2. Am I an ‘accredited primary care investigator’ (an ACPI)?
A system for identifying and accrediting individuals who are authorised to conduct research in primary care is still being devised, but the likely qualifying criteria are likely to be that the individual meets at least one of the following:

a. He or she has been accredited to undertake research in primary care by an appropriate     professional body such as the relevant Royal College;
b. He or she has completed a higher degree (at Masters level or above) that included some     original research based in primary care;
c. He or she is the first author of a peer-reviewed scientific publication based on original     research in primary care.

3. Is there a written protocol for the research?
All research must be supported by a written protocol that sets out the rationale for the enquiry and describes how it is to proceed. It can be anticipated that systems of RM&G will shortly insist that all research has first been subjected to scientific review by peers of the investigator(s). A written protocol is a necessity for meeting this standard, but generally provides a good discipline in requiring the investigator to specify exactly what is the question to be addressed by the project, and to select and defend the methods for answering it..

4. Has ethical approval been obtained for the project?
Under current guidelines from the EC and the central Office for Research Ethics Committees (COREC) all research undertaken in the NHS that involves patients, tissues or records, including that undertaken by students, requires clearance from a Local Research Ethics Committee. Coupled with moves to abolish the provision for approval of non-sensitive projects via ‘Chairman’s action’, and to impose a maximum of ten applications to be considered at any given meeting of an LREC, one can be confident that the system for ethical approval will slow from its present snail’s pace to a complete halt, but the principle that most research undertaken in the NHS requires ethical review of some kind is most unlikely to be amended significantly.

At present, research that will be limited to one Strategic Health Authority area needs approval from one LREC within that area. If appropriate, other LRECs are informed of the project via a ‘locality’ process in which the investigator submits to each such committee a copy of the original LREC application, a copy of the written protocol for the project, and a copy of the original LREC’s determination as to the acceptability of the study.

Rules regarding projects that cross more than one Strategic Health Authority area are presently (September 2003) in transition. Under the existing system, projects involving five or more such areas have to be submitted in the first instance to a Multicentre Research Ethics Committee (MREC). It is proposed that this will be replaced, before the end of 2003, by a threshold of three Strategic Health Authority areas.

5. Who needs to know about this project?
The advent of more rigorous RM&G in primary care imposes a further duty of notification on the would-be investigator in that his or her local ‘research lead’ within the PCT must be informed that the study is to take place, and provided with a copy of the ethical approval.

There is some discussion, in relation to connections between ‘research’ and ‘clinical governance’ for example, and the activities of the Commission for Health Improvement (CHI) and its successor, that this interaction with the local PCT should go beyond ‘notification’ to ‘approval’. Furthermore, approval by the PCT might be made contingent on a demonstrable link with local and national priorities, the latter reflecting the National Service Frameworks, for example.

Such thinking represents a push of the pendulum firmly towards ‘strategic research’ and away from ‘investigator-driven research’. The appropriate balance to be struck between these is continually contentious, but significant and sustained deviations from the vertical in either direction are probably not in the community’s best interests, because the one tends to suppress major innovation, while the other threatens an anarchic free-for-all in which it is can be very difficult to identify what may represent good value-for-(public)-money.

Rules regarding notification of multiple PCTs where a research project involves patients or records in more than one Trust have yet to be developed. The guiding principle, however, is that all relevant authorities need to know that the research is taking place and which NHS organisation has accepted responsibility for ensuring that good practice will be followed throughout the process of the investigation.

6. Do I need an Honorary Contract?
Where a research project involves a PCT with which none of the investigators has a formal affiliation, it is likely that at least one of them will require an Honorary Contract with that Trust. From the viewpoint of the NHS, one of the investigators having status as an ACPI is not enough, because this does not formally bind that individual to follow good research practice. All new contracts and honorary contracts with staff of the NHS will include a provision that any research undertaken by that individual is conducted in accordance with accepted rules of good research practice.
In regard to research, the quid pro quo of an honorary contract is that it also formalises the responsibility of the issuing Trust to ensure that good practice is followed in all research.

7. What other paperwork do I need to have?
Thus far these notes have identified the need for:
a.   A written protocol;
b.   Approval from relevant ethics committee(s);
c.   (Evidence of) notification of relevant PCT(s);
d.   Appropriate contracts or honorary contracts with NHS organisations.

In addition, the principal investigator leading a piece of research has a responsibility to keep:

e.   A record of all participants in the research, all medical records inspected, and all tissue       specimens collected, analysed or stored;
f.    Evidence of consent from individual subjects to their participation, where collection of such       consent was required;
g.   A register of all genetic material collected and stored in the course of the research;
h.   A register of withdrawals from the research, with relevant dates and reasons;
i.    A copy of the original data and the statistical and other analyses on which reports prepared for       publication were based;
j.    A register of adverse events, whether clinical, laboratory or ethical.

The list of participants in the research is required because new systems for RM&G include provision for an independent interview with participants regarding recruitment to, and conduct of, the project. Standard advice is that records of research projects, including relevant data and analyses, should be maintained for at least seven years after the project is completed and the results published, whichever is the later. This period is based on the usual ‘statute of limitations’
in civil law, but medical defence organisations regularly advise that obstetric records should be maintained for at least twenty-one years, suggesting a similar policy for (interventional) research involving pregnant women.

8. Who is ‘sponsoring’ and indemnifying the research?
This question supplies the answer to another less formal one, ‘Who will carry the can, should something go wrong and a complaint be made?’ Clearly, the responsible investigator will always be a respondent to official complaints, but consumers will also want to know which organisation apparently permitted a research project to be conducted in what they regard to be a sub-optimal fashion. The NHS or other organisation that accepts responsibility for ensuring that breaches of good research practice do not occur is the ‘sponsor’ of the research and would normally be expected to provide indemnity cover for those conducting the study.

9. Who is the financial sponsor of the research?
The sponsor of a piece of research, in the sense described by Question 8, is not necessarily the same entity as the one that is funding the research. The distinction is seen clearly in many drug trials, where a commercial entity with an obvious vested interest in the medicine commissions an independent entity such as a charitable research foundation to conduct a clinical trial of the product. In such instances, the foundation acts as guarantor of the intellectual propriety of the work. However, if the trial is based in a particular clinical unit, the NHS entity in which that unit is located may well be the ‘sponsor’ of the project, in the sense of Question 8, in that it will be a co-respondent should a participant suffer a misadventure or make a complaint about the study.

10. What are my responsibilities in regard to reporting?
Ethics committees and financial sponsors will have their own requirements in regard to reporting. Rules regarding routine reports to NHS entities acting as sponsors for research in primary care are still being developed. However, the guiding principle is that investigators should alert the sponsor quickly should a complaint or significant adverse event occur in the course of the research. This goes right back to the idea of CEOs of PCTs not having any ‘nasty surprises’ arising from research being conducted on their ‘patch’. back to top