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Regulatory Compliance

Regulatory Compliance

Responsibilities of the Faculty and the IRB at Eckerd College Regarding Research with Human Subjects

For purposes of research at Eckerd College, there are three levels of review, each requiring criteria that must be met in order for the research to pass review at that level:

A.The Review by a Supervising Faculty Member, using the Faculty Assurance Form that is submitted to the Chairperson of the IRB. Research covered under the Faculty Assurance Form must meet ALL of these conditions:

  • The research is course-related and required; and
  • The results will not be shared outside of the classroom environment; and
  • None of the stated conditions that necessitate further review via an Exempt/Expedited or a Full Review by the IRB are involved.

B. The Exempt/Expedited Review is conducted by the IRB Chairperson or his/her designee; it will be completed within two days after the necessary paperwork has been submitted at least one week prior to the proposed commencement of the research. Research submitted for the Exempt/Expedited Review must meet ALL of these conditions:

  • The research does not involve vulnerable populations, e.g., children, homeless, disabled individuals, etc.;
  • The data collected cannot identify any participant directly or through assigned identifiers;
  • The data collected will not put the participant at risk of legal or civil or financial or criminal liability or in jeopardy of damaging employability or reputation;
  • The data collected will not be shared outside of the institution or used to further knowledge within the discipline;
  • The research will be collected in a manner that is within normal educational practice using techniques that are commonly accepted within educational settings; and
  • Participants are fully informed about the purpose of the study, the analysis of the data, the procedures that will be used during the research, and their rights to refuse to participate at any time during the research period.

C. The Full Review, which is conducted by the full IRB, will occur when conditions within the proposed research design do not meet the procedural, ethical and/or legal safeguards to protect human subjects. These may include the following:

  • Involvement of more than minimal risk to a participant;
  • Features of the research that may be insensitive to the participant's well-being;
  • Lack of precaution regarding identifying information about participants on the data collected and/or lack of precaution on sharing or disposal of collected data;
  • Lack of sufficient information provided to the potential participants; and/or
  • Vulnerable populations as research participants.

Completing the Exempt/Expedited Review or the Full Review process is described in Instructions for Researchers Using Human Subjects.

Research at Eckerd

One of the hallmarks of a science education at Eckerd is the ability of students to do hands-on research. The purpose of this site is to outline the steps we take to ensure that our research is in compliance with a variety of guidelines and regulations.