There are several categories of research that may be exempt from the requirements of the Federal Policy for the Protection of Human Subjects (45 CFR 46). If research is found to be exempt, you must still submit a protocol application through ORahs. Although research that qualifies for exempt status is not subject to the federal regulations for human subjects research, researchers still have a responsibility to protect the rights and welfare of their subjects.
There is a difference between exempt and a non-human subjects research determination. Exempt still means it is human subjects research, per the federal definition of research AND human subjects. In order to be exempt research it must fall under one of the federally defined categories of exemption.
Non-human subjects research (NHSR) means that the project does not qualify as research or it does not involve the collection of private identifiable information or biospecimens, or interaction or intervention with human subjects, "about whom" you are collecting information.
If you think your proposed research does not meet the requirements for human subjects research and you would like to receive documentation for your records, email your request for confirmation to the HSC Coordinator at hsc@research.ucsb.edu along with the HSC Research Determination Form for review.
No. If you are conducting a classroom assignment that is purely for pedagogical (i.e., teaching) purposes, then the classroom activities are not subject to IRB review. Where data is collected from and about living individuals as part of a class exercise and/or assignment and is not intended for use outside of the classroom is not considered human subjects research. Course instructors are still expected to train students to conduct their project ethically with the three core principles of the Belmont Report in mind. Note: There may be instances where a student or instructor wishes to use data that was previously collected for non-research (i.e., educational) purposes. In these instances, an application should be submitted to the HSC when the intent of the project has changed and is intended to contribute to generalizable knowledge.
The UCLA Office for Protection of Research Subjects (OPRS) contacted Dr. Michael Carome, HHS-OHRP Associate Director for Regulatory Affairs, to seek his guidance concerning the matter of whether qualitative research utilizing open-ended interviews, especially activities performed by oral historians and other social scientists, would require IRB review.
In short, Dr. Carome clarified that the decision concerning whether activities that consist of open-ended qualitative type interviews (such as oral history projects or ethnographies) require IRB review hinges upon whether the activity meets the above definition of research—specifically, whether the activity is an "investigation" and “designed to contribute to generalizable knowledge.” The purpose of these activities is often to create a record of specific historical events and, as such, is not to generalize findings to a broader population or group. However, activities involving similar characteristics may be “designed to contribute to generalizable knowledge.” Below are examples of qualitative interviews that are considered to be research and examples of qualitative interviews that are not considered to be research.
• An oral history video recording of interviews with Holocaust survivors is created for viewing in the Holocaust Museum. The creation of the videotape is not intended to prove a hypothesis, inform policy, or draw conclusions. The sole purpose is to create a historical record of specific personal events and experiences related to the Holocaust and provide a venue for Holocaust survivors to tell their stories. Open-ended interviews that only document a specific historical event or the experiences of individuals without the intent to draw conclusions or generalize findings would not constitute research.
• Open-ended interviews are conducted with surviving Gulf War veterans to document their experiences in order to draw conclusions about those experiences, inform policy, and generalize findings. This would constitute research.
• Open-ended interviews are conducted with surviving Negro Baseball League players in order to create an archive for others to analyze and generalize findings in the future. Since the intent of the archive is to create a repository of information for others to use in research, the creation of such an archive would constitute research.
Yes. If the data is considered identifiable (even if recorded without direct or indirect identifiers) and not publicly available. The Secondary Uses Human Subjects Decision Tree may be used to help determine if research involving secondary or existing data requires Human Subjects Committee review.
Projects that use an existing data set, which includes identifiable data gathered in earlier research projects, may require a new IRB protocol for review. Secondary analysis of existing data may include the review of medical records, student records, data collected from previous studies, audio/video recordings, etc. that were initially collected for another purpose. In order to be existing, the information must be "on the shelf" (i.e., it has already been collected) at the time that the current research is proposed.
Though such projects do not involve interactions or interventions with humans, they may still require IRB review, since the definition of "human subject" includes living individuals about whom an investigator obtains identifiable private information for research purposes.
In addition to being identifiable, the existing data must include "private information" in order to constitute research involving human subjects. Private information is defined as information that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., a medical or school record). Information that contains identifiers and can be accessed freely by the public (without special permission or application) is not "private" and the research therefore does not therefore involve human subjects. For example, a study involving only analysis of the published salaries and benefits of public university presidents would not need IRB review since this information is not private.
Data analysis activities that meet the definition of research with human subjects may qualify for an exemption or require expedited or even full committee review. Any such project must receive IRB approval or a determination of exemption before the researcher accesses the data.
Unanticipated problems or adverse events must be reported to IRB if they are: 1) unexpected; 2) related or possibly related to participation in the study; and 3) suggest that the research places subjects or others at a greater risk of harm than was previously known or recognized. The IRB will review the report to assess whether any corrective actions or substantive changes are needed in order to protect the safety, welfare, and rights of subjects or others.
An initial report should be made by mail/delivery, phone, or email to the Human Subjects office or Director of Research Integrity as soon as possible, but within no more than one week (7 calendar days) of the Principal Investigator (PI) learning of the incident. The initial report must be followed by a formal written report within no more than two weeks (14 calendar days) of the Principal Investigator learning of the incident. For more information on unanticipated problems or adverse events, see our HSC SOP 023 Unanticipated Problems and Adverse Events.
Note: Other reporting requirements/deadlines may apply for certain research (e.g., involving the DoD, FDA).
To submit a formal report, email the IRB at hsc@research.ucsb.edu and include a brief summary of the incident including: