Federal regulations require that most research conducted with human subjects (i.e., focus groups, surveys, studies, etc.) secure informed consent from participants prior to collecting data. A sample of the consent forms being used must be submitted along with IRB applications if human subjects research will be conducted. Depending on the participants in the study, different consent forms for adults, minors (youth), and parents/legal guardians of minors may need to be developed. Forms should be written using appropriate vocabulary and language for each group of 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 The consent process does not end once the form is signed but continues throughout the study and can be withdrawn by the participant at any time.
Requirements of an Informed Consent Process per Department of Health & Human Services Guidelines
- Describes the overall experience that will be encountered
- Describes the benefits that subjects may reasonably expect to encounter
- Describes any alternatives to participating in the research project
- Informs subjects of the extent to which their personally identifiable private information will be held in confidence
- Provides an explanation of whatever voluntary compensation and treatment will be provided
- Identifies contact persons who will be able to answer questions for subjects about the research, rights as a research subject, and research-related injuries
- Includes a statement regarding voluntary participation and the right to withdraw at any time
Minors (youth under the age of 18) 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 minor’s 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 know about 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.
Conditions Under Which Parental Consent May Be Waived
- 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
- A debriefing about the research is 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.