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Exclusion of certain groups from clinical research
1Georgetown University School of Nursing, Washington, DC 20007.
Image--The Journal of Nursing Scholarship
|January 1, 1994
Summary
Clinical research often excludes underrepresented groups like the elderly, poor, and ethnic minorities without clear justification. Addressing these disparities is crucial for representative and efficient scientific inquiry.
Area of Science:
- Clinical Research
- Health Disparities
- Medical Ethics
Background:
- Evidence suggests underrepresentation of women, ethnic minorities, the elderly, and the poor in clinical research.
- Ensuring diverse participant populations is vital for generalizable research findings.
Purpose of the Study:
- To examine the demographic characteristics of subjects in approved research protocols.
- To identify patterns of exclusion and justification for demographic criteria in clinical research.
Main Methods:
- A review of 754 approved research protocols from a tertiary care center over two years (1989-1990).
- Analysis of exclusionary criteria and the explicitness of justifications provided for these exclusions.
Main Results:
- While most protocols included men and women, and over half included the elderly, significant exclusions were noted.
- Exclusions based on age, socioeconomic status, and race frequently lacked clear justification, particularly in nursing protocols for age.
- The elderly, poor, and ethnic minorities were identified as groups excluded without identifiable justification.
Conclusions:
- Disparities in clinical research participation must be addressed to ensure equity.
- Research design considerations are necessary to balance the need for representative populations with efficient study conduct.
- Future research should prioritize inclusive practices to enhance the generalizability and ethical integrity of clinical studies.