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Declassified record · U.S. Department of Energy

Institutional Assurance of Compliance, Assurance of Compliance with Dhew Regulations on Protection of Human Subjects (Human Subjects II LBL & Ucsf 1974 - 1975) (Companion Docs 713702 - 713746)

Document type
Correspondence
Length
2 pages
Open the original scanArchive record OSTI ID 16110815 · public domain

Document text

Machine-read from the scan, so expect some errors. Lines that couldn’t be read are left out.

Page 1

LAWRENCE BERKELEY LABORATORY ASSURANCE OF COMPLIANCE W I T H DHEW REGuLRTfONS ON PRDTECTION OF HUMAN SUBJECTS The University of Californh, Lawrence Berkeley Laboratory will comply with the Department Of Health, Education, and Welfare regulations on Protection of Human Subjects (45 CPR 46), and the implementing guidelines of the DHZW approved general assurance of the University of California-Berkeley, This Institution will comply w i t h the decisions of the University of CsliforniaBerkeley's Institutional Review Board, to which Board this Institution vi11 suhmit all projects and activities involvfng human subjects for review m d whether subjects will be placed at r i s k and if risk is involved, whether: The riab to the srcbject are so outweighed by the sum of tha benufit to the subject and the importrmce of the knaoledge to be gained 08 to uamznt a decision to a t t m the subject to accept these risk; The rights and welfare o f m y such subjects tail1 be udequatety Legatly effective infonned consent will be obtained by de qu at8 rmd appropriute methods i n accordunce with the provicriun of tho f i e conduct of the activity wilt be reviwed at time29 intervab. The Board shall determine for each activity as planned and conducted This Institution will provide for Board reviews to be conducted objectively and in a manner to ensure the exercise of independent judgment of the members. Members will be excluded from review of projects or activities in which thty have an active role or conflict of interest. This Institution will encourage continuing constructive comunication between the Board and the activity director as a means of safeguarding the rights and welfare of the subjects. This Institution will have available the facilities and professional atttntion required for subjects who may suffer physical, psychological or other ~ n j u r y as a result of participation in an activity.

Page 2

This Institution acknowldges~thatit w i l l bear full responsibility for t h e proper performance of all work and 6 ~ I E t bincluding the use of human .subjects under any grant or contract covered by this assurance including continuing ampliance with pertinent concerned with informed consent. Dr Local l a w s , particularly those This Institution will maintain appropriate and informative records of the Board's review of applications and activities, of documentation of informed consent, and of other documentation that may pertain to selection, participation, and protection of subjects and to the review of circumstances that adversely affect the rights or welfare of individual subjects. This Institution will at least annually reassure itself through appropriate administrative overview that its practices and procedures designed for the protection of the rights and welfare of human subjects are being effectively applied and are consistent with the regulation and with the implementation of this assurance as accepted by the Department of Health, Education, and This general assurance of compliance applies to The University of California, Lawrence Berkeley Laboratoxy. Appended hereto are (a) the implementing guidelines of the University of California-Berkeley, modified as noted to apply to this Institution and (b) t h e list Df Cuttent members of the Institutional Review Board responsible far review of projects and activities involving human subjects for this Signature of Authorized Official