Human Subject Research

Go to library resources in human subject research

Federal regulations require educational requirements of "key personnel" (all individuals responsible for the design and conduct of the study) i.e. principal investigators, co-investigators, researchers, research nurses, study coordinators, research staff, etc. The

CITI Human Subject Research Education must be completed by all key personnel.

 

The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
The seminal report

Guidance for Institutional Review Boards and Clinical Investigators
This document represents the FDA's current guidance on protection of human subjects of research

Human Subjects Protection 45 CFR Part 46
Code of Federal Regulations, Title 45, DHHS, Part 46--Protection of Human Subjects (Subpart A also called Common Rule)

The Nuremberg Code
The war crimes tribunal at Nuremberg laid down 10 standards to which physicians must conform when carrying out experiments on human subjects

Office for Human Research Protection
Information presented by the US Department of Health and Human Services.  Includes information on regulations, education, compliance and special populations

Office of Human Subjects Research
A National Institutes of Health informational website.  Includes guidelines, protocol review standards and more

World Medical Association Declaration of Helsinki
A statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data.

---

Library Resources

Selected book and audiovisual resources are listed.  For more titles in human subject research, please search the library online catalog.

Applebaum, Paul S.  Informed consent: legal theory and clinical practice.  2nd ed.  New York : Oxford University Press, 2001
W 32 A779I 2001

Bacchieri, Antonella.  Fundamentals of clinical research bridging medicine statistics and operations.  Milano : Springer. 2007.
W 20.5 F981B 2007

Federma, Daniel D.  Responsible research: a systems approach to protecting research participants.  Washington, DC : National Academies Press, 2003
W 20 R434I 2003

Houser, Janet.  Clinical research in practice a guide for the bedside scientist.  Sudbury, MA : Jones and Bartlett, 2006.

W 84 H842C 2006

Preserving public trust: accreditation and human research participation protection programs.  Washington, DC : National Academy Press, 2001.
W 20.5 P763I 2001

Sales, Bruce Dennis.  Ethics in research with human participants.  Washington, DC: American Psychological Association, 2000.
W 20.5 S192E 2000

Shamoo, Adil E.  Ethics of the use of human subjects in research practical guide.  New York : Garland Science, 2002
W 50 S573E 2002

Shamoo, Adil E.  Responsible conduct of research.  Oxford : Oxford University Press, 2003.
W 20.5 R434S 2003

Stone, Judy.  Conducting clinical research a practical guide for physicians nurses study coordinators and investigators.  Cumberland, MD : Mountainside MD Press, 2006.

W 20.5 S878C 2006