Not Human Subjects Research and Not Research

Not Research/Not Human Subjects Research

WVU OHRP recommends a stepwise approach in determining whether a project meets the criteria of human subjects research.

First, determine whether your study meets the definition of research.

Research, as defined by the Common Rule, is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Second, determine whether your study involves human subjects.

A human subject, as defined by the Common Rule, is a living individual about whom an investigator 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. [45 CFR 46.102(e)(1)]

Reference OHRP's Chart 01: Is an Activity Human Subjects Research for additional guidance.

Policy/Process guidance for projects that are considered "not research" or considered "NHSR."

Protocol Submissions

If the project meets both of the above definitions, a protocol submission in WVU kc is required for IRB review and approval.

If your project meets only one definition, your project likely meets the definition of Not Research (NR) or Not Human Subjects Research (NHSR).

A protocol submission in WVU kc is not required but is permitted if the study team requires an official determination. Please note: ALL WVU kc protocols require the submission of the WVU Research – Data Protection Certification.
NR/NHSR projects submitted in WVU kc receive an acknowledgment letter, stating the activities are not considered human subjects research. This letter is required in some cases for publication.
The acknowledgment term is 5 years but there is no requirement to renew if the project is still active after the 5-year term if there is no change in risk or protocol type.
Amendments and renewals are not allowed or required. To amend the project, a new protocol must be submitted.
For additional guidance/requirements, please review the NHSR and Not Research Decision Matrix. This includes institutional data storage requirements.

Examples of Not Human Subjects Research and Not Research Activities

Activities That Do Not Meet the Definition of Human Subjects (NHSR)

1. Publicly Available Data or Decedent Data: Collecting publicly available data, or data from a deceased individual.

HIPAA Waiver of Authorization or HIPAA Decedent Authorization is required for all activities involving WVU Medicine medical records.

2. Secondary Analysis of Data: The use of private information and/or biospecimens that are anonymous, deidentified, or coded (re-identification by the researcher is impossible). This also includes the re-analysis of either qualitative or quantitative data already collected in a previous study by a different researcher usually wishing to address a new research question. Use the NIH Decision Tool to determine if your activity or project involving private information and/or biospecimens constitute human subjects research or if it qualifies as NHSR.

Activities That Do Not Meet the Definition of Research (Not Research)

1. Quality Improvement/Quality Assurance: Quality improvement or quality assurance projects are intended to improve a process or practice within a specific institution. Quality improvement is not a process for maintaining or creating new standards and is not intended to contribute to generalizable knowledge. Use the QI/EBP/Program Evaluation Determination Tool to determine if your activity or project constitutes human subjects research.

2. Program Evaluation: An individual systematic studies conducted periodically or on an ad hoc basis to assess how well a program is working. The purpose of program evaluation is to improve, not prove. Use the QI/EBP/Program Evaluation Determination Tool to determine if your activity or project constitutes human subjects research

3. Evidence Based Practice: Evidence-based practice (EBP) is the process of collecting, processing, and implementing research already conducted and shown to be effective to improve clinical practice. Use the QI/EBP/Program Evaluation Determination Tool to determine if your activity or project constitutes human subjects research

4. Retrospective Case Studies (5 cases or less): A case study is an article that describes and interprets an individual case (or less than five total), often written in the form of a detailed story.

Please note: Prospective case studies are considered case reports and are considered human subjects research. Chart Reviews are always considered human subjects research and require IRB review and approval.

Case studies typically describe unique cases that cannot be explained by known diseases or syndromes, or those that show an important variation of a disease or condition

Case Study Authorization Form should be signed by each patient and submitted to the WVU CTSI.

5. Classroom/Educational Activities: Class projects and research methods classes involving data collection activities for training purposes with the sole intent to teach methods and not contribute to generalizable knowledge

6. Oral History: Interviews concerning the past that collect and interpret the voices and memories of people as a method of historical documentation and that are preserved by placement in some form of repository or archive for access by other researchers. This includes the collection and use of information that focus directly on the specific individuals about whom the information is collected without extending that information to draw generalizations about other individuals or groups. The exercise of professional ethics is expected. Examples: Eyewitness account of the Pentagon attack, Veterans History Project, Nevada test site oral history project, etc. 45 CFR 46.102(l)(1)

7. Scholarly and Journal/Documentary Activities: Activities that focus on collecting, verifying, reporting, and analyzing information or facts on current events, newsworthy issues, or stories about people or events. There is no intent to conduct a systematic investigation and does not test a hypothesis. The exercise of professional ethics is expected. Examples: journalism, biography, literary criticism, legal research, and historical scholarship. 45 CFR 46.102(l)(1)

8. Public Health Surveillance: The ongoing systematic collection, analysis, and interpretation of data, closely integrated with the timely dissemination of these data to those responsible for preventing and controlling disease and injury. 45 CFR 46.102(l)(2). The Centers for Disease Control and Prevention (CDC) provides guidance for determining whether a project is Public Health Surveillance or human subjects research.

Additional Considerations

The following items may apply:

For online surveys and other activities involving interaction with human subject participants, include a question to obtain voluntary participation: I voluntarily agree to participate and I understand that I can stop participating at any time? Yes/No

Explain the project in sufficient detail for the participant to make an informed decision regarding participation.

Surveys and electronic materials presented to participants must be ADA compliant. Refer to the Online Survey Guidance for more information.

Additional Definitions

Systematic Investigation – Uses a methodical procedure and plan, is theoretically grounded, and specifies a focused and well-defined research problem or question, is informed by the empirical findings of others, is analytically robust, and provides a detailed and complete description of data collection methods.

Generalizable Knowledge - Information that is expected to expand the knowledge base of a scientific discipline or other scholarly field of study and yield one or both of the following:

Results that are applicable to a larger population beyond the site of data collection or the specific subjects studied
Results that are intended to be used to develop, test, or support theories, principles, and statements of relationships, or to inform policy beyond the study.
Note that publication or other dissemination of findings does not in and of itself make the activity "research". It has been a long-standing myth that if you publish, IRB review is required. Some publications require an “acknowledgement letter” from an institutional IRB.