The St. Vincent Institutional Review Boards (IRB) review all study protocols to ensure the protection and ethical treatment of human subject research participants as well as the scientific integrity of the research. Our IRB's operate under a domestic Federal Wide Assurance for the Protection of Human Subjects (FWA #00001631) granted by the U.S. Department of Health and Human Services.
St.Vincent Health has established a Human Research Protection Program, and has designated an Organizational Official to oversee this Program. The St.Vincent Health Human Research Protection Program covers all research involving human subjects performed at or under the auspices of any St.Vincent Health system hospital or subsidiary ministry (Ministry). The term "research involving human subjects" includes any research-related procedure conducted at the Ministry or any Ministry-controlled facility.
Under the terms of the St.Vincent Human Research Protection Program, the Organizational Official is authorized to determine the Institutional Review Boards (IRBs) that shall be relied upon by the Ministry. The St.Vincent IRBs are currently the sole Boards that have received this reliance designation. The Ministry may rely upon IRBs of another organization subsequent to review and approval by the Organizational Official, who must ensure that appropriate steps have been taken to ensure local review of compliance with St.Vincent Ministry policies.
Telephone: 317-338-2194
Fax: 317-338-3058
Email: research@stvincent.org
| Name | Position | Phone | |
|---|---|---|---|
| Tina Noonan, MBA, CHRC, CIP | Executive Director | tnoonan@ascension.org | 317-338-6705 |
| Sandy Love, RN, CCRC | IRB Manager | sandra.love2@ascension.org | 317-338-2576 |
| Amy Shapiro, MD | IRB Chair | ashapiro@ihtc.org | 317-871-0000 |
| P.T. Hodgin, MD, MPH | IRB Vice Chair | pthodgin@ascension.org | 317-338-2359 |
| Eric Prystowsky, MD | IRB Chair | eprystow@ascension.org | 317-338-6024 |
| Jennifer Gilpin, CIM | IRB Coordinator | jennifer.gilpin@ascension.org | 317-338-3420 |
| Lisa Purlee, RN, BSN | Clinical Research Compliance Auditor | lisa.purlee@ascension.org | 317-338-7152 |
| Marissa Swanson, BA, CIM | IRB Coordinator | marissa.swanson@ascension.org | 317-338-2140 |
St. Vincent Institutional Review Board # 1 (Wednesdays)
St. Vincent Institutional Review Board # 2 (Thursdays)
8402 Harcourt Road, Suite 805, Indianapolis, IN 46260; 317-338-2194; 317-338-3058 fax
| Submission Deadline Due Tuesdays by 4:00 pm | IRB #1 Meets 7:00 - 9:00 AM |
IRB #2 Meets 7:00 - 9:00 AM |
|---|---|---|
| January 3, 2017 | January 12, 2017 | |
| January 17, 2017 | January 25, 2017 | |
| January 31, 2017 | February 9, 2017 | |
| February 14, 2017 | February 22, 2017 | |
| February 28, 2017 | March 9, 2017 | |
| March 14, 2017 | March 22, 2017 | |
| April 4, 2017 | April 13, 2017 | |
| April 18, 2017 | April 26, 2017 | |
| May 2, 2017 | May 11, 2017 | |
| May 16, 2017 | May 24, 2017 | |
| May 30, 2017 | June 8, 2017 | |
| June 20, 2017 | June 28, 2017 | |
| July 3, 2017 | July 13, 2017 | |
| July 18, 2017 | July 26, 2017 | |
| August 1, 2017 | August 10, 2017 | |
| August 15, 2017 | August 23, 2017 | |
| September 5, 2017 | September 14, 2017 | |
| September 19, 2017 | September 27, 2017 |
|
| October 3, 2017 | October 12, 2017 | |
| October 17, 2017 | October 25, 2017 | |
| October 31, 2017 | November 9, 2017 | |
| November 14, 2017 | November 22, 2017 | |
| December 5, 2017 | December 14, 2017 | |
| December 19, 2017 | December 27, 2017 |
45 CFR 46: DHHS Protection of Human Subjects
21 CFR 50: FDA Protection of Human Subjects
21 CFR 56: FDA Regulation of Institutional Review Boards
21 CFR 312: FDA Investigational New Drug Application
21 CFR 812: FDA Investigational Device Exemptions
42 CFR 50: US Public Health Service Financial Conflicts of Interest*
45 CFR 94: US Public Health Service Financial Conflicts of Interest*
US Department of Health and Human Services (DHHS)
National Institutes of Health (NIH)
Food and Drug Administration (FDA)
DHHS Office of Human Research Protection (OHRP)
DHHS Office of Research Integrity (ORI)
Centers for Medicare and Medicaid Services (CMS)
FDA Regulations Relating to Good Clinical Practice and Clinical Trials
Selected FDA GCP/Clinical Trial Guidance Documents
Information Sheet Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors
Federal Research Misconduct Policy
ICH Guidelines for Good Clinical Practice
Belmont Report
Ethical and Religious Directives for Catholic Health Care Services
Public Responsibility in Medicine and Research (PRIM&R)
NIH: Bioethics Resources
St. Vincent IRB policies, standard operating procedures, and guidelines can be accessed through the eIRB Library at https://eirb.stvincent.org.