A parent recently called the IRB office to inquire about a permission form her son brought home from school for her to review. She had three primary questions: (1) does my child have to be in this study, (2) what does “primary investigator” mean, and (3) what do I do if I cannot understand the study?
I reviewed the permission form with her and offered suggestions on how to interpret it. I also connected her with the researchers for more information about the study. Her questions prompted me to reflect upon the IRB (caregiver or guardian) Parental Permission Form Template and helped me reassess the way researchers present information to parents about studies.
When researchers create participant materials to review, they have many factors to consider including participant age, reading level, potential risk factors, informed consent, confidentiality, and time constraints. When asking parents (caregivers or guardians) to work with their children, researchers should also consider how the study information is disseminated (e.g., paper or online) and by whom (e.g., researcher to the parent or school leader to parent).
For example, when the parent on the phone call asked, “Does my child have to be in this study?” she worried that non-participation might interfere with her child’s access to educational resources. The researcher had explained in the permission form that the child’s participation was voluntary and did not impact grades or class standing. However, the parent overlooked this text within the document. Researchers should consider bolding or highlighting this text to ensure parents do not miss it. Additionally, researchers may need to repeat this information in a statement like:
“This study is voluntary. If you or your child choose to not be in this study nothing will happen. This study will not impact your child’s grades or class standing.”
The parent was concerned that the term “primary investigator” implied an association with a government agency or police force. The parent wondered if by being investigated, the child would be excluded from class activities. Despite having a “Participants Rights” section on the parent permission form stating the study was voluntary and nonparticipation would not prevent an individual access to the resources they were due, the parent was alarmed by the term “investigator” in this context. After affirming the intentions of the study and clarifying what “primary investigator” meant, I asked the parent if switching the word “investigator” to “researcher” would change her interpretation of the role. The parent responded that “researcher” implied someone doing a study, whereas “investigator” sounded (and felt) more related to police or law enforcement. In response to the parent’s concerns, we updated all templates to replace the term “investigator” with “researcher” and where appropriate, included a brief description of what it means to be a researcher on a parent (caregiver or guardian) permission form:
“This form explains why we are doing this study and what your child will be asked to do if you choose to allow your child to be in this study. It also describes the way we (researchers) would like to use and share information about your child.”
The parent also asked for clarification on the differences between individual and focus group interviews. This question prompted me to recommend that researchers (wherever appropriate) provide alternative explanations or examples on the parent (caregiver or guardian) permission form. For example, a researcher might include text like:
“If you agree to let your child be in this study, they will be asked to participate in an individual and focus group (small group) interview” or “In the focus group session, your child will be asked to meet with four other students to discuss their beliefs about math learning.”
Researchers have a responsibility to write consent, parent permission, and assent forms in clear and understandable ways (e.g. Writing for an IRB Review). Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. My recent phone conversation with a parent reaffirmed how important it is to engage with potential study participants and ensure they understand what is being asked of them.
Researchers are encouraged to engage parents (caregivers or guardians) in open conversations and determine the best paths to disseminate information. Researchers should also provide opportunities for parents to actively ask questions, engage in discussions about a study, and clarify any misunderstandings. Developing a positive connection with parents helps ensure they receive a clear message about research and how to best proceed when giving permission or consent to participate in a study.