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Inicio Spanish Journal of Legal Medicine Accesibility to informed consent documents in medical scientific societies
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Vol. 42. Issue 2.
Pages 67-71 (April - June 2016)
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1293
Vol. 42. Issue 2.
Pages 67-71 (April - June 2016)
Brief report
DOI: 10.1016/j.remle.2015.09.001
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Accesibility to informed consent documents in medical scientific societies
Accesibilidad a documentos de consentimiento informado a través de las sociedades científicas
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Esperanza L. Gómez-Durána,b,c,
Corresponding author
elgomezduran@comb.cat

Corresponding author.
, Berta Ferran-Ballúsa, Laia Torrent Jansàa, Carles Martin-Fumadóa,c, Josep Arimany-Mansob,d
a Departamento de Medicina, Universitat Internacional de Catalunya, Barcelona, Spain
b Servei de Responsabilitat Professional, Colegio de Médicos de Barcelona, Consejo de Colegios de Médicos de Cataluña, Barcelona, Spain
c Institut de Medicina Legal i Ciències Forenses de Catalunya, Barcelona, Spain
d Unidad de Medicina Legal, Departamento de Salud Pública, Universidad de Barcelona, Barcelona, Spain
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Table 1. Accessibility to informed consent documents from scientific societies grouped by medical speciality.
Abstract
Introduction

Informed consent document (ICD) must be obtained in those cases defined by law. The development of ICD templates by experts in medical scientific societies would ensure the quality of the information procedure.

Method/results

This study tracked (October–December 2014) the website of 152 official scientific societies and identified ICD in just 25.66% of them (39 societies); 56.41% of them (22 societies) offered free access to ICD (462 documents), and the others, restricted public access. Among the 17 societies that offered ICD exclusively for members, access was achieved in 6 of them with a total of 52 ICDs obtained. A 19.04% of the specialties assembled the 94.94% above all the ICD founded.

Discussion

The development and accessibility of ICD built by certain scientific societies is wide in certain specialties; however, despite its enormous potential, in the overall analysis it remains insufficient.

Keywords:
Autonomy
Informed consent document
Consent
Scientific society
Patient safety
Resumen
Introducción

El consentimiento informado precisa ser recogido por escrito en los supuestos establecidos por ley. El desarrollo experto de modelos de documentos de consentimiento informado (DCI) por las sociedades científicas ofrecería garantías a pacientes y profesionales sobre la adecuación del procedimiento de información.

Metodología/resultados

El presente estudio localizó, entre octubre y diciembre de 2014, las webs de sociedades científicas oficiales (152), identificando DCI en tan solo un 25,66% de ellas (39 sociedades), entre las cuales un 56,41% (22 sociedades) ofrecían los DCI en acceso libre (462 DCI), y las restantes, mediante acceso restringido. Se logró acceso a 6 de las 17 sociedades que ofrecían DCI exclusivos para socios, identificándose 52 DCI más. Un 19,04% de las especialidades agruparon el 94,94% de los DCI localizados.

Discusión

El desarrollo y la accesibilidad de DCI elaborados por las sociedades científicas es prolijo en determinadas especialidades, considerándose globalmente insuficiente en el conjunto de sociedades científicas, pese a su enorme potencialidad.

Palabras clave:
Autonomía
Documento de consentimiento informado
Consentimiento
Sociedad científica
Seguridad clínica
Full Text
Introduction

The respect for the patient's right to decide is a fundamental legal principal in health care, whose importance is acknowledged by health professionals.1 This right is exercised through informed consent, the procedure by which the patient, duly informed and competent, freely decides among the clinical options available.2

Both autonomous community3 and national legislation, by way of Law 41/2002, basic regulation on patient autonomy and the rights and obligations in terms of clinical information and documentation,2 establish that consent, as a general rule, will be verbal; however, written consent must be provided in certain cases which are generically described as: “surgical intervention, diagnostic procedures and invasive therapies and, in general, the application of procedures that involve risks and discomforts with a well-known and foreseeable negative impact on the patient's health”.2

Beyond the misguided myths existing regarding the informed consent document (ICD),4 appropriate patient information on the risks and possible alternatives is essential.5,6 It has been reported that the practice and the current standards for informed consent are often not useful for the patient and carry unnecessary risks in terms of medical professional responsibility for professionals.7,8 While patient information must be personalized, expert development of personalized ICD templates is recommended, increasing the guarantees for patients and professionals. This is being done by commissions designated for this purpose by autonomous communities9 or scientific societites,10 and they have been legally used as a standard of appropriate information.11,12 Access to and availability of those ICDs is basic, given that it guarantees patient autonomy and can serve to support professionals.

