Explanations of general guidelines and federal regulations for human subjects research.
Author(s): Elysa Koppelman, Ph.D.
The following is explanation of the federal regulations (45CFR46) concerning research with human subjects. Research with some vulnerable populations, like children and pregnant women, requires additional regulations which are discussed elsewhere.
Understanding and following regulations is important. However, ethical behavior involves more than simple adherence to rules; it requires discretion and judgment. Regulations do not necessarily cover all the choices and they do not give a formula for complete and mature ethical decisions. For example, these regulations tell us that we must get informed consent from potential subjects (or appropriate surrogate). But subtle questions about whether and under what conditions informed consent is actually obtained requires discretion and judgment.
These regulations will be discussed in terms of answering these key questions.
What is Human Subjects Research?, and The IRB review processes: The categories under which protocols are submitted
All research with human subjects is subject to review by the IRB (Institutional Review Board). Of course, not all activities constitute research with human subjects. Your first step in making sure you are following federal and institutional regulations is to determine whether your proposed activity constitutes research with human subjects.
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data through:
It is important to remember that you may be engaged in human subjects research even if you never come into direct contact with a living human being during the course of your activity. If you are examining medical records, viewing X-Rays of heart patients, or observing the behavior of people as they walk down the street you are engaged in human subjects research. Normally, it is easy to determine whether your activity constitutes human subjects research. When in doubt, contact your IRB.
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Once you have determined that your activity is research with human subjects, you need to determine what kind of review to which your project is subject.
Your IRB makes the final determination as to whether your project qualifies for exemption, expedited, or full review. But thinking about these categories ahead of time could help you to design your project in ways that may save you time and energy. Furthermore, many IRB's have different applications for each of these categories, so it helps if you know which category your project is likely to fall under.
It is the IRB's job to protect the welfare of human subjects. Some research, however, exposes subjects to only minimal risk. Minimal risk, as defined in the federal regulations, means "that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."
In general, research that (a) exposes subjects to no greater than minimal risk and (b) is designed such that data is recorded in a way that does not identify subjects, either directly or indirectly, qualifies for exemption. You may believe that your protocol qualifies for exemption, but your IRB makes the final determination as to whether your belief is correct. Most IRB's have a special exemption application to fill out and submit. Check with your IRB to determine their process for determining whether your project qualifies for exemption.
The following is a list of categories that fall under the classification of exemption in 45CFR46:
Notice that in all of these categories, with the exception of public officials, subjects are exposed to no more than minimal risk and the data is recorded without identifiers or will be kept confidential (by federal law) forever. As you design your research, you may want to keep this in mind. If you can design your research so that you are meeting these requirements without compromising your project, you should do so. Not only will doing so make your life easier, but (as we will see) it is required by the federal regulations.
Some research protocols will qualify for expedited review; a process which is normally easier and faster for all involved. There are three conditions under which a protocol qualifies for expedited review:
When the IRB approves a protocol, it approves a particular protocol for a certain period of time. If, during the approval time, you need to make changes to your protocol, you must report those changes to the IRB before you institute them. (The only exception here are emergency changes made because of unforeseen harm to subjects.) The IRB will then determine whether your changes require a new full review or an expedited review. If the changes are minor, the IRB may approve your submission for an expedited review.
When the IRB approves a protocol, it approves a particular protocol for a certain period of time (not more than one year). When your approval time is up, the IRB will send you a letter stating that it is time to apply for continuing review. The IRB must review your protocol again. If your continuing review falls under these conditions, it may qualify for expedited review.
The activities listed below should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
Research with human subjects that does not qualify for exemption or expedited review must be submitted to the IRB for full review. Your next question is how to design your research so that it meets the characteristics for which the IRB is looking. In other words, What must my protocol contain when I submit it to the IRB? In order to get an answer to this question, it is important that you understand the values that underlie the regulations to which your research is subject.