Use Of Patient Data For Research
1. Use of Existing records in research
Key points of which researchers should be
aware: (Extracted from GMC – Research: The Role and
Responsibilities of Doctors)
- Records made for one purpose, e.g. the provision of
care, should not usually be disclosed for another
purpose without the patient’s consent. If a GP is
asked to disclose, or seek access to, records containing personal
information for research purposes, express consent should be sought
from the participant wherever this is practicable.
- If it is not possible to obtain expressed consent for their
disclosure or for the records to be anonymised, data may be
disclosed for research provided that participants have
received prior information about access to their records and about
their right to object. Such disclosures must be kept to a minimum
and participants must previously have been told, or had access to
written material informing them:
- That their records may be disclosed to persons outside the team
that provides their care.
- Of the purpose and extent of the disclosure, e.g. to produce
anonymised data for use in research, epidemiology or
surveillance.
- That the person given access to their records will be subject
to a duty of confidentiality.
- That they have a right to object to such a process and that
this will be respected, except where the disclosure is essential to
protect the patient or someone else, from risk of death or serious
harm.
- The Research Ethics Committee must be informed if it is
not practicable to contact participants to seek their
consent to the anonymisation of their data or use of their
data for research. It is the role of the Research Ethics Committee
to consider whether the likely benefits of the research outweigh
the loss of confidentiality to the patient.
- Projects that do not require research ethics committee
approval but involve patient data
Some epidemiology, health
surveillance and monitoring is, for good reason, undertaken without
research ethics committee approval. Data can be used in these cases
where there is a statutory requirement to do so, for example where
the data relates to a known or suspected 'notifiable' disease, or
where there is a relevant order under the Section 60 of the Health
and Social Care Act 2001 obtained following an application to the
Patient Information Advisory Group(PIAG). (The PIAG was
established by the DH to provide advice on issues of national
significance involving the use of patient information and to
oversee arrangements created under Section 60 of the Health and
Social Care Act 2001. Its membership is drawn from patient groups,
healthcare professionals and regulatory bodies.)
For further information see:
General Medical Council: Research- The
Role and Responsibilities of Doctors – in full:
http://www.gmc-uk.org/guidance/current/library/research.asp#5
RoyalCollegeof Nursing:
Informed consent in health and social care research, RCN guidance
for nurses:
http://www.man.ac.uk/rcn/informedconsent/informedconsentdec05.pdf
Medical Research Council: Ethics Series –
Good Research Practice:
http://www.mrc.ac.uk/PolicyGuidance/EthicsAndGovernance/GoodResearchPractice/index.htm
Patient Information Advisory
Group:
http://www.advisorybodies.doh.gov.uk/piag/Index.htm
2. Summary of best practice with regard to patient consent to
research participation.
All members of practice
staff who are, or will be, involved in practice based research
activities need to be able to demonstrate an understanding of the
term ‘informed consent’ and its application to research .
It is essential that any
member of practice staff involved in recruiting patients is
competent to obtain informed consent as participants’ consent is
only legally valid and professionally acceptable when it is certain
that participants are competent to give consent, participants have
been properly informed and have given their consent freely and
without coercion. (GMC Research: The Role and
Responsibilities of Doctors)
Key elements of
informed consent (South London & Maudsley NHS Trust/Institute
of Psychiatry leaflet)
- It should be voluntary and is only voluntary if given without
any direct or indirect coercion or inducement.
- It should be properly informed and should be based on an
informed decision after sufficient information about the study has
been provided.
- It should be in writing but if participants are unable to give
written consent, oral consent in the presence of a witness is
acceptable.
What should practices have in place to
ensure this happens?
A system that will ensure the following:
- That staff charged with obtaining informed consent are fully
informed about the nature of the study to which they are recruiting
participants.
- That if consent has to be sought from vulnerable groups, staff
will be competent to do this.
- That the personal views of the researcher or the person
obtaining consent do not influence whether or not an individual
consents to take part.
- That sufficient time will be provided to explain fully what
will be required of participants together with any potential risks
and/or benefits and that the existence of potential benefits,
particularly financial ones, do not persuade individuals to
participate for the wrong reasons.
- That the opportunity will be provided for potential
participants to ask questions, seek further information and to
reflect before, and after, making their decision about
participation.
- That participants will not asked to sign the consent form until
they have had time to consider their decision and a check will be
made to ensure the individual fully understands what will be
required of them.
Check list of what
potential participants need to have a clear understanding of:
extracted from (RCN Informed Consent in Health and Social
CcareRresearch & GMC Role and Responsibilities of Doctors –
Good Practice in Research)
- The purpose of the research.
- The reason why they have been approached.
- The practicalities and procedures involved in
participating.
- The benefits and risks of participation and, if appropriate,
the alternative therapies.
- The proposed methodology and, if randomisation is involved, the
nature of the process, the reasons for it, what a placebo is (if
relevant).
- How data about them will be managed and used.
- What to do in the event of an adverse event where
appropriate.
- The consent form.
- Their role if they agree to participate in the research.
- How information will be provided to them throughout the
study.
- That their participation is voluntary.
- That they can withdraw at any time from the study, without
giving reason and without compromising their future treatment.
- The insurance indemnity arrangements for the conduct of the
research where appropriate.
- That the research has been approved by a research ethics
committee.
- Who to contact should they have further questions or wish to
withdraw.
- Details of the Research Sponsor and funding body.
- The arrangements for dissemination of study results.
List of further information:
GMC document: Research:The Role and
Responsibilities of Doctors:
http://www.gmc-uk.org/guidance/current/library/research.asp#5
RCN document: Informed consent in health
and social care research:
http://www.man.ac.uk/rcn/informedconsent/informedconsentdec05.pdf
Medical Research Council: Good Research Practice:
http://www.mrc.ac.uk/PolicyGuidance/EthicsAndGovernance/GoodResearchPractice/index.htm