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Not Human Subjects Research (NHSR)

The federal definition of research includes the designation for a certain classification of activities and other projects referred to as "Not Human Subjects Research" or NHSR. This designation allows certain non-research and research-related projects and activities to be excluded from IRB review and approval. For example, an activity or project might qualify for NHSR designation under federal guidelines because:

  • The activity does not meet the HHS or FDA federal definition of "research" that requires IRB review, amendments and/or approvals.
  • The activity meets the HHS or FDA definition of "research," but does not meet the corresponding regulatory definition of "human subject" requiring IRB review, amendments and/or approvals.

NHSR Protocol Terms, Renewals & Amendments

  • Submit as NHSR/Flex in WVU+kc
  • Approval Term - 5 Years 
  • Active after five years - Do not need to reapply if there is no change in risk or protocol type
  • Amendments and renewals are not allowed or required. To amend your study you will need to resubmit a new protocol.

NHSR Projects and Activities

  1. 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
  2. Explain the research in sufficient detail for the participant to make an informed decision regarding participation: This can be accomplished by attaching an Informational Cover Letter (WVU OHRP-25) or by entering the information into the survey using WVU OHRP-25 as a guide.
  3. Surveys and electronic materials presented to participants must be ADA compliant. Refer to the Online Survey Guidance for more information.
  4. A HIPAA Waiver of Authorization will be required for all activities involving WVU Medicine medical records.
  5. A Case Study Authorization form must be signed by each patient for Case Studies and submitted to WVCTSI.
  6. A Data Protection Certification must be attached to the protocol (FUTURE REQUIREMENT September 2021)

Forms and Templates

The following forms and templates may be required or helpful for your project. The forms and templates can be found on the WVU OHRP Forms Page.

Descriptions of NHSR Activities

Data Collection/Secondary Analysis

The information includes private information and biospecimens that are anonymous, deidentified, coded (re-identification by the researcher is impossible), publicly available, or from a deceased individual. 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 biospecimens constitutes human subjects research.

Quality Improvement/Quality Assurance

Quality improvement (for better control) is a process for changing standards. It is not a process for maintaining or creating new standards. Standards are changed through selection, analysis, corrective action on the standard or process, education, and training.
Use the QI/EBP/Program Eval Determination Tool to determine if your activity or project constitutes human subjects research.

Evidence Based Practice

A conscientious, problem-solving approach to clinical practice that incorporates the best evidence from well-designed studies, patient values and preferences, and a clinician's expertise in making decisions about a patient's care. Use the QI/EBP/Program Eval Determination Tool to determine if your activity or project constitutes human subjects research.

Program Evaluations

Needs Assessments are conducted to assist in determining the need for a program, defining program goals, and determining how a program should be designed or modified to achieve those goals. A needs assessment is often used as a tool for strategic planning and priority setting. Use the QI/EBP/Program Eval Determination Tool to determine if your activity or project constitutes human subjects research.

Case Studies (5 Cases or Less)

An article that describes and interprets an individual case, often written in the form of a detailed story. Case studies often describe Unique cases that cannot be explained by known diseases or syndromes. Cases that show an important variation of a disease or condition. A Case Study Authorization Form must be signed by each patient and submitted to the WV CTSI.

Classroom/Educational Research

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.

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.

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 do not constitute human subjects research. However, the exercise of professional ethics is expected. (For example; journalism, biography, literary criticism, legal research, and historical scholarship)

Oral History

A method of gathering and preserving historical information through recorded interviews with participants in past events and ways of life". Oral history is a recorded conversation about the past with named individuals in which knowledge about specific events and individual lives is narrated in story form and made available to the public through deposit in archives. Oral history projects are not considered human subjects research. Examples: Eyewitness account of the Pentagon attack, Veterans History Project, Nevada test site oral history project, Civil rights in Mississippi.