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Pacific Northwest Laboratories DHSC 76-3 Human Subjects Committee MEASUREMENT OF REGIONAL MUSCLE MASS CHANGES IN ADULT HUMAN VOLUNTEERS BY MEASURING CHANGES IN During the Human Subjects Committee meeting on Friday, April 2, 1976, it was agreed that the subject proposal would be distributed for formal review and comments. The following are asked to serve on DHSC 76-3: As noted in the attached memo, Shippert to Parker, dated March 9, 1976, this proposal was discussed by phone with Mrs. Judy, Dr. Norwood and Carlos Newton, and provisional agreement was given to H. E. Palmer to begin the measurementprogram described. May we have your completed reviews by Monday, April 19,
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MEASUREMENTS OF REGIONAL MUSCLE MASS CHANGES I N THE NATURALLY OCCURRING 4 0 K ADULT HUMAN VOLUNTEERS BY MEASURING CHANGES I N 1. The rights of the subject are: b. Not adequately protected because: (1 ) Written or verbal informed consent inadequate. ( 3 ) Special assurance needed because of type personnel. ( 4 ) Insufficient information presented. Need to know - 2. The welfare o f the subject is: (1) The risks are greater than potential benefits. ( 2 ) The risks are greater than the importance of the knowledge t o g a i n . (3) Psychological repercussion likely due t o possible or real existence (4) Insufficient information presented. Need to know - of adverse o r degrading nature o f experiment, pub1 i c reactions , religious impact, etc. (5) Other reason is: 3. The possible risks associated w i t h this project are: (aggravation o f anxiety status, preservation of confidentiality of data, psychological reactions due to.. ., inexperience o r possible incompetence of researcher, etc.
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4. The benefits outweighing the risks are: 5. The informed consent data includes/does not include t o my satisfaction the following basic elements: a. Afair explanation o f the procedures t o be followed, including an identification o f those which are experimental. b. A description of the attendant discomforts and risks. c. A description of the benefits t o be expected. d. A disclosure o f appropriate alternative procedures that would be advantageous for the subject. e. An offer t o answer any inquiries concerning the procedures. f . An instruction that the subject is free t o withdraw his consent and t o discontinue participation in the project or- activity a t any time. 6. This. project-requires continuing review and I desire..progress reports a t I desire personal interviews before the Comnittee each 9. This program is approved/disapproved. Program is t o be resubmitted when the intended use of human subjects becomes
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Pacific Northwest Laboratories CHANGES I N ADULT HUMAN VOLUNTEERS BY MEASURING CHANGES I N THE NATURALLY dated March 2,1976, same subject. O n March 3, 1976,I explained the subject memo over the phone t o Anna Judy, Dr. Norwood and Carlos Newton of HSC 76-3, each of whom provisionally agreed to Palmer ' s starting work on the measuring program described inthe Each also expects t o be provided with a written description of the complete measuring program when that becomes known.