At Evidation (formerly Achievement) Studies, our primary goal is to put individuals first.
One way we do this is by ensuring the safety, protection, and comfort of the individuals who participate in our studies.
To make sure we ALWAYS meet this goal, we follow a standard process for outlining important information related to the study and providing that information to potential participants to support knowledgeable, voluntary decision-making. We call that process Informed Consent.
We hope this information helps you better understand the informed consent process and how it fits into health research as a whole.
What is Informed Consent?
Informed consent is both a process and an action.
Researchers use the process of informed consent to give potential participants important information about a study. They do this so an individual understands the purpose of the research, potential risks, benefits, and alternatives available and has the voluntary option to participate based on what is best for them.
To provide consent, participants sign an Informed Consent Form (ICF). This form guides a person through all the relevant information related to the study and gives them the option to enroll. At Evidation studies, this process is done online through our online platform.
What information is in an Informed Consent Form?
It’s important that study participants understand all the important details of a study before providing their consent (in other words, their permission) to participate. To make sure participants have all the information they need, the Informed Consent Form (ICF) includes the following:
- The purpose of the research
- A description of each activity they will need to do and how long each should take to complete
- What data will be collected, who will have access to the data, how the data will be used, and how we will make sure the data stays safe
- Potential risks and benefits of participating in the study
- A statement that participation is voluntary and that participants can withdraw at any time during the study
- If and how they will be compensated for participating in the study (for example, direct deposit, gift card, travel vouchers, products, etc.)
Evidation Studies puts a lot of time and care into developing the Informed Consent Forms for each study. This helps to ensure that we communicate openly, honestly, and clearly with our participants.
Who creates the ICF?
Every study has a team of individuals dedicated to protecting the safety of participants. This team works together to decide what the ICF should include for each study and then submits it to an Institutional Review Board (IRB) for review and approval. An IRB is a group of qualified individuals who work to protect the rights and well-being of research participants. One way they do this is by making sure our ICFs are clear and thorough.
Why is Informed Consent Important?
Informed consent is important from an ethical point of view, because we need to make sure that everyone who participates in our studies is doing so voluntarily (by choice) and is comfortable with everything the study will involve.
Informed consent is also a legal requirement: it has to occur before a participant is enrolled in any clinical research study.
The guiding principles of the informed consent process are taken from historical documents that focus on respecting the people who participate in research. Documents like the Nuremberg Code and the Belmont Report detail the ethical principles of ‘Respect for Persons’. These principles include:
- Participants have the choice to agree to participate or not (“voluntary consent”).
- Participants have the option to withdraw at any time (that is, they are free to stop at any time).
- People are autonomous and should be treated with respect
- Protected groups like participants who are unable to consent for themselves/require additional protections. (The consent in these cases may be provided by a caregiver or legal guardian.)
Who do I contact if I have questions about the Evidation Studies informed consent process?
The Evidation Studies Support team is available to answer any and all questions participants may have about a study before signing the informed consent form, as well as any questions that come up throughout their study participation. We have a team of individuals (dedicated to making the experience as easy and comfortable as possible.
Want to know more about any of our Evidation Studies and how to get involved? Reach out to us at firstname.lastname@example.org and one of our friendly team members can help you get started.
If you want additional general information on health research, we recommend checking out the following public resources:
- U.S. Department of Health & Human Services, Office for Human Research Protections
- FDA, Clinical Trials and Human Subject Protection
- National Institutes of Health (NIH), Educational Resources
- Clinical Research Resource HUB, Resources for Participants