What Needs IRB Review

DEFINITION OF HUMAN SUBJECTS

An IRB (or a reviewer designated by one of the IRBs to conduct expedited reviews) must review all proposed research where the investigational procedures involve the use of information, specimens, data, etc, pertaining to living humans. This broad definition encompasses a wide variety of activities such as in vivo and in vitro studies, review of medical records, collection of data through surveys or observation, performance of blood tests, examination of existing pathological specimens, discarded tissue, or secretions, any use of investigational drugs or devices and randomized trials.

The federal regulations give the following definition:

45 CFR 46 section 46.102 (f). "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 associate with the information) in order for obtaining the information to constitute research involving human subjects.

There is occasional confusion about research that is "exempt". It has been mistakenly assumed that "exempt research" does not need review. However, "exempt" means that the research falls within one of the six narrowly defined categories specified by the regulations. Research believed to be exempt must be submitted to the IRB office to have an official determination made as to whether the research is exempt. The determination may not be made by the investigator.

DEFINITION OF RESEARCH

There is sometimes a question of whether a planned activity is "research" and therefore needs IRB review. The Code of Federal Regulations defines research as a systematic investigation, including research development, testing and evaluation, designed to develop or to contribute to generalizable knowledge. Other criteria that can be used to determine whether a planned activity is research include:

1. The collection of data with the intent to report them in scientific publications or presentations

2. Use of a standard procedure or medication if it is influenced by a consideration other than the direct welfare of the patient, even if both therapies seem equal to the physician in charge (e.g., a selection between different though widely accepted therapies according to a predetermined plan such as randomization)

3. Use of investigational drugs or devices

Innovative or newly-introduced therapies or procedures. Innovative or newly-introduced therapies or procedures do not require IRB review and approval except when they involve "research" activities (e.g., the systematic collection of data with the intent to evaluate the effectiveness of the therapy, use of an experimental drug or device, or use of any procedure such as randomization which is not done solely for the benefit of the patient). When such therapies or procedures involve research, a protocol for their use must be reviewed by the IRB and cannot be initiated without IRB approval.

If it is unclear whether an innovative or newly introduced therapy or medical procedure needs IRB approval, it should be presented to the dean of the respective school and to the IRB for consultation on this point.