The Temple Adverse Event reporting system
Temple University is a recipient of an NIH grant entitled: Human Subjects Research Enhancement Program (HSREP). Under this grant, which now is in its second award year, an Adverse Events Reporting and Tracking System was developed for use by clinical investigators. This AE reporting system is a joint development effort of the Institutional Review Board (IRB), the Office for Clinical Trials (OCT) and the Electronic Research Administration (ERA) office. This is a web-based system that will accept Serious Adverse Event Reports for Temple participants in research as well as reports received from external sites. The system stores information in a searchable database and can produce a variety of reports.

Essential to the operation and security of the system is the training and registration of principal investigators and the individuals given authorization by the principal investigator to complete AE reports. To this end, training sessions will be provided for users to access and use the system. Participation in a training session is necessary in order to gain access to the system. Sessions will last about 20 minutes – with additional time available if needed.

It is important that all serious adverse events be reported to the IRB in a timely manner. The web-based AE reporting system will help make this happen. Use of the TU-AE Reporting System will be mandatory beginning in January 2005. All investigators and authorized users must attend a training session to ensure compliance with the system requirements. Please review the IRB website(www.research.temple.edu/irb) for updates on training sessions and other IRB news.

IRB Update
The Medical Intervention Committees (A1 and A2), and the Social and Behavioral Sciences Committee (B), have been hard at work reviewing a significant number of protocols. In the past academic year, July 1, 2002 - June 30, 2003, Committees A1 and A2 received 294 Medical Intervention protocols for review by the HSC, and Committee B received 277 protocols for review by the Main Campus Committee B. Additionally, the (A) committees reviewed 306 continuing reviews, and the (B) committee reviewed 208.

The IRB recently updated its website, www.research.temple.edu/irb/index.html with a new look, providing new guidance and forms necessary to submit protocols for review and approval. Among the updates are: a new Request for Protocol Review Cover Page; Conflict of Interest Forms; HIPAA Authorization Form (in both English and Spanish); and detailed Adverse Events Reporting Forms for Temple and Non-Temple subjects. The web site will be updated as needed to bring other elements of the IRB process and guidance online. For example, the IRB has completely rewritten its Standard Operating Procedures (SOPs) for the operation and function of the IRB. These documents will be available on the web site in the near future.

Temple University was recently awarded its FWA - Federal Wide Assurance that covers all of our IRBs. Individual MPA numbers associated with the committees are no longer effective.

HIPAA Update
The "Privacy Rule" is a Federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that protects individually identifiable health information ("protected health information" or PHI). The intent of the rule is to balance an individual's interest in keeping his or her health information confidential with other social benefits, including health care research.

Temple University, as a health care provider, is a "covered entity" under HIPAA, and as such is subject to the Privacy Rule effective April 14, 2003. The Institutional Review Board (IRB) at Temple has been designated as the Privacy Board under HIPAA and is responsible for review and approval of requests for waivers and alterations to authorization in connection with the use or disclosure of PHI. Temple has chosen a stand-alone format for the HIPAA Authorization Form for use in all applicable research protocols approved by its IRB.

The form is composed of 3 sections:
Section 1) the standard language page,
Section 2) directions for customizing the form to individual studies, and
Section 3) the modifiable page including subject signature.

The form (both in English and Spanish) is available on the IRB web site, in the Information and Forms section. All subjects giving informed consent for research, whether in a new study approved on or after April 14, 2003, or using a modified/amended consent form for a study approved prior to this date, must sign the HIPAA Authorization Form customized to the individual study. Evidence must be provided that all subjects signing an Informed Consent (after April 14, 2003) received the form and acknowledged such with their signature.