Exempting low-risk health and medical research from ethics reviews

Comparing Australia, the United Kingdom, the United States and the Netherlands

Anna Mae Scott*, Simon Kolstoe, M. C.(corrette) Ploem, Zoë Hammatt, Paul Glasziou

*Corresponding author for this work

Research output: Contribution to journalArticleResearchpeer-review

5 Downloads (Pure)

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.

Original languageEnglish
Article number11
Number of pages8
JournalHealth Research Policy and Systems
Volume18
Issue number1
DOIs
Publication statusPublished - 28 Jan 2020

Fingerprint

Research Ethics
Medical Ethics
Netherlands
Biomedical Research
Health
Research
Professional Role
Ethics
United States Office of Research Integrity
Randomized Controlled Trials
Ethics Committees
United Kingdom
National Health Programs
Marketing
Research Personnel
Interviews
Costs and Cost Analysis

Cite this

@article{1b1e31981d95459a834c441b6ed88c37,
title = "Exempting low-risk health and medical research from ethics reviews: Comparing Australia, the United Kingdom, the United States and the Netherlands",
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.",
author = "Scott, {Anna Mae} and Simon Kolstoe and Ploem, {M. C.(corrette)} and Zo{\"e} Hammatt and Paul Glasziou",
year = "2020",
month = "1",
day = "28",
doi = "10.1186/s12961-019-0520-4",
language = "English",
volume = "18",
journal = "Health Research Policy and Systems",
issn = "1478-4505",
publisher = "BioMed Central",
number = "1",

}

Exempting low-risk health and medical research from ethics reviews : Comparing Australia, the United Kingdom, the United States and the Netherlands. / Scott, Anna Mae; Kolstoe, Simon; Ploem, M. C.(corrette); Hammatt, Zoë; Glasziou, Paul.

In: Health Research Policy and Systems, Vol. 18, No. 1, 11, 28.01.2020.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Exempting low-risk health and medical research from ethics reviews

T2 - Comparing Australia, the United Kingdom, the United States and the Netherlands

AU - Scott, Anna Mae

AU - Kolstoe, Simon

AU - Ploem, M. C.(corrette)

AU - Hammatt, Zoë

AU - Glasziou, Paul

PY - 2020/1/28

Y1 - 2020/1/28

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85078537634&partnerID=8YFLogxK

U2 - 10.1186/s12961-019-0520-4

DO - 10.1186/s12961-019-0520-4

M3 - Article

VL - 18

JO - Health Research Policy and Systems

JF - Health Research Policy and Systems

SN - 1478-4505

IS - 1

M1 - 11

ER -