Research FAQ: What You Need to Know About Informed Consent

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Published March 7, 2022

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It can be a rewarding experience to participate in research studies that offer many potential personal, medical, and financial benefits. However, if you are new to or are not entirely familiar with participating in a research study, you may still have some questions about your rights as a participant.

It is only normal to wonder how your health, interests, and confidentiality are protected when you participate in research. Perhaps, you have heard phrases like “informed consent” or “IRB approval” but remain unsure about their meaning or context. As a research study participant, or prospective one, it is important that you understand these terms and how researchers are obligated to share with you information about their study and any involved risks.

Buffalo Research News is here to answer these questions, and to provide you with additional resources so you can participate in research with confidence.

So, what is informed consent?

Informed consent is essential in research. It is an agreement by which researchers inform participants about the reason for the study, what participants will be asked to do, and potential risks and benefits of participation. This protects participants from being misled or lied to about study intent or details.

Informed consent is a process. When researchers conduct a study, they are obligated to keep participants informed before, during, and after their involvement.

Informed consent allows research participants to:

  • Stop participating in the study at any point. Participation is voluntary, and participants do not need to remain in a study if they no longer wish to be part of it.
  • Know what their participation involves. Researchers must provide information about their study that is clear and easily understood. They are obligated to answer participants’ questions about the study. Additionally, participants in clinical trials have the right to know if there are alternative treatments or therapies available.
  • Understand how researchers protect participants' privacy and data confidentiality.
  • Know if they will receive any form of compensation in the event that they are injured as a result of their participation in the study .

How is informed consent different from written consent?

Informed consent can be obtained either verbally or in writing. While there are some exceptions, most research studies document and require written consent. Situations in which participation involves little or no risk, or where it is important that participants remain completely anonymous, are the most common instances of verbal consent.

Regardless, it is important that research participants understand that informed consent does not end with their signature. Researchers must continue to inform participants of any relevant information about the study throughout the entire research process.

What is the Institutional Review Board (IRB) and how does informed consent fit into its requirements?

According to federal law, research involving human participants must be reviewed by an institutional review board, or IRB. Informed consent document and recruitment materials are examples of research materials that are submitted to and approved by the IRB. The IRB and informed consent make sure that study participants are protected from any harmful or unethical research practices. They monitor studies, confirming that participants’ rights are respected throughout the research process.

How is informed consent obtained for all populations?

In research, many groups of people, such as children, pregnant women, prisoners, individuals with language barriers, individuals with mental or cognitive disabilities, and socio-economically disadvantaged persons, are difficult to recruit for participation in a study.

Researchers must follow specific guidelines from the IRB to obtain informed consent from these populations. Guidelines provide additional protections to these groups defining when and how researchers may recruit and enroll these individuals in their studies. For example, children are unable to legally consent on their own. Researchers must, therefore, obtain consent from their parent or guardian.

Have additional questions about informed consent?

Reach out to the CTSI at researchadvocate@buffalo.edu or by calling 716-888-4845, or click on the additional resources, below to learn more about informed consent and the IRB: