Questions, Complaints or Concerns for the IRB

Participants

QUESTIONS/CONCERNS ABOUT A STUDY: The Consent form you receive when you are invited to be a research participant includes some contact information if you have questions or concerns about the study. You are encouraged to contact the researcher if you have questions.

QUESTIONS ABOUT RIGHTS AS A RESEARCH SUBJECT: Call the HSPPO at 502.852.5188 or toll free at 1.800.334.UofL (8635). If calling toll free, when the operator answers, ask to be connected to extension 502.852.5188. You can discuss any questions about your rights as a research participant, in private, with a member of the IRB.

ANONYMOUS QUESTIONS/COMPLAINTS: If you have concerns or complaints about the research or research staff and you do not wish to give your name, you may call toll free at 1.877.852.1167. This is a 24 hour hot line answered by people who do not work at the University of Louisville.

Researchers

HSPPO Customer Service Survey

The Human Subjects Protection Program Office (HSPPO) and the University of Louisville’s Institutional Review Boards (IRB) want to meet their primary responsibility of protecting participants in research at the University. They also want to work in a cooperative and collegial manner with investigators at the University to assure this protection as a team. If you have feedback, concerns or complaints about the service you received from the HSPPO or one of the IRBs, you have been unable to resolve the problem after direct communication with the HSPPO or IRB, or you do not wish to express your concerns or complaints using the HSPPO Customer Service Survey, please contact: Craig McClain at 502.852.6991 or by email.

 

ACCREDITATION

Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) accreditation is a public affirmation of an organization's commitment to protecting research participants. The University of Louisville Human Subjects Protection Program has full accreditation through AAHRPP.

ICH GCP Compliance Statement

The University of Louisville Institutional Review Boards and the Human Subjects Protection Program were accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) in 2005. The University of Louisville IRBs operate in compliance with Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) Guidelines insofar as those guidelines are consistent with the U.S. Food and Drug Administration regulations (21 CFR Parts 50 and 56) and the Department of Health and Human Services regulations (45 CFR 46) pertaining to the protection of human subjects in research.