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STUDY TITLE: Evaluating the barriers to evidence implementation in the clinical setting, and the utility of a computer support tool for overcoming these.

    

NAME OF PRINCIPAL INVESTIGATOR:   

  • Professor John Ryan (Principal Investigator)

  • Dr Cailbhe Doherty

You are being invited to participate in a research study. Thank you for taking time to read this. 

WHAT IS THE PURPOSE OF THIS STUDY?

Recent developments in computer support tools have enhanced our ability to consolidate large amounts of scientific evidence very quickly. The relative youth of these technologies has meant that it remains unclear how best to embed them in the care-pathway (with clinicians). Toward this end, this study will evaluate and test the utility of a computer-support tool called ‘SciScanner’, which will take the form of a mobile application, to fulfil healthcare professionals’ information needs. SciScanner is not intended for patients’ use.

WHY HAVE I BEEN CHOSEN?

You have been chosen because you are a practicing healthcare professional.

WHAT WILL HAPPEN IF I VOLUNTEER?

Subject to you fulfilling the experimental inclusion criteria, you will be asked to complete a 20-item multiple-choice questionnaire (MCQ) at three timepoints and attend a short interview with the research team, wherein you will be asked about how you access and use scientific literature. You will complete the MCQ under two conditions. In the ‘assisted’ condition, you will be able to use a smartphone application called SciScanner developed by the study investigators that synthesizes scientific evidence to answer any questions you have during the exam. In the ‘unassisted’ condition, you must rely on your own knowledge and cannot use any device(s). The MCQ takes between 30-60minutes to complete.

At a later date, you will be entered into a trial wherein you will be given access to the SciScanner smartphone application (‘app’) during your day to day practice. You will have access to the app for a pre-specified period of between 2-3-months. 

We are interested in learning about how you interact with this application to access scientific literature or to meet your information needs. However, using the application during your day-to-day practice is not mandatory.

ARE THERE ANY BENEFITS FROM MY PARTICIPATION?

This novel research project has the potential to improve our understanding of the barriers to effective information synthesis and delivery in the clinical and research settings.

ARE THERE ANY RISKS INVOLVED IN PARTICIPATING?

There are no risks associated with taking part in this study. However, it is important to note that all information that is provided by the app ‘SciScanner’ is health-related information, not medical advice or counsel. As such it cannot be reliably used to diagnose, treat or in any way manage an individual with a health-condition, or someone who may have a health condition. Specifically, we cannot guarantee that the content covers all possible uses, direction, precautions, drug interactions, or adverse effects that may be associated with any therapeutic treatments or diagnoses. Any information on SciScanner cannot be relied upon as being applicable to your specific circumstances. Neither SciScanner nor any SciScanner Entity assumes any liability or responsibility for damages or injury to you, other persons, or property arising from any use of any information, idea, or instruction contained on SciScanner.

WHAT HAPPENS IF I DO NOT AGREE TO PARTICIPATE?

There are no consequences for non-participation in this research, and it is completely up to you to decide whether or not to take part. However, you will be unable to access the SciScanner application at this time if you decide not to take part in this research. If you decide to take part but later change your mind, you are free to withdraw at any time without giving a reason.  

CONFIDENTIALITY

Your identity will remain confidential.  A study number will identify you.   Your name will not be published or disclosed to anyone.  

WHO IS ORGANISING AND FUNDING THIS RESEARCH?

This project is being conducted by a collaborative team based in UCD which includes Dr Cailbhe Doherty, Professor John Ryan and Professor Brian Caulfield. This project has received funding from the Health Research Board (HRB). This study carries no commercial interest.

HAS THIS STUDY BEEN REVIEWED BY AN ETHICS COMMITTEE?

The St. Vincent’s Healthcare Group, Ethics and Medical Research Committee have reviewed and approved this study.

 

CONTACT DETAILS

Cailbhe Doherty

C09 Insight centre for data analytics

O’Brien Centre for Science,

University College Dublin,

Belfield,

Dublin 4.

Cailbhe.doherty@insight-centre.org

RESEARCH PARTICIPANT’S RIGHTS

If you have any questions about your rights as a research participant, then you may contact the Hospital’s Quality & Patient Safety Department 01 2214013

CONFIDENTIALITY & DATA PROTECTION

1.               INTRODUCTION

1.1           This Participant Information and Consent Form provides guidance and information regarding participation in the study “Evaluating the barriers to evidence implementation in the clinical setting, and the utility of a computer support tool for overcoming these”, and the processing of the research participants’ personal data. St. Vincent’s University Hospital is committed to protecting and respecting your privacy. This Participant Information and Consent Form together sets out the basis on which any personal data we collect from you or that you provide to us will be processed by an independent data controller. Please read this Participant Information and Consent Form carefully to understand our treatment and use of your personal data. 

