For Participants

The Institutional Review Board (IRB) is a group of people who review and approve human research. The IRB includes professors, doctors, scientists, and people from the local community. They review human research to protect your rights and your welfare before and during the research study.

A research study is an organized activity to learn more about a problem or answer questions. Scientists conduct many different kinds of studies. A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes is called a clinical trial. Clinical trials are conducted in phases. The trials at each phase have a different purpose and help researchers answer different questions.

There may or may not be a direct benefit to you if you take part in a research study.  No one can predict what will happen with a research study or how it might affect you. The research study may not help you personally. The research study may result in information that will help others in the future.

Sometimes research procedures and treatments may cause discomfort and bad side effects. The research staff will discuss with you known possible risks, so you can decide if you want to volunteer. If you do volunteer, the research staff will tell you about any new risks that they learn about during the research study for as long as you take part in the research study.

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 involve 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 or about your rights as a participant.
  • A statement that you are free not to participate and can stop participating at any time.

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.

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 student, your teacher or professor can not hold this against you when determining your grade. If you are receiving treatment, that treatment can not be withheld if you do not agree to participate.

  • To be treated with respect, including respect for your decision whether or not you wish to enroll in, continue in, or stop being in a study.
  • To choose to stop being in a study at any time.
  • To be given time to read the consent form and have the research study explained to you
  • To be given time to ask questions, and to be told whom you can contact if you have any more questions.
  • To be given a copy of the consent form after you have signed it.

Research participants may have a complaint about their research project or have questions about their rights as a research participant.

Examples of a Human Research Concern

  • Research participation compensation
  • Issues in the informed consent process
  • Communication difficulties reaching the research team
  • Concerns about confidentiality
  • Concerns that research may have been conducted without IRB approval

Concerns and complaints are taken very seriously and are treated with the utmost respect and all possible confidentiality. We strive to continually improve research procedures and the experience of research participants/subjects at Georgetown University.

If you have questions about your participation in a research study you should first contact the Principal Investigator (PI) or study team member listed at the phone number/email on your consent form, information sheet or contact sheet that you were given when you enrolled in the study to try to discuss/resolve the concern.

If you remain dissatisfied with the outcome, are unable to receive a response after an appropriate amount of time, or have a concern about your participation that you do not wish to discuss with the PI or study team member, you can contact the Institutional Review Board (IRB) at the number below.

If you contact the IRB, please try to have your consent form or study information available because you will be asked to provide information about the particular study.

If you have questions about your rights as a research subject, please contact the IRB at the number below.

Phone: (202) 687-1506

E-mail: irboard@georgetown.edu