This study analyses the availability of such ICD templates through the official websites of the Spanish scientific societies.

Methodology

A list of 174 scientific societies was created based on the list of Scientific Societies of Health Professionals of the Ministry of Health, Social Services and Equality13 and the List of Spanish Medical Societies of MediRank.14 Between October and December 2014, we investigated whether the different societies had webpages, if reference was made to the ICDs in these, and if ICDs were available online, recording the access route to them (limited to members or open). Those societies which had a webpage but did not have an ICD on the webpage (whether open or with limited access) were contacted by email to ask whether they had developed an ICD, and if so, the way of accessing this.

Results

Of the 174 scientific societies, a total of 22 (12.64%) were excluded from the study as not having an official webpage. In the webpages of the remaining 152 (87.36%) societies, only 39 explicitly contain an ICD (25.66%), 22 of them through an open access section and the other 17 with restricted or authorized access. In the specific section of the 22 webpages with open access, a total of 462 ICDs were located. Contact was made with the 17 societies that requested authorized request, and we obtained a response in only 35.29% of cases (n=6). Among these we located another 52 ICDs, which, added to the 462 ICDs registered in open access, made a total of 514 registered ICDs. 113 scientific societies that did not contain ICDs in their webpage were contacted by email, obtaining responses from 53 of them (46.9%); all confirmed that they had not developed ICDs. No response was obtained from the remaining 60. The results are shown in Table 1. The table, for better understanding, groups the different societies together by each speciality, indicating in another column the number of societies which, within this group of specialities, have an official webpage. Finally, in another column, the type of access to ICDs registered for each of the groups of different specialities is shown, indicating in parentheses, in the event that the ICD was located, regardless of the type of access, the number of ICDs located.

Table 1.

Accessibility to informed consent documents from scientific societies grouped by medical speciality.

Medical speciality-specific area  Societies in the speciality  Societies with web  ICD availability on the web, type of accessa (number of ICDs available)  Percentage of ICD (out of a total of 514 ICD) 
Allergology  1 Open (1)
2 NO-confirmed 
0.19 
Anatomic pathology  1 NO-confirmed   
Anaesthesia and resuscitation  1 NO-no response   
Angiology  1 Authorized-no response   
Primary care  3 NO-no response
1 NO-confirmed 
 
Biochemistry and molecular pathology  1 NO-confirmed   
Care quality  1 NO-confirmed   
Cardiology  1 Open (8)
2 NO-no response 
1.56 
Surgery  10  2 Authorized (17+8=25)
1 Authorized-no response
1 NO-confirmed
3 NO-no response 
4.86 
Maxillofacial surgery  1 Authorized (16)  3.11 
Plastic surgery  1 Authorized (3)
1 Authorized-no response
4 NO-confirmed 
0.58 
Thoracic surgery  1 Open (52)
1 NO-no response 
10.12 
Vascular surgery  1 Authorized-no response   
Dietetics and nutrition  2 NO-confirmed
2 No response 
 
Digestive  2 NO-no response   
Scientific documentation and information  1 NO-confirmed   
Pain  1 Open (39)  7.59 
Drug dependency  1 NO-no response   
Medical education     
Electromedicine  1 NO-no response   
Endocrinology  2 NO-confirmed
1 NO-no response 
 
Infectious disease. AIDS  1 NO-confirmed   
Pharmacy  1 NO-confirmed
2 NO-no response 
 
Clinical pharmacology  1 NO-confirmed   
Physiology  1 NO-no response   
Genetics  1 NO-no response   
Geriatrics  1 NO-confirmed   
Gynaecology and obstetrics  2 Open (24+5=29)
1 NO-confirmed 
5.64 
Haematology  1 Open (1)
1 NO-no response 
0.19 
Medical hydrology     
Health informatics  1 NO-no response   
Aerospace medicine  1 NO-no response   
Sports medicine     
Aesthetic medicine  1 Authorized-no response   
Forensic and legal medicine and health law  1 NO-confirmed
2 NO-no response 
 
Imaging medicine  1 Free (4)
1 NO-confirmed
4 NO-no response 
0.78% 
Intensive medicine  1 NO-confirmed   
Internal medicine  1 Open (16)  3.11 
Marine medicine  1 NO-confirmed   
Nuclear medicine  1 Open (4)  0.78 
Palliative medicine  1 NO-confirmed   
Preventive medicine and public health  3 NO-confirmed
1 NO-no response 
 
