IRB tools and templates
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SOPs of IRB
Required educational training for each investigator
Educational resources is a repository of education presentations from the convened IRBs, workshop and conference presentations, and items of interest. Educational resources
Top Ten Investigator Responsibilities
Continuing education modules are intended for investigators at Duke institutional and non-institutional research sites; and for Duke physicians, staff and faculty involved with human subjects in research. Regardless of your involvement with human subjects, the materials offered here provide an opportunity for further education on the protection human subjects. New faculty/staff must first take the two Orientation Modules—Protecting Research Subjects and What Counts as Research.Additional annual modules are your choice of any of the offerings, but the pair must be from either the Duke site
IRB Certification requirements
All new research submissions MUST be submitted electronically to the DSRC (Duke Surgery Research Central) AND APPROVED prior to being submitted the the EIRB.
DSRC - Duke Surgery Research Central
National Healthcare Group(NHG)
The DSRB Investigator's Manual is a one step guide to the DSRB's review processes and its various application forms. It contains useful information regarding definitions, reporting requirements and other frequently asked questions.
299-001 DSRB Investigators' Manual (PDF File)
The Instruction sheet contains important submission information as well as the contact details of the various ethics boards.
IRB & DSRB Application Form Instruction
Principal Investigators of research conducted within NHG have to submit proof of research ethics training to the DSRB. The PI’s Minimum Training requirement is to complete the CITI Modules. Refer the following link for the same.
National University of Singapore(NUS)
The following link leads to the NUS-IRB guidelines for IRB review processes.
Summary protocol
Duke
Use of this template is helpful for ensuring that the research summary contains all necessary elements.
Research Summary Template and Instructions
National Healthcare Group(NHG)
These are the Forms that are required for a submission for DSRB review.
205-001: IRB & DSRB Application Form
205-014: DSRB Application Form - Exempt Category
Study Documentation Templates are provided as a guide for PI's to create their own study documents. These templates contains the critical elements which are required by the DSRB.
207-002: Study Protocol Template
National University of Singapore(NUS)
Following forms are required for a submission for IRB review.
Informed consent
Duke
Following Templates are required for use with the eIRB.
Consent Form Template - Adults
Consent Form Template - Minors
Consent Form Language for HIPAA Compliance
Decedent Research Notification
Waiver of Documentation of Informed Consent
Waiver or Alteration of Consent and HIPAA Authorization
National Healthcare Group(NHG)
Study Documentation Templates are provided as a guide for PI's to create their own study documents. These templates contains the critical elements which are required by the DSRB.
207-001: Participant Information Sheet & Consent Form Template
207-003: Sample language for documentation of Capacity
207-008: Assent Document Template
Original English Short Consent Form Template for non-english speaking subjects
Simplified Chinese language Consent Form template for non-english speaking subjects
Malay language Consent Form template for non-english speaking subjects
National University of Singapore(NUS)
Following forms are required for a submission for IRB review.
Participant Information Sheet & Consent Form (PIS & CF)
