Ethics in HIP

The HIP consortium will carefully address all ethical, legal, social and safety issues as they arise. Given the particular importance attached to ethical issues in neonatal research, a separate work package for the HIP Study, Study Monitoring and Ethics has been developed (WP 05). An ethics advisory board (EAB) and a data and safety monitoring board (DSMB) have been established to oversee all activities relating to study ethics.

The importance of ethics

We are very aware of the need for rigorous ethical standards in neonatal research. This is essential in therapeutic research involving ELBW infants within the first days of life. We have therefore developed a separate work package for this study, the ethics work package (WP 05). An ethics advisory board (EAB) and a data and safety monitoring board (DSMB) will be established to oversee all activities relating to study ethics. Article 2 of the EU clinical trial directive (2001/20/EC) recommends that the ethics committee should consist of healthcare professionals and non medical members whose responsibility it is to protect the rights, safety, and well being of human subjects involved in a trial and to provide public assurance of that protection by, among other things, expressing an opinion on the trial protocol, the suitability of the investigators and the adequacy of facilities, and on the methods and documents to be used to inform trial subjects and obtain their informed consent. It is our priority to ensure that all participating centres are in full compliance with EU, national and local ethical guidelines. The consortium will carefully address all ethical, legal and safety issues as they arise during the conduct of this trial.

Newborn in Clinic

Hypotension in the ELGAN is a complex area where many small studies have been performed but none have addressed the single most important question: How do you define shock or hypotension in the ELGAN. It is only then one can decide on the most appropriate intervention. The main reasons why there are no large controlled studies evaluating the management of hypotension in the preterm infant are because of the ethical and logistic difficulties involved. By making ethics an ongoing concern throughout the project we will ensure that the needs of these vulnerable babies and their families are met. Before embarking on any proposed trial involving the most vulnerable newborn it is of the utmost importance that there is clinical equipoise, i.e. there is present or imminent controversy in the clinical community over the preferred treatment. This aspect of clinical care certainly meets this definition.

We have satisfied ourselves that having extensively reviewed and published literature on this aspect of care there is no evidence to support (i) current diagnosis of hypotension (ii) current therapeutic modalities and finally (iii) there is no evidence that current management strategies result in any improvement in both short term and long-term outcome.