Institutional Review Board

Policies and Forms

 

To request an Application to Conduct Research,
please contact the IRB office:

Telephone: (805) 569-7439
FAX: (805) 569-7440
E-mail: Leilani Price or Tamara Norton


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POLICY  

TITLE   (HTML document)

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8012.01

Non-Affiliated Investigator Agreement

Non-affiliated Investigator Agreement

8012.02

Adverse Event Reporting

Adverse event reporting
 

Offsite Adverse Event Report form (Word document only)

Offsite AE Report
 

Onsite Adverse Event Report form (Word document only)

Onsite AE Report

8012.03

Billing for IRB Review of Research

IRB Billing

8012.04

Research Subject Recruitment and Advertisement

Research Subject Recruitment

8012.05

Investigator Responsibilities

Investigator Responsibilities

8012.06

IRB Review of Research

IRB Review

8012.07

Guideline for Surrogate Consenting

Surrogate Consent Guidelines

8012.08

Emergency Use of a Test Article

Emergency Use of a Test Article
  Emergency Use PC Form.doc (Word document only) Emergency Use Form

8012.09

Institutional Review Board Membership

IRB Membership

8012.10

IRB Records and Reporting Guidelines

Records and Reporting Guidelines
  Attachment A - Designated IRB Responsibilities (Word document only) Records and Reporting Guidelines

8012.11

IRB Standards for Privacy and Security of Protected Health Information

PDF

8012.12

Specimen Collection and/or Tissue Banking

Specimen Collection/Tissue Banking

8012.13

Informed Consent Guidelines for Research

Informed Consent Guidelines

8012.14

Conflict of Interest

Conflict of Interest

8012.15

Research and Data Requests with Varying Degrees of CHS Engagement

Reporting Guidelines

8012.16

CHS IRB Approval of Research Conducted Outside Cottage Health System

Offsite Study Research

8012.17

IRB Education, Compliance, and Audit Activities

Education, Compliance, Audits

8012.18

IRB Action Plan for Investigator Non-Compliance Non-compliance Action Plan

8012.19

Guidelines for the Compassionate Use of Investigational Agents

Compassionate Use
  Compassionate Use Consent Template (Word document only) Compassionate Use Consent
  Compassionate Use Form (Word document only) Compassionate Use Form
  Protocol Development Instructions (Word document only) Protocol Development

8012.20

Children's Assent Guidelines Children's Consent Guidelines
  Additional DHHS Protections for Children Involved as Subjects in Research (Word document) Children's Consent Guidelines
  Points To Consider In Pediatric Research (Word document) Children's Consent Guidelines
  Assent Decision Table (Word document) Children's Consent Guidelines
  Assent Form To Participate In Research For Children Ages 7- 14 (Word document) Children's Consent Guidelines
  Addendum for Reconsenting Subjects Who Subsequently Turn 18 Years of Age (Word document) Children's Consent Guidelines
8012.21 Research Participant Grievance Procedures Grievance Procedures

8012.22

Inclusion of Women and Minorities in Research

Women and Minorities in Research
  NIH Women in Research Form (Word document only) NIH Women in Research Form

8012.23

Medical Device Guidelines

Medical Device Guidelines
8012.24 Guidelines for Investigational New Drug Studies

8012.25

NCI CIRB Cooperative Research

Cooperative Research

8012.27

IRB Guidelines for Enrolling Vulnerable Subjects in Research

IRB Guidelines for Enrolling Vulnerable Subjects in Research
8012.28 Prisoners as Research Subjects Prisoners as Research Subjects
8012.29 Pregnant Women and Fetuses as Research Subjects Pregnant Women and Fetuses as Research Subjects
8012.30 Financial Conflict of Interest for PHS Funded Research Financial Conflict of Interest for PHS Funded Research

 

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