Intended for healthcare professionals

Rapid response to:

Analysis And Comment Confidentiality and consent in medical research

Overcoming barriers to recruitment in health research

BMJ 2006; 333 doi: (Published 03 August 2006) Cite this as: BMJ 2006;333:300

Rapid Response:

Difficulties in Conducting Research in Vulnerable Groups

Dear Sirs

Difficulties in Conducting Research in Vulnerable Groups

We were delighted to read the paper on “Overcoming barriers to
recruitment in health research”, as the points raised reflect our own
recent frustrating experience in trying to conduct clinical research. We
are psychiatrists in learning disability, a specialty in which the current
evidence base is very small. This partly reflects the difficulties
involved in conducting research on people who may not have the capacity to
give their consent to take part. Nevertheless, we feel it is important to
continue to try to conduct valid research in order to improve the service
we can provide to this group of people.

However, the current research ethics and governance requirements
seem, in our experience, designed to deter all but the most determined of
researchers and prevent any progress in expanding our knowledge base.

Our project is (we thought!) a simple one, involving only the
scrutiny of patients medical records and no other patient involvement.
However, in order to do this we have had to overcome the following

1. Apply to our Local Research Ethics Committee for ethical approval
(time from instigation of project to granting of ethical approval – 2

2. Obtain research approval from 5 PCTs in which the patients are

3. Obtain research sponsorship from our employing PCT (time for steps
2 and 3 to be completed – 8 months)

4. Obtain agreement from our consultant colleagues for them to
contact their patients and seek their agreement to being contacted by us.
Only then will we be able to approach them ourselves and ask for
permission to look at their records (ongoing)

We are not hopeful that we will get a sufficient number of responses
at the end of stage 4 to provide a statistically significant comparison of
subjects and controls. In patients with limited literacy skills, we are
dependent on the motivation of their carers to assist them in responding.

There must be a better way of doing this!

Yours sincerely

Leila B. Cooke Consultant Psychiatrist in Learning
Monica Mohan
Specialist Registrar in Learning Disability

Ref: Henison J., Haines. A

Overcoming barriers to recruitment in health research

BMJ 2006 : 333 : 300 - 302

Competing interests:
None declared

Competing interests: No competing interests

16 August 2006
Leila Cooke
Consulatation in Learning Disability
Monica Mohan, Specialist Registrar in Learning Disability
Bristol Central CLDT, New friends hall, Stapletol, Bristol. BS16 1EQ