The University of Toledo affirms the need for academic freedom in the conduct of research and the value of well-designed, responsible activities which involve human subjects. At the same time it recognizes the basic responsibility to assure the protection of any human subjects and has established the Department for Human Subjects Research (DHRP) to oversee that responsibility.  The DHRP offers guidance to researchers, and provides the administrative support for the Social Behavioral & Educational and Biomedical Institutional Review Boards.

Training Requirements: The University of Toledo requires all study personnel engaged in human subject research (including research using information and specimens from human subjects) to complete the training mandated by our Federalwide Assurance.  Training must be verified by completing the appropriate form (listed below) and returning it to the IRB office corresponding to your research submission. The training forms are linked below for your convenience.

• Social, Behavioral & Educational IRB Training Form                                        

          Main Campus, Room 2300, University Hall

• Biomedical IRB Training Form (with HIPAA/Privacy Rule)

          Health Science Campus, Room 0106, C.C.E. Building

The Social, Behavioral and Educational IRB resides on the Main Campus and reviews all university protocols involving human subjects that generate data by means of questionnaires, observation, studies of existing records, and other experimental designs involving exposure to some type of non-biomedical stimulus or intervention.

The Biomedical IRB resides on the Health Science Campus and reviews all University research designed to evaluate the safety, effectiveness, or usefulness of an intervention including research on therapies (e.g., drugs, diet, exercise, surgical interventions, or medical devices), diagnostic procedures (e.g., CAT scans), and preventive measures.

This IRB also reviews research on normal human functioning and development, which includes studies of the human body while exercising, fasting, feeding, sleeping, learning, or responding to such things as stress or sensory stimulation.  All of these types of experiments (and others) require IRB approval. Questions regarding the more appropriate committee for review may be addressed with the DHRP office.

For additional details on research categories, please read an excerpt from the Institutional Review Board Guidebook, CHAPTER V, BIOMEDICAL AND BEHAVIORAL RESEARCH:AN OVERVIEW

DHRP Contact Information

Carolyn Pinkston, Director of Operations, 419-383-6905

Samara Wisniewski, J.D., Director of Regulatory Compliance, 419-383-6903

Social, Behavioral & Educational Institutional Review Board 

Barbara Chesney, Ph.D., Chair 419-530-4075

Jeffrey Busch, Ph.D., SBE IRB Coordinator, 419-530-2416
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Michelle Shy, IRB Secretary, 419-530-6167

For questions, please call the numbers listed above or e-mail  IRB.SBE@utoledo.edu

** SBE IRB meeting will be held on this date only if business necessitates.

Biomedical Institutional Review Board

Roland Skeel, M.D., Chair 419-383-6796

Susan Mates, Biomedical IRB Coordinator, 419-383-6796

For questions, please call the numbers listed above or e-mail IRB.Biomed@utoledo.edu

*The IRB Meeting will be on the second Thursday in December.
** Protocols for the January 2008 meeting may be submitted earlier than 12/26 but no later. Thank you.

Summary and Review Criteria

What is the University of Toledo policy for the use of human subjects in research?
In summary, investigations conducted at or sponsored by The University of Toledo which involve the use of human subjects must adhere to the codes of ethics, policies, and procedures.  This document is currently under revision and will be available shortly. During the revision period, investigators are asked to continue to meet the following key requirements of research:

• Projects should be carefully designed to minimize risk to the subjects and to anticipate risk.
• Participation of human beings as subjects in research must be voluntary.
• Consent processes and documentation must conform to the IRB requirements and comply with applicable law and sponsor guidelines.
• Confidentiality of identifiable information is presumed and must be maintained unless the investigator obtains express permission of the subject to do otherwise.
• All research projects involving human subjects must be submitted for prior review unless certain specified instructional exemption criteria are fully met. The attached checklist may be used to assist in determining whether a project must be reviewed by the IRB.

Who is subject to the University’s requirements for the protection of human subjects in research and investigational activities?

