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Human Research Protection Program

Compliance Responsibilities

Overview

Individuals involved in human subject research have a responsibility to conduct research in an ethical manner and in compliance with both federal regulations and University of Toledo requirements. The Human Research Protection's Program (HRPP) at The University of Toledo is committed to providing education and guidance to all investigators and staff engaged in human subject research to assist with the researcher鈥檚 fulfillment of their responsibilities and to facilitate compliance with the UToledo Federalwide Assurance for the Protection of Human Subjects (FWA).

The best way to ensure compliance with all applicable principles, regulations, policies and procedures, and to fulfill the requirements of UToledo鈥檚 FWA is through education.听 The HRPP requires educational training for all researchers and research staff prior to engaging in human subject research.听 The HRPP staff also regularly conducts research compliance awareness seminars for various groups such as research coordinators, students and faculty members.

In addition to providing education, the HRPP conducts compliance monitoring activities such as compliance support visits and audits of suspected non-compliance.

The main areas of focus for human subject research compliance are:

The UToledo FWA, The Belmont Report and Human Research Subject Regulations

  1. The University of Toledo (UToledo) Federalwide Assurance听(FWA)
  2. The ethical principals discussed in , namely (1) respect for persons; (2) beneficence; and (3) justice.
  3. HHS Regulations for the Protection of Human Subjects ()
  4. FDA Regulations for the Protection of Human Subjects (), when applicable
  5. FDA Regulations Regarding Institutional Review Boards (), when applicable
  6. All other laws and regulations applicable to human subject research, including applicable state laws and regulations.

Links to Federal Regulations and Research Guidelines

HRPP and IRB Compliance Monitoring

The intent of compliance monitoring activities is to work in good faith with all UToledo researchers to facilitate research compliance. Compliance monitoring activities are conducted on studies from each UToledo IRB and include both for-cause audits and not-for-cause 鈥渃ompliance support visits.鈥澨�

Reporting Non-Compliance to the IRB or HRPP

Any person or entity may report suspected or confirmed non-compliance.听 Mechanisms for reporting include:

  • Written notice to the HRPP Office:

IRB Office
CCE Building, Suite 2102 |听Mail Stop 1035

Anonymous Reporting through Compliance Concepts. Compliance Concepts anonymous reporting line is available seven days a week, 24 hours a day, 365 days a year, toll toll-free, at 888-416-1308. 听You are greeted by a trained interviewer who documents your concerns. You don鈥檛 have to give your name, and the call or transaction is not recorded. A report number will be assigned, which you will need when you check back. Then the information will be relayed to the appropriate UToledo office to investigate your concern. Using the report number, you may call or e-mail to follow up or add more information and remain anonymous.听听