Southeast Missouri State University

Bill 13-A-17 - Revising the "Research" Description of Faculty Professional Responsibilities by establishing a policy section regarding research involving Human Subject (Approved)

FACULTY SENATESOUTHEAST MISSOURI STATE UNIVERSITY
FACULTY SENATE BILL 13-A-17

Approved by the Faculty Senate
March 13, 2013

REVISING THE "RESEARCH" DESCRIPTION OF FACULTY PROFESSIONAL RESPONSIBILITIES BY ESTABLISHING A "POLICY" SECTION REGARDING RESEARCH INVOLVING HUMAN SUBJECTS

BE IT RESOLVED THAT: subject to the passage and approval of both this bill and its companion bill establishing a corresponding "procedures" section, Chapter 3, Section D7 of the Faculty Handbook be amended by making the following changes to the existing content, thereby establishing a "policy" section (with the companion "procedures" to follow it in the Handbook):

so that the resulting Section D 7 of Chapter 3 read as follows:

Policy for Research Involving Human Subjects

Southeast Missouri State University recognizes its role in society to further human knowledge, to advance the sum of such knowledge through teaching and research, and to protect the rights and welfare of human subjects involved in research. Similarly, the University acknowledges the rights of the faculty, staff and administrators to utilize appropriate educational methods and research techniques in their classes, in instructionally related activities and in Student Services programming and activities.

Human subjects are involved in many areas of research in which there is potential risk to the individual, such as experimental research utilizing drugs, vaccines, and radioactive materials. Less obvious are classroom or Student Services programming-related research activities in which risks to human subjects may be significant.

To facilitate compliance with this policy, review committees will be established at the academic college level, the student services division level, and the University level.

The University Committee on Research Involving Human Subjects is best qualified to ensure that human subjects will receive adequate protective measures, that faculty, staff and administrative privileges to pursue the advancement of knowledge are guaranteed, and that restrictive policies which might discourage research, innovative teaching and programming are eliminated. This committee is the official review body for the University and functions as the Institutional Review Board as set forth in federal legislation. Its function is to conduct initial and continuing review of those research proposals which use human subjects and to determine that such proposals are in accordance with existing federal regulations. The committee operates under and reports directly to the Office of the Provost.

Members of the committee shall possess varying backgrounds so that their review of research proposals will assure that the rights and welfare of human subjects are adequately safeguarded. The committee must be sufficiently qualified through the expertise and diversity of its membership to ensure respect for its advice and counsel. When necessary, the committee will solicit opinions from individuals having recognized expertise in a specific area. In addition to possessing the professional competence necessary to review specific activities, the committee must be able to ascertain the acceptability of applications and proposals in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice.

Decisions concerning human subjects in research are not made unilaterally by the committee. Through a deliberative process, it is the responsibility of the department chairperson, the College Review Committee (CRC), the college dean of the research investigator conducting the study, and the University Committee to ensure that the rights of human subjects are protected. For projects originating from Student Services personnel, the Student Services Review Committee (SSRC) will act as the CRC, and the Dean of Students will assume the review functions delegated to the college dean in this document.

Definitions of Terms

As used in this document, research is defined as a trial or special observation, usually made under conditions determined by the investigator, which aims to test a hypothesis or to discover some unknown principle, effect, or relationship. Activities which use experiments, tests, and observations designed to elicit non-public information are types of research. Research does not include the conducting of classroom experiments or demonstrations or programming used for an educational purpose. Routine course and program development, including evaluation of the effectiveness of such development and the assessment of established courses or programs, is not research as defined and does not require review. (See next section for details of requirements for or exemptions from review.)

Determining the degree of risk in research involves making a series of judgments because certain risks are inherent in life itself. For certain types of research projects (especially medical), the risk is quite obvious. Somewhat different are those research procedures in which the subjects perform strenuous physical exertion or undergo varying degrees of public embarrassment and humiliation. These experiences may constitute a psychological threat to the subject, thereby posing another type of risk.

In reviewing research proposals involving human subjects, the reviewing body will place the research activity into one of two categories:

Category 1 - those research activities in which the subjects involved have no more than the risks associated with their customary everyday activities or risks associated with the performance of routine physical or psychological examinations or tests by qualified individuals.

Category 2 - those research activities in which the risk to subjects is greater than that encountered when performing customary activities under ordinary conditions.

As used in this document, human subjects are part of the investigator-subject relationship in a research activity which has the discovery of new knowledge as its primary objective. Of course, there are several types of human subjects, including adults, minors, residents of institutions, etc. Donors of organs, tissues, etc., are also considered to be subjects.

As used in this document, the definition of human subjects excludes the normal professional-client relationship which has the welfare of the client as the sole objective. Examples of such relationships are those in which the client is receiving aid or services consistent with accepted and established practice (e.g., physician and patient).

Treatment of Human Subjects

It is incumbent upon the investigator to make sure that all human subjects are treated with respect and dignity, not just by the principal investigator, but by the research associates as well. The principal investigator should make it clear to the subjects that they are free to discontinue their participation in the research at any time without prejudice to the subject.

In those research projects that have potential risk to the subject, the investigator must make every effort to minimize the risks or discomfort related to the subject's participation. For example, if the research activity exposes the subject to considerable physical risk, the investigator must consider whether the subject's response should be monitored by a physician during the testing.

The investigator whose research plans place subjects at risk has the responsibility for justifying that risk. Such a justification will indicate that a thorough search of the literature has been made to ascertain that either the experiment has already been performed with animal subjects or good reasons exist for not utilizing animal subjects; that similar research has not already provided an adequate answer to the research question; and that the design of the study is adequate to yield worthwhile data on the topic under investigation.

The investigator is responsible for the research procedures during the investigation and must be sensitive to individual differences which may predispose certain individuals to experience harmful psychological or physical consequences by participating in the study. Realizing this, the researcher must exercise care to exclude such individuals from the research sample. Should unanticipated harmful effects develop during the research, the investigator shall take immediate steps to correct the situation. For those studies having the potential to produce undesirable effects which may be manifested later, the investigator's responsibility is to plan appropriate follow-up procedures.

The responsibilities of the investigator include scheduling a debriefing session with the subjects following the conclusion of the research. The methodological procedures associated with the study may have caused certain subjects to experience anxiety, embarrassment, and loss of self-esteem. The experimenter should determine whether the subjects have suffered such effects. If they have, the investigator must take positive steps to counteract the effects the study produced. Debriefing procedures to be used must also be described to reviewers. The reviewers must then decide whether the subject's rights and welfare are adequately protected.

The investigator should make every effort to see that the subjects are rewarded or recognized for their participation. Such benefits could be material (money or gifts), educational (added information or knowledge), some other self-enhancing gains (e.g., improved health and well-being), or the award of a certificate of participation. Any payment intended for the subjects should not be so large as to constitute an excessive inducement to participate. The investigator's description of the research submitted to the committee shall include plans to reward or recognize the subjects.

The content of this policy and the procedures that follow it incorporate material from the April 18, 1979 "Belmont Report" of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

Academic Affairs Revised April 1993
Reenacted with slight amendment by Faculty Senate Bill 13-A-17 approved by the Faculty Senate March 13, 2013 and by the Board of Regents XXXX

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Action Date
Introduced to Senate 2/13/13
SEcond Senate Meeting 2/27/13
Faculty Senate Vote 3/13/13
President's Review 4/5/13
Board of Regents Approval 4/10/13
Posted to Faculty Handbook

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