Protecting Participants in a Global Research Community Dr. Jane Kaye University of Oxford, UK.

Protecting Participants in a Global Research Community

Dr. Jane Kaye University of Oxford, UK

SACHPRWashington DC - 20th October 2010

How do these trends test the basic principles of medical research?


1. Informed Consent

Unhealthy obsession with consent formso Designed for physical harm and ‘one project’ researcho Is required at the beginning of the research processo Difficult to inform research participants at the time of

collection of all the research uses and who will use ito Part of the ‘tick box’ procedural requirements

Focus is on individuals rather than the concerns of families, groups and populations


Broad Consent? Used in biobanking but contentious Consent for a broad range of purposes Asking individuals to give a one-off consent for the

use of their medical information, which will be used for many years building up profiles of individuals

Effectively is ‘consent for governance’ as hard decisions will be delegated to research ethics committees or advisory boards


2. WithdrawalResearch participants should be able to withdraw

from research at any time Withdrawal cannot be promised when data and

samples are shared widelyo Computer datasets containing personal information must

be continually archived o It is difficult to claw back minute segments of sequence

spread over a global networko Data used in multiple research projects


3. Social Contract

Research participation has been based on altruism and an appeal to solidarity

In return, participants have been promised: o Anonyminityo Confidentiality of personal information

Procedures and practice have been developed on the basis of this implicit agreement


The ChallengesWe can no longer promise the confidentiality of personal

information (Lunshof et al 2008)

– DNA is a unique identifier (Homer et al 2008)

– Data can be replicated indefinitely– Data is shared globally and can be linked to other datasets– Genome sequence is becoming more accessible to people other

than researchersYet participants are still expected to be altruistic and to

hold to their side of the bargain


4. New Dilemmas -FeedbackIf it is increasingly difficult to make

information anonymous Increased amount of information on

individuals also increases the likelihood of identifying serious treatable conditions and incidental findings

Is there an obligation to feedback?o Should secondary and tertiary researchers be held

responsible?


So what should we do?


New Forms of GovernanceDevelopment of IT ‘participant-centric’ approaches

Opportunity for people to have greater control over the use of their information if they so desire

Other bodies no longer stand in the shoes of participantsLess reliance on research ethics committees and their

perception of the concerns of participantsMakes re-consent for studies easierBased on participants as partners in the research process

and enabling an on-going dialoguePotential to deal with issues of feedback


IssuesWhat are the boundaries of this control?

All types of research?Can it be instituted at the global level?

Still need oversight of the proposals that are put to participants

Relies on participants being computer-literateDoes not address the issues of families, groups

or populations


In conclusionImplement IT mechanisms to give research

participants greater involvement in researchRequires a change in attitude as participants

must be seen as partners in the research process

Potential to develop new ways of carrying out research

Potential to enable the translation of results


Acknowledgements

EnCoRe Project www.encore.orgHeLEX –Centre for Health, Law and Emerging

Technologies http://www.publichealth.ox.ac.uk/helex/

Making Connections Group


2010 Publications Curren L., Boddington P., Gowans H., Hawkins N., Kanellopoulou N., Kaye J.,

Melham K., (2010) Identifiability, Genomics and UK Data Protection Law European Journal of Health Law Vol 17, 4: 329-344

Curren L. & Kaye J., (2010) ‘Revoking consent: a 'blind spot' in data protection law?’ Computer Law and Security Review Vol 26:3, 273-283

Curren L. & Kaye J., (2010) ‘Data subjects’ rights — are they inadequate?’ Privacy & Data Protection Journal Vol. 10 :5.

Kaye J., Boddington P., de Vries J., Hawkins N., Melham K., (2010) Ethical Implications of the Use of Whole Genome Methods in Medical Research European Journal of Human Genetics 18: 398-403

Heeney C., de Vries J., Hawkins N., Boddington P., Kaye J. Assessing the Privacy Risks of Data Sharing in Genomics Public Health Genomics (DOI:10.1159/000294150) Published Online: March 29, 2010

Protecting Participants in a Global Research Community Dr. Jane Kaye University of Oxford, UK.

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