Ethics Committees are part of the problem, not the solution.
Dear Sir
Your hope that Research Ethics Committees (RECs) have a role to play
in “ensuring that new scientific trials are scientifically justifiable”
must be faint indeed.(i) RECs are not remitted to undertake scientific
review of protocols, as clearly stated in the Governance Arrangements for
NHS Research Ethics Committees (GAfREC). “It is not the task of an REC
(sic) to undertake additional scientific review, nor is it constituted to
do so”. (ii)
Furthermore RECs and their members are as entangled with drug
companies as the rest of the medical profession, and their members just as
likely have financial and other conflicts of interest.
Of particular concern is lack of transparency within the ethical
review system. RECs operate in secrecy, explicitly in deference to the
pharmaceutical industry’s requirement that “commercial confidentiality” be
protected. Committee minutes are confidential, and members’ competing
interests, if declared, are not required to be included in annual reports,
the sole means by which RECs are publicly accountable. (Indeed, no MREC
annual report has yet been published, even though MRECs have been in
operation for nearly six years). The prevalence of conflict of interest
within committees, and whether and how bias is prevented is therefore
unknown and unknowable, and the commercial needs of the pharmaceutical
industry take precedence over those of democratic accountability within
the UK ethical review system.
Given the failure of the RECs to put their own house in order in
relation to conflict of interest, it is over-optimistic to hope they have
a part to play in policing the pharmaceutical industry, whose interests
their procedures are largely designed to serve.
i Abbasi K and Smith R. No more free lunches. BMJ 2003; 326, 1155-56
Rapid Response:
Ethics Committees are part of the problem, not the solution.
Dear Sir
Your hope that Research Ethics Committees (RECs) have a role to play
in “ensuring that new scientific trials are scientifically justifiable”
must be faint indeed.(i) RECs are not remitted to undertake scientific
review of protocols, as clearly stated in the Governance Arrangements for
NHS Research Ethics Committees (GAfREC). “It is not the task of an REC
(sic) to undertake additional scientific review, nor is it constituted to
do so”. (ii)
Furthermore RECs and their members are as entangled with drug
companies as the rest of the medical profession, and their members just as
likely have financial and other conflicts of interest.
Of particular concern is lack of transparency within the ethical
review system. RECs operate in secrecy, explicitly in deference to the
pharmaceutical industry’s requirement that “commercial confidentiality” be
protected. Committee minutes are confidential, and members’ competing
interests, if declared, are not required to be included in annual reports,
the sole means by which RECs are publicly accountable. (Indeed, no MREC
annual report has yet been published, even though MRECs have been in
operation for nearly six years). The prevalence of conflict of interest
within committees, and whether and how bias is prevented is therefore
unknown and unknowable, and the commercial needs of the pharmaceutical
industry take precedence over those of democratic accountability within
the UK ethical review system.
Given the failure of the RECs to put their own house in order in
relation to conflict of interest, it is over-optimistic to hope they have
a part to play in policing the pharmaceutical industry, whose interests
their procedures are largely designed to serve.
i Abbasi K and Smith R. No more free lunches. BMJ 2003; 326, 1155-56
ii Department of Health. Governance arrangements for NHS Research
Ethics Committees. http://www.corec.org.uk/Interim.htm
Competing interests:
None declared
Competing interests: No competing interests