Institutional Review Board

Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalized knowledge [45 CFR 46.102]. Under federal regulations, research involving human subjects is classified into three distinct categories or levels - exempt, expedited, and all other. Exempt and expedited projects are considered no risk to minimal risk to human subjects. All other research is considered a potential risk to human subjects or considered to place human subjects at risk. Any research involving children under 14 years of age must have full board review.

Human subjects/participants are defined as living individuals about whom an investigator 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 (e.g., collection of human tissue, blood samples, pathology, or diagnostic specimens) and manipulations of the subject or the subject's environment that are performed for research purposes. Much more common are interactions, which include communication or interpersonal contact between the investigator and the subject. Private information includes data about behavior that occurs in a context in which the individual will have provided the information for specific purposes and can reasonably expect that the information associated with his or her identify will not be made public [45 CFR 46.102].

Minimal risk in research is defined as harm or discomfort of no greater probability and magnitude than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination of tests [45 CFR 46.102].

Federal regulations mandate that very narrowly defined types of research are exempt.
Research activities in which the only involvement of human subjects will be one or more of the following categories and that do not involve vulnerable populations are exempt from 45 CFR 46.

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
    a. Research on regular and special educational instructional strategies.
    b. Research on the effectiveness of/or the comparison among instructional techniques, curricular, or classroom
management methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
    a. Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects.
    b. 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.
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraphs 2.b) of this section, if:
    a. The human participants are elected or appointed public officials or candidates for public office.
    b. Federal statute (s) require (s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
5. Research and demonstration projects which are conducted by/or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:
    a. Public benefit or service programs.
    b. Procedures for obtaining benefits or services under those programs.
    c. Possible changes in or alternatives to those programs or procedures.
    d. Possible changes in methods or levels of payment for benefits or services under those programs.
6. Taste and food quality evaluation and consumer acceptance studies,
    a. If wholesome foods without additives are consumed.
    b. If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Federal Regulation identifies ten restricted types of research that may be reviewed by the IRB using an expedited procedure. Research activities involving minimal risk and in which the only involvement of human subjects will be in one or more of the following categories (carried out through standard methods) may be reviewed through the expedited review procedure authorized in 45 CFR 46.110.

1. Collection of: hair and nail clippings, in a non-disfiguring manner; deciduous teeth; and permanent teeth if patient care
indicated a need for extraction.
2. Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.
3. Recording of data from subjects 18 years of age or older using noninvasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject's privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example, x-ray, microwaves).
4. Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often that two times per week, from subjects 18 years of age or older and who are in good health and not pregnant.
5. Collection of both supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques.
6. Voice recordings made for research purposes such as investigations of speech defects.
7. Moderate exercise by healthy volunteers.
8. The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
9. Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the research will not involve stress to subjects.
10. Research on drugs or devises for which an investigational new drug exemption is not required.

All other research must be reviewed in full by the IRB.

From the American Psychologist, June 1981, 637-638.

"The decision to undertake research rests upon a considered judgment by the individual researcher about how to contribute to knowledge and human welfare. Having made the decision to conduct research, the investigator considers alternative directions in which research energies and resources might be invested. On the basis of this consideration, the researcher carries out the investigation with respect and concern for the dignity and welfare of the people who participate and with cognizance of federal and state regulations and professional standards governing the conduct of research with human participants."

A. In planning a study, the investigator has the responsibility to make a careful evaluation of its ethical acceptability. To the extent that the weighing of scientific and human values suggests a compromise of any principle, the investigator incurs a correspondingly serious obligation to seek ethical advice and to observe stringent safeguards to protect the rights of human participants.
B. Considering whether a participant in a planned study will be a "subject at risk," according to recognized standards, is of primary ethical concern to the investigator.
C. The investigator always retains the responsibility for ensuring ethical practice in research. The investigator is also responsible for the ethical treatment of research participants by collaborators, assistants, students, and employees, all of whom, however, incur similar obligations.
D. Except in minimal-risk research, the investigator establishes a clear and fair agreement with research participants, prior to their participation, that clarifies the obligations and responsibilities of each. The investigator has the obligation to honor all promises and commitments included in that agreement. The investigator informs the participants of all aspects of the research that might reasonably be expected to influence willingness to participate and explains all other aspects of the research about which the participants inquire. Failure to make full disclosure prior to obtaining informed consent requires additional safeguards to protect the welfare and dignity of the research participants. Research with children or with participants who have impairments that would limit understanding and/or communications requires special safeguarding procedures.
E. Methodological requirements of a study may make the use of concealment or deception necessary. Before conducting such a study, the investigator has a special responsibility to
1. determine whether the use of such techniques is justified by the study's prospective scientific, educational, or applied
value;
2. determine whether alternative procedures are available that do not use concealment or deception;
3. ensure that the participants are provided with sufficient explanation as soon as possible.
F. The investigator respects the individual's freedom to decline to participate in or to withdraw from the research at any time. The obligations to protect this freedom require careful thought and consideration when the investigator is in a position of authority or influence over the participant. Such positions of authority include, but are not limited to, situations in which research participation is required as part of employment or in which the participant is a student, client, or employee of the investigator.
G. The investigator protects the participant from physical and mental discomfort, harm, and danger that arise from research procedures. If risks of such consequences exist, the investigator informs the participant of that fact. Research procedures likely to cause serious or lasting harm to a participant are not used unless the failure to use these procedures might expose the participant to risk of greater harm, or unless the research has great potential benefit and fully informed and voluntary consent is obtained from each participant. The participant should be informed of procedures for contacting the investigator within a reasonable time period following participation should stress, potential harm, or related questions arise.
H. After the data are collected, the investigator provides the participant with information about the nature of the study and attempts to remove any misconceptions that may have arisen. Where scientific and human values justify delaying or withholding this information, the investigator incurs a special responsibility to monitor the research and to ensure that there are no damaging consequences for the participant.
I. Where research procedures result in undesirable consequences for the individual participant, the investigator has the responsibility to detect and remove or correct these consequences, including long-term effects.
J. Information obtained about a research participant during the course of an investigation is confidential unless otherwise agreed upon in advance. When the possibility exists that others may obtain access to such information, this possibility, together with the plans for protecting confidentiality, is explained to the participant as part of this procedure for obtaining informed consent.