The Code of Federal Regulations of the United States of America

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U.S. Government Printing Office, 2004 - Administrative law
The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government.

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Page 106 - A description of any reasonably foreseeable risks or discomforts to the subject; (3) A description of any benefits to the subject or to others which may reasonably be expected from the research; (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; (6) For research involving more than minimal risk,...
Page 104 - IRB's use of the expedited review procedure. 11.111 Criteria for IRB approval of research. (a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied: (1) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or...
Page 93 - Testing or examination material used solely to determine individual qualifications for appointment or promotion in the Federal service the disclosure of which would compromise the objectivity or fairness of the testing or examination process; or (7) Evaluation material used to determine potential for promotion in the armed services, but only to the extent that the disclosure of such material would reveal the identity of a source who furnished information to the Government under an express promise...
Page 103 - IRB shall require documentation of informed consent or may waive documentation in accordance with 11.117. (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. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an...
Page 94 - ... of (A) information compiled for the purpose of identifying individual criminal offenders and alleged offenders and consisting only of identifying data and notations of arrests, the nature and disposition of criminal charges, sentencing, confinement, release, and parole and probation status; (B) information compiled for the purpose of a criminal...
Page 212 - farm operation" means any activity conducted solely or primarily for the production of one or more agricultural products or commodities, including timber, for sale or home use, and customarily producing such products or commodities in sufficient quantity to be capable of contributing materially to the operator's support. (9) The term "mortgage...
Page 104 - Review by institution. Research covered by this policy that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB.
Page 177 - State for the performance of a governmental duty, including a local public authority, a special district, an intrastate district, a council of governments, a sponsor group representative organization, and any other instrumentality of a local government. (k) Officer or employee of an agency includes the following individuals who are employed by an agency: (1) An individual who is appointed to a position in the Government under title 5, US Code, including a position under a temporary appointment; (2)...
Page 326 - Federal financial assistance or (ii) that have the purpose or effect of defeating or substantially Impairing the accomplishment of the objectives of the program or activity with respect to handicapped persons. (6) As used in this section, the aid, benefit, or service provided under a program or activity receiving Federal financial assistance includes any aid.
Page 510 - ... equivalent information to persons with a hearing loss or who are deaf. Such methods may Include, but are not limited to. visual paging systems using video monitors and computer technology. For persons with certain types of hearing loss such methods may Include, but are not limited to. an asslstlve listening system complying with 4.33.7.

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