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Human Subjects Division (HSD)

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Document Details

Last Updated 10/31/2014
Version 3.20
Filesize 350 KB
Audiences Researcher, Researcher
Doc Type Form

SUPPLEMENT: Protected and/or Vulnerable Populations

Purpose

This supplement, to be used in conjunction with the IRB Application: Standard, or Modification Form, asks for required regulatory information such that the IRB can ensure the research is compliant with the numerous regulations governing the participation of protected and/or vulnerable populations in research.

Change Notes

  • Related to Ver. 3.20, noted 10/31/2014 @ 11:17am
    Modified Prisoners section to be in line with Flexibility Policy. Use this version going forward.
    - sherrye
  • Related to Ver. 3.10, noted 04/03/2014 @ 05:18pm
    Added clarification that COPPA refers to collecting information about children online.
    - sherrye
  • Related to Ver. 3.00, noted 11/22/2013 @ 09:27am
    Added question regarding COPPA regulation.
    - sherrye
  • Related to Ver. 2.90, noted 11/01/2013 @ 01:28pm
    Updated new assent questions. Use this version going forward.
    - sherrye
  • Related to Ver. 2.80, noted 10/19/2013 @ 04:49pm
    Updated name to new naming convention on website.
    - sherrye
  • Related to Ver. 2.80, noted 08/30/2013 @ 09:03am
    Added section for researchers to request a waiver of assent for children.
    - sherrye
  • Related to Ver. 2.70, noted 05/31/2013 @ 09:24am
    Corrected small error. Okay to use previous version.
    - sherrye
  • Related to Ver. 2.60, noted 03/30/2012 @ 09:16am
    Corrected typo. Okay to use previous version.
    - sherrye
  • Related to Ver. 2.60, noted 12/30/2011 @ 09:18am
    Added note regarding children who are wards and the use of ward advocates.
    - sherrye
  • Related to Ver. 2.50, noted 04/29/2011 @ 08:59am
    Last section, question 6, changed for clarity: Other potentially vulnerable groups – Check all that apply only if you are intentionally recruiting/targeting these vulnerable groups for enrollment into this study.
    - sherrye
  • Related to Ver. 2.40, noted 04/11/2011 @ 08:37am
    Updated link to OHRP regulations in section C. Now directs to comprehensive FAQ.
    - sherrye