Article

Factors that influence parents' decisions to consent to their child's participation in clinical anesthesia research

Department of Anesthesiology, University of Michigan, Ann Arbor, Michigan, United States
Anesthesia & Analgesia (Impact Factor: 3.42). 02/1998; 86(1):50-3. DOI: 10.1097/00000539-199801000-00010
Source: PubMed

ABSTRACT There is concern that the environment in which consent for anesthesia research is sought may be coercive. We therefore designed this study to determine the factors that parents consider in consenting to their child's participation in clinical anesthesia research. The study sample consisted of 246 parents who had been approached for permission to allow their child to participate in a clinical anesthesia study. Parents were asked to complete a questionnaire detailing the reasons for their decision to consent or decline their child's participation. There were no differences in the demographics of the consenters (n = 168) and nonconsenters (n = 78). Perceived risk and the importance of the study were the primary factors in the parents' decisions to consent or decline. Only 2.8% of nonconsenters strongly considered a lack of privacy as a deciding factor; 15.3% stated that they had insufficient time in which to make a decision, and 0% reported having felt pressured. Furthermore, only 3.1% of consenters strongly considered an obligation to consent. Results of this survey highlight factors that influence parents' decisions to consent to their child's participation in clinical anesthesia research. We hope that this information will be important to researchers in providing an appropriate environment for obtaining consent for clinical anesthesia research studies. Implications: Parents who are approached for permission for their child to participate in a research study must be fully informed and under no pressure to consent. This study describes factors that influence parents' decisions to consent to their child's participation in clinical anesthesia research.

0 Followers
 · 
42 Views
  • [Show abstract] [Hide abstract]
    ABSTRACT: Background: The standard process of obtaining informed consent sometimes prevents physicians or patients from participating in clinical trials, partly because they are concerned about eventual treatment allocation or the physician is concerned the patient might harbor some uncertainty about the best treatment. Alternative randomization methods have been advocated that may address these and other concerns. Methods: After institutional ethics committee gave its approval, the authors interviewed 770 patients before operation and asked them to consider enrolling in a mock anesthesia trial. Patients were allocated randomly to one of five methods of randomization and consent: one-sided informed consent (the most common approach), prerandomized consent to experimental treatment, prerandomized consent to standard treatment, one-sided physician-modified informed consent, or one-sided patient-modified informed consent. Recruitment rates were compared and sociodemographic and perioperative predictors of recruitment were identified. Results: The randomization method did not result in any significant difference in recruitment rates: one-sided informed consent, 55.6%; prerandomized consent to experimental treatment, 53.3%; prerandomized consent to standard treatment, 53%; one-sided physician-modified informed consent, 60.7%; and one-sided patient-modified informed consent, 56.7% (P = 0.66). Multivariate predictors of recruitment were patient age >45 yr (odds ratio, 1.44; 95% confidence interval [CI], 1.08 to 1.93), English-speaking at home (1.49; 1.0 to 2.21), and male researcher-male patient interaction (1.37; 1.20 to 1.57). Conclusions: No evidence emerged that alternative randomization and consent designs resulted in increased recruitment rates compared with simple one-sided informed consent for a sham anesthesia trial in patients awaiting elective surgery. Older, male patients were more likely to provide consent.
    Anesthesiology 09/1999; 91(4):969. DOI:10.1097/00000542-199910000-00016 · 6.17 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: The standard process of obtaining informed consent sometimes prevents physicians or patients from participating in clinical trials, partly because they are concerned about eventual treatment allocation or the physician is concerned the patient might harbor some uncertainty about the best treatment. Alternative randomization methods have been advocated that may address these and other concerns. After institutional ethics committee gave its approval, the authors interviewed 770 patients before operation and asked them to consider enrolling in a mock anesthesia trial. Patients were allocated randomly to one of five methods of randomization and consent: one-sided informed consent (the most common approach), prerandomized consent to experimental treatment, prerandomized consent to standard treatment, one-sided physician-modified informed consent, or one-sided patient-modified informed consent. Recruitment rates were compared and sociodemographic and perioperative predictors of recruitment were identified. The randomization method did not result in any significant difference in recruitment rates: one-sided informed consent, 55.6%; prerandomized consent to experimental treatment, 53.3%; prerandomized consent to standard treatment, 53%; one-sided physician-modified informed consent, 60.7%; and one-sided patient-modified informed consent, 56.7% (P = 0.66). Multivariate predictors of recruitment were patient age >45 yr (odds ratio, 1.44; 95% confidence interval [CI], 1.08 to 1.93), English-speaking at home (1.49; 1.0 to 2.21), and male researcher-male patient interaction (1.37; 1.20 to 1.57). No evidence emerged that alternative randomization and consent designs resulted in increased recruitment rates compared with simple one-sided informed consent for a sham anesthesia trial in patients awaiting elective surgery. Older, male patients were more likely to provide consent.
    Anesthesiology 11/1999; 91(4):969-78. · 6.17 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Patients who are approached to participate in clinical studies just before delivery may have insufficient time to make an informed decision and/or may feel pressured into participation. This study was designed to examine factors that influence parturients to consent or decline participation in an anesthesia study related to their delivery. Parturients who had been approached to participate in a continuing clinical obstetric anesthesia study were subsequently given a questionnaire that documented their reasons for consenting or declining participation. There were no demographic differences among the consenters (n = 166) and nonconsenters (n = 109). The most important factors in the patient's decision to consent were related to their understanding and perceived importance of the study and the potential benefit to other women. Forty-one (40. 6%) nonconsenters strongly considered their pain/discomfort a factor in declining participation. Only one patient felt some pressure to consent, suggesting that the overall environment was noncoercive. Logistic regression analysis demonstrated that patients who read the consent form completely, those who had participated in a previous research study, and those who were less anxious about participating were more likely to consent. Implications: Obtaining informed consent for obstetric anesthesia studies presents a challenge to the anesthesiologist. Results from this study suggest that the environment in which consent for obstetric studies is sought is not coercive. However, it is important that the anesthesiologist ensures that the patient fully understands the study and develops a rapport with the patient to allay any anxiety associated with her participation as a potential research subject.
    Anesthesia & Analgesia 09/2000; 91(2):369-73. DOI:10.1097/00000539-200008000-00025 · 3.42 Impact Factor