IRB FREQUENTLY ASKED QUESTIONS
What is The University of Toledo policy for the use of human subjects in research?Who is responsible for applying the Policy and Procedures?
Who is subject to the University’s Policy and Procedures for Protection of Human Subjects in Research and Investigational Activities?
Who may conduct research involving human subjects?
To what activities do The University of Toledo Policy and Procedures for Research and Investigational Activities apply?
What is The University of Toledo policy for the use of human subjects in research?
The complete policy and procedures for the use of human subjects in research are presented
in The University of Toledo Policies and Procedures for Protection of Human Subjects
in Research and Investigational Activities. 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 set forth in this document.
Key requirements include:
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 Department for Human Research
Protections (DHRP) and 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 DHRP.
Who is responsible for applying the Policy and Procedures?
The primary responsibility for the subjects in research lies with the investigator(s)
and project supervisor(s).
The responsibility for the review of human subject research, the verification of the required training for those involved with research, and the administration of the Policies and Procedures is the province of the University’s Department for Human Research Protections. Compliance with ethical and professional procedures governing the use of human subjects at The University of Toledo is an important shared responsibility.
Who is subject to the University’s Policy and Procedures for 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, faculty or any other personnel of The University of Toledo and any studies conducted by and investigator using UT facilities and/or UTMC patients as subjects. See UToledo Policy #3364-70-05
Who may conduct research involving human subjects?
Any UToledo affiliated person may conduct IRB 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 University of Toledo Policy and Procedures for Research and Investigational Activities apply?
The University of Toledo Policy and Procedures 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; the research is conducted by faculty, students, or staff members; or involves minimal or more than minimal risk to the subjects.