ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)
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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Exempting low-risk health and medical research from ethics reviews: comparing Australia, the United Kingdom, the United States and the Netherlands (Papers: Anna Mae Scott, et al | January 2020)0

Posted by Admin in on April 1, 2020
 

Abstract

Background
Disproportionate regulation of health and medical research contributes to research waste. Better understanding of exemptions of research from ethics review in different jurisdictions may help to guide modification of review processes and reduce research waste. Our aim was to identify examples of low-risk human health and medical research exempt from ethics reviews in Australia, the United Kingdom, the United States and the Netherlands.

Methods
We examined documents providing national guidance on research ethics in each country, including those authored by the National Health and Medical Research Council (Australia), National Health Service (United Kingdom), the Office for Human Research Protections (United States) and the Central Committee on Research Involving Humans (the Netherlands). Examples and types of research projects exempt from ethics reviews were identified, and similar examples and types were grouped together.

Results
Nine categories of research were exempt from ethics reviews across the four countries; these were existing data or specimen, questionnaire or survey, interview, post-marketing study, evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, audit and service evaluation, and other exemptions. Existing non-identifiable data and specimens were exempt in all countries. Four categories – evaluation of public benefit or service programme, randomised controlled trials, research with staff in their professional role, and audit and service evaluation – were exempted by one country each. The remaining categories were exempted by two or three countries.

Conclusions
Examples and types of research exempt from research ethics reviews varied considerably. Given the considerable costs and burdens on researchers and ethics committees, it would be worthwhile to develop and provide clearer guidance on exemptions, illustrated with examples, with transparent underpinning rationales.

Scott, A.M., Kolstoe, S., Ploem, M.C., Hammatt, Z. & Glasziou, P.  (2020) Exempting low-risk health and medical research from ethics reviews: comparing Australia, the United Kingdom, the United States and the Netherlands. Health Research Policy and Systems. 18(11). https://doi.org/10.1186/s12961-019-0520-4
Publisher (Open Access): https://health-policy-systems.biomedcentral.com/articles/10.1186/s12961-019-0520-4

Friday afternoon’s funny – Risks already present0

Posted by Admin in on March 27, 2020
 

Cartoon by Don Mayne www.researchcartoons.com
Full-size image for printing (right mouse click and save file)

Some research projects (such as sport-related work) involve participants already engaged in a risky undertaking.  For research ethics reviewers this raises the question of whether their reflection on beneficence is the risks in the substantive activity or only the additional risk introduced by the research activity.

Friday afternoon’s funny – PI Action figure0

Posted by Admin in on March 20, 2020
 

Cartoon by Don Mayne www.researchcartoons.com
Full-size image for printing (right mouse click and save file)

Sometimes the different roles and special skills we demand of investigators do seem apt for an action figure from the 1980s.

Friday afternoon’s funny – Paper archives0

Posted by Admin in on March 13, 2020
 

Cartoon by Don Mayne www.researchcartoons.com
Full-size image for printing (right mouse click and save file)

The amount of paperwork generated by some human research (not just clinical trials) and research ethics review is no joke.  If your institution is still on paper records you should carefully consider the shift to an electronic approach.

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