I don't know about you, but for a long time, informed consent was a term I never thought about incurring in my career as bioengineer. However, as I study more and more about synthetic biology, I realized it is almost the opposite. With the growth of crowdsourcing, comes the need and the rights for the public to know, which is the purpose of informed consent.
Informed consent is a process for getting permission before conducting a healthcare intervention, a survey, or sample extraction on a person. It should be included in all iGEM projects that collect response from the public for further use. Examples include human sample extraction, online survey or participation in a video game. The most common reasons for iGEM projects are online data sharing and human sample extraction, both of which were part of our project this year.
In general, a consent form should include purpose of the study, summary of protocol that can be easily understood by people who have never heard of synthetic biology before, benefits and risks, terms to withdraw, usage of the data, whether there is financial compensation and contact information. For human sample collection, it is important to include how the samples would be disposed afterwards. As for data sharing, it is essential to talk about how much personal information would be released, how much information would the researchers know and how the response is an*lyzed. When genetic information is published, the potential usage of the genetic information by parties unexpectedly should be included in the risks.
An easy way to get you started on consent form writing is to read the ones on similar projects. Our consent form for sharing the microbiome sequence of individuals took the one for the Human Microbiome Project, a project with the same idea, as template. Remember that a consent form is only valuable when participants understand the content.Therefore, the most important and challenging part of a consent form is the language, which needs to be concise, clear and easily understood. For iGEMers, who have been working on one specific project for two months, certain concepts that are foreign to the public become unbelievably intuitive, which leads to a lack of explanation of certain procedure and purpose in the consent form. Therefore, it is essential to review the consent form by different parties: the iGEMers, the directors, etc. More efficiently, you should give the consent form to one of your friends who have no interests in Biology and see if this person would be able to understand the study.
A consent form can be on paper or online. In our project, we have both formats, partially because we have an online survey followed by sample collection, partially because we wanted to make sure participants are aware of the importance of consent. For a long-term research or any commercial project, the consent form needs to be approved by an institutional review board (IRB). However, for our project, because of lack of time, we did a peer review session among iGEMers. We would highly encourage you to go through an IRB if possible.