Informed Consent and Assent Process

 If you have ever participated in a focus group, survey, or study of any kind you may remember signing a consent form. Federal regulations require that most research conducted with human subjects secure informed consent from participants prior to collecting data. You will be required to submit a sample of your consent forms with your IRB application if you are conducting research. Depending on the participants in your study, you may need to develop different consent forms for adults, minors (youth), and parents/legal guardians of minors. Forms should be written using appropriate vocabulary and language for your participants and be accessible (non-technical). To view a sample consent form click here.

Obtaining informed consent from participants is more extensive than just having the proper documents signed. Participants must understand the nature and purpose of the study as well as any potential risks and benefits posed to them. The consent process does not end once the form is signed but continues throughout the study and can be withdrawn by the participant at any time.

Per the United States Department of Health and Human Services (HHS), the informed consent process should:

  • Describe the overall experience that will be encountered
  • Describe the benefits that subjects may reasonably expect to encounter
  • Describe any alternatives to participating in the research project
  • Inform subjects of the extent to which their personally identifiable private information will be held in confidence
  • Provide an explanation of whatever voluntary compensation and treatment will be provided
  • Identify contact persons who will be knowledgeable to answer questions for subjects about the research, rights as a research subject, and research-related injuries
  • Include a statement regarding voluntary participation and the right to withdraw at any time

 

Children cannot give legal consent to participate in research. A parent or legal guardian must sign a consent form on their behalf. However, it is still necessary to obtain a child’s (minor) assent to ensure their voluntary participation in a research study. For those who cannot give consent (like children) an assent is used to attain their voluntary participation. Depending on their age (anywhere from 7 to 17 depending on state law), a child may give verbal or written assent. As with consent, the research study must be explained to them in language they will understand. Cultural differences may also play a role in how parental consent and child assent is attained. The researcher should be knowledgeable of the different cultural understandings of children’s privacy. The local IRB will determine if assent is needed for a child to participate, and what items the assent must contain.

 

Parental consent may be waived under certain conditions:

  • The research involves no more than minimal risk
  • The waiving of parental consent does not negatively affect the rights of participants
  • The research could not be done without a waiver
  • Is a debriefing about the research possible

 

To read more detailed information about the consent process, as specified by HHS, click here.

Click here for a short ethics in research and evaluation case study and discussion questions.