6. What Research Requires Review?

What Research Requires Review?

If you are conducting research with human subjects, as defined below, your research requires review and approval for use of human subjects.

Title 45 Code of Federal Regulations Part 46.102(e)(1) defines a “human subject” as a living individual about whom an investigator (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.

(Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., 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 and subject.)

(Private information includes information such as medical records, blood, urine, or tissue samples, diagnostic specimens, and DNA samples, even if you did not collect these materials.)

Legal requirements to protect human subjects apply to a broader range of research than many investigators realize. Protections are required for research that uses:

  • Bodily materials, such as cells, blood or urine, tissues, organs, hair or nail clippings, even if you did not collect these materials.
  • Residual diagnostic specimens, including specimens obtained for routine patient care that would have been discarded if not used for research.
  • Private information, such as medical information that can be readily identified with individuals, even if the information was not specifically collected for the study in question. Research on cell lines or DNA samples that can be associated with individuals fall into this category.

These policies apply to research conducted by faculty, staff or students of Northeastern University, whether conducted on-campus or off-campus.  Research that uses any NU property or non-public information to identify or contact prospective subjects must be reviewed and approved prior to recruiting participants or collecting data.  Approval by NU is required in addition to approval from any other institution.