Answer: When individuals are doing "research" with human subjects. Research is defined by the federal regulations, as "a systematic investigation including reserach development, testing and evaluation, designed to develop or contribute to generalizable knowledge." When research is going to be presented in a public domain (journal, book, conference, internet) then the intent is typically to contribute to generalizable knowledge. If instructors, departments, or schools are collecting data for internal use only, it is often termed "evaluation" instead of "research" and does not need IRB approval
Answer: Pilot studies, feasibility studies, and other preliminary studies clearly fall under the definition of research. They need to be approved by the IRB.
Answer: The answer is "yes" and "no". Informed consent refers to an actual form that is signed by both the researcher and the participant.
According to federal regulations, "An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that;
So, "NO" you don't always need to include an informed consent form. However, "YES" you must always include (at minimum) an implied consent statement. Just because "informed consent" is waived, does not mean that you do not need to inform the study participants. You can find examples of informed consent under the "Handbook and Forms" tab in this website. For adult populations implied consent needs to include the following eight items:
If there is any chance that any individuals under the age of 18 (even college students) may receive the instrument, then you must also include the phrase, "You must be 18 years or older to participate in this study." In the well-accepted book "Planning Ethically Responsible Research - A Guide for Students and Internal Review Boards" (by Joan E. Sieber, 1992, ISBN 0-8039-3964-7), the following statement is made and accepted throughout the country for higher educational IRBs: "Just because signed consent is not required does not mean that consent is not necessary. Consent is necessary and a copy of the consent statement may be given to the subject; only the signed agreement to participate is waived." (p. 38).
Question: What is the difference in the IRB process between an expedited and an exempt submission?
Answer: The exempt submission must be reviewed by the IRB Administrator and the IRB Coordinator. An expedited packet must be reviewed by the IRB Administrator, IRB Coordinator, and another member of the IRB (preferably someone in your own discipline). Typically, a professional, thorough, well-written IRB packet (faculty, staff, or student research) can be approved within 1-2 weeks. Expedited packets typically take 2-3 weeks. The timing generally hinges on 1) the quality and thoroughness of the submission (if we need to request additional information or items then it will take longer); and 2) the timing of the submissions
We review packets on Monday mornings. If submissions are received by Thursday afternoon, they will be reviewed the following Monday. If it is a well-done exempt submission then it can be immediately approved. If a packet is not submitted until Monday afternoon then it will not be reviewed by the IRB administrator until the following Monday (1 week later). If there are any issues then we will contact the researcher and then re-review, if all the items or concerned have been addressed, the following Monday. We ask the third reviewers (if an expedited submission) to have their responses back to us within one week. We must have this review back before we can proceed.
In 95% of the cases (since August 2006) delays are caused by incomplete submissions on the part of the principal investigators. All items must be addressed at a thorough level of depth for us to make an ethical determination regarding confidentiality, privacy, research design, risk, informed or implied consent, and so forth. This must include a thorough answer for research abstract and methods. We can't make ethical determinations if we don't have a justification for the research. This often includes information from past research which demonstrates a need or gap in the existing research. Frivolous research is an ethical concern.