Informed Consent Guidelines

 

The following elements must be included in all consent processes.  If this information has not been provided to and understood by research participants, there is no informed consent to participate, and using data that is collected is in violation of Aquinas College policy.

This information should be provided in language that the person providing consent can understand (and in the language that they read), read aloud to the person if there is any suspicion that the person providing consent is not able to read what is written, and should be written in second person tense (e.g. You are being asked to participate in a research study...).

When reviewing your application, the Aquinas College IRB will need to identify each of these elements in both your process and documents.

The project title as listed on the Application for Institutional Review of Research Involving Human Subjects.

Application Self-Evaluation Form

Principal Investigator name, discipline, and institutional affiliation.

Contact information for the primary investigator and the faculty research advisor for student research. This includes campus address and telephone (for faculty researchers and advisors of student research), and email addresses (for both faculty and student researchers). Aquinas researchers should use their College email address. Do not list the researchers' home phone or addresses.

Purpose of the study. This is a description of the purpose of your research written in language that can be understood by the participant.

How will the research findings be used? Describe how the results will be used and presented (e.g. a community presentation; report to community leaders; presentation at a conference; publication; a master’s thesis; part of a data set that will be used in the future).

The research methods. Include a description of what the participant will do. This should include the length of time this process will take. For example, “You will be asked a series of 20 questions about the Creston Neighborhood. Answering these questions should take no longer than 15 minutes.”

Benefits of the research. Identify potential benefits for both the participant and others. For example, “Information collected in this research will help the Creston Neighborhood Association respond to the concerns of neighborhood residents,” and “in exchange for your participation in this research, you will be provided with a $2 gift certificate for the Moose Café.” All research participants must receive equal compensation, and a chance in a drawing for a prize is not equal compensation.

Risks or discomforts. Identify any potential physical or psychological discomforts a participant may possibly experience. For example, “You will be asked questions about your parents’ divorce, which may lead you to recall events and experiences that are emotionally painful.”

Anonymity. Will the participant’s anonymity be protected? How will anonymity be protected (e.g. using an online survey program, separating informed consent forms from completed questionnaires prior to data analysis)? Anonymity means that no one (including the researcher) can identify the participant.

It is important to remember that you may not be able to ensure anonymity due to your methodology or sample size. This is perfectly acceptable, but you need to be clear about this in the informed consent process.

Confidentiality. How will the participant’s confidentiality be protected? Explain how data will be handled and stored so that responses will remain confidential. Identify who will have access to the data or questionnaires/tests/measures, and a description of how paperwork and data will be handled (e.g. storing documents in locked cabinets, destroying identifying information). When data is presented in publications or reports, how will identities of research participants be kept confidential.

Voluntary participation and withdrawing consent. The participant needs to be advised that their participation in the research is voluntary, and they can withdraw from the study at any time without penalty. Even if they initially consent, this consent can later be withdrawn.

Dated signature of participant or their parent/guardian below a statement acknowledging that they understand the information that has been presented, have had an opportunity to have their questions answered, and agree to participate in the research.  

A signed copy of the consent document is retained by the researcher and a copy is provided to the participant (or their parent/guardian in cases where the participant is not providing consent).