Human Subjects Information

Brandeis University requires all faculty and students engaged in research that involves human subjects to obtain the approval of the university's Institutional Review Board (IRB). You should read the Brandeis University Human Subjects Procedures and the federal regulations governing the Protection of Human Subjects.

Pay special attention to two sections:

  • Section 46.101 describes the kinds of research covered by the regulations, including: "survey procedures, interview procedures or observation of public behavior [in which]
    • (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
    • (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation."
  • Section 46.102(f) defines what constitutes a human subject: Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
    • (1) data through intervention or interaction with the individual, or
    • (2) identifiable private information. 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 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.

You should also consult the Institutional Review Board Guidebook. Pay particular attention to Chapter 5 (Biomedical and Behavioral Research: An Overview), which provides information about matters of confidentiality, privacy and risk (to human subjects). It is also relevant to the special circumstances of fieldwork, noting that IRBs "should keep in mind the possibility of granting of waiver of informed consent" to fieldworkers.

You also need to complete the NIH Human Subjects Tutorial; follow the instructions for participating in the online tutorial.

In addition, you should read the National Science Foundation's "Frequently Asked Questions" about human subjects.