Randomised evaluation of government health programmes does present a challenge to standard research ethics frameworks

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Randomised evaluation of government health programmes does present a challenge to standard research ethics frameworks. / Watson, Samuel I; Dixon-Woods, Mary; Lilford, Richard J.

In: Journal of Medical Ethics, Vol. 46, No. 1, 14.01.2020, p. 34-35.

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@article{9082e9fbf4684e7497b2e2a09ef42e4f,
title = "Randomised evaluation of government health programmes does present a challenge to standard research ethics frameworks",
abstract = "In a recent issue of Journal of Medical Ethics (JME), we discussed the ethical review of evaluations of interventions that would occur whether or not the evaluation was taking place. We concluded that standard research ethics frameworks including the Ottawa Statement, which requires justification for all aspects of an intervention and its roll-out, were a poor guide in this area. We proposed that a consideration of researcher responsibility, based on the consequences of the research taking place, would be a more appropriate way delineate the scope of research ethics review. Weijer and Taljaard present a counterargument to our proposal, which we address in this reply. They claim that a focus on researcher responsibility will weaken the protection of research participants and link it to 'unethical research' and a 'government experimenting on its own people'. However, the moral responsibility of researchers is defined in terms of the consequences of the research on human welfare and harm, not in opposition to it. Weijer and Taljaard argue that researchers must justify what they are studying whether or not they have any control over it and that governments must justify their programmes, including by demonstrating equipoise, to a research ethics committee if they implement them in a randomised way. We strongly disagree that this is a defensible way to define the scope of research ethics review and argue that this provides no further protections to research participants beyond what we propose, but places a potential barrier to learning from government programmes.",
keywords = "clinical trials, policy guidelines/Inst review boards/review cttes, research ethics",
author = "Watson, {Samuel I} and Mary Dixon-Woods and Lilford, {Richard J}",
note = "{\textcopyright} Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.",
year = "2020",
month = jan,
day = "14",
doi = "10.1136/medethics-2019-106003",
language = "English",
volume = "46",
pages = "34--35",
journal = "Journal of Medical Ethics",
issn = "0306-6800",
publisher = "BMJ Publishing Group",
number = "1",

}

RIS

TY - JOUR

T1 - Randomised evaluation of government health programmes does present a challenge to standard research ethics frameworks

AU - Watson, Samuel I

AU - Dixon-Woods, Mary

AU - Lilford, Richard J

N1 - © Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2020/1/14

Y1 - 2020/1/14

N2 - In a recent issue of Journal of Medical Ethics (JME), we discussed the ethical review of evaluations of interventions that would occur whether or not the evaluation was taking place. We concluded that standard research ethics frameworks including the Ottawa Statement, which requires justification for all aspects of an intervention and its roll-out, were a poor guide in this area. We proposed that a consideration of researcher responsibility, based on the consequences of the research taking place, would be a more appropriate way delineate the scope of research ethics review. Weijer and Taljaard present a counterargument to our proposal, which we address in this reply. They claim that a focus on researcher responsibility will weaken the protection of research participants and link it to 'unethical research' and a 'government experimenting on its own people'. However, the moral responsibility of researchers is defined in terms of the consequences of the research on human welfare and harm, not in opposition to it. Weijer and Taljaard argue that researchers must justify what they are studying whether or not they have any control over it and that governments must justify their programmes, including by demonstrating equipoise, to a research ethics committee if they implement them in a randomised way. We strongly disagree that this is a defensible way to define the scope of research ethics review and argue that this provides no further protections to research participants beyond what we propose, but places a potential barrier to learning from government programmes.

AB - In a recent issue of Journal of Medical Ethics (JME), we discussed the ethical review of evaluations of interventions that would occur whether or not the evaluation was taking place. We concluded that standard research ethics frameworks including the Ottawa Statement, which requires justification for all aspects of an intervention and its roll-out, were a poor guide in this area. We proposed that a consideration of researcher responsibility, based on the consequences of the research taking place, would be a more appropriate way delineate the scope of research ethics review. Weijer and Taljaard present a counterargument to our proposal, which we address in this reply. They claim that a focus on researcher responsibility will weaken the protection of research participants and link it to 'unethical research' and a 'government experimenting on its own people'. However, the moral responsibility of researchers is defined in terms of the consequences of the research on human welfare and harm, not in opposition to it. Weijer and Taljaard argue that researchers must justify what they are studying whether or not they have any control over it and that governments must justify their programmes, including by demonstrating equipoise, to a research ethics committee if they implement them in a randomised way. We strongly disagree that this is a defensible way to define the scope of research ethics review and argue that this provides no further protections to research participants beyond what we propose, but places a potential barrier to learning from government programmes.

KW - clinical trials

KW - policy guidelines/Inst review boards/review cttes

KW - research ethics

UR - http://www.scopus.com/inward/record.url?scp=85077677924&partnerID=8YFLogxK

U2 - 10.1136/medethics-2019-106003

DO - 10.1136/medethics-2019-106003

M3 - Comment/debate

C2 - 31852742

VL - 46

SP - 34

EP - 35

JO - Journal of Medical Ethics

JF - Journal of Medical Ethics

SN - 0306-6800

IS - 1

ER -