Human Research Protection Program: Policy

Reporting Questions, Suggestions and Concerns about HRPP and IRBs

 

Adopted By: Associate Dean for Research Policy, UW-Madison Graduate School

Adoption Date: December 11, 2006

Purpose:  This document describes how questions, suggestions and concerns about the Human Research Protection Program or an IRB can be brought to the attention of the UW-Madison’s IRBs, Research Policy Office and Institutional Official.

Policy

I.      The UW-Madison Institutional Official (IO) is responsible for assuring that UW-Madison IRBs comply with all applicable ethical principals, federal and state laws and institutional policies and procedures for the protection of human research participants, setting the "tone" for an institutional culture of respect for human research participants, and ensuring effective institution-wide communication regarding human research issues.

II.     The UW-Madison’s Research Protection Office (RPO) provides staff support for the IO in fulfilling these responsibilities.

Procedure

I.      Questions, suggestions and concerns regarding an IRB or a human research protocol may be brought to the IRB chair by a research participant, investigator, IRB member, IRB staff member, UW-Madison faculty or staff member or other member of the UW-Madison community.  Contact information for the IRB chairs is posted on the UW-Madison website.  

II.     If the question, suggestion or concern cannot be resolved through discussions with the IRB chair or the individual believes that bringing the issue to the IRB chair would be inappropriate due to the nature of the question, suggestion or concern, the individual may contact the RPO.  Contacting the RPO office may be done anonymously.  Contact information for the RPO is posted on the UW-Madison website.   

III.    If a question, suggestion or concern relates to an urgent or a sensitive issue, the individual may contact the IO directly.  Contact information for the IO is posted on the UW-Madison website.  

IV.   In response to a question, suggestion or concern, the RPO may consult with the IO and/or the IRB.

V.    In response to a question, suggestion or concern, the RPO and/or the IO may:

A.  conduct an investigation

B.  notify the IRB of the complaint or concern

C.  make recommendations for resolution of the question, suggestion or concern.

VI.   The RPO or the IO will notify the individual of the results of any investigation and any action taken.

VII.   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.  Such reprisal is prohibited by law and perpetrators are subject to sanctions.  Individuals who feel that a personnel action has been taken against them because they reported apparent violations of human research protection requirements should consult the UW-Madison Whistleblower Policy.