Human subject research ethics in software engineering

Ética na pesquisa com seres humanos é tema de discussão desde o final da Segunda Guerra Mundial. Desde então, as ciências sociais e de saúde estabeleceram uma base sólida para a minimização dos riscos aos sujeitos da pesquisa. Um elemento chave para a proteção dos sujeitos são os Comitês de Ética em Pesquisa (CEPs), que analisam os projetos quanto ao atendimento aos princípios de ética. Cada vez mais, as pesquisas e atividades industriais em Engenharia de Software (ES) envolvem seres humanos, mas esses projetos raramente são submetidos a CEPs. O modelo estabelecido para a análise dos projetos de pesquisa por comitês de ética foi baseado nas pesquisas em saúde, em que pode haver risco à vida e à saúde das pessoas. Embora os riscos nas pesquisas de ES sejam reduzidos, esses projetos também têm o potencial de causar dano a pessoas. Este artigo discute a necessidade de submissão a CEPs dos projetos de ES com envolvimento de seres humanos. Recursos de apoio ao pesquisador são propostos para se levarem em conta os riscos mais comuns nestes projetos.Palavras-chave: ética em pesquisa com seres humanos, engenharia de software.Human subject research ethics is a matter of regulation since the end of World War II. Since then, social and health sciences have established a sound basis for reducing risks in the involvement of human beings in research. A key factor for human subjects’ protection is the Institutional Review Boards (IRBs) that analyze if a given project respects ethical principles. Presently, Software Engineering research and industrial activities systematically involve people, but these projects are seldom submitted to IRBs. The established model for research project analysis by ethics committees has been based on healthrelated researches, in which risks to human life and health can be threatening. Although risks are lower, Software Engineering projects can bring harm to people. This paper discusses the need of submission of Software Engineering projects that involve humans to IRBs. Resources to aid the researcher in considering common risks in such projects are proposed.Keywords: research with human subjects, ethics, software engineering

The use of novel information technology in military medicine and mass casualty situation training

