The Research Review Committee (RRC) reviews research in accordance with current Department of Health and Human Services (DHHS) and Food and Drug Administration (FDA) regulations. The main purpose of the RRC is to protect the rights and welfare of human subjects who take part in research. More specifically, the RRC assures that:

§         Risks to subjects are minimized. For example, the RRC evaluates whether procedures to be performed on subjects are consistent with sound research design and do not unnecessarily expose subjects to risk.

§         Risks to subjects are reasonable in relation to any benefits that might be expected from taking part in a research study and to the importance of the knowledge that may result.

§         Selection of subjects is fair and equitable. For example, the RRC seeks to determine that no eligible individuals are denied the opportunity to take part in any study, particularly those from which they may benefit, based on an arbitrary criterion such as gender or because they do not speak English.

§         Participation is voluntary and informed consent is obtained from each prospective subject or where appropriate, from the subject's legally authorized representative.

§         The research plan provides for monitoring the data collected to ensure the safety of subjects.

§         There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

Definition of Human Subjects

The RRC must review all proposed research where the investigational procedures involve the use of anything human.   The federal regulations give the following definition:

21 CFR 56.102 (e). "Human subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control.  A subject may be either a healthy individual or a patient."

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.

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:

§         The collection of data with the intent to report them in scientific publications

§         Use of a standard procedure or medication if it is influenced by any 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)

§         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.