The Wellcome Trust: funding of brain research

Sources of information

This chapter is based on:

-  a meeting with Dr Michael Dexter, Director of the Trust, on 14 May 2002 when the Trust's conditions for its grants and awards were discussed;

-  the Trust's awards to the joint programme that are recorded in contemporaneous papers.

Development of the Trust's policy on ethical approval

Since Ethics Committees were first established, all researchers receiving support from the Trust have been expected to obtain Ethics Committee approval when necessary, complying with the requirements of the Circulars issued to the NHS in 1963 and 1975 (Chapter 6) without the necessity for the Trust to remind them of their obligations.

From the early 1980s, applications to the Trust were routinely checked to ensure that these included reference to approval by an Ethics Committee.

At that time the Trust did not have any special requirements for research on organs and tissues from post mortems, and it did not provide advice on ethical questions for applicants who intended to work on post mortems specimens. In this regard the Trust's procedures were no different from those of other research funding bodies.

A specific question was added to the Trust's grant application form in 1987 to confirm that LREC permission had been obtained, and the Committee which gave it. This requirement was further strengthened in 1990 when the head of the institution applying to the Trust was required to confirm in writing that 'all necessary licences and approvals have been obtained or are being sought'.

Policy statement

In 1994 the Trust issued a policy statement on the conditions that applied to all its grants and awards which, among other matters, stated 'The Trustees will consider applications before the consent of the relevant ethics committee is obtained, but no award will be made until it is satisfied about the ethical aspects of the proposal'. The 1994 statement remains in force as does the application form.

Annex 111

The Trust recently updated its guidelines and in January 2002 issued 'Guidelines on Good Research Practice'.

Ethical practice is one of the subjects covered by the guidelines which also address the specific question of access to confidential personal information about research subjects. The guidelines have been widely distributed.

Appendix 44

Research awards to the joint programme

In 1988 a three year project grant was awarded to the joint team in Manchester and a second grant was awarded in 1991, Chapter 11. Both these awards were made after 1987, so the Trust would have required written confirmation that ethical clearance had been or would be obtained.

Other brain research

The Trust has made grants to other researchers who planned to study post mortem brains, but has not issued any guidance about access to post mortem material from Coroners' cases.

The statement the Trust issued in 1992 referred specifically to the Human Tissue Act. In doing so the Trust drew researchers' attention to the Act before post mortem retention of organs became a matter of public concern.

The Wellcome Trust Standing Advisory Group on ethical aspects of Trust-funded research

While it has been firm policy since 1987 to ask about LREC approval for all applications, the Trust has its own Ethics Committee. The Committee can be asked to consider any applications about which the Trust has ethical concerns.

Summary

Since the first circulars on Ethics Committees were issued to the NHS, the Trust has expected researchers to comply with the guidance and obtain appropriate consents from Ethics Committees.

In 1987 the Trust introduced an additional check to ensure that ethical aspects of all research applications submitted to it had been properly considered.

The two applications from the joint programme that were funded by the Trust would have required written confirmation of ethical clearance.

The Trust has its own Ethics Committee to which applications of concern can be referred.

In guidelines issued in January 2002, the Trust has further strengthened the ethical principles and requirements for all research that it supports.