Office of Human Research Ethics SOP 0501: Human Subject Research Determination

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 investigation” as provided by the Common Rule and FDA regulations (See definitions in SOP 101.3). 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 individuals' initial determination. If the activity is not human subjects research, they will receive a NHSR determination letter from the OHRE 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 institution’s 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 SOP 101.3, 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 whether an activity constitutes human subject research will be made according to the definitions in SOP 101.3. Determinations regarding activities that are either clearly human subject research or clearly not human subject research, may be made by the IRB 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 through the OHRE will be recorded and maintained in IRBIS.

2.4 Changes or Modifications in Projects Previously Determined to be NHSR

Projects or submissions that receive an NHSR determination may change, be modified, or have revisions in personnel throughout its lifecycle that are not required to be submitted 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

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Details

Article ID: 132221
Created
Thu 4/8/21 9:26 PM
Modified
Fri 3/18/22 4:54 PM
Effective Date
If the date on which this document became/becomes enforceable differs from the Origination or Last Revision, this attribute reflects the date on which it is/was enforcable.
04/06/2018 12:00 AM
Issuing Officer
Name of the document Issuing Officer. This is the individual whose organizational authority covers the policy scope and who is primarily responsible for the policy.
Issuing Officer Title
Title of the person who is primarily responsible for issuing this policy.
Vice Chancellor
Last Review
Date on which the most recent document review was completed.
11/29/2021 11:03 AM
Last Revised
Date on which the most recent changes to this document were approved.
04/06/2018 12:00 AM
Next Review
Date on which the next document review is due.
11/29/2023 12:00 AM
Origination
Date on which the original version of this document was first made official.
04/06/2018 12:00 AM
Responsible Unit
School, Department, or other organizational unit issuing this document.
Research-IRB and Human Research Ethics