Time for Decision Making
"What is the length of time that potential participants will have to make a decision about their participation in the study?"
In order to make an informed decision concerning study participation, potential participants should be given ample
time to review the consent form, to ask questions, and to discuss their decision with others as desired.
Many institutional review boards provide guidance to investigators on this issue, including recommendations that
potential participants take the consent form home to discuss it with family members or primary care providers before
making an enrollment decision.
Investigators and IRBs should consider the following:
- Participants in gene transfer studies may desire or require very different amounts of time to decide whether to
participate in the study.
- Some potential participants may come to the consent process having already decided to participate - perhaps having
already traveled and made plans or financial commitments. This possibility should be acknowledged in the consent
process so that, when appropriate, the investigator can emphasize the significance of the information conveyed in the
consent form and process.
- Commitment to research participation is ongoing. It may be advisable to design a process for revisiting consent,
reporting regularly to participants on significant developments that may affect their decision to remain in the study.
Such a process may be used at intervals during participation and for long-term follow-up to reconfirm participation.
It may also be required whenever new information is learned that could affect a participant's willingness to continue
in the study, or that may have health implications for persons who have received the intervention.
SAMPLE LANGUAGE FOR CONSENT PROCESS
Process Sample 1
You may have already thought a lot about participating in this study. You may even have already made a decision about whether to be in the study. Even if this is true for you, it is important that we provide you with this information and talk about it before we start you in the study. Some information may be new or different. Some could even change your mind. It is always okay to change your mind about being in the study. And even if you don't change your mind, the information can help you understand the study better.