The non-response of the alleged bioethics guarantors to an inquiry by a member of US Congress
by H. Peter Aleff
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List of attachments to the letter in the preceding pages, in their order:
3 June 97 memo at the OPRR from "marianne" to "Joe"
June 30, 1997 Letter from Dr. Cassells, OPRR, to Dr. Adams, Associate Dean for Research, University of Texas Southwestern Medical Center
July 21, 1997 Same letter from Dr. Cassells, OPRR, to Dr. Putnam, IBR Chairman, Children's Hospital of Buffalo
Aug. 11, 1997 Reply to Dr. Cassells from Dr. Reynolds, Children's Hospital of Buffalo, plus a two-page summary of the LIGHT-ROP study, dated June 97
Page 9 from "Multiple Project Assurance of Compliance with DHHS Regulations for Protection of Human Subjects", Buffalo, with the "Tuskeegee-Loophole"
Page 8 and 9 from "OPRR Reports - Protection of Human Subjects", Title 45 Code of Federal Regulations, Part 46, see page 8 for the 'Tuskeegee- Loophole" and page 9 for informed consent.
Page 8 from the "Cochrane Review" of light and ROP, co-ordinated by Dr. Dale Phelps, March 1997
"Standards of Practice and the Pain of Premature Infants" by Jill R. Lawson, from "Zero to Three", December 1988, pages 1 to 6
Aug. 13, 1997 OPRR record of phone call from Don Everett, National Eye Institute, to Dr. Cassells
Aug. 19, 1997 Reply to Dr. Cassels from Dr. Putnam, Children's Hospital of Buffalo
Letter dated August 21, 1997, from Helen Harrison on nursery lighting at the Children's Hospital in Oakland, California
Page from "Aesclepius - The Official Idea-Letter of the Center for Health Design" with a call for the replacement of fluorescent lamps in baby nurseries
Sept. 11, 1997 Reply to Dr. Cassells from Dr. Adams, Southwestern Medical Center at Dallas with atttachments:
study protocol approval letter of February 7, 1992, from Dr. Jarrett to Dr. Adams, and
consultant advice letter of February 3, 1992, from Dr. Herman to Dr. Jarrett -- see second page for "the normal control for the goggled infants would be totally patched infants receiving no light."
Dec. 8, 1997 Letter from Dr. Crandall, OPRR, to Dr. Putnam at Children's Hospital of Buffalo, asking for clarification of the apparent contradiction in the two different nursery lighting protocols from Buffalo.
Dec. 19, 1997 Reply to Dr. Crandall from Dr. Reynolds in which Dr. Reynolds denies having discouraged draping of the isolettes or lowering of the light levels
"Environmental/Developmental Care Protocol for the ICN" from the Children's Hospital of Buffalo, dated October 1995, with instructions to cover the isolettes and to keep the lights off during specified quiet times.
Page 19 from "Multiple Project Assurance ...", Buffalo, see item IV.D. on top for the researchers' duty to report protocol changes.
Page 7 from "Progress Report Summary" filed by Dr. van Heuven, San Antonio, on January 22, 1997, with the comment "No change in the protocol has been made".