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Ethical Advisory Boards

In addition to the review by the institution's own IRB, any research governed by this section must also be reviewed by a national ethical advisory board:

(a)
One or more Ethical Advisory Boards shall be established by the Secretary. Members of these board(s) shall be so selected that the board(s) will be competent to deal with medical, legal, social, ethical, and related issues and may include, for example, research scientists, physicians, psychologists, sociologists, educators, lawyers, and ethicists, as well as representatives of the general public. No board member may be a regular, full-time employee of the Department of Health and Human Services.

(b)
At the request of the Secretary, the Ethical Advisory Board shall render advice consistent with the policies and requirements of this Part as to ethical issues, involving activities covered by this subpart, raised by individual applications or proposals. In addition, upon request by the Secretary, the Board shall render advice as to classes of applications or proposals and general policies, guidelines, and procedures.

(c)
A Board may establish, with the approval of the Secretary, classes of applications or proposals which:

(1)
Must be submitted to the Board, or

(2)
need not be submitted to the Board. Where the Board so establishes a class of applications or proposals which must be submitted, no application or proposal within the class may be funded by the Department or any component thereof until the application or proposal has been reviewed by the Board and the Board has rendered advice as to its acceptability from an ethical standpoint.

(d)
No application or proposal involving human in vitro fertilization may be funded by the Department or any component thereof until the application or proposal has been reviewed by the Ethical Advisory Board and the Board has rendered advice as to its acceptability from an ethical standpoint. (sec. 45 CFR 46.204) [At the time of this writing, none of the ethical advisory boards had been properly constituted; thus no research had yet been approved under this section.]

General Limitations


(a)
No activity to which this subpart is applicable may be undertaken unless:

(1)
Appropriate studies on animals and nonpregnant individuals have been completed;

(2)
Except where the purpose of the activity is to meet the health needs of the mother or the particular fetus, the risk to the fetus is minimal and, in all cases, is the least possible risk for achieving the objectives of the activity.

(3)
Individuals engaged in the activity will have no part in: (i) Any decisions as to the timing, method, and procedures used to terminate the pregnancy, and (ii) determining the viability of the fetus at the termination of the pregnancy; and No procedural changes which may cause greater than minimal risk to the fetus or the pregnant woman will be introduced into the procedure for terminating the pregnancy solely in the interest of the activity.

No inducements, monetary or otherwise, may be offered to terminate pregnancy for purposes of the activity. (sec. 45 CFR 46.206)


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