In this section
Local guidance and SOPs
This page outlines local guidance and standard operating procedures (SOPs) for investigators and study teams conducting human subjects research at Children's Wisconsin.
Local guidance
These documents provide guidance for study teams to operationalize investigations.
Foundational guidance
Are you new to working with the Children's Institutional Review Board (IRB)? These guidance documents are especially helpful for beginners!
- Departmental sign-off for research (Updated 01/18/2021)
- Getting started with Children's Wisconsin IRB (Updated 08/06/2020)
- IRB review process flow chart (Updated 08/12/2019)
- Reliance agreement internal process flow sheet (Updated 08/06/2020)
- Submission documents checklist (Updated 11/20/2019)
- Training requirements (Updated 05/09/2019)
Guidance library
- Bar codes for consent documents- Guidance: Health information management (Updated 02/24/2020)
- Bar codes for consents - To print: Consent for research (Updated 02/24/2020)
- Bar codes for consents - To print: Permission to use health information (Updated 02/24/2020)
- Certificates of confidentiality information sheet (Updated 10/09/2017)
- Corrective and preventative action plans (Updated 06/17/2020)
- Consent for continued participation when a child reaches age 18 (Updated 12/13/2019)
- Continuing review submission (Updated 04/25/2018)
- Coronavirus (COVID-19) considerations for researchers (Updated 01/18/2021)
- De novo review (Updated 01/21/2021)
- Exempt categories reference tool (Updated 08/29/2018)
- Expanded access - Single patient (IND; emergency and non-emergency use) (Updated 05/10/2022)
- Human subjects research determinations (Updated 11/13/2020)
- Informed consent discussion checklist (Updated 03/11/2020)
- Investigator-initiated multi-center collaborative research (Updated 12/19/2019)
- Planned protocol exception requests (Updated 11/17/2020)
- Quality improvement/operations vs. research guidance (Updated 11/13/2020)
- Recruitment for human subjects research (Updated 05/04/2022)
- Reportable events/new information (Updated 04/03/2020)
- Research specimen ordering (Updated 10/01/2018)
- Safety committee review (prior to IRB submission) (Updated 07/23/2019)
- Submission of investigator's brochure to the IRB (Updated 02/10/2021)
SOPs
Governing policies and procedures for conducting human subject research.
- Coming soon