Human Subjects in Research

FAQs - Frequently Asked Questions

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 UT Policy #02-001
 
Who may conduct research involving human subjects?
 
Any UT 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.
 

What kinds of research must be reviewed by the DHRP and 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.  Protocols are reviewed by the DHRP or the IRB office staff under the regulations set forth in 45 CFR 46 and placed into one of three categories: convened review, expedited review or exempt. The DHRP may also determine that a certain application is not human subject research under the definitions set forth in 45 CFR 46.102
It is the prerogative of the DHRP and IRB to determine whether proposed research is human subject research and which category of review is appropriate for the research.  Only human subject research that is designated exempt by the IRB is exempt from review. Investigators may not make an independent determination that their research proposal is exempt.  For additional information regarding categories of review, please access the federal guidance information at http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm
To assist investigators in determining whether their project is exempt from review, please review the following information (table):
1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricular or classroom management methods.  This category may include children
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless(i)information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employment or reputation.  Research which deals with sensitive aspects of the subject’s own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol, cannot be exempt from review.
2a. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement) for which subjects can not be identified, or release of the information would not be harmful to the subject.  This category may include children.
2b. Research involving the use of survey procedures or interview procedures or observation of public behavior for which subjects can not be identified, or release of the information would not be harmful to the subject. This category may not include children.
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b) (2) of this section if (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statue(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.  Research which deals with sensitive aspects of the subject’s own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol, cannot be exempt from review.
4. Research involving the collection or study of existing data2, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. This category  may include children.
5. Research and demonstration projects which are conducted by or subject to the approval of federal department or agency heads and which are designed to study, evaluate, or otherwise examine:  (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.  This category may include children.
6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the U.S. Food and Drug Administration or approved by the  Environmental Protection Agency or the Food and Safety and Inspection Service of the U.S. Department of Agriculture.  This category may include children.

 

1 Harm to subjects means that any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or can be damaging to subjects’ financial standing, employability, or reputation.

2 Existing data means the items exist before the research was proposed or was collected prior to the research for a purpose other than the proposed research. (For purposes of a grant, this refers to data collected prior to the time the research was proposed.)

 

 

Last Updated: 3/23/15