For Prospective Human Subjects

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This section is meant to be a resource for individuals who are considering participating as human subjects in a research study.

If you are considering involvement in a research study, you should know that you have certain rights as a research participant. Whether or not you participate in a research study is entirely up to you.

Informed Consent

You are likely to be presented with an informed consent form indicating approval by the IRB. This document is intended to provide you with relevant information necessary to decide whether or not you want to participate. This form itself should be coupled with a discussion of the research.
Generally, informed consent will include a description of the following:

  • An explanation of the purpose of the research.
  • A description of what you will be asked to do and how long it will take should you participate and whether or not you will be compensated for your time.
  • A description of any risks involved in participating. These risks could be physical, psychological, social or criminal. The steps taken to minimize these risks should also be described.
  • A description of any benefits to you or to society as a whole.
  • The degree to which the information will be kept confidential.
  • Who to contact should you have questions about the research, about your rights as a participant, or in the event of a research related injury.
  • A statement that you are free not to participate and can stop participating at any time.
  • A disclosure of alternative procedures or treatments.

You should not sign the form agreeing to the research until all of your questions have been answered to your satisfaction. Signing this form does not waive any of your legal rights or alter your ability to stop participating at a later time. You should be given a copy of the form to take with you in case you have questions later.

Voluntary Participation

Any participation in a research study is completely voluntary. You are free to decline to participate for any reason. You may also stop participating at any time or refuse to answer any individual questions. Even after you sign the consent form, you can stop. Should you decide to decline or stop participating, this decision will in no way influence any services to which you are otherwise entitled. For example, if you are a DOE or DOE site employee, your supervisor can not hold this against you when determining your rating.

Reporting Concerns

If at anytime while participating in a study or after that you have any questions or concerns, you can contact either the researcher or the IRB, using the contact information on the consent form.  If you are not satisfied with the information provided by the researcher or the IRB, you can contact the DOE/NNSA Human Subjects Protection Program Managers, at DOE Headquarters.