Whose research is it anyway?
BMJ 2006; 333 doi: https://doi.org/10.1136/bmj.333.7560.0-f (Published 20 July 2006) Cite this as: BMJ 2006;333:0-fAll rapid responses
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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
Competing interests: No competing interests
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
Competing interests: No competing interests