Research Investigator Start-up Education (RISE)
The RISE program is a collaborative, educational initiative designed to assist Principal Investigators (PI) and study teams with regulatory and ethical issues associated with their IRB 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.
Criteria that may be used to select a protocol for a RISE include:
- School or department that has not recently participated in a RISE review,
- Study presents greater than minimal risk,
- Study meets the definition of a clinical trial,
- PI who is new to research or the institution,
- Study involves a vulnerable subject population,
- Protocol includes an established investigator who has never undergone a RISE review,
- PI who is a student,
- Focus of research is considered high profile, or
- Study is supported by federal funds.
The RISE review lasts approximately 60 to 90 minutes and covers all elements of study conduct including the logistics of implementing study procedures. If subjects are enrolled at the time of the RISE review, some research records may be assessed for compliance with the applicable regulations and institutional policies.
Record review may include, but is not limited to, the evaluation of:
- Informed consent documents/consent process notes,
- Eligibility documentation,
- Screening/enrollment/randomization logs,
- Source documentation to substantiate adherence to the protocol, SOPs, applicable regulatory requirements and Good Clinical Practice,
- Drug and device accountability records, if applicable, and
- Appropriate reporting of unanticipated problem/noncompliance/deviations and adverse events.
A report summarizing the RISE review and research record review, if applicable, is generated by the ECS-HSR and provided to the appropriate parties. All RISE reports are reviewed by the Compliance Activity Review (CARs) Committee and may be reviewed by the IRB Executive Committee.
If you'd like to request a RISE review email us at ECS-HSR@pitt.edu.