• IRB: ETHICS & HUMAN RESEARCH

Potential Benefits to Families, Children, and Adolescents Enrolled in Longitudinal Qualitative Research

Abstract: Previous research has focused on the risks of research participation but has rarely considered possible benefits. For a study of family decision-making during pediatric bone marrow transplant, we conducted qualitative interviews with 132 family members across 36 families up to three times over the course of a year, before and after transplant. We concluded the study with qualitative interviews of 70 family members from 21 of the original families one year after the transplants, focusing on benefits and concerns regarding their research participation. Participants, including children and adolescents, reported benefits including the opportunity to talk, be altruistic, reflect, have a safe space, gain understanding or perspective, and express emotions. Sixteen percent expressed concerns, mostly finding aspects of the methodology annoying. We encourage institutional review boards to understand that sensitive conversations with adults, children or adolescents may not always increase the risk of the study and may offer benefits to those who agree to be interviewed. We therefore suggest that language describing potential benefits could be included in consent and assent forms for qualitative studies.

Keywords: human subjects research, pediatric research participants, research benefits, research risks, research participation, hematopoietic stem cell transplant, institutional review boards, qualitative research