The Informed Consent Process
Informed consent is more than a form; it’s a process. What does it involve?
The Big Picture
- The informed consent process ensures that research participants can make voluntary and knowledgeable decisions about whether to take part in a research study.
- Informed consent must be accessible and understandable to the potential research participant. Accessibility and comprehension can be achieved in a variety of ways.
- Genomics research requires careful explanation about how the participant’s genomic information will be used during and after the study, as well as any implications that arise from the sequencing of their DNA.
What is the informed consent process for research?
In research, informed consent is a process — often more than a one-time endeavor. It is interactions between a research team and a potential research participant or their legal representative. During these interactions, members of the research team provide potential research participants with a description of the study, including benefits and risks of participation, that will help them make informed decisions about whether to begin or continue participating in a research project.
The three key features that must be met during this process are:
- providing key information.
- confirming the participant understands the information.
- ensuring any decision to participate is voluntary and not coerced.
One common component of informed consent is the “consent form,” which participants sign to indicate their willingness to take part. The consent form summarizes the research project and its benefits and risks, and it explains the individual's rights as a research participant. Usually, the researchers and the potential participant discuss the study and contents of the consent form, and researchers answer any questions the participants may have. These conversations can be an ongoing process depending on the nature of the research study, rather than a one-time informational session.
Institutional Review Boards (IRBs) can waive the requirement for a signed form in a few circumstances, for instance when there is minimal risk to participation such as responding to a survey.
What is an Institutional Review Board (IRB)?
IRBs are groups of five or more people with various backgrounds who are appropriately authorized to review and monitor research involving human participants. They ensure the rights and welfare of participants are respected.
What about special groups that are unable to provide informed consent?
The IRB may allow for a legally authorized representative to provide informed consent on behalf of an adult who lacks capacity to do so themselves. Similarly, parents or guardians must also provide permission for their child’s participation, and children must be informed about their participation in a developmentally appropriate manner and indicate their agreement to participate through a process known as “assent.”
How do researchers make the informed consent process accessible to research participants?
When developing an informed consent process and consent form, researchers should use appropriate language, videos or other educational materials that fall within cultural expectations of potential research participants. Authors of written materials should strive to use simple but accurate language that describes the concepts.
The amount of time each participant needs to understand and to consent to research participation varies, but researchers should ensure that participants are given adequate time and know that they do not have to make an immediate decision. This enhances the voluntariness of the consent process.
To ensure that participants have sufficient understanding of the study to provide their consent, researchers can ask participants to explain their understanding of the research project so the researchers can correct any misconceptions.
What else should researchers consider when obtaining informed consent for genomics research? In what ways can researchers obtain informed consent for large genomics projects?
Certain genomic concepts can be challenging to convey. With advances in genome sequencing technology, increased data sharing and concerns around genomic privacy, the genomics field recognizes the need for flexible approaches to communicate the informed consent process and the consent form with prospective research participants. Additionally, in 2018, regulators added the requirement for participants to be informed if their biospecimens will undergo whole-genome sequencing.
Genomics research often requires large numbers of diverse participants across large geographic areas. To overcome the challenge of reaching many people across long distances, researchers may carry out some or all of the informed consent process remotely by phone, videoconference or web-based methods.
Last updated: January 3, 2022