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LETTERS: Michael Baum, I G Kestin, S E Josse, David H Brewster, Marion R S Bain, James W T Chalmers, Ann Gould, John A Dewar, W David George, John Nottingham, Andrew J Winter, David Mullis, Keith W Radcliffe, D T Wilcox, F Wilcock, L Spitz, and A Pierro Informed consent BMJ 1998; 317: 947a [Full text]

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Informed consent in trials: a psychologist's perspective

Sarah Clement   (30 October 1998)

Is the birth plan an advance directive?

Catherine Ralph   (17 March 1999)

Informed consent in trials: a psychologist's perspective 30 October 1998
Sarah Clement, Lecturer in Health Services Research Department of General Practice and Primary Care, Guy's, King's and St Thomas's School of Medicine Send response to journal: Re: Informed consent in trials: a psychologist's perspective	I would like to contribute a psychologist's perspective to the ongoing debate about informed consent in randomised controlled trials (1). One of the central issues debated has been the ethics of withholding the fact of randomisation from participants, for example, in the trials of support after stroke (2) and of sore throat management (3). Psychologists recognize that there are occasions when it is necessary to withhold full information from participants, to minimize bias. However, our professional code of conduct (http://www.bps.org.uk/charter/codofcon.htm) states that in these situations we must "provide … full information retrospectively about the aims, rationale and outcomes of the procedure as far as is consistent with a concern for the welfare of participants". There may be a case for introducing a similar requirement for medical researchers. The planned debriefing of participants would avoid the potential distress of those who discover from sources other than the investigators that important information about the research they had participated in was withheld from them (4). The most practical way of debriefing participants would be to include the debriefing information with a summary of research findings offered to participants, with an invitation to contact the researcher for a verbal discussion, if the participant wishes. There has been much speculation about the possible psychological harm that may result from partial informed consent (4). The introduction of debriefing may help to alert investigators to the existence and extent of any such harm. Formal assessment of participants' feelings after debriefing, and research investigating lay views about informed consent in different types of trials, would provide additional evidence to help guide research practice. I agree with Warnock that we need to "distinguish things that differ" (5). The introduction of debriefing, and research on patients' views and experiences, would help us to do this. For example, do patients feel differently about being randomised to different treatments without full informed consent (as in the sore throat trial (2)) than they do about being randomised to other, non-treatment interventions, such as additional social support (1), information leaflets, or health promotion advice? Do participants believe that it is acceptable not to be informed of randomisation if assigned to the control group receiving routine care, but not if assigned to the intervention group receiving a new type of care? The answers to questions like these would help investigators to make their own informed decisions about the amount of information to provide at the time of consent. 1. Baum, M, Keston IG, Josse SE et al. Informed consent. BMJ 1998; 317:947. 2. Dennis M, O' Rourke, S, Slattery J, Staniforth T, Warlow C. Evaluation of a stroke family care worker: results of a randomised controlled trial. BMJ 1997; 314: 1071-7. 3. Little P, Williamson I, Warner G, Gould C, Gantley M, Kinmonth AL. Open randomised trial of prescribing strategies in managing sore throat. BMJ 1997:314:722-7. 4. Doyle L. Informed consent: a response to recent correspondence. BMJ 1998; 316;1000. 5. Warnock M. Informed consent: a publisher's duty. BMJ 1998; 316:1002.
Is the birth plan an advance directive? 17 March 1999
Catherine Ralph, Specialist registrar in anaesthetics Derriford hospital Send response to journal: Re: Is the birth plan an advance directive?	EDITOR- Following the recent ruling regarding St George's Healthcare NHS Trust v S and consenting or refusing to medical treatment our trust has issued guidance on issues relating to consent to treatment and the Mental Health Act. Incorporated in the guidance is the advice from the BMA : Advance statements about Medical Treatment: BMJ 1995. I am not sure if a birth plan is an advance directive. These birth plans are written by a competent person giving insructions about a specific event ( labour). Usually they are witnessed by the midwife or partner. Not infrequently I have seen the birth plan clearly and unambigously state " I do not want an epidural in labour". Until recently if this woman then requested epidural analgesia in labour I would have complied with the request following oral consent with the midwife and if possible the partner as witness. The labouring woman may be in pain and exhausted and I understand she may not be competent to give consent in her distressed state. Should I deny this woman epidural analgesia and comply to her written advance directive?