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

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 - IRB number will need to be entered, it is IRB00000400
FWA Renewal Approval Email
Conflict of Interest Policy

NEW INFORMATION
Expedited Reviews

Please be advised that SCRIHS has a new email address that should be used for any expedited protocol reviews - scrihsexpedited@siumed.edu
All information for expedited reviews should be submitted electronically to this email address. Paper copies will no longer be needed for submission. You will need to scan in any information that requires signatures.
Tissue Banking and Specimen Collection Templates
The new Tissue Banking and Specimen Collection consent form templates are now available for use. Any existing research studies that include tissue banking or specimen collection will need to be updated with the new, applicable templates, at the time of continuing review. Please call SCRIHS staff with any questions.
Adverse Event Reporting
SCRIHS Adverse Event Reporting Policy
Adverse Event Policy Quick Reference Sheet
Adverse Event 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 - Effective September 1, 2009

Initial Review

  • Full Board - $2000
  • Full Board Continuing Review - $750
  • Expedited - $500
  • Expedited Continuing Review - $200

    Sponsor-required protocol
    Amendments/revisions - $300

*There is no fee for:

    • Federally-funded, state-supported or non-profit funded clinical research
    • SIU Investigator-initiated research
    • Exempt research
Call 545-7602 if you have any questions


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 next course will be November 20th
.
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. Space is limited.
View Course Description (pdf)


IRB Membership, Meeting and Audit Dates and Agenda Submission Instructions


SCRIHS Membership

Meeting Dates and Agenda deadlines 2009-2010 (pdf)

Instructions for SCRIHS Submissions (pdf)

Mandatory SCRIHS Education

Notice:
All persons involved in human subjects research, that is reviewed by SCRIHS, are required to complete the SCRIHS education requirements prior to implementation of, or participation in, a research study. SCRIHS education requirements are fulfilled by completing coursework through the Collaborative Institutional Training Initiative (CITI). CITI can be accessed through the following link: https://www.citiprogram.org/default.asp?language=english

Instructions for completing this training are available in this pdf file.

Once completed, Human Subjects Research training re-certification will be required every two years. If you have questions regarding training or require assistance accessing the coursework, please contact SCRIHS office at 217-545-7602.


For SCRIHS Committee Members Only


Secure area for SCRIHS Reviewers (password required)


SCRIHS Forms

Please Note: The "Certification of Protocol Termination" is now called the "Certification of Study Closure.

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
Certification of Study Closure
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 Specimen Collection
- This template to be used when collecting specimens for a specific, known research purpose.
Consent Form for Tissue Banking - This template to be used when banking specimens/tissue for future research purposes.
Assent Form for children between ages 5-11
Assent Form for children between ages 12-17
Assent Form for Cognitively Impaired

Protocal Templates

Protocol Template
Protocol Template for Exempt and Expedited Studies

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