Papers

Unjustified exclusion of elderly people from studies submitted to research ethics committee for approval: descriptive study

Antony Bayer, director, Cardiff Memory Team, Win Tadd, research fellow. 

University Department of Geriatric Medicine, University of Wales College of Medicine, Llandough Hospital, Penarth CF64 2XX

Correspondence to: A Bayer bayer{at}cf.ac.uk

Ageism in clinical practice¹ and published research² is well recognised. We were interested in whether research protocols submitted to the local research ethics committee contained unjustified upper age limits and how the committee dealt with this.

	Methods and results

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We reviewed all studies submitted to Bro Taf local research ethics committee in the first seven months of 1999 to determine whether any upper age limits were justified and whether the committee had commented on such age restrictions. We then made a judgment on the appropriateness of the upper age limit.

Of 225 studies whose protocols were reviewed, 65 were on topics or conditions that automatically excluded elderly people. Five studies specifically concerned elderly people and had a lower age limit but no upper limit. Of the remaining 155, 90 (58%) had an upper age limit, which ranged from 45 years (in a smoking cessation intervention) to 100 years (in a study of an open access mental health service), with a median of 70 years (interquartile range 65 to 75 years). In five studies an upper age limit was reasonable (participants were required to have no important disease, or prolonged follow up was planned).

In 85 studies the age restriction was inappropriate and unnecessary, but ethical review had failed to highlight this issue. Justification was offered by researchers in only one study. Age limits often conflicted with the aims of the studyfor example, in a study of "subjects randomly selected to reflect each life stage," another "of consecutive patients attending for bone scan," and another that claimed "no special groups to be excluded." In some studies exclusion of older patients was likely to result in an atypical clinical populationfor example, an investigation of "exclusion of vulnerable people from services," studies of type II diabetes, glaucoma, or non-steroidal anti-inflammatory drugs that were restricted to people aged under 65, and a study comparing incontinence aids that was limited to those aged under 70.

A total of 46 studies were approved by a multicentre research ethics committee; of these 20 had an upper age limit that seemed unjustifiable.

	Comment

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Of the 155 studies that were of relevance to elderly people, over half had an upper age limit that was unjustified, and neither the local ethics committee nor the multicentre research ethics committee had requested justification for the age restrictions.

Negative stereotyping of elderly people was reflected in comments in the studies that participants need to be "fully competent," "reliable," or "without cognitive impairment." One argument for an upper age limit is that it minimises the rate of dropout. However, we know of no evidence that elderly people are less compliant with the demands of research protocols, and their fewer family and employment commitments may make participation easier.

Furthermore, exclusion of elderly participants can affect the generalisability of a study's findings. If researchers can be certain that elderly people will not respond differently from other age groups, their specific inclusion may not be an issue; if this is not the case, however, their inclusion is essential.³ Abolishing ageist practices and attitudes in research, as well as in clinical practice, is important if elderly people are to gain maximum benefit from advances in health care.⁴

Ethics committees are in a strong position to influence research practice and to reduce unethical age discrimination. We encourage them to request justification whenever protocols include inappropriate age restrictionsand if this is not forthcoming, approval might be conditional on age limits being removed. This policy would promote more positive attitudes towards elderly people among researchers as well as safer, more effective treatments and services.

	Acknowledgments

We thank Carl Phillips (executive officer, Bro Taf local research ethics committee) for his administrative help and support.

Contributors: AB and WT designed and performed the study and wrote the paper. AB is guarantor for the paper.

	Footnotes

Funding: None.

Competing interests: AB and WT are both members of Bro Taf local research ethics committee.

This article is part of the BMJ's randomised controlled trial of open peer review. Documentation relating to the editorial decision making process is available on the BMJ's website

	References

Top Methods and results Comment References

1.	Bowling A. Ageism in cardiology. BMJ 1999; 319: 1353-1355[Free Full Text].
2.	Bugeja G, Kumar A, Banerjee AK. Exclusion of elderly people from clinical research: a descriptive study of published reports. BMJ 1997; 315: 1059[Free Full Text].
3.	European Commission Committee on Proprietary Medicinal Products. Guidelines on clinical investigation of medicinal products in the elderly. Brussels: CPMP, 1998.
4.	Age Concern. Turning your back on us. London: Age Concern, 1999.

(Accepted 16 June 2000)