Informed Consent
Requirements
CITI
Student Investigator



Research News @ Tufts


What Must be Reviewed?

Research plans that propose the use of living human subjects, tissues or materials from living humans, or data on humans must be reviewed and approved or granted an exemption by the IRB before the research begins. This includes all research at Tufts University regardless of funding source, whether conducted by members of the faculty, students, fellows, administrators or others, across all departments and campuses.

The following questions might be helpful in determining whether or not IRB review is required:

1. Is it research?

Research is defined as a systematic investigation designed to develop or contribute to general knowledge. It can include research development, testing, evaluation and pilot studies. An intent to publish the results of the study is often an indication that it could be considered research. An exercise designed to demonstrate to students how research is done with no expectation of results that would be published or otherwise contribute to general knowledge may not be considered research. If it is not research, the IRB does not need to review it.* However, this is sometimes a difficult distinction to make and it is advisable to request an exemption from the IRB if there is any chance that what you propose to do could be considered or could evolve into research.

2. Are there human subjects involved?

The Code of Federal Regulations defines a human subject as a living individual about whom an investigator conducting research obtains

  • data through intervention or interaction with the individual (including from interviews and surveys) or
  • identifiable private information.

This does not always require that the researcher interact with a person. Such things as obtaining identified or identifiable secondary data or blood or tissue samples or even playing a small part in someone else's research where there are human subjects and where you would be listed as a co-author would constitute human subject research.

The Code of Federal Regulations provides the following clarification of terminology:

Intervention includes both physical procedures by which data are gathered (for example, drawing blood) 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.

*Although certain categories of activities involving human beings do not fall under the purview of the IRB, it is important to keep in mind that it is always necessary to respect the rights and safety of all participants in an activity. The concept of informed consent can be applied in non-research settings where it is important to assure that participation is voluntary and consent is documented. Privacy rules apply to research and to other activities. Care should be taken to respect confidentiality and privacy rights of all individuals.

Tufts University, Office of the Vice Provost for Research
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