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EDITOR'S CHOICE: Trish Groves Whose research is it anyway? BMJ 2006; 333: 0-f [Full text]

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It is the participant’s research.

Jeevan P Marasinghe, Amarasinghe A A W,MD, Mcdonough, Georgia, USA.   (22 July 2006)

Confidentiality begins where?

Peter A West   (23 July 2006)

It is the participant’s research. 22 July 2006
Jeevan P Marasinghe, Registrar in Obstetrics and Gynecology,General Hospital( Teaching), Peradeniya, Sri Lanka. 20300, Amarasinghe A A W,MD, Mcdonough, Georgia, USA. Send response to journal: Re: It is the participant’s research.	Informed consent in medical issues has a great historical value and had been documented in Egyptian civilization and in Greek and Roman cultures. Despite the widespread agreement on the importance of informed consent in clinical research, uncertainty remains about the adequacy, usefulness and practical problems of current consent procedures and documentation. No doubt that it is mandatory in current clinical background and the editorial by Trish Groves (1) highlights the importance of it and sometimes the difficulties the researcher has to tackle in carrying out the study. It is mostly due to a minority of people who do not value the dignity and privacy of the participant. People are knowledgeable and informative than ever before and they are interested on what is happening around them. Some participants are smart enough to give their consent only to studies which are approved by a board of ethics and they are bold enough to inquire about it. So the clumsy researcher may find it difficult to thrive on the hands of smart participants. But the things may not be as hard as we think since most of the participants in medical research are satisfied simply for being able to participate in a medical research and being able to help medical science(2). In contrary to these facts, subgroups of our population are not that knowledgeable and some may be weak enough in their ability to catch and recollect the most basic information about the study (3).This highlights the importance of effective strategies such as additional time and resources for obtaining consent and repetition of information if necessary. But this may be time consuming and laborious documentation of several mechanical aspect of the research process may not be practical especially in developing countries and questions the true comprehension of the participants (4).Culturally appropriate methods in obtaining the informed consent and sharing the information about the research are warmly welcome and highly evaluated. People have tried several innovative and user-friendly ways of obtaining informed consent which have ensured initial and continuous good comprehension of research participants (5), (6 ),(7 ). At the end, it is our moral duty and ethical responsibility to make sure that the participants of a research are respected and their privacy are protected. So if I am to answer the editorial headline, it is the participant’s research and it is their information that are being manipulated, rearranged and presented for the benefits of the medical science and future generations to come. References. (1)Trish Groves, Whose research is it anyway? BMJ 2006; 333(22 Jul). (2)Pope JE et al. Are subjects satisfied with the informed consent process? A survey of research participants Rheumatol.2003 Apr; 30(4):646- 7. (3)Griffin JM et al, Long Term Clinical trials: How much information do participants retain from the informed consent process? Contemp Clin Trials 2006 May 12. (4)Bhutta ZA, Beyond informed consent. Bull World Health Organ 2004 Oct; 82(10):771-7. (5)Joseph P et al, The use of an educational video during informed consent in an HIV clinical trial in Haiti Acquir Immune Defic Syndr, 2006 Jul 10. (6)Woodsonq C, Karim QA, A model designed to enhance informed consent: experiences from the HIV prevention trials network. Am J Public Health 2005 Mar; 95(3):412-9. (7)Dobscha SK et al, Use of videoconferencing for depression research: enrollment, retention and patient satisfaction .Telemed J E Health .2005 Feb; 11(1):84-9. Competing interests: None declared
Confidentiality begins where? 23 July 2006
Peter A West, Senior Research Associate, YHEC, University of York York and London Send response to journal: Re: Confidentiality begins where?	I have some sympathy with those who argue that a patient's data should be kept confidential. As a researcher, given an individual's full post code, age and symptoms, it is possible that I could track them down. But since the most detailed data I might access would be hospital data, it is relatively easy to track down individuals with particular symptoms, particularly outside large urban areas, by simply going to the relevant ward or clinic. I might spot lots of people I know or want to know simply by hanging around different parts of the local hospital. Indeed, once the finer granulation of post code is removed from any data I can access, this would probably be the easier way to find things out about individuals. My point? NHS healthcare is not delivered with total confidentiality. In- patients are not seen and their cases discussed in soundproof, wholly private rooms but behind nylon curtains round the beds, beds clearly labelled with their names. Outpatients are gathered in smaller or larger groups in areas where their diagnosis or potential diagnosis can be obvious to any passing observer and where their names are often shouted across the waiting room. A visit to a radiotherapy unit, for example, reveals many of the local population currently being treated for cancer. If we are serious about giving patients full confidentiality, then should we not treat everyone in total privacy, with no other patients present, no other visitors and the bare minimum of staff? But we cannot. So having compromised local confidentiality in so many ways, why is it so important to frustrate researchers with arguments such as "if there are less than five cases in this cell, we cannot tell you" even when no postcode or other identifier is being provided? 5 may be a dangerously low number of cases for a clinician or trust to provide per year so it might be worth knowing this and other things, so long as there is reasonable protection for the patient. Ommitting the final elements of the postcode is surely good enough for this purpose when a simple visit to any part of the NHS will reveal the faces and many of the names of current patients. Competing interests: Peter West is a health economist with a contract research company owned by the University of York. The company has carried our research for the NHS, DH and private pharmaceutical and device companies. He is currently on a full time secondment to a public sector body but is writing in a personal capacity