Research Integrity and Protection Documents

SOPs

SOP-206 Engagement in Human Subject Research

SOP-207 Determination of Human Subjects Research

SOP-602 Treatment and Emergency Use of Investigational Products

SOP-702 Humanitarian Used Devices

Guidance

Determining if Your Project is Human Subject Research

QI Self-Certification Decision Tool
Humanitarian Use Device (HUD) Responsibilities, Requirements and Instruction Guide

Templates

Consent Template- Emergency or Compassionate Use

HIPAA Template- Case Report Forms

Other Tools and Reference
Ascension Wisconsin IRB QI Self-Certification Tool

Emergency and Compassionate Use page

IRB Report Form for Emergency Use of HUD

SOPs

SOP-001 Definitions
SOP-105 Materials for Human Subject Research Review
SOP-204 Reportable Events-New Information
SOP-302 Human Subject Research Exempt from IRB Review    
SOP-303 Expedited Review
SOP-304 Ancillary Reviews
SOP-603 Lapse (Expiration) of IRB Approval
SOP-905 Study Recruitment 

Related Guidance
Ancillary Review Requirements
Certificates of Confidentiality (CoC)

Data and Safety Monitoring Plan Guidelines
Exempt Human Subject Research
Key Research Personnel
Mentor eIRB Researcher User Manual

Preparing Research Data in a Spreadsheet

Reportable Events- New Information
SmartForm Questions and Guidance for Completing the SmartForms

See the Templates section below for Consent form and HIPAA templates

SOPs
SOP-701 Use/Disclosure of Protected Health Information for Research 
SOP-901 Informed Consent for Research
SOP-902 Documentation of Informed Consent
SOP-904 Informed Consent Process for Research: Legally Authorized Representative (LAR)

Guidance
Research Informed Consent and HIPAA Authorizations-Waivers in the Medical Record
Use of Contraception in Clinical Trials & Model Language for IRB Consent
Use of Short Form Consent for Non-English Speaking Subjects

SOPs

SOP-906 Special Considerations for Vulnerable Populations
SOP-907 Research Involving Adults with Decreased Decision Making Ability
SOP-908 Research Involving Children

SOP-909 Research Involving Subjects with Limited English Proficiency

SOPs

SOP-810 IRB Reliance

Guidance
IRB Reliance- Relying on NCI CIRB
IRB Reliance- Requesting Single IRB Review (non-NCI-CIRB)

Other Tools and Reference
IRB Reliance Page

SOPs
SOP-803 Responsibilities of Investigators Conducting Human Subject Research

SOP-804 Human Subject Protection Education and Training for Researchers

Local Site Supplement and SmartForm
The Local Site Supplement form must be uploaded in the SmartForm Submission for all new human subject studies that includes any interaction or intervention with human subjects, where the WI IRB will serve as the IRB of record.

Local Site Supplement to Study Protocol 

Protocol Template- Minimal Risk
Protocol Template- Greater than Minimal Risk

Consent Templates & Examples
Consent template- Clinical Intervention
Consent Template-Minimal Risk
Consent Template- Pregnant Partner Consent 

Example Research Consent Procedure Section Format Options
Example Consent Form Addendum

Consent Template- Emergency or Compassionate Use

HIPAA Forms and Templates
The following stand-alone HIPAA authorization templates must be used for any study involving access, use or collection of PHI at any Ascension Wisconsin site. 
HIPAA Authorization for Research
HIPPA Authorization Waiver Request Form
HIPAA Decedent Certification Addendum
HIPAA Authorization for Case Reports
HIPAA Data Use Agreement for Disclosing a Limited Data Set
HIPAA Authorization for Research- Spanish

Short Form Consent Documents
Spanish and Hmong short forms may not be used for studies involving care or treatment based on the Institutional Vital Document policy- the full consent must be translated before obtaining consent. 
Short Form Consent- English
Short Form Consent- Spanish
Short Form Consent- Russian
Short Form Consent- Hmong
Short Form Consent- Bosnian

Human Subjects Research Regulations and Gudiance
45 CFR 46 Protection of Human Subjects (DHHS)
21 CFR e-CFR (FDA)
     Part 50 FDA Protection of Human Subjects
     Part 56 FDA IRB Regulations
     Part 312 and 812 Investigational Drugs and Devices, respectively
OHRP Guidance
FDA Information Sheets for Investigators and IRBs

Ethical Guidelines and Codes
Belmont Report
Declaration of Helsinki
Ethical and Religious Directives for Catholic Health Care Services

Government Websites
DHHS Office for Human Research Protections (OHRP)
DHHS Office of Research Integrity (ORI)
FDA Center for Drug Evaluation and Research (CDER)
FDA Center for Devices and Radiological Health (CDRH)
National Cancer Institute (NCI)

International Guidelines
International Conference on Harmonization (ICH-GCP: E6(R2) Good Clinical Practice)

SOP-101 Assurance of Compliance and IRB Registration
SOP-102 Authority and Independence of the IRB
SOP-103 IRB fees
SOP-104 IRB Records, Storage and Retention
SOP-201 Intake and Processing of Submitted Items
SOP-203 IRB Pre-Review.pdf
SOP-208 Review Standards for Research Not Covered by Federalwide Assurance- Flexibility Policy and Procedures
SOP-305 IRB Review of Contracts and Funding Agreements
SOP-401 IRB Meeting Preparation
SOP-402 IRB Meeting Conduct
SOP-404 IRB Meeting Minutes
SOP-502 Consultants, Observers and Guests
SOP-503 Post-Review Approval Completion
SOP-604 Suspension or Termination of IRB Approval
SOP-801 IRB Membership and Management
SOP-802 Human Subject Protection Education and Training for IRB Members and Staff
SOP-809 Transfer of IRB Oversight

Guidance

Revised Common Rule Key Changes and Transition Plan

Coming Soon