By John F. Ennever, MD, PhD, CIP, Director, BUMC IRB
One of the more confusing areas to our research community is, “What makes an activity human subjects research (and, therefore, subject to IRB oversight); and what makes an activity NOT human subjects research?” The confusion exists not just among our researchers, but also with grant administrators, project officers at funding agencies, journal editors, and many others. The default at BU/BMC as well as many other institutions has been to require that the IRB (or more correctly, staff within the IRB Office) make the determination that a specific activity is “not human subjects research,” abbreviated “NHSR.” The purpose of this article is to help you understand how we in the IRB Office make this determination. Armed with this understanding, you might recognize ways you can change the research design of a proposed study that would make your study “NHSR” and, thus, not subject to further IRB oversight.
The federal regulations that cover human subjects research are found in 45 CFR 46. These regulations are also called the “Common Rule” because they have been adopted by most of the departments and agencies of the Federal Government.
The Common Rule carefully defines what is meant by “research” and what is meant by “human subjects.”
RESEARCH means “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy…”
Ambiguity about whether an activity is research most commonly arises when someone is doing quality assurance or quality improvement work (QA/QI) that could also be used to contribute to generalizable knowledge. A discussion of this issue has been previously discussed in the CR TIMES, see April, 2008 issue. An updated discussion of QA/QI will be the subject of a subsequent CR TIMES article.
The far more confusing area is what constitutes a “human subject.” The following is the definition in the Common Rule.
HUMAN SUBJECT means “a living individual about whom an investigator conducting research obtains:
(1) Data through intervention or interaction with the individual, or
This leads to four further definitions:
Intervention includes both physical procedures by which data are gathered (e.g., venipuncture, having a subject perform a task on a computer or run on a treadmill); and manipulations of the subject or the subject's environment that are performed for research purposes (e.g., placing color coded nutritional information on packaged sandwiches, acting like a homeless person at a bus stop).
Interaction includes communication or interpersonal contact between investigator and subject for the purpose of gathering data (e.g., interview, email survey).
Private information means information that is generated in a context in which an individual can reasonably expect that no observation or recording is taking place; and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., behavior in a person’s home, answers to a survey where confidentiality was promised, medical records).
Obtaining private information per se does not constitute involvement of human subjects unless this information is “identifiable.”
Identifiable means that the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
In summary, human subjects research is obtaining data by intervening or interacting with living subjects or obtaining identifiable private information about living subjects.
All other research is not human subjects research (NHSR).
There is research going on throughout the University and BMC that has not been officially determined to be NHSR by the IRB because the investigators are absolutely certain that what they are doing is not human subjects research. For example, many years ago I worked with bilirubin and human serum albumin (both purchased from a chemical supply house). Even though I used HUMAN serum albumin, I was confident that what I was doing was NHSR.
Often, it is not as clear whether or not a project is NHSR. An approach to how we make the decision is illustrated by the questions below. You begin with the first question and if the answer is “b” you move to the next one. As long as the answer is “b” you keep going. If an answer is “a” you have the answer as to whether or not a project is Human Subjects Research or Not Human Subjects Research.
In the following examples, I have given the answers to the above questions to illustrate how this tool could be used to make a Human Subject Research or Not Human Subject research determination.
Typical categories of “Not Human Subjects Research (NHSR):
Examples of research that DOES meet the definition of human subjects research. I have included the reason why the research is human subjects research and what changes could be made to make the research NHSR:
The IRB has responsibility for research that meets the regulatory definition of Human Subject Research. Research that does not meet this definition is termed Not Human Subject Research (NHSR). The purpose of this article is to help you understand how we in the IRB office analyze a particular project to determine whether or not it is NHSR.
When there is ever a question about whether or not an activity is human subject research, you should consult with us in the IRB office. We can ask for help by sending an email to email@example.com, or by calling us at 617-638-7207.
This Quiz applies to the current recertification period from July 1, 2013 to June 30, 2015. We recommend that you take this quiz now so you can stay up-to-date.