Tässä väitöskirjatyössä tutkitaan uuden mobiiliteknologian käyttöä sotilaslääketieteen ja suuronnettomuustilanteiden koulutuksessa. Yhteenvetona voidaan todeta, että uudesta informaatioteknologiasta on paljon hyötyä sekä pedagogisesti että teknisesti sotilaslääketieteellisessä koulutuksessa ja suuronnettomuustilanteiden lääkinnällisessä valmiudessa. Tutkimukseen valittiin seuraavat uudet informaatioteknologiat: lyhyet videoleikkeet (multimedia), mobiilit lääketieteen tietokannat ja RFID-teknologia (Radio frequency identification, radiotaajuinen etätunnistus). Sotilaslääketiede on osa kansallista terveydenhuollon järjestelmää, jossa tällaista tekniikkaa varten on eritystarpeita, kun kehitetään ensiavun ja ensihoidon opetusta kliinisesti vaativissa tilanteissa. Lääkintäaliupseerikurssin oppilaat (N=60) satunnaistettiin käyttämään joko kurkunpääputkea (LT), n=30 tai kurkunpäämaskia (ILMA), n=30. Kurkunpääputken (LT) sai onnistuneesti 10 kertaa peräkkäin paikoilleen 100 % ja kurkunpäämaskin (ILMA) 93,1 % oppilaista. Keskimäärin ensimmäinen onnistunut suoritus kesti hieman yli 20 sekuntia kummallakin menetelmällä, ja 10 suorituksen keskiarvo oli hieman yli 10 sekuntia. Kokemattomat ja kouluttamattomat lääkintäaliupseerikurssin oppilaat voivat oppia lyhyen videoleikkeen avulla varmistamaan hengitystiet kurkunpääputkella (LT) tai kurkunpäänaamarilla (ILMA) simuloidussa tilanteessa. VAS-asteikolla mitattu itsearviointi varmisti, että suoritus koettiin helpoksi. Mobiilia lääketieteen tietojärjestelmää ja sen käyttöä verrattiin lääketieteen opiskelijoiden ja varusmiespalvelustaan suorittavien lääkäreiden kesken. Tämä tutkimus on auttanut ymmärtämään sitä, miten nämä kaksi ryhmää käyttävät mobiilia lääketieteellistä tietojärjestelmää. Samalla se tarjoaa oivalluksia joihinkin pedagogisiin eroihin näiden kahden ryhmän välillä. Ryhmien väliset erot eivät kuitenkaan olleet tilastollisesti merkitseviä. Tutkimuksissa RFID-järjestelmä osoittautui toimivaksi. Verrattaessa järjestelmää tällä hetkellä käytettävään järjestelmään se paransi ratkaisevasti lääkinnällisen pelastustoiminnan valmiutta. Järjestelmä voidaan mukauttaa ilman vaikeuksia siviilialan suuronnettomuus- ja katastrofitilanteiden hallintaan. Testattu järjestelmä toteutettiin kaupallisesti saatavilla olevalla teknologialla (RFID ja matkapuhelinteknologia). Järjestelmän suoria hyötyjä ja sen toistettavuutta verrattiin suuronnettomuudessa käytettäviin paperisiin potilasluokittelukortteihin kahdessa erillisessä simuloidussa suuronnettomuustilanteessa Suomessa ja Ruotsissa. Molemmissa oli mukana monia viranomaistahoja. RFID-pohjainen järjestelmä, jossa potilaat luokiteltiin kiireellisyysluokkiin (triage) käyttämällä matkapuhelinjärjestelmää, lähetti välittömästi ja automaattisesti tilannetiedon harjoituksen johtoon ja sairaalaan. Molempien potilastietojärjestelmien avulla voitiin mitata tilannetietoisuuden kehittymistä suuronnettomuudessa siten, että verrattiin paperisista potilasluokittelukorteista saatua tietoa kännykän avulla saatuihin potilasluokittelutietoihin hoitoketjun eri vaiheissa. RFID-järjestelmä osoittautui helppokäyttöiseksi ja se paransi merkittävästi suuronnettomuuksien hallintaa ja tilannetietoisuutta. Koordinoivat yksiköt saivat RFID-järjestelmällä tietoja uhrien kiireellisyysluokista ja sijainnista yli tuntia aikaisemmin kuin perinteisellä menetelmällä. RFID-järjestelmä on helppokäyttöinen, nopea ja vakaa. Se osoittautui saumattomasti toimivaksi jopa ankarissa kenttäolosuhteissa. RFID-järjestelmä ylitti kaikilta osin perinteisen järjestelmän. Se tehosti merkitsevästi lääkinnällisen pelastustoiminnan organisatorista valmiutta.In developed countries, novel information technologies have become an essential part of education in modern healthcare field. However, using these expensive and continuously developing technologies is often a challenge both for trainers and for students. In military medicine, as a part of national healthcare services, there are special needs for this kind of technology, especially when optimizing first aid and initial treatment in challenging field situations. The purpose of this thesis was to study the use of novel information mobile technologies in the training for military medicine and mass casualty situations. Methods chosen were short video clips, mobile medical information system (IS) and radio frequency identification technology (RFID). Short video clips are potentially applicable as educational material in teaching advanced airway management and as the first means of introducing the use of a laryngeal tube (LT) or an intubating laryngeal mask (ILMA) to inexperienced military first-responder trainees with no prior hands-on experience. In a study, sixty medical non-commissioned officers were randomly assigned into one of two groups: the LT- and the ILMA-group. After viewing the video clips, the trainees were required to perform 10 consecutive, successful insertions of the given instrument into a manikin. The goal of 10 consecutive successful insertions was attained by all 30 subjects in the LT-group, and by 27 of 29 subjects in the ILMA-group with a maximum of 30 attempts. Satisfactory to good skill levels can be achieved with the applied video-clip demonstration method, even in inexperienced first-responder trainees lacking previous hands-on experience. Self-assessment measured by VAS score showed that the performance felt easy. A mobile medical information system (IS) was compared between civilian medical students and physicians undergoing compulsory military service in Finland. Special emphasis was placed on differences in system usage and perceptions towards the mobile medical IS. Other points of interest were the important features of the mobile medical system, advantages and disadvantages of using the system in actual emergency situations and use of the device to search for general information. A questionnaire was handed to both sixth-year medical students at the University of Oulu, as well to medical students of similar academic level undergoing their military service. The two groups were found to have similar approaches towards the mobile system in different contexts. The results have helped to develop an understanding of how the two groups of users use a mobile medical information system while also providing insight into some behavioral differences between them. Not all of the differences were significant; indicating the possibility of developing a universal tool for both military and with some civilian application, but with supplemental content in military medicine for military medical officers (MO). When reporting on the possibility of the development of a universal tool for both military and civilian use, MO`s said that they would have liked to complement the mobile medical information system with military medical data. The applicability of radio frequency identification (RFID) technology and commercial cellular networks designed to provide an online triage system for handling civilian mass casualty situations was tested during a military field exercise. The system proved to be usable. Compared to the current system in use, it dramatically improved the general view of mass casualty situations and enhances medical emergency readiness in this military medical setting. The system can be adapted without any difficulties by the civilian sector for the management of disasters. The feasibility and the direct benefits of the system were evaluated in two separate, simulated civilian mass-casualty situations; one in Finland involving a passenger ship accident and another at a major airport in Sweden with a plane crash scenario. Both simulations involved multiple authorities and functioned as a test setting for comparing the disaster management s situational awareness using the RFID -based system, where triage was done using both a mobile phone system with information sent automatically to the situation command center and the hospital, alongside a traditional method using paper triage tags. The development of situational awareness could be measured directly by comparing the availability of up-to date information at different points in the care chain with both systems. The RFID system proved easy to use, quick and stabile, and improved the situational awareness for the disaster management significantly. Information about the numbers and status of casualties was available for the coordinating units over an hour earlier in comparison to the traditional method. Results surpassed the traditional systems in all respects. It also dramatically improved the general view of mass casualty situations and enhanced medical emergency readiness in a multi-organizational medical setting. The novel information technologies addressed here are of great value both pedagogically and technically in medical training in military medicine and mass casualty situations