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MAIN POINTS Potential participants should be informed: That they may decline to enroll That they may withdraw at any time About the implications of withdrawing That the investigator may terminate the participant's enrollment

NIH GUIDELINES: "The subjects should be informed that participation in the study is voluntary and that failure to participate in the study or withdrawal of consent will not result in any penalty or loss of benefits to which the subjects are otherwise entitled."

DISCUSSION
Deciding not to enroll: Investigators should inform potential participants that they may decline to participate in the study without risk of compromising present or future medical care and without suffering a penalty or loss of benefits to which they are otherwise entitled. Investigators may also emphasize that full participation is important for scientific reasons and that participants should enroll only if they are willing and able to complete the entire study.

Withdrawal: Participants have the right to withdraw from the study at any time, including during follow-up. The implications and consequences of withdrawal (from the intervention only or from the entire study) should be discussed as part of the consent process. Potential issues to consider include:

• Irreversible course of action: Whenever applicable, potential participants should be informed that, in the event that they withdraw after receiving the experimental intervention, the intervention cannot be undone. If early withdrawal could pose any special risks of harm to participants or others, they should be described.
• Request for follow-up: If follow-up is necessary or highly desirable for health and safety purposes, participants should be encouraged (but not required) to return for needed follow-up in the event that they withdraw from the study.
• Risks to close contacts: If early withdrawal could pose risks to third parties, for example, transmission of vector to close contacts if the participant withdraws during a period of viral shedding, participants should be strongly urged to comply with any necessary precautions to minimize the risks.
• Data and stored specimens: Potential participants should be informed about what will happen to data and specimens, if any, already collected from them should they withdraw from the study. Investigators should inform potential participants about their rights to withdraw data and specimens.

Investigators may emphasize that withdrawal may deprive the research of important data, and they may request (but not require) that participants who do not want to complete a full course of the experimental intervention or long-term follow-up nonetheless remain in the study and complete all study visits.

Study Discontinuation: Potential participants should be informed that the investigator or the study sponsor may terminate their participation in the study at any time without their consent if it is believed to be in their best interest, if they do not comply with study requirements, or if the study is discontinued. The investigator should explain the reason for terminating participants' involvement in the study and what arrangements will be made for continued care.

SAMPLE LANGUAGE

Sample 1

You do not have to be in this study. You can say no. If you join the study, you can leave it at any time. If you choose not to participate, there will be no penalties, and no bad effects on any benefits or medical care that you are entitled to get from this hospital or from your health care providers. If you leave the study, please tell the investigator or research coordinator. Then we will ask you to come back to the clinic for a final assessment and discussion of future treatment options.

Sample 2

Being in this study is completely voluntary. You may withdraw at any time without penalty, without loss of benefits to which you are entitled, and without affecting the medical care you get at our hospital. However, once you receive the gene transfer, there may be some effects that cannot be reversed.

Sample 3

The investigators may stop your participation at any time. This could be because you have had an unexpected reaction or because the whole study has been stopped.