Box 4.4What a Participant Might Want to Know

Potential Benefits and Harms

  • If I am ill, will this research help me?
  • What are the risks to me?

Protecting Participant Interests

  • What are the realistic alternatives to study participation?
  • What is involved? What will I have to do?
  • Who will be in charge of my care? Can I see my own doctor?
  • Are checks and balances in place to protect my safety?
  • How was the research reviewed and approved?
  • Will I be charged anything or be compensated for my participation?
  • How can I end my participation if I change my mind?
  • What will happen to me when the study is over? Will I be told the results?

Study Design and Leadership

  • Who designed the protocol?
  • Is the protocol well designed?
  • Is the investigator competent?
  • Why is this research important?
  • Who else is involved in this research?
  • Was anyone in the advocacy community involved in the design or review of the research?

Conflict of Interest, Study-related Controversy

  • Is the study controversial?
  • Has anyone conducted this study already, or one like it?
  • Who will benefit financially if this works? What's in it for the investigator?

Institutional Oversight

  • Whom do I contact to express concerns or obtain information?

NOTE: The information in this box was supplemented by elements described in the Department of Veterans Affairs' booklet, I'm a Veteran: Should I Participate in Research? (VA, 2002).

From: 4, The Participant-Investigator Interface

Cover of Responsible Research
Responsible Research: A Systems Approach to Protecting Research Participants.
Institute of Medicine (US) Committee on Assessing the System for Protecting Human Research Participants; Federman DD, Hanna KE, Rodriguez LL, editors.
Washington (DC): National Academies Press (US); 2002.
Copyright © 2003, National Academy of Sciences.

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