Title
Office of Human Research Ethics SOP 0501: Human Subject Research Determination
1. Purpose
All human subjects research must be reviewed by an IRB as outlined in SOP 601 Exempt Studies and SOP 701 IRB Review Process. The first step in determining whether an activity must be reviewed is to determine whether it falls within the regulatory definitions of human subjects research.
2. Procedure
2.1 Initial Determination by Investigator or Responsible Individual
The responsibility for initial determination of whether an activity constitutes human subject research rests with the investigator or the individual with primary responsibility for the activity. This individual should make the determination based on the definitions of “human subject”, “research”, and “clinical trial” as provided by the Common Rule and Food and Drug Administration (FDA) regulations (See UNC-Chapel Hill Human Research Protection Program (HRPP) SOP 6001: Definitions). As individuals will be held responsible if the determination is not correct, and the analysis can be complex due to the nuances of the regulations, individuals are encouraged to request a determination that an activity is or is not human subject research.
The request must be made through IRBIS using the “Not Human Subject Research” (NHSR) form that guides individuals through the definitions and aides in determining as to whether their project is human subjects research. All requests must include sufficient description of the activity and the rationale for the individual’s initial determination.
If the activity does not involve research, a human subject, or a clinical trial as defined by SOP 6001, the activity does not require IRB oversight. In this case, while investigators are still expected to adhere to ethical principles, the project does not fall under the purview of the IRB. Investigators will receive a letter determining the project does not meet the definition of human subjects research. If the submission appears to be human subject research, the submitter will be advised to change to the appropriate application type by revising the screening questions response.
Other institutions’ determinations, or the use of electronic or other forms of determination tools, do not substitute for review and determination by UNC-Chapel Hill OHRE.
2.2 Guidance on Identifiability
As outlined in UNC-Chapel Hill HRPP SOP 6001: Definitions, the definition of human subject includes obtaining, using, studying, analyzing, or generating identifiable private information. As the Common Rule provides provisions regarding specific purposes and reasonable expectations for use of individuals information, publicly available data may still be considered private information and be considered human subject research at the discretion of the OHRE reviewer.
Under the Common Rule, information is considered identifiable, and thus involving human subjects, when the identity of the subject is or may readily be ascertained by the investigator or associated with the information. It should be noted that this definition differs from de-identified in accordance with HIPAA standards. However, the FDA regulations do not incorporate the concept of “identifiability” in the evaluation of whether an activity is a clinical investigation (or research) subject to FDA regulations. For example, the use of de-identified human specimens to evaluate the safety or effectiveness of a diagnostic device is considered human subjects research subject to FDA regulations. Investigators are urged to submit for a determination whenever they are uncertain if a research study involves “human subjects” as defined by the Common Rule or FDA. Such requests should be submitted as outlined in section 2.1 of this SOP.
2.3 Determinations by the OHRE
Determinations regarding whether an activity constitutes human subject research will be made according to the definitions in UNC-Chapel Hill HRPP SOP 6001: Definitions. Determinations regarding activities that are either clearly human subject research or clearly not human subject research, may be made by the OHRE staff as identified in the “Training Matrix-Sign Off”. Determinations regarding less clear‐cut activities may be referred to the IRB Chair, who may make the determination, or refer the matter to the full IRB.
Determinations will be made according to the definitions, applicable federal regulations, and federal guidance. As part of the reviewer’s assessment, they will consider the aims and measures, activities being conducted, and the significance of how this information may be used. A previous NHSR determination does not guarantee a future NHSR determination, even if projects are similar in nature.
As the NHSR application encompasses nuanced information and different regulatory frameworks regarding the definition of human subject research, consultation with the OHRE on NHSR determinations is available. However, no formal determination can be made via phone, email, or other alternate methods. The request must be submitted through the IRBIS system to obtain a formal determination and a letter documenting the determination. Such documentation may be requested by journals, conferences, or others.
Documentation of all determinations made by OHRE will be recorded and maintained in IRBIS.
2.4 Changes or Modifications in Projects Previously Determined to be NHSR
Modifications to projects previously determined to be NHSR will not generally be accepted for review. The only modifications that are required to be submitted is if the “Screening Questions” section of the NHSR application is being revised, which may result in submission of a new application (e.g., new data sources that may be identifiable, changes in aims or measures). Individuals can consult with the OHRE office if they are uncertain whether a change or new application needs to be submitted.
Contact Information
Policy Contact
Office of Human Research Ethics
CB 7097
720 Martin Luther King Jr. Blvd.
Bldg # 385, Second Floor
Chapel Hill, NC 27599-7097
Ph: 919-966-3113
Fax: 919-966-7879