	IRB Committee Meets
September 23, 2008	October 7, 2008, 6:00 pm
November 18, 2008	December 2, 2008, 6:00 pm
January 20, 2009	February 3, 2009, 6:00 pm
March 24, 2009	April 7, 2009, 6:00 pm
May 19, 2009	June 2, 2009, 6:00 pm

IRB Registration and Assurance

The USP IRB is registered with the United States Department of Health & Human Services. The IRB Federalwide Assurance (FWA) Protection for Human Subjects (FWA00001629) is in effect until October 1, 2008.

Resources for Investigators

Information Sheets - Guidance for Institutional Review Boards and Clinical Investigators - 1998 Update

• Code of Federal Regulations Title 45: Public Welfare. Department of Health & Human Services. Part 46 - Protection of Human Subjects 

• Protecting Human Research Subjects at the NIH: Education in Human Subjects Research. This program was developed for NIH staff and is an educational requirement for all researchers in NIH's Intramural Research Program and other NIH employees who conduct or support research involving human subjects. Non-NIH individuals may take this CBT.
   

• This computer-based training course was developed to provide information to NIH IRB members about their roles and responsibilities. Completion of this CBT is required by NIH IRB members. Non-NIH individuals may take this CBT.
   

• Information about the OHSR; links to online training programs for researchers and IRB members; information on topics related to human subjects research, including: research forms, checklists and guidelines. 

• Compilation of annotated web links and resources on topics related to bioethics, including human subjects research

• U.S. Department of Health and Human Services (DHHS) website (formerly Office for Protection from Research Risks [OPRR]) for research policy and assurances. Research regulations, including 45 CFR 46; research guidance and educational materials; informed consent information; project assurance information and sample documents; general DHHS information, including  
  Public Health Service (PHS) grants and NIH research information. 

Related Internet Sites

Society of Research Administrators 

GrantsWeb: Grants, Contracts, Funding Opportunities. Federal Regulatory and Policies, Grant Forms; Tips for Proposal Writing.

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Educational materials related to human subjects research are also available at USP. For additional information, email:Karen Mitchell IRB Administrator, or telephone 215-596-7491.