91¶ÌÊÓƵ

No.  4-34

Rev.

Date 11-08-05

I. PURPOSE

To state the principles governing the use of human and animal research subjects.  This policy is in concert with the U.S. Department of Health and Human Services, Office for Human Research Protections, IRB Guidebook; and the U.S. Department of Agriculture, Animal Use and Care Committees, Special Reference Briefs, 92-16, Updates SRB 90-06.

91¶ÌÊÓƵ is committed to the proper treatment of human and animal research subjects.  The dignity and privacy of human subjects are to be respected.  Unnecessary pain to any creature is to be avoided.

Awareness and discussion of these issues are part of the professional development and responsibility of faculty and the education of students.

All empirical investigations involving human or animal subjects must meet federal and relevant professional standards, regardless of their funding, whether carried out by faculty or students.

The principal responsibility for determining that an empirical investigation falls within the purview of government or professional guidelines lies with the principal investigator.

Members of Departments carrying out investigations using humans or animals should acquaint themselves with the pertinent standards.  They are also responsible for acquainting any Student Investigators in their charge with the relevant principles of, and guidelines for, ethical research and for monitoring compliance. 

II.  REFERENCES

U. S. Department of Health and Human Services, Office for Human Research Protections, IRB Guidebook.

U. S. Department of Agriculture, Animal Use and Care Committees, Special Reference Briefs, 92-16, Updates SRB 90-06. 

III  DEFINITIONS

The Institutional Review Board (IRB) is a diverse board composed of at least five members, with varying backgrounds, experience, and expertise, with knowledge about the subjects to be reviewed.

Informed consent means consent obtained in a legally effective manner, without coercion to the subject. 

IV.  POLICY

A. Levels of Review

Different categories of investigation require different levels of review.  Department Chairs should be consulted first about whether or not any investigation meets the relevant standards.  Research investigations by faculty and/or students engaging in independent studies or funded research must be reviewed by the IRB review procedures.

B.  Requirement for Review

All research affiliated with 91¶ÌÊÓƵ, using 91¶ÌÊÓƵ facilities and/or personnel, and using human subjects, must complete a Protocol Review by the Institutional Research Board (IRB), coordinated by OSP.

All research affiliated with 91¶ÌÊÓƵ, using 91¶ÌÊÓƵ facilities and/or personnel, and using animal subjects, must complete a Protocol Review by the Animal Care and Use Committee (ACUC), coordinated by OSP.

C. Oversight for Human Research

1.  Three ethical principles and six points of procedures (Belmont Report, 1978) define the philosophy and practice of research on human subjects. The three ethical principles are:

a)  Respect for persons and their capabilities, including the idea that those with diminished autonomy, such as minors, are entitled to protection;

b)  Beneficence, or the dedication to the fact that the investigator will not harm the research participant physically or psychologically, will minimize risk of harm, and maximize possible benefits; and

c)  Justice, or the idea that all individuals should be treated equally and fairly in research investigations.

2.  The six points of procedure are:

a)  Risks to subjects are minimized;

b)  Risks to subjects are reasonable in relation to anticipated benefits (if any) to subjects, and the importance of knowledge that may reasonably be expected to result;

c)  Selection of subjects is equitable;

d)  Informed consent will be sought from each prospective subject or the subject's legally authorized representative and be appropriately documented;

e)  When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects; and

f)  When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

D.  Oversight for Animal Research

1.  Research should be undertaken with a clear scientific purpose and in compliance with applicable U.S. Department of Agriculture regulations and the Animal Welfare Act.  There should be a reasonable expectation that the research will (a) increase knowledge of the processes underlying the evolution, development, maintenance, alteration, control, or biological significance of behavior; (b)  determine the replicability and generality of prior research; (c) increase understanding of the species under study; or (d) provide results that benefit the health or welfare of humans or other animals.

2.  The scientific purpose of the research should be of sufficient potential significance to justify the use of animals.  Investigators should act on the assumption that procedures that would produce pain in humans will also do so in other animals.

3.  The species chosen for study should be best suited to answer the question(s) posed.  The principal investigator should always consider the possibility of using other species, non-animal alternatives, or procedures that minimize the number of animals in research, and should be familiar with the appropriate literature.

4.  Research on animals may not be conducted until the protocol has been reviewed by the Animal Care and Use Committee (ACUC) to ensure that the procedures are appropriate and humane.

5.  The investigator should monitor the research and the animals' welfare throughout the course of an investigation to ensure continued justification for the research.

E.  Student proposals for course-required research projects:

When a course requires students to conduct research on human and/or animal subjects, the research proposals must be reviewed by the course instructor prior to submission to the IRB or ACUC.