Realizing Informed Consent in Times of Controversy: Lessons from the SUPPORT Study

2016 ◽  
Vol 44 (3) ◽  
pp. 402-418 ◽  
Author(s):  
Robert J. Morse ◽  
Robin Fretwell Wilson
Keyword(s):  
Informed Consent ◽  
Extremely Low Birth Weight ◽  
Positive Pressure ◽  
Low Birth Weight Infants ◽  
Patient Centered ◽  
Human Research ◽  
Clinical Research Trial ◽  
Sound Mind ◽  
Consent To Medical Treatment

This Essay examines the elegantly simple idea that consent to medical treatment or participation in human research must be “informed” to be valid. It does so by using as a case study the controversial clinical research trial known as the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (“SUPPORT”). The Essay begins by charting, through case law and the adoption of the common rule, the evolution of duties to secure fully informed consent in both research and treatment. The Essay then utilizes the SUPPORT study, which sought to pinpoint the level of saturated oxygen that should be provided to extremely low birth weight infants to demonstrate modern complexities and shortcomings of the duty to secure informed consent. This Essay shows how the duty is measured by foreseeability of risks and benefits in human research and why federal regulators believed the tradeoffs in risk and benefits from differing oxygen levels administered in the support study were foreseeable. It then explores the contours of the duty to secure informed consent when applied to researchers who also serve as treating physicians, highlighting how common law duties differ in jurisdictions that apply the professional standard and those that apply the patient-centered material risk standard. This Essay provides new insight into what the law must do to make real the notion that [e]very human being of adult years and sound mind has a right to determine what shall be done with his body.”

Kangaroo Mother Care Reduces Noninvasive Ventilation and Total Oxygen Support Duration in Extremely Low Birth Weight Infants

2019 ◽  
Author(s):  
Xiaohua Xie ◽  
Xueyu Chen ◽  
Panpan Sun ◽  
Aifen Cao ◽  
Yanzhu Zhuang ◽  
...  
Keyword(s):  
Birth Weight ◽  
Low Birth Weight ◽  
Supplemental Oxygen ◽  
Kangaroo Mother Care ◽  
Extremely Low Birth Weight ◽  
Positive Pressure ◽  
Low Birth Weight Infants ◽  
Cpap Ventilation ◽  
Objective Evidence ◽  
Tertiary Center

Abstract Objective Evidence on the safety and influence of kangaroo mother care (KMC) in extremely low birth weight infants (ELBWIs) on ventilation is lacking. Study Design This is a retrospective cohort study performed in 145 ELBWIs on noninvasive mechanical ventilation from a tertiary center. Results The duration of nasal intermittent positive pressure ventilation (nIPPV) and continuous positive airway pressure (CPAP) ventilation was significantly shorter in infants with KMC compared with infants without (21 vs. 13.5 days, p = 0.001 and 29.5 days vs. 20.5 days, p = 0.001, respectively). The frequency of apnea during hospital stay was fewer in KMC infants, compared with no KMC (23 vs. 20 times, p = 0.002). Multiple linear regression analysis showed that KMC was an independent protective factor for shortening nIPPV/CPAP duration (β = −9.90, 95% confidence interval [CI] [−13.20, −6.60], p < 0.001), total supplemental oxygen support (β = −10.52, 95% CI [−16.73, −4.30], p = 0.001), and reducing times of apneas (β = −5.88, 95% CI [−8.56, −3.21], p < 0.001). Conclusion KMC benefits ELBWIs by shortening nIPPV/CPAP ventilation duration and total supplemental oxygen support, and reducing the frequency of apneas.

Seeking Approval from Universities to Research the Views of Their Staff. Do Gatekeepers Provide a Barrier to Ethical Research?

2022 ◽  
pp. 155626462110683
Author(s):  
Katherine Christian ◽  
Carolyn Johnstone ◽  
Jo-ann Larkins ◽  
Wendy Wright
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Ethics Committee ◽  
University Staff ◽  
Institutional Approval ◽  
Human Research ◽  
Human Research Ethics ◽  
Risk Research ◽  
Case Basis

A “gatekeeper” controls access to an organization; “gatekeeper approval” is often needed before external research can take place within an organization. We explore the need for gatekeeper approval for research with university staff employing, as a case study, a project which collected data in Australia. This case study addresses known issues, seemingly rarely addressed in the literature. The Human Research Ethics Committee (HREC)'s requirement for approval from individual universities to approach their staff brought significant consequences, exacerbated by the lack of university procedures for such approvals. Simultaneously, since invitations could legitimately be distributed via other avenues, such approval was superfluous. We recommend the HREC's blanket requirement for institutional approval instead be considered on a case-by-case basis depending on the risk of the research, and perhaps waived for low-risk research where participants are able to provide informed consent, and that universities establish processes to deal with requests from external researchers.

scholarly journals Think of the Children: Liability for Non-Disclosure of Information Post-Montgomery

2019 ◽  
Vol 28 (2) ◽  
pp. 270-292
Author(s):  
Emma Cave ◽  
Craig Purshouse
Keyword(s):  
Informed Consent ◽  
Medical Treatment ◽  
Relevant Information ◽  
Tort Law ◽  
Treatment Decisions ◽  
Best Interests ◽  
Health Board ◽  
The Supreme Court ◽  
Sound Mind ◽  
Consent To Medical Treatment

Abstract In 2015, the Supreme Court in Montgomery v Lanarkshire Health Board handed down a landmark decision on informed consent to medical treatment, heralding a legal shift to a more patient-centred approach. Montgomery, and the extensive commentary that has followed, focuses on ‘adult persons of sound mind’. Cave and Purshouse consider the potential claims that may flow from a failure to adequately inform children. They argue that the relevance of the best interests test blurs the boundaries between negligence and battery. Limitations on children’s rights to make treatment decisions for themselves impact on their potential to claim in negligence for non-disclosure and, conversely, enhance the potential relevance of the tort of battery. In paediatric cases, Montgomery raises expectations that the law is currently ill-equipped to satisfy. Tort law provides a legal incentive to disclose relevant information to children but limits the availability of a remedy.

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