1.  Federal mandates exist from both NIH and FDA on including children in clinical research. However, when and how to include children, particularly in clinical trials, is highly debated. Concerns are particularly heightened when:  Children have life-threatening conditions  There is little time to make this decision  Parents / legal guardians give permission for their children to participate in research. Older children (~>7yrs.) are asked to give assent.  Much of the previous research related to parents’ decision making around children’s participation in research has been conducted separately in the contexts of pediatric cancer, surgery or neonatology.  There are many barriers to informed permission / consent when parents are asked to make decisions about their child’s participation in research:  Time constraints  Complicated research protocols  Inadequate understanding  Stress imposed by child’s condition  Less than ideal communication Background Parent Decision Making in Pediatric Research Denise B. Angst, PhD, RN * ; Emily Hadley, MS, RN * ; Bryan Coyle, MA # Advocate Center for Pediatric Research * ; Advocate IRB # Parent Decision Making in Pediatric Research Denise B. Angst, PhD, RN * ; Emily Hadley, MS, RN * ; Bryan Coyle, MA # Advocate Center for Pediatric Research * ; Advocate IRB # Sample  Any parent who enrolled or declined enrollment of their child in a clinical research study at AHCH or ALGCH  Approached within 12 weeks of the original study  English-speaking Measurements  Demographic and Decision Making Supplement  31 items, evaluating parent and child demographics; perception of research risks and benefits, previous experience with research, decision making process  Parent Decision Making (DM) Survey  Based loosely on survey by Tait et al.  65 items were reviewed by 5 content experts  Final tool was 70 items, each item with a 5-point Likert scale (1 strongly disagree – 5 strongly agree), organized in 11 themes/domains Data Analysis  Descriptive statistics; t-tests to compare subgroups  Reliabilities and correlational analyses to evaluate DM survey Conclusions ResultsMethods Specific Aims 1)Examine parents’ decision making regarding their children’s research participation across various illness and other contexts 2)To develop and evaluate an instrument that could be used across pediatric conditions and decision making contexts. Results  These results are most representative of parents who decide to enroll (vs. decline enrollment), and only represent some of our preliminary analyses to date  The vast majority of parents are making this decision in a very short period of time (75% <1 day)  Fewer parental resources (education, SES) may make it more difficult for them to decline  Features that distinguish those who enroll vs. decline appear consistent with prior research:  Beliefs in benefits for their child and other children  Beliefs in the importance of research  Perception of risks  Compared to other conditions, parents of children with cancer see the research as benefiting their child and see their child’s condition as more serious  Decision making tool results are highly preliminary, given sample size. Tool shows some promise, but needs further evaluation when additional parents have been enrolled Enrolled N = 55 (n, %) Declined N = 14 (n, %) All Parents N = 69 (n, %) Child’s Condition Oncology Neonatology Other Chronic Condition 32 (58) 15 (27) 8 (15) 1 (7) 9 (64) 4 (29) 33 (48) 24 (35) 12 (17) Child’s Age < 1 month 2-10 years 11-17 years 13 (34) 12 (32) 11 (92) 1 (8) 0 24 (48) 14 (28) 12 (24) Parent’s Highest Education High school grad Some college > College grad 10 (18) 15 (27) 30 (55) 1 (7) 2 (14) 11 (79) 11 (16) 17 (25) 41 (59) Race/ Ethnicity Caucasian African American Other 42 (76) 6 (11) 7 (13) 13 (93) 0 1 (7) 55 (80) 6 (9) 8 (11) Annual Household Income < $50k $50k - 89,999 ≥ 90k 17 (32) 16 (29) 20 (38) 0 5 (36) 9 (64) 17 (25) 21 (30) 29 (42) Table 1. Sample Characteristics: Enrolled vs. Declined Table 2. Selected DM Survey Item Responses Enrolled N = 55 (mean, SD) Declined N = 14 (mean, SD) p- value Perception of Seriousness of Child ’ s Condition (1=mild, 10 = severe) 7.2 (2.5)7.2 (2.2).96 Benefit for Child (1=no benefit, 10 = extremely beneficial) 6.1 (3.0)2.5 (2.1).0001 Benefit for Other Children (1=no benefit, 10 = extremely beneficial) 8.4 (2.2)6.2 (2.0).002 Perception of Risk (1=no risk, 10 = extremely risky) 3.4 (2.3)6.4 (2.6).0002 Importance of Research (1=not impt., 10 = extremely impt.) 8.6 (2.0)6.2 (1.6).0002 Table 3. Parent Perceptions: Enrolled vs. Declined Parents of Children with Cancer vs. Other Conditions Decision Making Survey  Based on analysis of first 50 parents  2-3 domains / scales appear to have subscales  Internal consistency:  = 0.41-0.87; 7 scales with  >0.74  Discrimination: Enrolled vs. Declined  Most scales did not discriminate based on participation  3 scales showed differences: Decisional Uncertainty, Influence of Child’s Condition, View of Study  Discrimination: Diagnostic Groups  Oncology vs. NICU vs. Other Chronic Condition  6 scales appear to differentiate groups: Quality of Consent Process-1, Quality of Consent Process-2, View of Study, Other Decisional Influences, Trust / Relationship with Dr. / Staff, Quality of Consent Form Acknowledgements Thanks to the research coordinators and clinical staff who assisted in recruiting parents: Ramona Donovan, Rina DiMaso, Bonnie Hughes, Suellen Moen, Lorene Schweig, Regina Schwartz, and Jane Suszek. Next Steps  Parents are continuing to be enrolled; goal N=100 parents Advocate Hope Children’s Hospital Advocate Lutheran General Children’s Hospital Parent Decision Making in Pediatric Research Denise B. Angst, PhD, RN * ; Emily Hadley, MS, RN * ; Bryan Coyle, MA # Advocate Center for Pediatric Research * ; Advocate IRB # Parent Decision Making in Pediatric Research Denise B. Angst, PhD, RN * ; Emily Hadley, MS, RN * ; Bryan Coyle, MA # Advocate Center for Pediatric Research * ; Advocate IRB #  Compared to parents of children with other conditions, parents of children with cancer viewed,  Their child’s condition as more serious (8.2 vs. 6.3; p=0.002)  The research as more important (6.8 vs. 4.1; p=0.0005)  The research as benefiting their child (8.8 vs. 7.5; p=0.01)  However, there were no statistically significant differences in their perception of study risks (4.1 vs. 3.9; p=0.68) Enrolled N = 55 (n, % Agreed or Strongly Agreed) Declined N = 14 (n, % Agreed or Strongly Agreed) p- value Altruism Participating in Research will Help Other Children 53 (96)12 (86)0.18 Decisional Uncertainty Wanted Study Doctor to Advise me on Decision 14 (26) * 2 (14)0.49 Child Influences Would Participate in Any Study to Benefit Child 44 (81) # 4 (29)0.0003 Study Characteristics Study Seemed Very Risky2 (4)7 (50)0.001 Trust / Relationship with Dr. and Staff Study Wouldn’t have been Offered unless Beneficial36 (65)5 (36)0.07 Understanding I Understood What was Required46 (84)9 (64)0.14 Quality of Permission / Consent Process Had Enough Time to Make Decision43 (78)8 (57)0.17 Satisfaction with Decision Making Make Same Decision Again44 (81) # 13 (93)0.44  Parents completed DM supplement and survey at a median of 7 days from their decision making regarding the original research.  75% parents made their decision re: the original study in < 1day. * N = 53 # N = 54