Any individual who is responsible for a research activity involving human subjects conducted at, sponsored by, or utilizing facilities, students, or personnel of, The University of Toledo.

Who may conduct research involving human subjects?

Any UT faculty, student or staff member may conduct appropriately approved research. However, a qualified faculty or staff member must supervise any research project involving human subjects and is responsible for monitoring the conduct of the research. A qualified faculty member must hold the rank of instructor or above. A qualified staff member is one who holds an equivalent rank.

To what activities do the standards for the protection of human subjects in research and investigational activities apply?

The University standards for the protection of human subjects in research and investigational activities apply to any research activity which involves human subjects, independent of whether or not the research is undertaken on a large or small scale; the project is preliminary or fully designed; the project is externally or internally funded or unfunded; the research is conducted by faculty, students, or staff members; or involves minimal or more than minimal risk to the subjects.

What kinds of research must be reviewed by the IRBs?

In order to determine whether or not the research proposed meets the criteria for approval set by The University of Toledo and certain sponsoring agencies, all research involving human subjects must be submitted for prior review.   

Who is responsible for applying the standards for human research protections?

Compliance with ethical and professional standards governing the use of human subjects at The University of Toledo is an important shared responsibility. The primary responsibility for the subjects in research necessarily lies with the investigator(s) and project supervisor(s). The responsibility for review of human subjects research is the province of the University’s Department for Human Research Protections and the associated IRBs.

SBE IRB Review Criteria

In order to determine what qualifies as a bona fide research project and requires review by the IRB the following questions should be answered:

1. Is the purpose of the project to carry out a systematic investigation which is designed to develop or contribute to generalizable knowledge?

2. Is the project part of an internship, research practicum, independent study, independent research, honors project, thesis, dissertation or other formal research activity?

3. Does this project involve working directly with people, i.e. collecting information through intervention such as interviews, procedures, or questionnaires?

4. Does this project collect data indirectly through the review of records or non-detected observation e. g., through a one-way glass?

5. Can the data or information as collected be linked with an individual through a name, ID number, etc., or through deductive reasoning?

6. Will the data collected in this project be used at a later time as part of a research project? Example: data about an employer, age or gender.

7. Will this project involve children, prisoners, incompetent persons, pregnant women, University of Toledo students, faculty or staff as subjects in the study?
If the answer to any of the questions posed above is 'Yes', then the project is subject to review by the IRB and the investigator must submit the project on either a Protocol Application or Claim of Exempt Application as determined by the level of risk.  A worksheet to assist in determining whether your protocol meets exempt category can be found on the first three pages of the Claim of Exempt Instructions and Form. If your protocol does meet an exempt category, complete the Claim of Exempt Form and submit it for IRB review.

A project may be determined to be “instructional” and not require IRB review if it satisfies the criterion listed below:

1. Is the purpose of the project strictly instructional in nature and is the aim the development of student knowledge and skills independent of the data collected?

If the answer is ‘Yes”, the project does not meet the definition of human subjects research and does not require review by the IRB.  A qualified faculty member must still be in charge and assume responsibility for assuring that the project is carried out according to the principles detailed in The University of Toledo Policy and Standards for Protection of Human Subjects in Research and Investigational Activities.

All research projects involving human subjects not falling in the “instructional” category must be reviewed by the IRB Chair, Chair Designee or the full IRB in order to comply with federal and University regulations concerning the use of human subjects in research. An investigator should allow sufficient lead time for the review of any project submitted to the IRB as the committee meets on a monthly basis. 

Categories for review by the SBE IRB are: full convened, expedited and exempt. Following submission of the protocol application, projects will be pre-reviewed and assigned to either the convened or expedited category.  Expedited applications will not require the review of the entire committee but will be evaluated in detail by the Chair or Chair Designee to determine compliance with human subject research guidelines, 45 CFR 46 and the University’s Federalwide Assurance.  Exempt applications will also be reviewed in the same manner.  Convened items will be reviewed by the entire board at the monthly meeting.  Submission dates and meeting schedules are listed above.

This page was modified on March 11, 2008 .