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’s fulfillment of their responsibilities and to facilitate compliance with the UT 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 UT’s FWA is through education.  The HRPP requires educational training for all researchers and research staff prior to engaging in human subject research.  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 UT FWA, The Belmont Report and Human Research Subject Regulations:

  1. The University of Toledo (UT) Federalwide Assurance
  2. The ethical principals discussed in The Belmont Report: Ethical Guidelines for the Protection of Human Subjects, namely (1) respect for persons; (2).beneficence; and (3) justice.
  3. HHS Regulations For The Protection Of Human Subjects (45 CFR 46);
  4. FDA Regulations For The Protection Of Human Subjects (21 CFR 50), when applicable;
  5. FDA regulations regarding Institutional Review Boards (21 CFR 56), when applicable;
  6. All other laws and regulations applicable to human subject research, including applicable state laws and regulations

OHRP, FDA and ICH Guidance: Guidance issued by OHRP, the FDA and ICH shall be applied when appropriate and necessary for the protection of human subjects.

Links to Federal Regulations and Research Guidelines

DHHS Regulations for the Protection of Human Subjects

FDA Regulations Relating to Good Clinical Practice and Clinical Trials

ICH Guidance for Industry – E 6 Good Clinical Practice: Consolidated Guidance

HRPP and IRB Compliance Monitoring

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

Reporting Non-Compliance To The IRB or HRPP.

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

  • Written notice to the HRPP Office:

IRB Office
CCE Building, Suite 2102
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.  You are greeted by a trained interviewer who documents your concerns. You don’t 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 University 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.  
 

 

 

 

 

 

 

Last Updated: 3/7/19