The Temple University Institutional Review Boards (IRBs) are responsible for the regulation and monitoring of all University research on or involving human subjects. The IRB must ensure that all federal and state regulatory requirements are met by the University. The Temple Research Administration (TRA) is responsible for enforcing the policies and directives of the IRB. Two committees of the IRB review research at Temple University. Committee A reviews research in which subjects receive medical intervention. Committee B reviews behavioral and social sciences studies in which subjects do not receive medical intervention.
Learn how to Track your protocols in eRA@TUImportant Notice Regarding IRB Protocol Submissions
Regulations inform that protocol projects submitted to an IRB may be reviewed by Full Committee Review, Expedited Review, and Exempt for review. Regulations further inform that only the Chair or other designated IRB member may determine the level of review assigned to individual protocol projects. Many times, Investigators have the knowledge to pre-determine the level of review most likely to be assigned by the IRB. The document provides guidance in selecting the review level – however, only the IRB can make the final determination of the level of review the will be assigned. If the planned protocol project does not clearly fit into an expedited or exempt category, prepare the submission for full committee review.
Continuing Review of Protocols - Investigators Responsibility
Protocols are generally approved for a maximum time period of one year. The Office for Human Research Protections (OHRP) mandates that all approved protocols be re-certified within 365 days or sooner. In accordance with Federal Regulations, if a study is not revisited by the IRB and re-approved within the 365 day window, it is automatically terminated. THERE WILL BE NO EXCEPTIONS TO THIS RULE. If an investigator wishes to continue with the research protocol, and the study has lapsed - a new protocol submission must be submitted for committee review before any activity may take place.
NIH alert on financial conflict of interest (FCOI) requirements and tutorial
A recent NIH Alert (NIH/OD) was received regarding the position of the NIH on Financial Conflict of Interest Requirements. The NIH has developed a Web-based tutorial which reviews the requirements of, and the Institutional and Investigator responsibilities for compliance with the regulation. Lisa Staiano-Coico is the designated Institutional Official for research activity for Temple University. Lisa Staiano-Coico strongly recommends that all Investigators and members of research teams review the tutorial – as all Investigators and teams are responsible for knowing and complying with the content.
The alert instructs the Institutional Official of the importance of the financial conflict of interest (FCOI) requirements applicable to all Institutions that apply for NIH research funding. Proper stewardship of Federal funds includes ensuring objectivity of results by protecting Federally-funded research from comprise by FCOI. It is essential that all NIH-funded Institutions and Investigators are fully aware of their obligations under the FCOI regulation (42CFR Part 50, Subpart F). The tutorial is designed for use by Institutional officials responsible for managing NIH funded projects and for individuals who are responsible for the design, conduct or reporting of NIH-supported research. The NIH urges the Institutional official to encourage all NIH-funded investigators to take the tutorial located at: http://grants.nih.gov/grants/policy/coi/index.htm
Important Update on Subject Recruitment Materials from the IRB
Direct advertising represents the majority of recruitment tools used by investigators to identify potential research subjects. It is important to be mindful that recruitment methods are the first step in the informed consent process. All subject recruitment materials must be reviewed and approved by the IRB before they may be utilized for the intended purpose. There is an important change to information requried to be displayed on/or contained in messages regarding all subject recruitment materials approved by the IRB. Detailed information on these new requirements here.
IRB Review Invitation
The Temple University Institutional Review Board (IRB) would like to extend an invitation to all Principal Investigators and Advisors/Instructors assisting Student Investigators as Principal Investigator to attend the IRB Committee meetings when they have a protocol on the agenda to be reviewed by the full committee.
Recruitment of Study Subjects
Direct advertising represents the majority of recruitment tools used by investigators to identity potential research subjects. It is important to be mindful that recruitment methods are the first step in the informed consent process. Every aspect of research, including recruitment should adhere to the guidelines set fourth in The Belmont Report and the Code of Federal Regulations.
Required IRB Education in Human Subject Protections
CITI – Collaborative Institutional Training Initiative is the premiere online human subjects education program. It is currently used by more than 700 institutions and growing. It was created, developed, and is maintained by experts from the human subjects research community.
