Rapid Responses to:
|
|
a response to recent correspondence • Changing the BMJ's position on informed consent would be counterproductive • Informed consent
Rapid Responses: Rapid Responses published:
-
![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Informed Consent - The Role of Research Ethics Committees
- Terence W Wiseman (14 September 1998)
-
Informed consent, neonatal research and audiotaping of conversations.
- T H H G Koh (30 October 1998)
-
Re: Informed consent, neonatal research and audiotaping of conversations.
- Brian Morgan (2 November 1998)
-
Implications of Dutch law on clinical trials in Intensive Care medicine
- Jozef Kesecioglu, Marcus J. Schultz, Peter Bruins, Jacintha Maas, Rob B. de Wilde, and Jozef Kesecioglu (11 July 2004)
|
|
|||
|
Terence W Wiseman
Send response to journal:
|
In all the articles and comments on informed consent in research I came across not one mention of Research Ethics Committees! Surely all involved in any form of research in the NHS are aware that ALL research protocols must be approved by either a Multi-Centre Research Ethics Committee (MREC) or a Local Research Ethics Committee (LREC). One of the tasks of the these committees is to ensure that the guidelines on informed consent are understood by the researchers concerned and that the Patient Information Sheet and the Consent Form are written in such a way the the patient DOES give informed consent. If anyone is carrying research within the NHS and are not obtaining REC consent then they are guilty of professional misconduct. Scientific journals (including the BMJ) should require copies of the REC approval letter before publishing any papers in this field. Terence W. Wiseman Lay Member - Local Research Ethics Committee. |
|||
|
|
|||
|
T H H G Koh, Senior Specialist in Neonatology Kirwan Hospital, Townsville, Queensland 4817 AUSTRALIA
Send response to journal:
|
Dear Editor, The many difficult challenges that neonatal researchers face when obtaining informed consent for randomisation have been comprehensiveley covered by your editorial (ref.1 ) and the many letters subsequently. I would like to draw attention to another hitherto not mentioned issue. Apart from the shock and confusion of giving birth to a sick baby the mother may be under medication which could further compromise her comprehension. In our evaluation of audiotaping of parents-neonatologist conversations and giving the recording to the parents (ref.2) 48% of the mothers had some analgesia or sedation during their first meeting with the neonatologist. In the same study there were two mothers who, on listening to the tape recording, could not recall that the conversation ever took place. Clinical research is essential and we must throw the baby out with the "informed consent" bath water. However we must continue to strive to ensure that the bath water is not too hot for the parents. Audiotaping of the discussion with the parents when the informed consent are obtained may be another adjunct to promote parental understanding. Such an approach guarantees that informed consent was properly carried out and will allow the parents to, if they so wish, listen to the explanation repeatedly should they need clarifictaion. Yours sincerely, Koh T.H.H.G. Senior Specialist in Neonatology, FRCPCH, FRACP, Kirwan Hospital Townsville Queensland 4817 AUSTRALIA Smith R. Informed consent: the intricacies. BMJ 1997; 314: 1059-106 |
|||
|
|
|||
|
Brian Morgan, Freelance Journalist Cardiff
Send response to journal:
|
Taping conversations which lead to consent may be valuable additional protection for the parents of the baby entering a study and the clinician undertaking the research - but if it is the case that a proportion of the parents giving consent do not afterwards remember doing so, even when asked to listen to the tape, then surely this tells you something about the quality of the consent being given? There is one school of thought which suggests that valid consent cannot be given by parents recovering from medication or traumatised by the unexpected illness of their new baby. If the illness is not entirely un-expected, say in a baby being delivered preterm, then as suggested by, amongst others, the Association for the Improvement of Maternity Services, shouldn't consent be sought before delivery and at a considered pace? Brian Morgan |
|||
|
|
|||
|
Jozef Kesecioglu, staff-member Cardio-thoracic&Neurosurgical Intensive Care University Medical Center Utrecht, Postbox 85500, E03.511, 3508GA Utrecht, The Netherlands, Marcus J. Schultz, Peter Bruins, Jacintha Maas, Rob B. de Wilde, and Jozef Kesecioglu
Send response to journal:
|
Editor- Some years ago, Doyal and collegues have discussed the acceptable limits of informed consent in medical research performed on either competent or incompetent patients.1 More recently Singer and Müllner expressed their concern that due to the European "Clinical Trials" Directive 2001/20/EC,2 clinical trials for emergency medicine patients would be impossible to perform.3 Intensive Care patients, who are temporarily incapable of giving informed consent, form a similar population.
In the Netherlands, the law on “Medical Research Involving Human Subjects”(http://www.ccmo.nl,) regulates medical research. For patients who are incapable of giving informed consent the law specifies that either a legal representative or a person authorized by the patient himself, the spouse or another companion in life are eligible to give written consent. This differs from the law on “Medical Treatment Agreement Act” (http://www.minvws.nl), which aims to assure that the patient is adequately informed with regard to giving consent for a certain treatment. The latter law accepts parents, adult children, and siblings as representatives for permission for a medical treatment, whereas the former law does not allow these persons to give consent for medical research. We have recently analysed recruitment of Intensive Care patients in three Dutch university hospitals participating in a trial. At present 28 patients with respiratory failure were randomised (table). From the 37 patients who could not be randomised because there was no written consent, 30 had no adequate party as stated in the law. Moreover, certain age groups (< 30, 51-60 and >70 years old) whose spouse or life companion either did not yet exist or was deceased were more affected. Unless amended, this situation results in the exclusion of a certain group of patients and potentially affects the outcome of studies performed in the Netherlands. Moreover, the findings of Dutch studies performed on patients incapable of giving informed consent cannot be generalised to the whole population. References 1. Doyal L, Tobias JS, Warnock M, Power L, Goodare H. Informed consent in medical research. BMJ. 1998;316:1000-1005. 2. Singer EA, Müllner M. Implications of the EU directive on clinical trials for emergency medicine. BMJ 2002; 324: 1169-70. 3. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (2001). Off J Eur Comm: L 121–134. Authors Marcus J. Schultz, internist-intensivist. Department of intensive Care, Academic Medical Center, University of Amsterdam, Amsterdam Peter Bruins, anaesthetist-intensivist. Division of Perioperative Medicine and Emergency Care, Cardiothoracic and Neurosurgical Intensive Care, University Medical Center Utrecht Jacinta Maas, neurologist-intensivist. Department of intensive Care, Leiden University Medical Center, Leiden Rob B. de Wilde, research nurse. Department of intensive Care, Leiden University Medical Center, Leiden Jozef Kesecioglu, anaesthetist-intensivist. Division of Perioperative Medicine and Emergency Care, Cardiothoracic and Neurosurgical Intensive Care, University Medical Center Utrecht, the Netherlands.j.kesecioglu@azu.nl Competing interests: None declared |
|||