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Electrophysiological Measurements and Analysis of Nociception in Human Infants
Published on: December 20, 2011
Neonatal research and the validity of informed consent obtained in the perinatal period
Hubert O Ballard1, Lori A Shook, Nirmala S Desai
1Department of Neonatology, University of Kentucky Medical Center, MS 467, 800 Rose Street, Lexington, KY 40536-0298, USA.
Insights
Obtaining valid informed consent from parents in neonatal research is challenging. Mothers should be more involved in the consent process, with greater attention paid to study risks.
Area of Science:
- Neonatal research ethics
- Informed consent validity
- Clinical trial methodology
Background:
- Informed consent is crucial for ethical clinical research, ensuring participants understand and voluntarily agree.
- Validity of informed consent in neonatal intensive care populations is under-researched.
- This study evaluated informed consent validity in the NEOPAIN (neurologic outcomes and pre-emptive analgesia in the neonate) multicenter randomized trial.
Purpose of the Study:
- To determine the validity of informed consent obtained from parents of infants enrolled in the NEOPAIN study.
- To assess parental understanding of the study's purpose, benefits, risks, and voluntary nature.
Main Methods:
- Parents of infants who survived and were enrolled in the NEOPAIN study provided consent.
- A 20-question survey based on the NEOPAIN consent form assessed parental understanding.
- Responses were scored on a Likert scale (1=no understanding, 5=complete understanding).
Main Results:
- 7.8% of parents had no recollection of the study or consent.
- Only 67.8% understood the study's purpose; mothers had higher understanding than fathers (p=0.029).
- While 95% could state benefits, only 5% understood potential risks. No parents felt coerced, and all would re-enroll their child.
Conclusions:
- Achieving valid informed consent in the antenatal/perinatal population is difficult.
- Including mothers more actively in the consent process may improve validity.
- Enhanced focus on explaining potential study risks is necessary.
Background:
Consent for participation in clinical research is considered valid if it is informed, understood, and voluntary. In the case of minors, parents give permission for their child to participate in research studies after being presented with all information needed to make an informed decision. Although informed consent is a vital component of clinical research, there is little information evaluating its validity in neonatal intensive-care populations. The objective of this project was to determine the validity of informed consent obtained from parents of infants enrolled in the multicenter randomized research study, neurologic outcomes and pre-emptive analgesia in the neonate (NEOPAIN).
Design/Methods:
Parents of infants who survived to discharge and had signed consent for their newborn to participate in the NEOPAIN study at the University of Kentucky were asked 20 open-ended questions to determine their level of understanding about the NEOPAIN study. The NEOPAIN consent form, which had been approved by the University of Kentucky Medical Institutional Review Board (IRB), was used to formulate these questions. Questions addressed the timing of consent, parental understanding of the purpose, benefits, and risks of the study, the voluntary nature of the project, and their willingness to enroll in future studies if the opportunity presented. Answers were scored on a Likert scale, with 1 for no understanding and 5 for complete understanding.
Results:
Five of 64 parents (7.8%) had no recollection of the NEOPAIN study or of signing consent. Of those who remembered the study, only 67.8% understood the purpose of the study, with a higher proportion of the mothers than fathers knowing the purpose of the study (73.3% vs 57.1%), (p=0.029). Of those who understood the purpose of the study 95% were able to verbalize the benefits, but only 5% understood any potential risks. No parents reported feeling pressured or coerced to sign consent for the project and all parents reported they would enroll their child in additional studies if asked.
Conclusions:
Valid consent in the antenatal/perinatal population is difficult, if not impossible, to obtain. To maximize validity of consent in the antenatal/perinatal population every effort should be made to include mothers in the consent process. Additional attention during the consent process should be given to possible risks of the study.
