药物临床试验质量管理规范-NMPA2020
CFR (Code of Federal Regulations)
50.55 (e) In addition to the determinations required under other applicable sections of this subpart D, the IRB must determine, in accordance with and to the extent that consent is required under part 50, that the permission of each child’s parents or guardian is granted.(1) Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient for clinical investigations to be conducted under §50.51 or §50.52.(2) Where clinical investigations are covered by §50.53 or §50.54 and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. 50.51 Clinical investigations not involving greater than minimal risk. Any clinical investigation within the scope described in §§50.1 and 56.101 of this chapter in which no greater than minimal risk to children is presented may involve children as subjects only if the IRB finds that:(a) No greater than minimal risk to children is presented; and(b) Adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians as set forth in §50.55. 50.19 (k) Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. 50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects. Any clinical investigation within the scope described in §§50.1 and 56.101 of this chapter in which more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject’s well-being, may involve children as subjects only if the IRB finds that:(a) The risk is justified by the anticipated benefit to the subjects;(b) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and(c) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians as set forth in §50.55. 50.53 Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects’ disorder or condition. Any clinical investigation within the scope described in §§50.1 and 56.101 of this chapter in which more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is not likely to contribute to the well-being of the subject, may involve children as subjects only if the IRB finds that:(a) The risk represents a minor increase over minimal risk;(b) The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;(c) The intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or condition that is of vital importance for the understanding or amelioration of the subjects’ disorder or condition; and(d) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians as set forth in §50.55. 50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. If an IRB does not believe that a clinical investigation within the scope described in §§50.1 and 56.101 of this chapter and involving children as subjects meets the requirements of §50.51,§50.52, or §50.53, the clinical investigation may proceed only if:(a) The IRB finds that the clinical investigation presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; and(b) The Commissioner of Food and Drugs, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, determines either:(1) That the clinical investigation in fact satisfies the conditions of §50.51,§50.52, or §50.53, as applicable, or(2) That the following conditions are met:(i) The clinical investigation presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children;(ii) The clinical investigation will be conducted in accordance with sound ethical principles; and(iii) Adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians as set forth in §50.55.
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