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Rights of a Human Subject Participating in Research

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Human Research Subjects have the right to:


 

  • Be told what area, subject, or issue is being studied,
  • Be told what will happen to you and what the procedures are,
  • Be told about the potential risks or comforts, if any, or the research,
  • Be told if you can expect any benefit from participating and, if so, what the benefit might be,
  • Be allowed to ask any questions concerning the study, both before agreeing to be involved and during the course of the study,
  • Be told what medical treatment is available if any complications or injuries arise because of the research study,
  • Refuse to participate in the study or to stop participating after the study starts, without penalty,
  • Receive your signed and dated copy of the Consent Document, and
  • Be free of pressure when considering whether you wish to be in the study.

Personal Health Information is protected by:


 

  • The Health Insurance Portability & Accountability Act of 1996 (HIPAA). These regulations establish standards for protecting individually identifiable health information and for guaranteeing the rights of individuals to have more control over such information.
    • HIPAA Privacy law gives you the right to:
    • Look at or get a copy of the health information,
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    • Ask to correct information, including certain health information, if the information is wrong or incomplete,
    • Ask for a list of the times health information have been disclosed about you for reasons other than treatment, payment, health care operations, and certain other reasons as provided by law, except when you have authorized or asked that DSHS disclose the information,
    • Ask to limit the use or disclosure of health information about you more than the law requires,
    • Tell where and how to send you messages that include health information about you,
    • Ask for and get a paper copy of the privacy notice, and
    • Withdraw permission you have given to use or disclose health information that identifies you.
  • PHI may be used or disclosed for research if a research board approves the use. The board will ensure that your privacy is protected when your health information is used in research. Your health information may also be used:
    • To allow a researcher to prepare for research, as long as the researcher agrees to keep the information confidential, or
    • After you die, for research that involves information about people who have died.
  • See more information about HIPAA in the Additional Resources Page.
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Last updated September 08, 2010