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Human Protection

Consenting to Participate in a Research Study

It's your choice to participate in a research study. You will be part of the study only if you (or your designee) give informed and written consent.

A consent form generally is long and detailed. The reason it is long and detailed is to ensure that you have all the information you need to make an informed decision.

The consent form contains the following information:

• An invitation to participate in a research project
• An explanation of the study’s purpose
• Duration of research subject’s participation
• Description of study procedures
• A statement about the company or agency funding the study
• Detailed information about good and bad effects of the study treatment
• Information about other treatment options, should you choose not to participate in the research trial
• Identification of who will have access to the study records and results
• Whom to contact for research information, research related injury and subject’s rights

The protocol (the details of how the study is conducted) and consent form must be approved by an Institutional Review Board (IRB). The IRB is a group of experts and non-medical people who review the protocol and informed consent to ensure the safety of study participants, that the consent form is complete and understandable to people unfamiliar with medical terminology, and that there is enough information provided in the consent form to allow you to make an informed choice and to be comfortable with your decision.

You are under no obligation to participate in a research trial.

Experimental Subject's Bill of Rights

Any person who is asked to consent to participate as a subject in a research study involving a medical experiment, or who is asked to consent on behalf of another, has the right to:

1. Be informed of the nature and purpose of the experiment.
2. Be given an explanation of procedures, tests, drugs and devices to be used in the medical experiment.
3. Be given a description of any reasonable discomforts and risks that may be expected from the experiment.
4. Be given a disclosure of appropriate alternative procedures, drugs or devices that might be advantageous to the subject, and the relative risks and benefits.
5. Be informed of the avenues of medical treatment, if any, available to the subject after the experiment if complications arise.
6. Be given an opportunity to ask any questions concerning the experiment or procedures involved.
7. Be instructed that consent to participate in the medical experiment may be withdrawn at any time, and that the subject may discontinue participation in the medical experiment without prejudice.
8. Be given a copy of a written consent form when one is required.
9. Be given the opportunity to decide to participate (consent) or not to consent to a medical experiment without any element of force, fraud, deceit, undue coercion or undue influence on the subject’s decision.