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Neonatal resuscitation is a common and important intervention. It is also a stressful and sometimes chaotic experience. Recollections of events may be inaccurate and teaching and learning in such circumstances are difficult. Video can accurately document events during delivery room (DR) resuscitation; it can therefore be used to assess compliance with guidelines and the effect of interventions.
In many hospitals photographs or video recordings of infants can only be made with written parental permission. It is difficult and may be inappropriate to prospectively obtain parental permission to video all DR resuscitations. When a high-risk delivery is imminent, parents are invariably anxious and mothers may be in pain or unwell. They may thus be unable to give permission appropriately. If previous permission is needed, it is only possible to record resuscitations where there is considerable advance warning. This seriously limits the applicability of the findings because infants born after an unanticipated emergency, likely to be the most ill and thus of most interest, are excluded.
We wished to audit the care given to newborns in the DRs of our hospital. Here, we describe the ethical and legal issues we encountered before we commenced recording DR resuscitations at our hospital.
AUDIT AND QUALITY ASSURANCE
Audit is the testing of current practice against previously established guidelines or benchmarks; this contrasts with research, which is aimed at the discovery of new knowledge that is intended ultimately to help establish guidelines. In general, previous informed consent of participants is a prerequisite for research, but not for audit. Quality assurance activities are an integral part of healthcare delivery.1 Healthcare providers recognise the need to ensure that their service is of a high quality and consistent with available resources; and that not to do so is unethical.2 First reported in the 1960s,3 videotaping emergency medical procedures has long been known to be useful in assessing and improving performance at resuscitation, and a valuable educational tool.3–13 Videotaping neonatal resuscitation was pioneered by Finer’s group in San Diego.4 6 7 Since 1999, they have used video to compare their practice with the standards set in the neonatal resuscitation programme.14 They reported deviations from guidelines in over half of resuscitations, which occur more frequently the more complex the resuscitation.4 They found the process to be a powerful educational tool, which was valuable in auditing and improving performance.
PERMISSION FOR VIDEO RECORDING
A US survey of more than 200 trauma centres reported that among institutions where resuscitations were recorded, videotaping was neither mentioned in the departmental consent form nor was written permission obtained from the patient or family in 98%.5 No centre reported encountering problems with patient confidentiality or consent. Finer’s recordings are a quality assurance study protected by California state law; written permission from parents is not required. In Australia, trauma resuscitations have been videotaped at the Royal Melbourne10 and the Royal Children’s Hospitals in Melbourne.15 At both, approval from the human research and ethics committees (HREC) was sought but deemed unnecessary as the studies were audits of clinical practice and not research.
Videotaping neonatal resuscitation is a quality assurance activity as defined by the National Health and Medical Research Council (NHMRC) of Australia2 as the primary purpose is to monitor, evaluate and improve the quality of health care. According to NHMRC,2 audits do not require approval by a HREC or informed consent if the study is consistent with National Privacy Principle 2.1(a) (see box 1).
Box 1 National privacy principle 2.1(a)
Personal information is not used or disclosed for a purpose other than the primary purpose of collection unless directly related thereto.
Participants are unlikely to suffer burden or harm.
It poses no risk for any patients beyond those of their routine care.
It poses no burden on patients beyond those experienced in their routine care.
It is not conducted by a person who does not normally have access to the patient’s clinical records.
It does not risk breaching the confidentiality of any individual’s personal information, beyond that experienced in the provision of routine care.
It does not involve any clinically significant departure from the routine clinical care provided to the patients.
It does not involve the randomisation of or the use of a control group or use of placebo.
It does not seek to gather information about the patient beyond that collected in routine clinical care.
It does not potentially infringe the rights, privacy or professional reputation of carers, healthcare providers or the institution.
WAIVING INFORMED CONSENT IN EMERGENCY RESEARCH
In an emergency it is difficult to discuss and seek consent for recruitment to a study. Thus if previous consent is mandatory, many important and potentially life-saving measures cannot be studied. To facilitate appropriate emergency research the NHMRC suggests that a “waiver of informed consent” may be granted by HRECs providing four criteria are fulfilled16:
Inclusion in the research project is not contrary to the interests of the patient.
The research is intended to be therapeutic and the research intervention poses no more of a risk than that which is inherent in the patient’s condition and alternative methods of treatment.
The research is based on valid scientific hypotheses that are supported by a reasonable possibility of benefit over standard care.
As soon as reasonably possible, the patient’s relatives or legal representatives will be informed of the patient’s inclusion in the research and of the option to withdraw from the research without any reduction in the quality of care.
