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Declassified record · U.S. Department of Energy

Transmittal Letter of the Commissioner's Charge to the Task Force on Human Subject Research

Dated
Apr 29, 1994
Document type
Correspondence
Length
3 pages
Open the original scanArchive record OSTI ID 16384456 · public domain

Document text

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

Page 1

The Tabk Force to ReviewACHl.000004.009b Human Subiect Research Degartment of Mental Retardation I am pleased to present the report of the Human Subject Task Force to YOU. This z-eTortcait,alns a set of- - the seri(ts of research activities which utilized xadi3activz material in D.M.R. facilities from the late I would like to acknowledge the work and dedication of i)ecb_r O'Meara who served as the Project Manager and Coe West who served as Project Coordinator for the task force. Ms. West, who functioned in her role on a full- (I. time basic, really deserves much of the credit for ctcrdinating, managing aad keeping the day-to-day activities of the task fcrcc an track. I would also like to ackncwledge ar,d thank the task force members who so graciously gave of their time and support to rnis worth.] ezdravor. Their contributions to the deliberations of the task force and to the development of the final report are enormous. I would also like to personally thank you for the support and confidence you showed in me by providing me with the opportunity to chair this task force. . f hope my costributions and t h e work of the task force have lived up to your expectaciccs. It: has bem my privilege and tionor tc serve the 3epartaent of Meztal Xetardation os this task force.

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Task Force on Human Subject Research The original charge, written on December 29, 1993, stated that the Task.Force on Human Subject Research was escablished to review and report on any and a l l research that utilized radioactive or other potentially harmful materials involving human subjects who resided in facilities operated by the Commonwealth of Massachusetts for persons with mental retardation, with a report due to the Commissioner by March 31, /Within the first 60 days of research and review of archival materials, the Task Force info-med the Commissioner that the i original charr;e was too broad to be accomplished within the time - frame. The Task Force requested that its reporting be limited to only research that utilized radioactive materials. To continue the archival review for "other potentially harmful materials" would not be feasible in this initial review. The Task Force felt strongly that the research studies utilizing radioactive naterials shotlld be a top priority. Furthermore, due to the establishment of federal laws pertaining to the protection of human subjec:s by way of institutional review boards (IRBs) ir, 1973, the boundary of the review was requested to end at this year. The beginning boundary was set at 1943 due to the finding of archival materials (noted in this report) that indicated the I r o n study which utilized radioactive tracers was :he first study dzne with researchers from outside A new charzs was issue2 or: Nsrck 22, 1294, to kclu5.et kes e new boundaries ar.5 to sef a new due Gate for the reporz to be submitte5 to the Coaaissioner by April 15, 1994.

Page 3

The Commonwealth of hbssachusetts Executive Office of Health & Human Senices Department of Mental Retardation 160 North Washington Street TASK FORCE TO REVIEW EmMAN SUBJECT =SEARCH There is hereby established a task force to review and report on any and all research projects which utilize radioactive materials involving human subjects within the facilities for the mentally retarded operated by the Commonwealth of Massachusetts between the years 1943 and 1973, said review is to commence immediately. The task force shall report to the Office of Commissioner on or ,before April 15, 1994 its findings with a written report in such form as the task force members deem appropriate. members of the task force to target the scope of this initial review to address the studies utilizing radioactive materials. Further investigation into any and all studies that utilized other potentially harmful materials, as well as the addition of potentially ha,mful behavioral studies, shall be done as a next' step of review by the Office of the Commissioner at a later date to be identified upon the acceptance of the initial report from this task force. The task force shall be comprised of such individuals with appropriate background, training, and interest as the Commissioner shall determine appropriate. There shall be a , chairperson of the task force who shall be the Deputy Commissioner, Frederick M. Misilo, Jr. The task force members shall se,?re at the,pleasure of the Commissioner. The task force shall meet on a regular basis and shall make its major progress report to the Connissioner in writing.