1.2           The processing of your personal data will be in compliance with the Data Protection Acts 1988 to 2018 (as amended) and the General Data Protection Regulation (the “Data Protection Legislation”). 

1.3           Please note that agreeing to participate in a research program with St. Vincent’s University Hospital, you acknowledge that you have read, understood and agree to this Participant Information and Consent Form. 

 

2.               IDENTITY OF THE CONTROLLER OF PERSONAL INFORMATION

For the purposes of the Data Protection Legislation, St. Vincent’s University Hospital is an independent data controller in the following circumstances: 

  1.  

PI Name: Professor John Ryan

Company/PI Type:  St Vincent’s University Hospital employee

  1.  

PI Name: Dr Cailbhe Doherty

Having its registered office  at:  the Insight centre for data analytics, O’Brien Centre for Science, University College Dublin.

 

3.          CONTACT DETAILS OF THE DATA PROTECTION OFFICER*

 

3.1            

The data protection officer for SVUH and PI* is: 

 

Orlaith McCarthy, SVUH, Elm Park, Dublin 4, Contact 01 221 3591

 

Email: dataprotection@svuh.ie

 

 

4.               PROCESSING OF YOUR PERSONAL DATA

(the following information is presented digitally, via the SciScanner smartphone app)

Additional information is available at https://www.sciscanner.com/privacy-policy

The purpose or reason for processing their personal data. 

We only use your information where you’ve given us your consent, where it is necessary to deliver the SciScanner service, where it’s necessary to exercise or comply with legal rights or obligations, or for normal purposes of the kind set out in this policy.

 

What personal data do we collect?

Everyone who uses our platform will have bits and pieces of information about them collected, stored and processed. However, we don’t collect more information than we need.

We can’t provide information without information! So, when you use our platform, we have to collect, keep and share some personal data and ask that you agree to that in line with this policy. 

 

We collect information in two ways:

  1. You give it to us voluntarily

  2. We generate or collect it automatically

 

Personal data

Purpose of processing[1]

1. Identification (name, clinical experience , DOB)

2. used for purpose of carrying out research

3. Test results from the multiple choice questionnaire exams

4. To determine the presence of information needs, and the capacity of computer support tools to fulfil these.

5. Interviews

6. Feedback on the functionality of the ‘SciScanner’ application

 

Additional information about the information we collect is available at https://www.sciscanner.com/privacy-policy

5.               SHARING OF PERSONAL DATA

We will be interested in many variables related to the time you spend accessing scientific literature sourced from the Information Suppliers currently included on the SciScanner platform (Wikipedia, Pubmed, Youtube), what information you access, how frequently you access this information, and how what information you access changes.  These variables will be quantified via the app itself, when you are using it. 

 

We use your personal data when we need to deliver the SciScanner platform or fulfil an information need, such as finding research related to the treatment of a disease, with us or an Information Supplier. To improve or optimise the SciScanner platform and to otherwise protect or further our legitimate interests. 

 

Additional information about our legitimate is available at https://www.sciscanner.com/privacy-policy

 

If you’ve got a SciScanner account, you can request for access or to delete key personal data associated with your profile at any time by emailing the research group. 

 

You also have rights in relation to the personal data we have about you. You can exercise these rights by getting in touch with us via our contact details.

 

These rights may be limited, for example if fulfilling your request would reveal personal data about another person, or if you ask us to delete information which we are required by law or have compelling legitimate interests to keep. If you have unresolved concerns, you have the right to complain to a data protection authority.

 

To the extent that you’re unable to satisfactorily exercise any of these rights via your Profile, you can do so by contacting our Data Protection Officer by post at SciScanner, C9, Insight Centre for Data Analytics, Science Centre East, O’Brien Centre for Science, UCD, Belfield, Dublin 4.

 

You have the right to ask us for a copy of your personal data; to correct, delete or restrict processing of your personal data; and to obtain the personal data you have provided to us in a structured, portable, machine readable format. In addition, you can object to the processing of your personal data in some circumstances (in particular, where we don’t have to process the data to meet a contractual or other legal requirement).

 

Will there be automated decision making, including profiling?  

