Do I Need to Submit to IRB?

The IRB is responsible for reviewing human subjects research (HSR) and ensuring that the research is conducted in accordance with applicable federal regulations and institutional policies. Refer to the HRP-103-GENERAL-ORSIRB Principal Investigator Manual for more detailed information. The manual can be found in the IRB library within the electronic IRB system.

The IRB will use the following definition of “research” and “human subject” as well as criteria found in DOE Order 443.1C to make the human subjects determination.

What is Research?

A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. For the purpose of this definition:

  • Systematic: Having or involving a system, method, or plan.
  • Generalizable: Information/research findings that are intended to be applied to populations or situations beyond that which was studied/will have meaning and impact outside of the single immediate activity itself.

What are Human Subjects?

A living individual about whom a principal investigator (PI) (whether professional or student) conducting research

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

For the purpose of this definition:

  • Intervention: Physical procedures by which information or biospecimens are gathered (for example, venipuncture) or manipulations of the subject or the subject’s environment that are performed for research purposes (even if no data is collected about the individuals participating in the study).
  • Interaction: Communication or interpersonal contact between PI and subject.
  • Private Information: Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, or information which has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
  • Identifiable Private Information: Private information for which the identity of the subject is or may readily be ascertained by the PI or associated with the information.
  • Identifiable Biospecimen: A biospecimen for which the identity or the subject is or may be readily ascertained by the PI or associated with the biospecimen.

DOE Order 443.1 C Criteria

DOE has additional requirements of research that must be submitted to the IRB for review and determination before the research study begins.

  • All research involving datasets, whether identified or de-identified.
  • Research that uses social media data.
  • Human subjects research that involves DOE federal and/or contractor employees who are vulnerable to pressures to appear cooperative with regard to projects conducted by their managers and/or coworkers. These vulnerable populations must first be reviewed and approved by the appropriate DOE IRB (the DOE site IRB or one of the Central DOE IRBs), or if deemed more fitting by the federally assured DOE site or Headquarters, other appropriate IRB of record, in accordance with an reliance agreement (IAA) or memorandum of understanding (MOU) negotiated between the DOE site or Headquarters and the organization responsible for IRB review.
  • Research that involves the study of humans in a systematically modified environment. This may include efforts such as: testing new energy-efficient devices in homes or offices and responding to surveys on such devices and personal energy use practices; studies of airflow in public places or individuals’ homes, using tracer gases; and other similar studies.