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Investigator Handbook

This Handbook was developed by The University of Texas Health Science Center at Houston (UTHSC-H) Human Research Protection Program for investigators who conduct research involving human subjects. Its primary purpose is to inform, educate, and assist investigators as to policies/procedures required by Federal laws, State laws, and the Institution, and the ethical principles that guide such research.

While being a leader in groundbreaking biomedical research, UTHSC-H also strives to be an example for ethical, compassionate, and responsible treatment for the individual human subject who willingly offers themselves for advancement of science, and this Handbook supports that goal.

The Human Research Protection Program is led by the UTHSC-H Executive Vice President for Research in a collaborative effort with the faculty led Committees for the Protection of Human Subjects and Office of Research Support Services.

Full Table of Contents

Chapters:

  1. Introduction to Human Subjects Research
  2. Investigator Responsibilities
  3. The Role of the Committee for the Protection of Human Subjects (CPHS)
  4. CPHS Review
  5. Informed Consent
  6. Research Participants
  7. Investigational Drugs, Agents, Biologics and Devices
  8. Health Insurance Portability and Accountability Act (HIPAA)
  9. Unanticipated Problems, SAEs and Emergencies
  10. Other Considerations

Glossary

Office of Research Support Committees (713) 500-7942

Copyright © 2008 by The University of Texas Health Science Center at Houston
Site Policies | State of Texas | Site Publisher
Office of Research Support Committees | 6410 Fannin, Suite 1100, Houston, Texas 77030
phone 713.500.7943 | IRIS Support 713.500.7960 | fax 713.500.7951 | email orsc@uth.tmc.edu
last modified November 11, 2009

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