SOP 011: Human Subjects Research Determination (NHSR)

Purpose

This SOP describes applicable DHHS and FDA definitions, the scope of human subject research for which WVU’s OHRP has responsibility, and the process by which determinations are made that an activity is research involving human subjects. This SOP also describes Not Human Subject Research (NHSR) submission procedures for any project that does not qualify as human subject research, but for which the individual would like to receive an acknowledgement from WVU’s OHRP/IRB.

Overview

Federal regulations define when an activity is research involving human subjects. As described below, an activity is human subjects research (i.e., and subject to regulatory and institutional requirements) if it fits either the DHHS or FDA definitions. All research involving human subjects must be approved by an IRB before being performed unless the research has been determined to be exempt from the federal regulations in accordance with 45 CFR 46.104.

Definition for FDA-Regulated Research

Activities are considered human subjects research and are subject to FDA regulations when they meet the FDA definition of “clinical investigations” and involve a “subject” as defined in FDA regulations.

Under FDA regulations, activities are “clinical investigations” when they involve:

• Use of a drug other than the use of an approved drug in the course of medical practice; OR
• Use of a medical device other than the use of an approved medical device in the course of medical practice; OR
• Gathering data that will be submitted to or held for inspection by FDA in support of a FDA marketing permit for food, including a dietary supplement that bears a nutrient content claim or health claim, an infant formula, a food or color additive, a drug for human use, a medical device for human use, a biologic product for human use, or an electronic product (in some cases).

NOTE: In the above criteria, “approved” means “approved by the FDA for marketing.”

Under FDA regulations, individuals are considered “subjects” when they become a participant in research, either as a recipient of the test article or as a control. If the research involves a medical device, individuals are considered “subjects” when they participate in an investigation, either as an individual on whom OR on whose specimen an investigational device is used or as a control.

Definition for DHHS-Regulated Research

Activities are considered human subjects research and are subject to DHHS regulations when they meet the DHHS definition of “research” and involve a “subject” as defined in DHHS regulations.

DHHS defines “research” as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Under DHHS regulations, “subject” means a living individual about whom an investigator (whether professional or student) is conducting research:

• obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; OR
• obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between investigator (or study personnel) and subject.

Private information includes information about behavior that occurs 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 (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Application of this Policy

WVU defines research involving human subjects as any of the following:

• Human subjects research that is subject to the FDA regulation;
• Human subjects research that is subject to the DHHS regulation;
• Human subjects research that meets the DHHS definition of research, regardless of the source of funding.

WVU IRB will review all research conducted at the institution and its affiliates when it meets this definition.

WVU has agreed to a Federalwide Assurance (FWA) to apply to the Health and Human Services regulations and terms of the assurance to all federally funded research conducted at this institution. Generally, WVU IRB will apply the Health and Human Services regulations to all human subjects research conducted at the institution and its affiliates, regardless of the source of funding. Research that is not federally funded and that is outside of the FWA is subject to the same level of review except where otherwise described in WVU OHRP’s policies.

Research that does not meet the definition of research involving human subjects must be determined by WVU OHRP, not an individual researcher (see exceptions below). Researchers should submit their inquiries to irb@mail.wvu.edu.

For the purposes of this policy, the following activities are not considered research; however, the PI may want to submit an NHSR application if he or she wishes to publish the research in the future or would like to obtain an WVU OHRP NHSR acknowledgement letter:

• Scholarly and journalistic activities (e.g. oral history, journalism, biography, literary criticism, legal research and historical scholarship), including the collection and use of information that focus directly on specific individuals about whom the information is collected
• Public health surveillance activities, including the collection and testing of information or biospecimens conducted, supported, requested, ordered, required, or authorized by a public health authority
• Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes
• Authorized optional activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions
• Research projects involving analysis of secondary data from pre-approved, publicly available datasets/repositories will not require prior WVU IRB approval
• Quality Improvement/Quality Assurance/Evidence Based Practice
• Program Evaluations
• Case Reports/Case Studies with five cases or less (can be retrospective or prospective in nature)
• Classroom/Educational research involving data collection activities for training purposes with the sole intent to teach methods and not contribute to generalizable knowledge

NHSR Determination Procedures

1. A researcher who wishes to conduct research activities, or activities which he or she feels does not meet the regulatory definition of human subjects research, should review WVU OHRP’s online guidance to determine whether or not to submit an NHSR application to WVU’s electronic IRB system.
2. The researcher may want to submit an NHSR application even if their activities do not appear to require WVU OHRP or IRB review and approval. For example, if the researcher wishes to publish the research in the future or would like to obtain an NHSR acknowledgement letter, he or she should submit an NHSR application. If a researcher is unsure whether to submit, they should e-mail WVU OHRP staff at irb@mail.wvu.edu for additional assistance.
3. Once an NHSR application is submitted via WVU’s electronic IRB system, WVU OHRP staff will review all information submitted by the researcher. Additional information may be requested by the WVU OHRP staff, as needed.
4. If a determination of “non-human subject research” is made by the WVU OHRP staff or the IRB, the PI is notified via the WVU electronic IRB system, typically in the form of an acknowledgement letter.
5. If the WVU OHRP staff or the IRB determine the project meets the regulatory definition of human subjects research, WVU OHRP staff will communicate with the PI accordingly as to how they should proceed with the submission and review of the research.

References

Federal Regulations:
21 CFR 46.102
21 CFR 56.102

AAHRPP:
Element I.1.A.