SCRIHS

Springfield Committee for Research Involving Human Subjects

SCRIHS Staff
Please feel free to call the SCRIHS office at 545-7602 with any questions.

Gary Fifer, Human Subjects Research Specialist • 545-7602 gfifer@siumed.edu
Alisha Mirabile, Human Subjects Research Specialist • 545-7602 amirabile@siumed.edu
Susan Ball, Office Systems Specialist • 545-7602 sball@siumed.edu
Dr. Elvin Zook, SCRIHS Committee Chairman • 545-7015 ezook@siumed.edu

NOTE
Effective May 12, 2008, Ms. Erin Campbell has resigned her position as the SCRIHS Office Coordinator and assumed new responsibilities as the full-time Clinical Trials Contract Coordinator for SIU School of Medicine.

Ms. Alisha Mirabile, M.S., C.I.P. will assume new responsibilities as the IRB Administrator for Cancer Research. This includes all cancer cooperative group studies, industry-sponsored and investigator-initiated cancer studies. Mr. Gary Fifer, B.A. will assume new responsibilities as the IRB Administrator for Non-Cancer Research. Please direct all questions regarding your cancer studies to Alisha and all questions regarding non-cancer studies to Gary.

Ms. Susan Ball, B.S., M.A., SCRIHS Office Manager will continue to provide administrative support for SCRIHS.

The Springfield Committee for Research Involving Human Subjects (SCRIHS) is charged with the responsibility of ensuring that any research effort involving humans as subjects: 1) which is sponsored by SIU, or 2) conducted in any SIU facility, or 3) conducted by SIU faculty, or 4) conducted by a community physician who will implement the study at Memorial Medical Center or St. John's Hospital, is in compliance with the policies defined by Department of Health and Human Services and the Food and Drug Administration. The committe also interprets federal regulations to develop procedures to assist investigators in their research end.

Procedures Manual for the Springfield Committee for Research Involving Human Subjects (SCRIHS)

SCRIHS Federal Wide Assurance

Conflict of Interest Policy

Feedback Forms
Customer Satisfaction
Audit Feedback

Adverse Event Reporting
SCRIHS Adverse Event Reporting Policy
Adverse Event Policy Quick Reference Sheet
Reporting Table
PowerPoint Slides from Previous Training Session

The following is a link to the new OHRP Adverse Event Reporting Guidance: http://www.hhs.gov/ohrp/policy/AdvEvntGuid.htm

SCRIHS Fees
Initial review for all industry sponsored studies will be $1800. Continuing review fees are $500.

Miscellaneous
Please do not submit electronic or paper information for monthly full-board meetings until the 10th of the month. This will assure that SCRIHS staff has adequate time to process the previous month's agenda and helps to alleviate confusion.

The Department of Surgery Clinical Trials Office is offering a basic clinical trials course designed to provide clinical research education with a primary focus on the administrative aspects of sponsored clinical trials (drug and device). The content is a supplement to, not a substitute for, the training required by SCRIHS. The course is a one-day program for investigators, coordinators, and clinical research staff. Participants will receive 7 hours of CME. For more information and registration, Joseph Milbrandt, PhD via email at jmilbrandt@siumed.edu or by phone at 545-7811 or Dave Pence via email at dpence@siumed.edu or by phone at 545-7579. Space is limited.

IRB Membership, Meeting and Audit Dates and Agenda Submission Instructions

SCRIHS Membership
Meeting Dates and Agenda Deadlines for 2007-2008 (pdf)
Instructions for Agenda Submission (pdf)

Mandatory SCRIHS Education

Instructions for Training are available in pdf format in the following links:
• Instructions for CITI training

Once completed, Human Subjects Research training re-certification will be required every two years.

For SCRIHS Committee Members Only

Secure area for SCRIHS Reviewers (password required)

SCRIHS Forms

Application for Approval of a Research Study
Investigator Request for Exemption
Amendment Summary Form
Revised Authorized Study Personnel Form
Local Adverse Event Report Form
Unanticipated Problem Report Form
Protocol Deviation Report
Continuing Review Statement
Certificate of Protocol Termination
Protocol-Related Conflict of Interest Disclosure Form
Quality Improvement through Self-Assessment
Reviewer Checklist

HIPAA Forms

A Guide to HIPAA
Authorization To Use and Disclose Protected Health Information for Research Purposes
Data Use Agreement
HIPAA De-Identified Certification Form
Investigator Request for a Partial Waiver of Authorization for Recruitment Purposes
Investigator Request for a Waiver of Authorization
Investigator Request for Waiver of Consent/Authorization
Request for Access to PHI for Work Preparatory to Research
Researcher Representation for Research on Decedents

Informed Consent Templates

Informed Consent Form - Master Template used for all consent form submissions
Alternative Consent Form Front Page - Alternative front page for subjects who are not patients undergoing treatment (e.g. educational studies).
Consent Form for Collecting Blood - Informed consent form for collecting blood from diseased subjects - applicable to studies which only involve blood collection.
Consent Form for Collecting Blood - Informed consent form for collecting blood from healthy subjects - applicable to studies which only involve blood collection.
Consent Form for Tissue Banking
Assent Form for children between ages 5-11
Assent Form for children between ages 12-17
Assent Form for Cognitively Impaired