This is consistent with US regulations where, in 1996, the Food and Drug Administration amended their regulations to allow emergency research under an exception from informed consent (EFIC), the 21 CFR 50.24 rule.17 This regulation permits waiver of consent in minimal-risk experiments where consent would be impossible to obtain because of the nature of the emergency. Similarly, the UK Medical Research Council18 says that “provided that the specific approval of a research ethics committee has been obtained for the project overall, it is ethical to carry out research involving children on occasions of extreme urgency without obtaining prior consent” and that “the parents and child must be informed about the research as soon as possible afterwards and their consent for future involvement sought.” Important trials that have contributed to improvements in emergency care of infants19–21 and adults22–27 have used such waivers.
As many neonatal resuscitations occur in emergency situations, provisions similar to those that apply to a “waiver of informed consent”16 should be applied when seeking permission to video DR resuscitation.
RESEARCH AND ETHICS COMMITTEE APPROVAL
While video recording resuscitations is an audit of clinical practice, it is a sensitive matter with the potential to cause anxiety for both families and staff. Also there is the potential to breach the confidentiality of individual’s personal information and to infringe the privacy of carers (see box 1). We therefore submitted a proposal to video DR resuscitation to our hospital’s HREC for approval.
To protect the anonymity of the patient, families and staff, we proposed
To position the camera above the resuscitation trolley to show only the baby, the forearms of the staff present and interventions used
Not to have the date or time identified on the recordings
To further de-identify the tapes and store them securely
Not to make copies for individuals outside the research group, including parents, as we could not guarantee confidentiality of recordings not in our possession.
We proposed to prospectively seek parental permission where possible. Where impractical to do so, we proposed to record the resuscitation, to subsequently explain the study to parents and seek their permission to view the recordings. Should they not permit us to view the recordings, we proposed to erase them without review. Should they permit us to view them, we proposed to seek their written permission to extract data from the video for collection and to retain recorded material for educational purposes, including showing them to medical and nursing colleagues from our own and other institutions.
The HREC endorsed our application. This process had many benefits; it allowed us explore our own concerns about the study and it reaffirmed institutional support for audit. Also, it enabled us to share our observations, as many journals require that any study involving human subjects has HREC approval before accepting it for publication.
A concern for staff attending resuscitations is the potential for video recordings to be used for medicolegal purposes. A US survey of trauma centres found medicolegal concerns were a major reason why trauma resuscitations had never been recorded in many centres.5 Interestingly, among centres that had previously recorded resuscitations, lack of staff participation and adequate personnel, rather than medicolegal concerns, were reported as the reasons for no longer recording resuscitations. No centre reported problems with tapes being sought for medicolegal purposes. Finer’s recordings are protected by California state law and are not discoverable in legal cases. As our recordings are de-identified, subsequent identification of infants is difficult. As no medicolegal concerns have, as yet, arisen, it is unclear whether infants could be identified with sufficient certainty to render them admissible as evidence in court.
ACCEPTABILITY OF VIDEORECORDING TO FAMILIES AND STAFF
Since January 2004 we have recorded 165 resuscitations. Parents of two infants requested that the recordings be erased without review. Parents of 163 infants have given their permission to extract data from the recordings and keep them for educational purposes. Five parents refused permission for their infant to be recorded in the DR. We prospectively obtained permission from parents of many infants who were not ultimately recorded, frequently because an anticipated high-risk delivery did not occur (for example, resolved threatened preterm labour), less often because an investigator was not available when the infant delivered. As yet, no parent has expressed difficulty with the study.
Neonatal medical and nursing staff are accustomed to scrutiny of their practice for quality assurance purposes and accept video recording as little different from being observed and instructed by senior colleagues. As yet, no staff member has expressed difficulty with the study; indeed many senior and junior medical and nursing staff have sought and been given feedback, and have found it useful to review their own performance.
We have made video recordings of neonatal resuscitation to objectively assess our performance. They have allowed us to identify areas of practice that can be improved. Videotaping has allowed staff involved at resuscitations to discuss concerns about the conduct of particular resuscitations. It has been an invaluable teaching tool, giving staff an experience of high-risk resuscitations not previously available and has enabled us to contribute to the literature on neonatal resuscitation.28–32
We would like to thank the following: the infants and their parents for their altruism at a most difficult time of their lives; Professors Neil Finer and Wade Rich at UCSD for their advice and support; Professor James King, Chairman of the Royal Women’s Hospital Research Committee; Ms Elizabeth Kennedy, Royal Women’s Hospital Corporate Counsel; and the medical and nursing colleagues at the Royal Women’s Hospital, Melbourne.
Competing interests: None.
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