The IRB-SBS is charged with ensuring that participants have the information they need in order to make an informed and pressure-free decision about participating in a study. We need to ensure that confidentiality is protected as well as privacy, and the recruitment and consent process is designed to ensure both to the greatest extent. The IRB-SBS also needs to ensure that participants are equitably selected and that no particular group is bearing an undue burden from research participation. The questions in this section are meant to cover all participant groups; if there are different recruitment and consent process for each participant group, make sure to describe each process in a clear and organized way. The “associate participant groups with consent forms tool” will help you to delineate which consent form goes with what group (if there is more than one of each).
How will participants be approached or contacted for recruitment into the study?
The IRB-SBS needs to evaluate your process for recruiting participants in the study. If you are contacting a specific group, how will you obtain contact information for the participants? What letters, advertisements, flyers, etc, will you use to contact participants (make sure to upload them in the Recruitment and Consent Upload section!)? If you are approaching a participant in person, what will you say to them about the study? For more guidance on developing your recruitment materials, see Participant Recruitment: The First Step to Informing Participants.
Do participants have any limitations on their ability to consent?
Some participants, particularly those described in the Vulnerable Participants section in the IRB-SBS website, have limitations on their ability to consent. Limitations could be related to diminished cognitive ability or legal status (minors are not able to provide legal consent). Some participants may be in situations where they are at a greater risk for coercion (either direct or indirect); for example prisoners may feel compelled to participate or a student may feel that study participation is part of their grade. The consent process description needs to include information about how you will navigate consent limitations and the provided consent forms also need to match this process. The Special Consent Situations section details processes and requirements for groups that have specific consent needs.
What is the consent process for this study? Who will present the consent information and how will it be presented? Are your participants either unable or unwilling to document their consent (i.e. sign a form)?
As previously stated, the consent process is the keystone for informing participants about the research process and providing a mechanism for them to participant freely. The consent process is more than just a consent form—it describes how the participant is informed about the study and the mechanism for obtaining and documenting the participant’s consent. Federal regulations have specific requirements for the process, including elements that need to be included on the consent form, etc. With that said, the IRB-SBS also expects the consent process to be tailored to participants’ needs. Where the consent form is presented, who presents it, what language and reading level is it presented in, etc., can all have an impact on the participant’s ability to process the information appropriately and make an unconstrained decision to participate. For some studies, consent may not be appropriate (see previous question about consent limitations) and for most minimal risk studies, it may not be required (though the IRB-SBS usually requires that participants receive information about the study before they participate). For more information about developing a consent process, see Consent.
Describe the participants/inclusion and exclusion criteria.
This question provides the Board with additional context regarding the participants in the study and why they would (or would not) be included in the study. Some groups may require special permission to access; for example you may need permission from a school administrator to access students in a public elementary school. You will address those issues in the “Permission to Access Data Source and Participant Group” section as well as upload proof of permission in the “Proof of Permission” upload.
Will participants be deceived and/or have information withheld from them about the study?
The Board needs to understand whether or not participants will know the full nature of the study when they are provided the initial consent information, and if not, additional details about what information is withheld and why. Provide details about how the deception process will affect the consent process as well. In addition, mark the question regarding “debriefing” as yes; providing a debriefing process and a post deception consent form is always required for deception studies. For more information about deception studies, see Deception.
Will participants be debriefed?
Debriefing a participant refers to providing additional information to the participant after the study. Participant debriefing can be appropriate in multiple situations and generally involves helping the participant to better understand what took place during the study by providing a form and/or additional in person session with a member of the research team. Participant debriefing can be an opportunity to educate a participant about the study which is why the Board requires studies that involve participant pool participants to provide a debriefing form. For studies where the participant may be at risk for becoming upset or disturbed as a result of their participation and/or they are deceived during the study, the Board requires participant debriefing as an opportunity to help participants process their experience. Often a debriefing experience can mitigate risks related to emotional upset, etc. For more information, please see Deception.
- Researcher provided a complete description of the recruitment and consent process.
Checklist items specific to vulnerable populations
- (minors) Determination of the minor’s capacity to provide assent is described.
- (minors) The study includes an adequate description for obtaining and documenting assent of the subject and consent from the parent or guardian.
- (minors) The study includes an adequate description for obtaining and documenting assent of the subject and consent from the surrogate.
- (prisoners) The prisoner is informed in advance that participation in the research will have no effect on his/her legal case.
- (diminished mental capacity) Determination of the participant’s capacity to consent is described.
- (participant pool students) Consent form provides equivalent alternatives for earning credit outside of research participation.
- (participant pool students) Participants (participant pool students) are assured that their status (grades, etc.) will not be affected by their decision to participate.
- (students) Participants (students) are assured that their status (grades, etc.) will not be affected by their decision to participate.
- (employees) Participants are assured that their status (employment, etc.) will not be affected by their decision to participate.
Checklist items related to deception/debriefing:
- (deception study) The researcher describes a post-debrief consent process.
- (debriefing) The researcher provided the required debriefing process and document.
- Any issues with informed consent for secondary study subjects have been addressed.
- It is clear who is authorized to obtain informed consent for the study.
- The circumstances of the consent process minimize the possibility of coercion or undue influence.
- The investigator will obtain legally effective informed consent of the participant or of the participant’s legally authorized representative.
- The method for presenting the consent information and explaining the study to the participants is appropriate for the subject population.
- The subject selection is equitable.
- The timing of and setting for explaining the research and obtaining informed consent are conducive to good decision making and participants (or legally authorized representatives are provided with sufficient opportunity to consider whether to participate.
Checklist items specific to vulnerable populations:
- (minors) The assent process is appropriately based on the participants' capacity to provide assent.
- (minors) The documentation of parental consent is adequate.
- (minors) The documentation of the assent is adequate.
- (minors) The parent consent process is appropriate for the study conditions.
- (diminished mental capacity) There are adequate provisions for obtaining permission of the legally authorized representative for an individual with diminished mental capacity.
- (minors or diminished mental capacity) There are adequate provisions for soliciting the assent of the subject.
Checklist items relating to deception/debriefing:
- The deception is justified.
- The subjects are appropriately debriefed about the deception.
- The debriefing process is appropriate for the study.