Researching Vulnerable Groups: Ethical Issues and the Effective Conduct of Research in Local Authorities

The Data Protection Act 1998 and Research Governance Frameworkfor Health and Social Care (Department of Health, 2003a) havebrought consideration of ethical issues in the conduct of researchinto sharper focus. This paper, based primarily on the authors’experiences of conducting research on children in need and outcomesfor vulnerable children, examines the impact these changes havehad on the research process. The difficulties experienced byresearchers in gaining access to research participants in orderto develop evidence-based policy and practice are explored.Finally, the paper outlines some practical steps that can betaken to facilitate the effective conduct of research.     

The Inclusion of Minority Groups in Clinical Trials: Problems of Under Representation and Under Reporting of Data

Objective: To evaluate the representation of minority groups in randomized control trials (RCTs), and the frequency with which this information is reported.

Study Design: Reviewers collected data on the racial/ethnic composition of study samples from all RCTs published in six leading medical journals in 1999.

Results: Of the 280 RCTs, most (204, 71.3%) provided no information on the race/ethnicity of participants. Of the 89 U.S.-based RCTs, 50 (56.1%) reported their minority distribution. Relative to other trials, those funded by the National Institute of Health (NIH) (n = 52) were more likely to report race/ethnicity data (55.8% vs. 23.7%; χ² = 20.9, p ≤ 0.001) and to include nonwhite participants (13.5% vs. 12.5%; χ² = 22.7, p ≤ 0.001).

Conclusion: Minority groups are currently under-represented in clinical trials. Information on the race and ethnicity of clinical trial participants is currently underreported in six leading medical journals. Reporting of minority group information was significantly better only in NIH funded trials, which also were more likely to include nonwhite participants. This suggests that mandatory reporting policies may have a positive effect on both reporting and representation.