Human Subjects Regulation

Human Subjects Definitions

• Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research whether they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities (45 CFR 46.102)(d)).
  
  
• Pilot studies and other preliminary studies e.g. convening a focus group to help researchers develop a questionnaire or pilot testing a questionnaire fall under the definition of research.

  The human subject definition is triggered if the information and biospecimens are obtained through intervention or interaction with the living individual, regardless of whether the information or biospecimen has identifiers attached (for example, anonymous surveys or collections of samples using a swab).

  A Human Subject is a "living individual about whom an investigator (whether professional or student) conducting research: (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."

Any research involving human subjects should be reviewed if it is: 1) sponsored by the University, 2) conducted by or under the direction of any University employee in connection with his or her university responsibilities, 3) conducted on or with University property, or 4) involves the use of the University's nonpublic information to identify or contact subjects or prospective subjects. Note that the IRB does not require review of student projects conducted in the context of course work.

The IRB must review and approve human subjects research:

• Before any work is started.
• Ongoing research at least annually (expedited and full studies only).
• All changes to research protocols before implementation (except when necessary to eliminate any immediate hazards to subjects or others).

Instructions

1. Download and fill out one of two protocol submission forms (Exempt or Expedited/Full), depending on the nature of the study. Obtain all required signatures.
2. Prepare accompanying materials as appropriate. Email completed forms and required accompanying materials to FIT_IRB@fit.edu

3. Allow approximately 2 weeks for Exempt review and 2-3 weeks for Expedited/Full review

Which Form to Choose

1. The Expedited/Full Protocol Submission Form should be submitted if there is more than minimal risk associated with the research (none of the exempt conditions below apply) or if the research utilizes a special population (children, prisoners, institutionalized individuals etc.).
   
   
2. The Exempt IRB Submission Form should be submitted if there is little to no risk to human subjects and one or more of the conditions below apply.
   • Research conducted in established or commonly accepted educational settings, that specifically involves normal educational practices, that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes
     1. research on regular and special education instruction strategies, or
     2. research on the effectiveness of or the comparison among instruction techniques, curricula or classroom management methods
        
        
   • Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
     1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; or
     2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
     3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and IRB can determine if there are adequate provisions in place to protect the privacy of the subjects and confidentiality of the data.
     4. Note: Subcategories 2a and 2b can include research with children if the research only includes educational tests or public observation and investigator does not take part in activities being observed; Subcategories 2c does NOT apply to research involving children.
        
        
   • Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
     1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; or
     2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
     3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and IRB can determine if there are adequate provisions in place to protect the privacy of the subjects and confidentiality of the data.
        
        
   • Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable bio specimens, if at least one of the following criteria is met:
     1. The identifiable private information or identifiable bio specimens are publicly available;
     2. Information, which may include information about bio specimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
     3. The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated by HIPAA as health care operations, research, or public health activities and purposes; or
     4. Analysis of data on behalf of a federal agency or department – as opposed to an investigator-initiated analysis of federally supplied data – if the requirements of certain federal laws are met. These sources are publicly available OR if the information is recorded in such a manner that subjects cannot be identified, directly or indirectly, through identifiers linked to the participants.
        
        
   • Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads, and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.  Examples of such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants.
     
     
   • Taste and food quality evaluation and consumer acceptance studies if:
     1. wholesome foods without additives are consumed, or
     2. Food is consumed that contains food ingredients found to be safe by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
        
        
   • Storage or maintenance for secondary research (prior to secondary analyses) for which broad consent is required:
     1. Storage or maintenance of identifiable private information or identifiable bio specimens for potential secondary research use if an IRB can determine adequate provisions in place to protect the privacy of the subjects and confidentiality of the data. E.g. Storing student data collected from previously conducted surveys
        
        
   • Secondary Research for Which Broad Consent is Required: Research involving the secondary analysis of existing private identifiable data and identifiable bio specimens if the following criteria are met:
     1. Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable bio specimens was obtained, and
     2. Documentation of informed consent or waiver of informed consent was obtained
     3. The IRB determines that there are adequate provisions to protect the privacy of subjects and maintain the confidentiality of data, and
     4. The investigator does not include returning individual research results to subjects as part of the study plan.