View in EDS

The DHEW Requirements for the Protection of Human Subjects: Analysis and Impact at the University of California, Berkeley. One of a Series of Analysis and Impact Reports of Major Federal Requirements Areas.

Saved in:
Bibliographic Details
Title: The DHEW Requirements for the Protection of Human Subjects: Analysis and Impact at the University of California, Berkeley. One of a Series of Analysis and Impact Reports of Major Federal Requirements Areas.
Authors: Millstein, Eugene J., California Univ., Berkeley.
Availability: Research Management Improvement Project, 423 University Hall, University of California, Berkeley, California 94720 (Grant NM-39538, $2.00)
Peer Reviewed: N
Page Count: 45
Publication Date: 1974
Sponsoring Agency: National Science Foundation, Washington, DC.
Document Type: Reports - Research
Descriptors: Administration, Behavioral Science Research, Conflict, Contracts, Costs, Evaluation Criteria, Federal Government, Grants, Higher Education, Recordkeeping, Research, Research Criteria, Research Methodology, Research Problems, Research Proposals, Safety
Abstract: This project identifies institutional research management problems imposed by certain requirements of the sponsoring Federal agencies; assesses the impact on the institution when meeting the requirements; and, where appropriate, recommends standardization or modification of the requirements or their implementation. One fundamental DHEW requirement is that no grant or contract involving human subjects will be made unless the research design has been reviewed and approved by an institutional review committee composed of research professionals. Chapters 1 and 2 of this report provide the background on this requirement and describe the Berkeley campus policy and process for implementation of this requirement. Appendix A describes the seven impact elements used. These elements are: (1) benefits, (2) costs, (3) delays, (4) introduction of conflict, (5) nonstandard requirements, (6) recordkeeping, (7) time and effort. Appendix B gives a description of each major requirement area considered for study and the nine areas chosen for individual research projects. The studies include: (1) cash flow, (2) cost recovery, (3) federal management, (4) health and safety, (5) human subjects, (6) procurement, (7) property management, (8) proposal preparation, (9) negotiation and award, (10) time and effort reporting. (Author/KE)
Journal Code: RIESEP1975
Entry Date: 1975
Accession Number: ED105783
Database: ERIC
Description
Abstract:This project identifies institutional research management problems imposed by certain requirements of the sponsoring Federal agencies; assesses the impact on the institution when meeting the requirements; and, where appropriate, recommends standardization or modification of the requirements or their implementation. One fundamental DHEW requirement is that no grant or contract involving human subjects will be made unless the research design has been reviewed and approved by an institutional review committee composed of research professionals. Chapters 1 and 2 of this report provide the background on this requirement and describe the Berkeley campus policy and process for implementation of this requirement. Appendix A describes the seven impact elements used. These elements are: (1) benefits, (2) costs, (3) delays, (4) introduction of conflict, (5) nonstandard requirements, (6) recordkeeping, (7) time and effort. Appendix B gives a description of each major requirement area considered for study and the nine areas chosen for individual research projects. The studies include: (1) cash flow, (2) cost recovery, (3) federal management, (4) health and safety, (5) human subjects, (6) procurement, (7) property management, (8) proposal preparation, (9) negotiation and award, (10) time and effort reporting. (Author/KE)