Occupational medicine  1 NO-no response   
Alternative medicine  1 NO-confirmed
2 NO-no response 
 
Microbiology and parasitology  1 NO-confirmed   
Nephrology  1 NO-confirmed   
Pulmonology  1 Open (53)
1 Authorized-no response 
10.31 
Neurosurgery  1 Authorized-no response   
Neurology  1 NO-confirmed
2 NO-no response 
 
Ophthalmology  1 Open (4)
1 NO-confirmed
4 NO-no response 
0.78 
Oncology  1 Open (1)
1 Authorized-no response
3 NO-confirmed 
0.19 
Otorhinolaryngology  1 Authorized-no response   
Paediatrics  21  20  2 Open (13+1=14)
1 Authorized-no response
7 NO-confirmed
10 NO-no response 
2.72 
Psychiatry, psychology  13  10  3 NO-confirmed
7 NO-no response 
 
Hospital radio-physics  1 NO-confirmed   
Radiology  1 Open (125)
1 Authorized-no response
1 NO-confirmed 
24.32 
Rehabilitation  1 NO-no response   
Human reproduction  2 Open (14+5=19)  3.70 
Rheumatology  1 Open (17)
1 NO-confirmed 
3.31 
Environmental health  1 NO-confirmed   
Traumatology and orthopaedics  3 Open (53+1+21=75)
1 Authorized (8)
2 NO-confirmed
1 NO-no response 
14.59
1.56 
Emergency  1 NO-no response   
Urology  1 Authorized-no response   
Total  174  152  (514)  100 
a

Open (ICD available with open access); Authorized (ICD available with restricted access); Authorized-no response (ICD presumably available with restricted access, unsuccessful attempt to contact by email); NO-confirmed (no availability of ICD confirmed); NO-no response (no ICD on line, unsuccessful attempt to contact by email.

Discussion

Accessibility to ICDs by professionals is key. This study appropriately reflects, in our opinion, the accessibility that professionals from different specialities have to ICDs through the websites of their scientific societies, given that the available ICDs were located through 71.8% of the websites that had a dedicated space for these. No other studies have been found that analyze the ICDs available through scientific societies.

Although most of the scientific societies identified have an official webpage (87.35%), of those only 25.66% devote a space on their website to ICDs and therefore, it can be understood that the majority of the scientific societies have not specifically worked on the patient information process within their speciality nor have they prioritized the dissemination of the work in that respect. This is a striking result when the vast majority of specialities provide for the completion of procedures for written consent.

Furthermore, the mean of ICDs by speciality among those did have them was 18.35. 19.04% (12) of the 63 specialities identified registered 94.94% (488) of the 514 ICDs located: up to 24.32% of the total of ICDs in the specialities of Radiology (125), followed by Traumatology and Orthopaedics (83), Pulmonology (53), Thoracic Surgery (52), Pain Treatment (39), Gynaecology and Obstetrics (29), Surgery (25), Human Reproduction (19), Rheumatology (17), Maxillofacial Surgery (16), Internal Medicine (16) and Paediatrics (14). This may reflect the multiplicity of procedures that fall under these specialities requiring written consent and/or special sensitivity in these scientific societies towards patient autonomy and legal safety with regard to professionals (among them are specialities with a greater number of claims for presumed medical professional liability in our environment).15 This second option may be fundamental if we consider the existence of specialities that involve procedures requiring written consent and in which we confirmed the lack of development of an ICD by the corresponding scientific societies.

On the other hand, and maybe as a limitation to this study, there are specialities in which not all interventions require the development of an ICD.

Lastly, 56.41% of societies with ICDs and 89.88% of the ICDs located are provided with open access, which exemplifies the function of information dissemination of these documents and of the societies that create them.

Although patient information is a fundamental part of health care, there are currently few scientific societies that make efforts to establish standards in the information process in the area of their speciality and to optimize their dissemination through official websites. On the other hand, those that do so, create a considerable amount of ICDs as a sample of the potential of this work.

We consider that the development of ICD templates by the scientific societies would establish a framework of better guarantees for professionals and patients for the benefit of patient rights and the legal safety of professionals.

Funding

There is no funding.

Conflict of interest

There is no conflict of interest.

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Please cite this article as: Gómez-Durán EL, Ferran-Ballús B, Torrent Jansà L, Martin-Fumadó C, Arimany-Manso J. Accesibilidad a documentos de consentimiento informado a través de las sociedades científicas. Rev Esp Med Legal. 2016;42:67–71.

Copyright © 2015. Asociación Nacional de Médicos Forenses
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