Institutional Review Board
USciences Investigator Information
Any project involving human subjects, research, sponsored or non-sponsored, conducted by employees of University of the Sciences, 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 "personnel" listed on the proposal are required to complete training in human subjects 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 a required document for protocol submissions to the IRB. (See Resources for Investigators below.)
Application for Human Subjects Research Project Review
All protocols for IRB approval (including revisions and renewals) must be submitted electronically via IRBNet, and all review decision letters will be issued electronically via IRBNet.
Please review the “IRBNet User Guide” document for information and instructions.
- 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.
Research Project Continuing Review/Termination Report
All projects are reviewed periodically depending on degree of risk, but in no case less frequently than every 12 months. Investigators are required to submit a project report for IRB continuing review or termination of a project. The Continuing Review or Termination Report form is available below.
Protocol Amendments
Any changes in the approved research protocol or consent form must be approved by the IRB prior to implementation. Submit a “Request for Protocol Review” form as an amendment:
- check the "Amendment Box" at the top of the form.
- complete ALL of Section 1.
- complete only the sections that will change in Sections 2 thru 7.
- 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.
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.
USciences Institutional Review Board Forms & Templates
Policies & Procedures:
University of the Sciences IRB Policies & Procedures
Templates:
Consent Form
Forms:
Continuing Review/Termination Report Form
IRB Committee Meetings Calendar
Protocols that require full IRB Committee review should be submitted at least 3 weeks prior to the scheduled meeting date. Investigators are encouraged to attend the meeting on the day when their protocol is being reviewed; if you plan to attend an IRB meeting please notify OSPR at least one week in advance. All meetings are held in Wilson Hall room 205 from 6:15pm - 7:15pm.
Protocol form due to OSPR |
IRB Committee Meets |
6/21/2011 |
7/5/2011 |
7/19/2011 |
8/2/2011 |
8/23/2011 |
9/6/2011 |
9/20/2011 |
10/4/2011 |
10/18/2011 |
11/1/2011 |
11/22/2011 |
12/6/2011 |
12/20/2011 |
1/10/2012 |
1/24/2012 |
2/7/2012 |
2/21/2012 |
3/6/2012 |
3/20/2012 |
4/3/2012 |
4/17/2012 |
5/1/2012 |
5/22/2012 |
6/5/2012 |
IRB Registration and Assurance
The USciences 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 18, 2013.
Resources for Investigators
Food and Drug AdministrationEducational materials related to human subjects research are also available at University of the Sciences. For additional information, email Karen Mitchell IRB Administrator, or telephone 215-596-7491.