Personalising your experience involves us creating a profile and timeline of your activity on SciScanner. However, we are careful to ensure that our activities do not involve undertaking any profiling or automated decision making that might have any legal or other significant effects on you (including your career).
We generate or collect some information from your computer or device automatically as you use our services. This includes your IP address, information about the device and browser you are using to access our services, the website URL you visited us from and the third party sites you visit when you click on links to exit the SciScanner site or app. It also includes details of the search queries you have made via SciScanner. We may also know your location from your mobile or your IP address. This helps us to improve your experience and make sure you receive the content that’s most relevant to you.

 

6.               TRANSFERS OUTSIDE THE EUROPEAN ECONOMIC AREA[2]

Your data will only be processed by suppliers who provide appropriate contractual safeguards for the information they process. We store the information we collect from you on secure servers in various locations, depending on where you are in the world when you access our site. Currently, we use Google servers that are located in Amsterdam, Ireland, Frankfurt, Hong Kong, Russia, Singapore, Tokyo and the UK.  We will only store European users’ personal data outside the European Economic Area where a European Commission-approved method of validating the transfer has been put in place.

7.               HOW IS MY PERSONAL DATA SECURED 

 

We have in particular taken appropriate security measures to protect your personal data from accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access, in connection with this research study. Access is only granted on a need-to-know basis to those people whose roles require them to process your personal data. In addition, our service providers are also selected carefully and required to use appropriate protective measures.

8.               STORAGE OF PERSONAL DATA

 

We will keep your personal data for the duration of the study period (until May 2022). This may mean that some information is held for longer than other information. 

 

We have different retention policies for different types of personal data, taking into account:

  • The purpose for collecting the personal data;

  • How long it will take to fulfil that purpose; and

  • Any specific reason or overriding legal obligation to retain the personal data for a specific amount of time.

 

Additional information about how long we store your personal data is available at https://www.sciscanner.com/privacy-policy

9.               YOUR RIGHTS 

 

Where we have asked for your consent to take part in our research, you may withdraw consent at any time. If you ask to withdraw your consent to SciScanner processing your data, this will not affect any processing which has already taken place at that time.

 

You may have various rights under Data Protection Legislation. However, in certain

circumstances, these rights may be restricted[3]. In particular, your rights may be restricted

where this is necessary: (i) for the prevention, detection, investigation and prosecution of

criminal offences; (ii) in contemplation of or for the establishment, exercise or defence of a

legal claim or legal proceedings (whether before a court, tribunal, statutory body or an

administrative or out-of-court procedure); and/or (iii) for the performance of a task carried

out in the public interest or in the exercise of official authority vested in St. Vincent’s

University Hospital.

 

These rights may include:  

 

(i)             The right of access enables you to check what type of personal data we hold about you and what we do with that personal data and to receive a copy of this personal data;

 

(ii)            The right to object to processing of your personal data where that processing is carried out on the basis of our legitimate interests. We will stop using your personal data unless we can demonstrate an overriding legitimate ground for the continued processing of this personal data;

 

(iii)           The right to rectification enables you to correct any inaccurate or incomplete personal data that we hold about you;

 

(iv)           The right to erasure enables you to request that we erase personal data held about you in certain circumstances;

 

(v)            The right to restrict processing of your personal data by us in certain cases, including if you believe that the personal data held about you is inaccurate or our use of the personal data is unlawful; and

 

(vi)           The right to data portability enables you to receive your personal data in a structured, commonly used and machine readable format and to have that personal data transmitted to another data controller

 

10.             YOUR RIGHT TO LODGE A COMPLAINT WITH A SUPERVISORY AUTHORITY

 

If you have unresolved concerns, you have the right to complain to a data protection authority.  Without prejudice to any other administrative or judicial remedy you might have, you may have the right under data protection legislation in your country (where applicable) to lodge a complaint with the relevant data protection supervisory authority in your country (i.e. the Office of the Data Protection Commissioner in Ireland) if you consider that we have infringed applicable data protection legislation when processing your personal data. This means the country where you are habitually resident, where you work or where the alleged infringement took place.  

 

11.             CHANGES TO THIS INFORMATION

 

11.1        We may decide to make changes to this Participant Information and Consent Form. If a change is made, we will notify you in person of such changes. An updated Participant Information and Consent Form will be provided to you in advance of any change actually taking effect. 

12.             CONTACT US

 

12.1        For further information or if you have any questions or queries about this Participant Information and Consent Form, please contact:

By letter:

Orlaith McCarthy, Data Protection Officer, St Vincent’s University Hospital
Elm Park, Dublin 4

By email:

dataprotection@st-vincents.ie  

By telephone:

(01) 221 3591

 

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