SONOMA STATE UNIVERSITY—INSTITUTIONAL REVIEW BOARD FOR THE RIGHTS OF HUMAN SUBJECTS

Research Activities Eligible for Exemption or Expedited Review

 

Note to Investigators:  Federal regulations governing the protection of human research subjects contain exemptions for broad categories of research which involve little or no risk to subjects (see A below), and provide expedited review of research activities involving no more than minimal risk and in which the only involvement of human subjects will be one or more of ten specified categories (see B on reverse side).  Sonoma State Universityís Institutional Review Board (IRB) follows the procedures set forth in these regulations.

Please review the research activities described in this appendix.  If your project fits one of the categories, indicate your claim for exemption from review or claim for expedited review in the first box on page two of the application form (e.g., Exemption A-3; Expedited Review B-9).   If your project does not appear to fit any of the categories, indicate N/A in that box.  In such cases, the IRBís decision regarding approval of your application will be stated in the ďCommentsĒ section at the bottom of page two.  A copy of the form, duly signed and dated, is your approval to proceed with the proposed research.

 

 
A.     Exemption Categories [45 CFR 46.101(b)]

 

Research activities in which the only involvement of human subjects will be in one or more of the following categories:

 

1.        Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

2.        Research involving survey or interview procedures, except where all of the following conditions exist: (i) responses are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects; (ii) the subjectís responses, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subjectís financial standing or employability; and (iii) the research deals with sensitive aspects of the subjectís own behavior, such as illegal conduct, drug use, sexual behavior, or the use of alcohol.  All research involving survey or interview procedures is exempt, without exception, when respondents are elected or appointed officials or candidates for public office.

3.        Research involving the observation (including observation by participants) of public behavior, except where all of the following conditions exist: (i) observations are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects; (ii) the observations recorded about the individual, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subjectís financial standing or employability; and (iii) the research deals with sensitive aspects of the subjectís own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol.

4.        Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), if information taken from these sources is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

5.        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.

 

 

 

 
B.  Research Activities Which May Be Reviewed Through Expedited Review Procedures

 

Research activities involving no more than 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 by the IRB through the expedited review procedure authorized in 46.110 or 45 CRF, Part 46.

 

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 excretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of 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 subjectís privacy.  It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroetinography.  It does not include exposure to electromagnetic radiation outside the visible range (for example, x-rays, microwaves).

4.        Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often than 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 sub-gingival 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 subjectís behavior and the research will not involve stress to subjects.

10.    Research on drugs or devices for which an investigational new drug exemption or an investigation device exemption is not required.