Definitions and procedures

 “Research on human subjects” is identified according to definitions developed by federal regulators that have given Institutional Review Boards (IRBs) the mandate to consider proposals for such research.

  1. Research is “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
  2. A human subject is “a living individual about whom an investigator (whether professional or student) conducting research obtains 1) data through intervention or interaction with the individual or 2) identifiable private information.”
    • Intervention includes both physical procedures by which data are gathered...and manipulations of the subject or the subject’s environment that are performed for research purposes.
  3. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place and information which has been provided [to the researcher] for specific purposes by an individual and which the individual can reasonably expect to not be made public.”

In order to ensure that research involving human subjects conducted at or under the auspices of Bluffton University meets accepted ethical standards, a review process managed by the Bluffton University Institutional Review Board has been implemented. Three kinds of documents are required for review by two or more members of the IRB if you are planning research involving human subjects:

  1. A brief (not more than two-page) description of the proposed research covering the purpose of the projects, the manner in which human subjects will be involved, and, if applicable, the measures taken to protect the welfare of human subjects, including confidentiality of information obtained, and/or justification for any risks of physical or psychological harm the project imposes on human subjects. 
  2. Documentation of informed consent procedures to be used (or justification for non-use). Usually this will be a copy of the statement to be signed by subjects, or those responsible for them (e.g., in the case of children), informing them about the research and its purpose/benefits, how they will be involved and about their rights to withdraw without penalty and to privacy/confidentiality.
  3. A complete IRB certification form which is used to decide what level of review is required and to document approval by the IRB.

Initial review takes place at the departmental level and is conducted by the principal investigator and the departmental representative to the IRB (departmental reviewer) based on documents submitted by the investigator. If they, or they together with the chairperson and/or secretary of the IRB, determine that the research proposed is exempt from further review, the departmental reviewer and IRB board chairperson sign off on the certification form and the materials are presented to the full IRB at its next meeting for information purposes. Research can be initiated as soon as the chairperson signs off on the certification form.

If the proposal is determined at departmental level to be appropriate for expedited review, the IRB chairperson and one other non-departmental member of the board conduct this review and may sign off on the research on behalf of the IRB. Again, research can be initiated at this point. The proposal materials are presented to the full IRB at its next meeting for information purposes.

If the principal investigator and departmental reviewer, in consultation with the IRB chairperson and/or secretary, determine that the proposal needs full review, the proposal materials are brought to the full IRB for a decision at its next meeting.

In decisions about exemption or expedited review, the IRB chairperson and secretary may consult other members of the IRB; when consensus cannot be reached at this level, the proposal will be brought to the full IRB for a decision.