Reporting of Suggestions and Concerns Regarding the Protection of Research Participants

This document describes how suggestions and concerns about the protection of research participants can be brought to the attention of the relevant UW-Madison officials.

  1. Suggestions and concerns related to the protection of research participants should be resolved using the following mechanisms.

    1. The suggestion or concern should first be directed either to the researchers, IRB office staff, or IRB chair, or, in the case of health sciences research, patient relations offices at UW Health or the Madison VA, as appropriate.

      1. Research participants will find contact information for researchers responsible for the study on the consent forms.

      2. Contact information for the appropriate patient relations offices is included in health sciences consent documents.

    2. If the suggestion or concern cannot be resolved through discussions with the above persons or the individual thinks that bringing the issue to them would be inappropriate due to the nature of the suggestion or concern, the individual may contact the Office of Research Policy (ORP) or relevant Deputy Institutional Official (DIO) who directly oversees the IRB’s function.

      1. ORP hosts an email address and anonymous dedicated voicemail box, which is listed on the ORP website.

    3. If a suggestion or concern relates to an urgent or a sensitive issue, the individual may directly contact the UW-Madison Associate Vice Chancellor for Research Policy who is Institutional Official for human subjects research (IO).

  2. Contact information for the IRB offices, DIOs and IO is located on the ORP website.

  3. In response to a suggestion or concern, IRB staff or chair, Deputy IO, the ORP and/or the IO may:

    1. collect additional information to evaluate the report or concern

    2. notify and consult with all responsible parties regarding the suggestion or concern

    3. make recommendations to all responsible parties for resolution of the suggestion or concern

    4. notify the individual reporting the suggestion or concern of the results of any evaluation and any action taken.

  4. UW-Madison will not tolerate any reprisal against an individual who has come forward with concerns or allegations of violations of human research protection requirements. UW-Madison employees who retaliate against a research participant may be subject to discipline.

  5. Generally, the individual who is the subject of the suggestion or concern should have access to the identity of the persons who made the allegations and provided information.

    1. However, if individuals wish to maintain their anonymity, every effort will be made to protect their identities. At the same time the individual who is the subject of the suggestion or concern will be afforded the opportunity to respond.

    2. Anonymity cannot be guaranteed.

Adopted By: Associate Dean for Research Policy, UW-Madison Graduate School
Adoption Date: December 11, 2006
Revised: March 1, 2012 by HRPP Advisory Committee
Revised By: Cross-Campus Human Research Protection Program (HRPP) Advisory Committee
Effective Dates of Revisions: August 28, 2015

Copyright © 2015 University of Wisconsin System Board of Regents

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Keywords:questions suggestions concerns complaints human research protection program HRPP institutional review board IRB report institutional official office of research policy   Doc ID:29231
Owner:Ryan M.Group:VCRGE and Graduate School
Created:2013-03-26 10:40 CDTUpdated:2017-04-19 10:55 CDT
Sites:VCRGE and Graduate School
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