Informed Consent of Human Subjects in Research
An informed consent process is the ethical foundation for any research involving human participants. In addition, federal regulations require IRBs to ensure that participants are fully informed about a study before they agree to participate.
These regulations are based on the belief that researchers are ethically obligated to fully inform potential study participants so that they can make a decision regarding participation that is based on a complete understanding of the risks and benefits of participation. In addition, informed participants are better participants; they are more serious about participating in a study and they are better able to understand what a researcher needs to know about them and what is required of them. The type and extent of the consent process will depend on the kind of research you are conducting and the level of risk that is involved.
In general, the Board will need to have a detailed understanding of how participants will be recruited to participate, how the consent information will be presented to them, and how their consent will be documented. This section details the requirements for consent that are outlined in the federal regulations as well as additional options that are available for participants that do not fit the basic consent scenario.
Consent Process in Five Phases
1. Providing participants with realistic information through the recruitment process.
2. Having a conversation about the study between the researcher and the participant which may happen in person or using digital media and is usually supported by written documentation called a consent form.
3. Asking the individual for permission to include them in the research study and documenting consent either with a physical or electronic signature.
4. Providing ongoing consent which means the researcher continues to check in with participants to make sure they understand what their participation means as the study progresses.
5. Keeping accurate records so that your consent forms match the number of participants in your data records, and the consent form versions match the versions provided in the protocol.
Depending on the study, this process could be a brief five minutes as a participant reads the study information prior to taking a one-time anonymous survey or could be a longer session with a researcher prior to starting a longitudinal psychology study. In order to develop a good consent procedure, you need to understand the needs of your participants and create a process that will support those needs throughout the study.
Considerations for a Consent Process
- What is the anticipated reading level of your participants?
- Do all of the participants speak English? Are there any cultural expectations where a traditional Western consent process would be problematic?
- Are your participants capable of consenting (e.g. minors, adults with diminished capacity)? Could they be in situations where consent is challenging because of a lack of autonomy (e.g. prisoners) or because consent could put them at risk?
- What is your relationship with the participants? Could that relationship (or the relationship of anyone on the research study team) make participants feel pressured to participate? If the possibility exists, do you need to adjust your consent process so that participants can decide freely? e.g. employer/employee, teacher/student, etc.
- Will the participants' data be used in areas beyond the research project (e.g. in classrooms, public data sets, or archived in libraries)? Do you need to notify participants that their materials will be used elsewhere?
- Will the participants be deceived as part of your study? Will they need to be debriefed after the data collection is complete?
The answers to these questions will help determine what approach you need to take in developing an instructive consent procedure.