Designer Drugs: Hearing Before the Subcommittee on Crime of the Committee on the Judiciary, House of Representatives, Ninety-ninth Congress, First Session, on H.R. 2014, H.R. 2977, H.R. 3936, and S. 1437, May 1, 1986
U.S. Government Printing Office, 1986 - Designer drugs - 199 pages
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Page 120 - Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.
Page 122 - ... risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable; 2. anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent; 3.
Page 119 - Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members...
Page 119 - IRB shall require documentation of informed consent or may waive documentation in accordance with §46.117. (d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity.
Page 29 - I would be pleased to respond to any questions you or members of the committee may have.
Page 128 - Requirements for permission by parents or guardians and for assent by children. (a) In addition to the determinations required under other applicable sections of this subpart. the IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent.
Page 121 - ... reports submitted by investigators, and reports of injuries to subjects. (2) Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution. (3) Records of continuing review activities. (4) Copies of...
Page 128 - Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children...
Page 119 - Except when an expedited review procedure is used (see § 46. 1 10), review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.