Activities and Services
The Research Investigator Start-Up Education (RISE) program is a collaborative, educational initiative designed to assist Principal Investigators and their teams with regulatory and ethical issues associated with their newly approved research protocols. The goal of the RISE program is to protect human subjects and foster compliance by providing protocol-specific regulatory guidance and study documentation tools at the time of study initiation or shortly thereafter.
Research protocols are selected for a RISE review from a list of studies recently approved by the IRB. Criteria that may determine which protocols are selected include:
- Federal funding
- Greater than Minimal Risk
- Investigator new to the University of Pittsburgh
- Student researcher or PhD candidate
- Investigator who has never participated in an ECO-HSR compliance activity
The RISE review includes an interview lasting approximately 45 minutes followed by a review of the regulatory records. The interview covers all elements of the conduct of the study including the logistics of implementing individual study procedures. If subjects are enrolled at the time of the review, several of the research records are assessed for compliance with the applicable regulations and institutional policies. Record review may include evaluation of:
- Informed consent documents/narrative note of informed consent
- Eligibility documentation/screening/enrollment logs
- Protocol adherence
- Source documentation
- Drug and device accountability (if applicable)
- Regulatory file/binder
- Unanticipated problem/Adverse event reports
The PI need only be present for the interview portion of the RISE review. Following the review, the ECO-HSR staff prepares a report summarizing the discussion and record review findings. If no compliance issues are identified in the report, a written response is not required and the IRB Executive Committee is notified that the review occurred. However, the report may include a request for a written response due two weeks from the date of the report. Both the report and the PI response are then reviewed at the next convened meeting of the IRB Executive Committee. Further correspondence is between the PI and the IRB Executive Committee.
The ECO-HSR staff is available to conduct RISE reviews upon request. Please contact the education coordinator for scheduling at 412-383-1985.