Human Subjects in Research

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 Department for Human Research Protections (DHRP) 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 DHRP requires educational training for all researchers and research staff prior to engaging in human subject research.  The DHRP staff also regularly conducts research compliance awareness seminars for various groups such as research coordinators, students and faculty members.

Inaddition to providing education, the DHRP 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; and the corresponding Terms of Assurance for Protection of Human Subjects for Institutions Within The United States;
  2. The ethical principals discussed inThe 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

DHRP Policies and Procedures for the Protection of Human Subjects in Research and Investigational Activities

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.

 Federalwide Assurance (FWA) for the Protection of Human Subjects

The University of Toledo’s FWA and the corresponding Terms of Assurance provide the framework for the human research subject protection program and associated institutional review boards at UT. Because compliance with the FWA and Terms of Assurance is vital to prevent federally imposed restrictions or suspension of all human subject research at UT, everyone involved in human subject research should have a solid understanding of the content and importance of these documents. Please take a moment to review the discussion of UT’s FWA and Terms of Assurance

 University of Toledo Department for Human Research Protections Policies and Procedures

The DHRP Policies and Procedures were prepared to help investigators and others involved in human subject research meet individual and institutional obligations with respect to human subject research. They have been developed in accord with federal regulations (45 CFR 46, 21 CFR 50, and 21 CFR 56), the UT FWA, UT policies, human research ethical codes, and the ethical principles embodied in The Belmont Report (respect for persons, beneficence and justice).

Topics covered in the Policies and Procedures include:

Policies
I           Introduction
II         Definitions
III        Applicability
IV        Compliance Requirements for UT Research
V         Basic Principles of UT-Related Research
VI        Administration
VII       Educational Training for Human Subject Research
VIII      IRB Member Conflict of Interest

Procedures
I          Definitions
II         Eligibility to Conduct Human Subject Research
III        General Requirement for Review of Human Subject Research
IV        IRB Membership and Membership Responsibilities
V         Application Requirements for IRB Review of Research
VI        IRB Review of Research
VII       IRB Operations and Recordkeeping
VIII      Investigator Responsibilities
IX        Research Conducted Off Campus With A Non-UT Researcher
X         IRB Compliance Activities

Any person conducting *UT-Related Research must be familiar with the DHRP Policies and Procedures and agree to comply with them. Outside investigators collaborating on UT-Related Research must also agree to comply with the DHRP Policies and Procedures.

*UT-Related Research means research carried out on- or off- campus (including other states or countries) by UT faculty, students, or other employees, and any studies conducted by any investigator using UT facilities and/or UTMC patients as subjects, including patient records, biological samples, or surveys.

 Information Regarding Children as Research Subjects

There are special requirements for research involving children that are found in Subpart D of the HHS regulations for the protection of human subjects in research. All University of Toledo related research that involves individuals less than 18 years of age must apply these protections.  Please read the UT Guidance for Research Involving Children to learn the details and responsibilities associated with this special category of research.

 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

 DHRP 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 at least monthly and include both for-cause audits and not-for-cause “compliance support visits.”  Additional information regarding compliance activities can be found in the DHRP Policies and Procedures.

Reporting Non-Compliance To The IRB or DHRP. Any person or entity may report suspected or confirmed non-compliance.  Mechanisms for reporting include:

  • Written notice to the DHRP Office:

Attention: Associate General Counsel - Regulatory Compliance
Main Campus - Mail Stop # 944
The University of Toledo
2801 W. Bancroft Street
Toledo, Ohio 43606-3390

Attention: Associate General Counsel - Regulatory Compliance
Health Science Campus - Mail Stop # 1035
The University of Toledo
3000 Arlington Avenue
Toledo, Ohio 43614-2598

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.  
 

IRB Reports of Non-Compliance to UT and Federal Officials

The IRB is required by federal regulations to report the following to UT officials and the federal Office for Human Research Protections:

  • Unanticipated problems involving risk to subjects;
  • Serious or continuing non-compliance; and
  • Suspension or termination of IRB approval.                                                                                          

Suspension or termination of research approval

The IRB may suspend or terminate IRB approval of research that is not conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects.  Any suspension or termination of IRB approval will be communicated in writing to the investigator with a statement of reasons for the action. All suspensions or terminations will be reported to UT officials and the federal Office for Human Research Protections.

 The Federal Office for Human Research Protections’ Compliance Oversight

From http://www.hhs.gov/ohrp/compliance/

OHRP's Division of Compliance Oversight (DCO) reviews institutional compliance with the federal regulations governing the protection of human subjects in HHS-sponsored research [45 CFR 46].

The DCO evaluates all written substantive allegations or indications of noncompliance with the HHS regulations. If complaints or concerns arise regarding an institution's human subject protection practices, OHRP opens a formal evaluation and, if necessary, requires corrective action by the institution.

During the course of an evaluation, DCO issues findings of non-compliance in the form of determination letters. OHRP makes these determination letters available on its website.

Financial Conflict of Interest

PHS policy requires that all those involved in the design, conduct or reporting of federally sponsored research disclose any financial conflicts of interest at least on a yearly basis. PHS policy also requires that these individuals undertake training in financial conflict of interest issues.

Form for disclosure for non-UT Personnel on funded IRB Protocols or for all personnel on unfunded IRB Protocols.

 

 

 

 

Last Updated: 5/5/15