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" 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,... "
Code of Federal Regulations Title 49: Transportation
2004 - 810 sivua
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Children As Research Subjects : Science, Ethics, and Law: Science, Ethics ...

Program in Medical Ethics Michael A. Grodin Director, Leonard H. Glantz Associate Director and Professor of Health Law both at the Boston University Schools of Medicine and Public Health - 1994 - 290 sivua
...require documentation of informed consent or may waive documentation in accordance with § 46.117. (d) An IRB shall notify investigators and the institution...party observe the consent process and the research. § 46.1 10 Expedited review procedures for certain kinds of research involving no more than minimal...
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Validation Compliance Annual: 1995

International Validation Forum - 1995 - 1114 sivua
...or in writing. (e) An IRB shall conduct continuing review of research covered by these regulations at intervals appropriate to the degree of risk, but...party observe the consent process and the research. §56.770 Expedited review procedures for certain kinds of research involving no more than minimal risk,...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1996 - 1146 sivua
...require documentation of informed consent or may waive documentation in accordance with §26.117.(d) An IRB shall notify investigators and the institution...research. (Approved by the Office of Management and Budget under control number 9999-0020) $26.110 Expedited review procedures for certain kind* of research...

The Code of Federal Regulations of the United States of America

1997 - 656 sivua
...activity, or of modifications required to secure IRB approval of the research activity. If the ERB decides to disapprove a research activity, it shall...the consent process and the research. (Approved by tbe Office of Management and Budget under control number 9999-0020) S 46.110 Expedited review procedures...

The Handbook of Psychopharmacology Trials: An Overview of Scientific ...

Marc Hertzman, Douglas E. Feltner - 1997 - 492 sivua
...or in writing. (e) An IRB shall conduct continuing review of research covered by these regulations at intervals appropriate to the degree of risk, but...party observe the consent process and the research. (Code of Federal Regulations 1994, 21:56.109) An IRB is generally capable of making a better informed...
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The Ethics of Biomedical Research: An International Perspective

Baruch A. Brody - 1998 - 412 sivua
...shall require documentation of informed consent or may waive documentation in accordance with §46.117. (d) An IRB shall notify investigators and the institution...party observe the consent process and the research. §46. / 70 Expedited Review Procedures For Certain Kinds of Research Involving No More Than Minimal...
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Source Book in Bioethics: A Documentary History

Albert R. Jonsen, Robert M. Veatch, LeRoy Walters - 1999 - 524 sivua
...or in writing. )e) An IRB shall conduct continuing review of research covered by these regulations at intervals appropriate to the degree of risk, but...party observe the consent process and the research. § 46.110— Expedited review procedures for certain kinds of research involving no more than minimal...
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Beyond Regulations: Ethics in Human Subjects Research

Nancy M. P. King, Gail Henderson, Jane Stein - 1999 - 300 sivua
...shall require documentation of informed consent or may waive documentation in accordance with § 117. (d) An IRB shall notify investigators and the institution...research. (Approved by the Office of Management and Budget under Control Number 9999-0020.) no Expedited Review Procedures for Certain Kinds of Research...
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The Code of Federal Regulations of the United States of America

1999 - 692 sivua
...investigator an opportunity to respond in person or In writing. (e) An IRB shall conduct continuingreview of research covered by this policy at intervals appropriate...research. (Approved by the Office of Management and Budget under control number 9999-0020) §46.110 Expedited review procedures for certain kinds of research...

Ownership of Human Tissues and Cells: New Developments in Biotechnology

Office of Technology Assessment United S, United States. Congress. Office of Technology Assessment - 2002 - 184 sivua
...or in writing. (e) An IRB shall conduct continuing review of research covered by these regulations at intervals appropriate to the degree of risk, but...party observe the consent process and the research. §46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk,...
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