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)	WORD document
8012.01	Non-Affiliated Investigator Agreement
8012.02	Adverse Event Reporting
	Offsite Adverse Event Report form (Word document only)
	Onsite Adverse Event Report form (Word document only)
8012.03	Billing for IRB Review of Research
8012.04	Research Subject Recruitment and Advertisement
8012.05	Investigator Responsibilities
8012.06	IRB Review of Research
8012.07	Guideline for Surrogate Consenting
8012.08	Emergency Use of a Test Article
	Emergency Use PC Form.doc (Word document only)
8012.09	Institutional Review Board Membership
8012.10	IRB Records and Reporting Guidelines
	Attachment A - Designated IRB Responsibilities (Word document only)
8012.11	IRB Standards for Privacy and Security of Protected Health Information
	Frequently Asked Questions (Word document only)
8012.12	Specimen Collection and/or Tissue Banking
8012.13	Informed Consent Guidelines for Research
8012.14	Conflict of Interest
8012.15	Research and Data Requests with Varying Degrees of CHS Engagement
8012.16	CHS IRB Approval of Research Conducted Outside Cottage Health System
8012.17	IRB Education, Compliance, and Audit Activities
8012.18	IRB Action Plan for Investigator Non-Compliance
8012.19	Guidelines for the Compassionate Use of Investigational Agents
	Compassionate Use Consent Template (Word document only)
	Compassionate Use Form (Word document only)
	Protocol Development Instructions (Word document only)
8012.20	Children's Assent Guidelines
	Additional DHHS Protections for Children Involved as Subjects in Research (Word document)
	Points To Consider In Pediatric Research (Word document)
	Assent Decision Table (Word document)
	Assent Form To Participate In Research For Children Ages 7- 14 (Word document)
	Addendum for Reconsenting Subjects Who Subsequently Turn 18 Years of Age (Word document)
8012.21	Research Participant Grievance Procedures
8012.22	Inclusion of Women and Minorities in Research
	NIH Women in Research Form (Word document only)
8012.23	Medical Device Guidelines
8012.24	Guidelines for Investigational New Drug Studies
8012.25	NCI CIRB Cooperative Research
8012.27	IRB Guidelines for Enrolling Vulnerable Subjects in Research
8012.28	Prisoners as Research Subjects
8012.29	Pregnant Women and Fetuses as Research Subjects
8012.30	Financial Conflict of Interest for PHS Funded Research

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