The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1996 - 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. |
Other editions - View all
Common terms and phrases
action activities administrative agen agency head amended amount ance appeal applicable appropriate approved assistance audit authority Board cation certification cial claim cluding conduct contract covered transaction debarment debt debtor decision Department of Health department or agency determined disclosure documents employee employee's entity eral Federal agency fees fetus FOIA funds Government grant Health and Human hearing HHS awarding agency hospital Human Services indirect costs individual informed consent institution Institutional Review Boards interest involving means ment notice notify Office offset organization paragraph participant partment party payment person ployee procedures prohibited proposed purposes pursuant quired real property recipient regulations request research agreement responsible retary Secretary Single Audit sion Social Security Act specific statement statute submit Subpart system of records termination tion United States Code unless waiver
Popular passages
Page 119 - General requirements for informed consent. Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate...
Page 118 - 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 treatment purposes. (2) Risks to subjects are reasonable...
Page 120 - An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the IRB finds and documents that: (1) The research or demonstration project is to be conducted by or subject to the approval of State or local government officials and is designed to study, evaluate, or otherwise examine: (i) Public benefit of service programs; (ii) procedures for obtaining benefits...
Page 117 - Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. (a) The Secretary, HHS, has established, and published as a Notice in the FEDERAL REGISTER, a list of categories of research that may be reviewed by the IRB through an expedited review procedure.
Page 112 - ... (1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public...
Page 119 - IRB members in the same detail as described is §46.103(b)(3). (6) Written procedures for the IRB in the same detail as described in §46.103(b)(4) and §46.103(b)(5). (7) Statements of significant new findings provided to subjects, as required by §46.116(b)(5). (b) The records required by this policy shall be retained for at least 3 years, and records relating to research which is conducted shall be retained for at least 3 years after completion of the research. All records shall be accessible...
Page 49 - Affairs) as follows: (a) If he finds that there is adequate assurance that the invention will either be effectively dedicated to the public, or that any patent which may be obtained thereunder will be generally available for royalty-free and nonexclusive licensing, the effectuation of these results may be left to the grantee. (b) If he finds that the invention will thereby be more adequately and quickly developed for widest use and that there are satisfactory safeguards against unreasonable royalties...
Page 39 - ... (6) to the National Archives of the United States as a record which has sufficient historical or other value to warrant its continued preservation by the United States Government, or for evaluation by the Administrator of General Services or his...
Page 125 - The purpose of the activity is to meet the health needs of the particular fetus and the fetus will be placed at risk only to the minimum extent necessary to meet such needs, or (2) the risk to the fetus imposed by the research is minimal and the purpose of the activity is the development of important biomedical knowledge which cannot be obtained by other means. (b) An activity permitted under paragraph (a) of this section may be conducted only if the mother and father are legally competent and have...
Page 28 - Under this exemption, we may withhold routine internal agency practices and procedures. For example, we may withhold guard schedules and rules governing parking facilities or lunch periods. Also under this exemption, we may withhold internal records whose release would help some persons circumvent the law or agency regulations. For example, we ordinarily do not disclose manuals that instruct our investigators or auditors how to investigate possible violations of law, to the extent that this release...