UI Investigator’s Guide\IRB Standard Operating Procedures

UI Investigator’s Guide\IRB Standard Operating Procedures

The 2019 Investigator's Guide (Version 2) is now available reflecting changes required as part of the University of Iowa Human Research Protection Program Reaccreditation review.  A 2019 track change version is available to easily identify changes.

A summary of those changes is contained below:

Section\Page

Summary of Change

Part 4:  University of Iowa Institutional Review Board 

Text added “and external IRBs”

Section 5.B.i What does this mean? 

Text added on ICH-GCP standards

Section 5.B.ii. 

Adding disclosure statements to consent based on ICH-GCP (E6) (R2) guidelines

Section 5.B.ii. 

Adding documentation procedures for consent process based on ICH-GCP (E6) (R2) guidelines

5.C.iii  Screening, recruiting, or determining eligibility prior under a waiver of consent 

Removing expectation to request a waiver of informed consent or waiver of documentation of consent for screening purposes

7.A Who is a Subject? 

Adding statement regarding when UIHC Decedent Privacy Board review is required

7.M.vi  Non Therapeutic Clinical Trials following full ICH-GCP (E6)(R2) This is a new section header

Adding section on ICH-GCP (E6) (R2) guidelines for non-therapeutic clinical trials

8.B  Collaborative Research with non-UI Entities

Revised content on UI as a lead site under sIRB model

9.D.v  Emergency Settings: Research in the Emergency Setting (Planned Emergency Research) 

Added relevant expectations when following FDA regulations, DHHS regulations, and ICH-GCP (E6) (R2) regulations

11.A.ii Screening, recruiting, or determining eligibility prior to a signed informed consent document 

Removing requirement to obtain a waiver of consent, or waiver of documentation of consent, for screening purposes

11.A.ii.b  Use of University of Iowa ITS mass email 

Revised process for submitting mass email requests

11.B.iii.b  Translators 

Revision adds an IRB recommendation back translation of informed consent documents

11.C.ii  Consent via online

Requirements for obtaining electronic consent clarified

12.B.i  Distribution/storage by use of Redcap

Added statement about Redcap use under FDA regulations

Part 23:  Record Retention Requirements (formerly Record Keeping)

Clarification added to expectations of record retention. Specific documents required now identified

23.A  How long to keep records

Section revised and adding statement regarding study sponsor expectations

 

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