Mandatory CITI education fulfills Temple University commitment to promote ethical conduct towards Human Subjects in all research projects, funded or unfunded. Temple University maintains an Assurance from the Office for Human Subject Protections identified as Federal Wide Assurance 00004964. As part of the Assurance, Temple University is committed to following the ethical principals found in the Belmont Report and assures that all Faculty, Staff and Students involved in human subject research projects receive IRB education in Human Subject Protections.
An IRB application, with personnel listed who do not have valid proof of current IRB education for all members of the study team WILL NOT BE REVIEWED/APPROVED by the IRB and will be returned to the PI.
| Committe A1- 8:30 AM | Committe A2 - 12 PM | Committe B - 1 PM | Committe AE - 12 PM |
| Thursday, January 8, 2009 | Friday, January 23, 2009 | Friday, January 16, 2009 | Thursday, January 22, 2009 |
| Thursday, February 12, 2009 | Friday, February 27, 2009 | Friday, February 20, 2009 | Thursday, February 26, 2009 |
| Thursday, March 12, 2009 | Friday, March 27, 2009 | Friday, March 20, 2009 | Thursday, March 26, 2009 |
| Monday, April 6, 2009 | Friday, April 24, 2009 | Friday, April 17, 2009 | Thursday, April 23, 2009 |
| Thursday, May 14, 2009 | Friday, May 29, 2009 | Friday, May 15, 2009 | Thursday, May 28, 2009 |
| Thursday, June 11, 2009 | Friday, June 26, 2009 | Friday, June 19, 2009 | Thursday, June 25, 2009 |
| Thursday, July 9, 2009 | Friday, July 24, 2009 | Friday, July 17, 2009 | Thursday, July 23, 2009 |
| Thursday, August 13, 2009 | Friday, August 28, 2009 | Friday, August 21, 2009 | Thursday, August 27, 2009 |
| Thursday, September 10, 2009 | Friday, September 25, 2009 | Friday, September 18, 2009 | Thursday, September 24, 2009 |
| Thursday, October 8, 2009 | Friday, October 23, 2009 | Friday, October 16, 2009 | Thursday, October 22, 2009 |
IRB Announces Change in Policy for Social and Behavioral Research Student Protocols
An IMPORTANT message from the IRB regarding Social and Behavioral Research - Committee B IRB submission and review process.
Beginning June 1, 2006 - all student research protocols/projects now will have the student's advisor identified as the
Principal Investigator (PI) and the student identified as a Sub-Investigator (SI).
Important Announcement and Information concerning all IRB submission for Committee A - Medical Intervention Research
Please Note: All submission processes and forms have changed. Please review carefully. Visit the IRB home page frequently for updates on IRB processes.
IRB establishes requirements for protocol submission to the Institutional Review Board
The IRB has established requirements for protocol submission to the Institutional Review Board in the form of a Guidance Memorandum.
The guidance details these requirements including: IRB education, access net id, Temple email address, selection of appropriate IRB
application forms and declaration of Biohazards and Medical Radiation required reviews. Incomplete applications will not be scheduled
for review.
Social and Behavioral Sciences Institutional Review Board "B" Help Desk at Main Campus
A representative of the Temple University IRB will be available on the Main Campus to assist Researchers on IRB issues on designated dates each month. Appointments are suggested and walk-ins will be accommodated when ever possible.
Location:
Scheduled appointments will be seen at 1938 Liacouras Walk, Second Floor, Temple Research Administration.
Dates:
Times:
8:30 AM to 12:00 Noon
1:00 PM to 3:00 PM
To schedule a meeting please email Richard Throm with the time and date you prefer(email contact must be from a temple email address). You will be contacted via email to confirm the appointment. Please bring your research materials, correspondence and questions with you.
Temple Adverse Events Reporting System
The Temple University Adverse Events Reporting system is now
available to begin collecting events. All serious adverse events will be required to be reported to the IRB via the system.
Training sessions have been scheduled to allow all Principal Investigators and their designated reporters (Study Coordinators)
to gain access to the system. The system will be AccessNet activated and users must register with the IRB. Please refer to the
Adverse Events information from the Temple Research Administration (TRA) listed above for more
information.
Click here for the Adverse Events Reporting System Manual
Click here for the PI Authorization Form
Voice: (215) 707-3390
Fax: (215) 707-8387
Institutional Review Board
3rd floor Hudson Building
3425 N.Carlisle Street
Philadelphia,
Pennsylvania 19140
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