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: https://doi.org/10.1136/bmj.333.7562.300 (Published 03 August 2006) Cite this as: BMJ 2006;333:300

Rapid Response:

Opt-in

We welcome Hewison and Haines’ discussion of the ethics and
practicalities of the opt-in process and agree that it may lead to “low
response rates, wasted resources, and research of limited validity” (1).Based on our own research experience, we
would argue that these factors are particularly relevant to research with
ethnic minority populations and that there is the potential for inequity in
participation if an opt-in process is mandatory.

In 2001 we carried out a qualitative interview study on
perceptions of pain and ill-health among Pakistani Punjabi, Chinese Cantonese and
European-origin English speakers in Scotland.Our initial sampling strategy was general
practice-based, and we proposed that identified patients return, within two
weeks of receiving information in English and in translation, an opt-out form.Otherwise, they were to be contacted by
telephone by a researcher speaking their language.Telephone contact would have given potential
participants information verbally, assessed their willingness to be involved
and if appropriate screened for potential inclusion in the interview study.

Our local research ethics committee rejected the above
protocol, citing the GMC guidelines on disclosure of personal information, and
required that patients return opt-in consent forms by post to their GP to
permit their names and telephone numbers to be passed to LH.

Whilst time and resource-intensive, this approach failed to recruit
sufficient participants from the Pakistani and Chinese groups, as shown in the
following table:

GP-based
sampling responses in 3 linguistic/ethnic groups in Edinburgh to the opt-in scheme

General Practice

Number of information
packs posted

Number of patients
giving written postal consent for their contact details to be given to the
researcher (%)

A

100 English

39 (39%)

A

31 Cantonese/ English

5 (16%)

B

31 Urdu/ English

4 (13%)

C

90 Cantonese/ English

5 (6%)

C

42 Urdu/ English

4 (10%)

The very low opt-in rates among ethnic minority people need reflection.Firstly, literacy, trust and familiarity with
official letters may be lower in the ethnic minority groups studied.This may be a function of culture, or a
function of socio-economic and educational status. Second, the concept of 'informed consent' may
have different dimensions in different ethnic groups; where cultural groups
tend towards a collective emphasis, it is possible that a decision about
participation is made not by an individual but by a group or authority figure
(2).This requires that researchers make
contact to identify the route for consent.

To ensure equity in research, it is vital that participants
from all ethnic groups are given equal opportunity to participate, and
achieving this may require varying approaches. There is extensive UK
experience demonstrating that high response rates can be achieved in studies
with ethnic minority populations, and that verbal communication holds the
key.Given appropriate circumstances
researchers can expect high response rates from ethnic minority populations (3).We believe written opt-in consent impacts on response
rates in ethnic minority populations more than in the White population- and
perpetuates the existing inequities in research (4).

References

1. Hewison J, Haines A. Overcoming barriers to recruitment
in health research. BMJ 2006;333;300-302.

1. Bowman KW, Hui EC.Bioethics for clinicians: 20.
Chinese bioethics.CMAJ 2000;163 (11): 1481-1485.

2. Wendler D, Kingon R, Madans J, Van Wye G, Christ-Schmidt
H, Pratt LA et al.Are racial and ethnic
minorities less willing to participate in health research? PLoS Med 2006Feb;3(2):e19.
Epub 2005 Dec 6.

3. Ranganathan M, Bhopal R. Exclusion and
inclusion of nonwhite ethnic minority groups in 72 North American and European
cardiovascular cohort studies. PLoS Med 2006 Jan 3;3(3):e44 [Epub ahead of
print].

Competing interests:
None declared

Competing interests: We welcome Hewison and Haines’ discussion of the ethics andpracticalities of the opt-in process and agree that it may lead to “lowresponse rates, wasted resources, and research of limited validity” (1).

17 August 2006
Lisa C Hanna
Research Fellow
Raj Bhopal
General Practice Section, Community Health Sciences, University of