Center for the Study of Ethics in the Professions at IIT

Most granting agencies, be they private foundations or the federal government, require written assurance from the investigator or institution, that for any study involving the use of human subjects, the investigator will abide with the ethical guidelines of his profession.

The policy as stated in this report is intended to serve as ethical guidelines for the dental investigator in order to protect the rights and welfare of human subjects involved in clinical research studies. The policy also applies to institutional and academic training programs including the use of residents, interns, and pre and postdoctoral students. Study clubs are especially encouraged to review paragraph 6 of part 1, Basic Principles.

The ethical guidelines shall be implemented by the appointment of appropriate committees by either the institution or the individuals concerned to review research proposals involving human subjects and approve or disapprove them; such committees will include at least one person from the laity, preferably a lawyer or clergyman, who will add additional objectivity to the opinion of the scientific or professional members

I. Basic principles involving human subjects

1. Research involving human subjects must conform to the moral and scientific principles that justify such research and should be based on the findings obtained from laboratory or animal experiments or other scientifically established facts.

2. Research involving human subjects should be conducted only by scientifically qualified persons or under the professional supervision of the dentist or an associated clinical investigator.

3. Research involving human subjects should not be carried out unless the importance of the

objective is in proportion to the inherent risk to the subject.

4. Every research project involving human subjects should be preceded by careful assessment of the inherent risks in comparison to foreseeable benefits to the subject or to society as a whole

5. Special caution should be exercised by the dentist (clinical investigator) in performing research on human subjects in which the health or personality of the subject may be altered or disturbed by either drugs or experimental procedures.

6. Consent: The informed consent of subjects will be obtained by methods that are adequate and appropriate. Informed consent is the agreement obtained from a subject, or from his authorized representative, to the subject's participation in an activity.

The basic elements of informed consent are:

-1. A fair explanation of the procedures to be followed, including an identification of those which are experimental;

-2. A description of the attendant discomforts and risks;

-3. A description of the benefits to be expected;

-4. A disclosure of appropriate alternative procedures that would be advantageous for the subject;

-5. An offer to answer any inquiries concerning the procedures;

-6. An instruction that the subject is free to withdraw his consent and to discontinue participation in the project or activity at any time.

In addition, the agreement, written or oral, entered into by the subject, should include no exculpatory language, through which the subject is made to waive or to appear to waive, any of his legal rights, or to release the institution, group, or individual or its agents from liability for negligence. Use of exculpatory clauses in consent documents is considered contrary to public policy. Tunki vs. Regents of University of California, 60 Cal 2d 92, 32 Cal Rptr 33, 383 P 2d 441 (1969) Annot 6A LR 3d 696 (1966). (This paragraph was excerpted from the Institutional Guide to DHEW Policy on Protection of Human Subjects.)

II. Clinical research combined with professional care

1. In the treatment of any dental disease related condition the dentist (clinical investigator) must be free to use a new therapeutic measure if in his judgment it offers hope of establishing health and the relief of pain suffering.

If at all possible, consistent with patient psychology, the dentist (clinical investigator should obtain the patient's freely given formed consent after the patient has been given a full explanation of his role in the research. case of legal or physical incapacity, consent should be procured from the legal guardian

2. The dentist (clinical investigators) can combine clinical research with professional care, the objective being the acquisition of new knowledge, only to the extent that clinical research is justified by its therapeutic value the patient

III. Non-therapeutic research involving human subject

1. In the purely scientific application of search carried out on human subjects, it is duty of the dentist (clinical investigator) to protect the life, health, and welfare of the subjects.

2. The nature, the purpose, and the risk of the research must be explained to the subject (or the subject's parents or guardian) by the dentist (clinical investigator).

3. Research on a human subject must not undertaken without his free consent after he has been informed, or that of a legal guardian The subject should be assured that his privacy will be respected and that maximum confidentiality of information will be maintained.

4. The subject of research should be in such a mental, physical, and legal state as to be able exercise fully his power of choice.

5. Consent should, as a rule, be obtained in writing. However, the responsibility of research always remains with the dentist (clinical investigator); it never falls on the subject even after consent is obtained.

6. The dentist (clinical investigator) must respect the right of each individual to safeguard his personal integrity, especially if the subject is in a dependent relationship to the dentist (clinical investigator).

7. At any time during the course of research the subject or his guardian should be free to withdraw permission for research to be continued.

8. The dentist (clinical investigator) or the dental team should discontinue the research if in his or their judgment, it may, if continued, be harmful to the individual.

Comments

The policy stated in this report provides the basic guidelines, but its application to individual situations may be difficult. When there is doubt in the investigator's opinion as to whether a therapeutic procedure is still in the experimental stage, the patient must be informed and permission should be obtained prior to use. The dentist must conscientiously self-evaluate his own competency before employing newly developed techniques that carry inherent risks. The use of procedures that are basically hazardous and of questionable benefit to the patient is rarely justified in dental research.

When dealing with large groups in surveys, a simple and clearly written consent form, which will be presented to the subject or the parent, should be part of the proposal that has been approved by the review committee.

These ethical guidelines, formulated initially to protect the rights and welfare of human subjects involved in clinical research studies, serve indirectly to protect the dental investigator form unforeseen or unpredicted litigation should the situation so arise.

It is anticipated that certain conditions may exist that may or may not be included or are, in themselves, pertinent to these ethical guidelines. The Council on Dental Research welcomes any comments from the profession.