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.

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)