advice on consent and confidentiality for sharing research data ethics and consent issues: one-day...

Advice on Consent and Confidentiality for Sharing Research Data

Ethics and Consent issues: one-day workshop

Belfast, 18 January 2005John Southall

Sharing data• sharing of raw data has always been common at

an informal level

• funded research formalises the research process including sharing of raw data

• issues of consent and confidentiality allowing archiving should be included in the project management plan and addressed before data collection starts

• researchers should not make commitments to informants which preclude archiving their data

• a waiver on archiving/sharing can be agreed with the ESDS and the ESRC if strong grounds exist

Data creation and deposit: best practice

• early advice to data creators:– high quality data and documentation– consent and ethical issues are taken on board– longer-term rights management in place– IPR issues considered

• promoting standards in: – research design– transcription techniques– data and project management– documenting data collection and analysis

Characteristics of an ideal archived research collection

• rich content

• accurate data, well organised and labelled files

• appropriate measurement of key concepts

• supporting documentation created– major stages of research recorded

• full range of raw data available in appropriate format

• clarity of consent, confidentiality and copyright

Extensive raw data

• types of research data assembled

– survey data – in-depth interviews– focus groups– field notes/participant observation– case study notes

• images and audio-visual materials

• all require consent to be shared/archived if they form part of the final collection

Consent for archiving

• anonymity and privacy of research participants should be respected

• explicit ‘informed’ consent gained in writing

• information for research participants should be clear and coherent and include:

– purpose of research – what is involved in participation – benefits and risks – storage and access to data – usage of data (current and future uses)– withdrawal of consent at any time– Data Protection and Copyright Acts

Consent for archiving (contd)

• N.B. additional measures are needed when participants are unable to consent through incapacity or age

• reflect needs and views of all

• works in practice

Transcribing research

• integrated into the ongoing research – budget accordingly

• integrated into the ethical foundations of the research

• full transcriptions or summaries

• costs and benefits– self transcription– internal team transcription– external transcription

• full transcriptions– consistent layout– speaker tags– line breaks– header with identifier/other details – checked for errors

Identifiers removed• scheme devised – different for each dataset

• ideally should reflect any pseudonyms used in publications

• confidentiality respected

• anonymisation?

• problems of anonymisation– applied too weakly– applied too strongly– timing – potential for distortion– examples

• user undertakings

• appropriate and sympathetic

Labelling and listing research

• list of contents of research collection

• acts as a point of entry for secondary user

• qualitative data: template approach – interviewee/case study characteristics

Ethical practice - history

• The Nuremberg Code – principles for conducting research with human

subjects arises from the Nuremberg Trials, which took place after the Second World War

– sets out statements of certain moral, ethical and legal principles relating to research involving human subjects

• Declaration of Helsinki – adopted in 1964 by the World Medical Assembly– provides guidance for physicians in biomedical

research with human subjects– most recently amended in 1989 and 1996

• the ethical guidelines of many professional organisations endorse these principles

Legal issues in data preparation

• ‘Duty of confidentiality’

• Law of Defamation

• Data Protection Act 1998 and EU Directive

• Copyright Act 1988

• Freedom of information Act 2000

Duty of Confidentiality

• disclosure of information may constitute a breach of confidentiality and possibly a breach of contract

• not governed by an Act of Parliament

• not necessarily in writing

• can be a legal contract

• exemptions are:– relevant police investigations or proceedings– disclosure by court order– ‘public interest’ - defined by the courts– ethical obligations in cases of disclosure of child

abuse

Law of Defamation

• a defamatory statement is one which may injure the reputation of another person,

company or business

Options for preserving confidentiality

• anonymisation

• consent to archive at the time of field work

• researcher contacts informants retrospectively

• user undertakings

• in exceptional circumstances - permission

to use or closure of material

Sharing data through deposit• data should be deposited to a standard that would enable them

to be used by a third party, including the provision of adequate documentation

• projects vary widely but standardisation is introduced through the catalogue record

• any potential problems in archiving the data should be discussed with ESDS acquisitions as soon as possible

• issues of consent and confidentiality allowing archiving should be included in the project management plan and addressed before data collection starts

• unless a waiver on deposition has been agreed with the ESDS and the ESRC, researchers should not make commitments to informants which preclude archiving their data

ESRC Datasets Policy –what is expected of award holders?

• to preserve and share data from ESRC-funded research

• funding allowed to prepare data for archiving

• offer data for deposit to the ESDS within 3 months of the end of the award

• potential problems should be discussed with the ESDS at the earliest opportunity

• final payment withheld if dataset is not deposited within 3 months of the end of the award, except where a waiver has been agreed in advance

• ESRC Datasets Policy www.esrc.ac.uk/esrccontent/researchfunding/sec17.asp

Conclusion: sharable research

• clarity of consent regarding use and re-use

• suitable formats for re-use and long-term preservation

• in-house data processing

– ‘cleaning up’ research/ documenting– repairing minor errors– meeting user expectations

• meeting users needs