Frequently Asked Questions For Investigators and Coordinators
What is the scope of the Human Subject Protection Program overseen by the St.Vincent Research and Regulatory Affairs Department?
The St.Vincent Research and Regulatory Affairs Department provides support services for clinical research conducted throughout the St.Vincent Health system. The Department also oversees and administers the St.Vincent Human Subject Protection Program, which ensures the safety of human subjects enrolled in research performed at or under the auspices of any St.Vincent Health system hospital or subsidiary ministry (Ministry). This includes research in which any research-related procedure is conducted at the Ministry or any Ministry-controlled facility.
Where can I find the policies and procedures related to the conduct of clinical research at St.Vincent Health ministries?
All Policies, Standard Operating Procedures (SOPs), Worksheets, Forms, Templates and other documents referenced in this Manual can be found on the St.Vincent Research and Regulatory Affairs Department intranet website. Definitions of specialized terms used in any of the Policies, SOPs, Worksheets, Forms, and Templates, may be found in SOP: Definitions (SOP-001).
What is Clinical Research?
Clinical Research is any activity that represents "research" that involves "human subjects", as those terms are defined by the US Federal Government's Common Rule or by the Food and Drug Administration (FDA):
- As defined by the Common Rule at 45 CFR 46.102(d), the term Research means a systematic investigation involving Human Subjects, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge
- As defined by the FDA at 21 CFR 50.3(c), the term Research means an experiment that involves a test article and one or more human subjects
- As defined by the Common Rule, the term Human Subject means a living individual about whom an investigator conducting research obtains 1) data through intervention or interaction with the individual, or 2) information that is both private and identifiable.
- As define by the FDA at 21 CFR 50.3(g), the term Human Subject means an individual who is or becomes a participant in research, either as a recipient of a test article or as a control
The terms "Human Subject Research", "Research Involving Human Subjects", "Clinical Investigation", "Clinical Study", and similar phrases are considered to be synonyms for the term "Clinical Research".
What is the Human Research Protection Program (HRPP)?
As described in St.Vincent Human Research Protection Program Plan (HRP-100), the HRPP is St.Vincent Health's overall plan to protect subjects enrolled in clinical research.
This Plan describes:
- The mission of the Human Research Protection Program.
- The ethical principles that the Ministry follows governing the conduct of Human Research.
- The applicable laws that govern Human Research.
- When the Ministry becomes "engaged in Human Research" and when someone is acting as an agent of the Ministry conducting Human Research.
- The types of Human Research that may not be conducted.
- The roles and responsibilities of individuals within the Ministry.
How do I contact the Research and Regulatory Affairs Department?
You can reach the St.Vincent Research and Regulatory Affairs Department by calling 317-338-2194 or emailing email@example.com.