HUMAN SUBJECTS

ratified: Academic Council, March 7, 1994, Academic Dean, April 6, 1994, with note: "The faculty member who is sponsoring the student conducting the research will develop and keep the HUM-1 form on file, and the student will keep copies of consent forms."
last update: 11/99
archived versions:

(Procedures for Use of Human Subjects in Experiments)

RATIONALE:

To insure that all students, faculty and staff meet ethical principles in the conduct of research using human participants (APA, 1982) and the Federal Policy for the Protection of Human Subjects ("Code of Federal Regulations", 45 CFR 46).

DEFINITIONS (45 CFR 46):

• Research: a systematic investigation including research development, testing and evaluation designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

• Human subject: a living individual about whom an investigator (whether professional or students) 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'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.

• Minimal risk: means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

EXEMPT CATEGORIES (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, or b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom methods.

2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

(i) information obtained is recorded in such a manner that subjects can be identified, directly or through identifiers linked to the subjects;
(ii) 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 subject's 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 paragraph (2) of this section, if:

(i) The human subjects are elected or appointed public officials or candidates for public office; or
(ii) 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, 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:

(i) Public benefit or service programs;
(ii) procedures for obtaining benefits or services under those programs;
(iii) possible changes in or alternatives to those programs or procedures; or
(iv) 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,

(i) if wholesome foods without additives are consumed or
(ii) if a good 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.

EXPEDITED CATEGORIES (informed consent form required)

1. Collection of : hair and nail clippings, in a non-disfiguring manner; deciduous teeth; and permanent teeth if patient care indicates 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 non-invasive 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 radiography, diagnostic echography, and electroretinography.

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 of 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 devices for which an investigational new drug exemption or an investigational device is not required.

GENERAL PROCEDURES

• When the project director/principal investigator has determined that the research falls under one or more of the exempt categories, the project director does not need to file a HUM-1 form.

• When it appears that the project does not qualify for "exempt" status, the project director/principal investigator must file a HUM-1 Form, together with an "Informed Consent Form" to a committee or individual identified for the approval process.

• Student projects involving the use of human subjects must comply with these regulations, whether or not the projects are in partial fulfillment of degree requirements. The faculty advisor or staff supervisor must complete the HUM-1 Form.

• When a project requires collaboration with another institution, (i.e., hospital), the project director/principal investigator must obtain approval from both participating institutions.