SOPs and Guidance

Search the topics below to review RI&P policies, procedures, guidance, templates and other references.

Informed Consent and HIPAA/Privacy

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
Vulnerable Populations

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
IRB Reliance

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
Researcher Requirements and Training

SOPs
SOP-803 Responsibilities of Investigators Conducting Human Subject Research
SOP-804 Human Subject Protection Education and Training for Researchers

Guidance
CITI Instructions for completing CITI training
Disclosure and Management of Financial Interests (research COI)
IRB Operations

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
Research Integrity and Protection

SOP-002 Research Integrity and Protection and IRB Resources
SOP-004 Managing Concerns and Complaints Regarding Human Subject Research
SOP-005 Research Covered by the HRPP
SOP-006 Policies and SOPs
Research Education and Quality Management

SOP-101 Investigator Self Assessments
SOP-102 Study Start Up Meetings
SOP-103 Routine Reviews
SOP-104 Virtual Reviews
SOP-105 Observation of the Consenting Process
SOP-106 For Cause Audits
SOP-107 Routine IRB Evaluations
SOP-108 Reporting Research Education and Quality Management Outcomes
Regulatory and Other References

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)
AWRI Research Policies

* PolicyStat login required
Human Subject Research Policy w/Human Research Protection Program Plan
Financial Conflicts of Interest in Research
Responding to Allegations of Research Misconduct
Authorship on Scientific and Scholarly Publications
Forms and Templates 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 Supplements

Local Site Supplement- Initial Study Protocol

Local Site Supplement- Continuing Review

SmartForm Questions and Guidance for Completing the SmartForms

Protocol Templates
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 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 (English) (Spanish)
HIPAA Decedent Certification Addendum
HIPAA Authorization for Case Reports
HIPAA Data Use Agreement for Disclosing a Limited Data Set

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- Hmong
Short Form Consent-Russian
Short Form Consent- Bosnian
Determining IRB Oversight and Non-Research Activities (including HUDs)

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
HUD User Attestation Form
Research Conduct

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

RI&P SOPs and Documents

IRB Checklists

Coming Soon

CK-101 IRB Pre-Review

CK-301 Waiver-Alteration of Consent Process
CK-401 Waiver of Written Documentation of Consent Process

CK-501 Pregnant Women
CK-601 Non-Viable Neonates
CK-701 Neonates of Uncertain Viability
CK-801 Prisoners
CK-901 Children
CK-1001 Cognitively Impaired Adults

CK-1101 Non-Significant Risk Device
CK-1201 Waiver of Consent Process for Emergency Research
CK-1501 HIPAA Waiver of Authorization
IRB Operations SOPs

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
Research Education and Quality Management SOPs

SOP-101 Investigator Self Assessments
SOP-102 Study Start Up Meetings
SOP-103 Routine Reviews
SOP-104 Virtual Reviews
SOP-105 Observation of the Consenting Process
SOP-106 For Cause Audits
SOP-107 Routine IRB Evaluations
SOP-108 Reporting Research Education and Quality Management Outcomes
Research Integrity and Protection SOPs

SOP-002 Research Integrity and Protection and IRB Resources
SOP-004 Managing Concerns and Complaints Regarding Human Subject Research
SOP-005 Research Covered by the HRPP
SOP-006 Policies and SOPs