(d) Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.

§46.304
Composition of institutional review boards where prisoners are involved.

In addition to satisfying the requirements in §46.107 of this part, an institutional review board, carrying out responsibilities under this part with respect to research covered by this subpart, shall also meet the following specific requirements:


(a) A majority of the board (exclusive of prisoner members) shall have no association with the prison(s) involved, apart from their membership on the board.


(b) At least one member of the board shall be a prisoner, or a prisoner representative with appropriate background and experience to serve in that capacity, except that where a particular research project is reviewed by more than one board only one board need satisfy this requirement.

[43 FR 53655, Nov. 16, 1978, as amended at 46 FR 8366, Jan. 26, 1981]

§46.305
Additional duties of the institutional review boards where prisoners are involved.

(a) In addition to all other responsibilities prescribed for institutional review boards under this part, the board shall review research covered by this subpart and approve such research only if it finds that:

(1) The research under review represents one of the categories of research permissible under §46.306(a)(2);

(2) Any possible advantages accruing to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired;

(3) The risks involved in the research are commensurate with risks that would be accepted by nonprisoner volunteers;

(4) Procedures for the selection of subjects within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless the principal investigator provides to the board justification in writing for following some other procedures, control subjects must



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