All Bookmarks

Informed Consent and Cluster-Randomized Trials

Julius Sim and Angus Dawson Informed Consent and Cluster-Randomized Trials. American Journal of Public Health: March 2012, Vol. 102, No. 3, pp. 480-485.
doi: 10.2105/AJPH.2011.300389

ABSTRACT
We argue that cluster-randomized trials are an important methodology, essential to the evaluation of many public health interventions.

However, in the case of at least some cluster-randomized trials, it is not possible, or is incompatible with the aims of the study, to obtain individual informed consent. This should not necessarily be seen as an impediment to ethical approval, providing that sufficient justification is given for this omission.

We further argue that it should be the institutional review board’s task to evaluate whether the protocol is sufficiently justified to proceed without consent and that this is preferable to any reliance on community consent or other means of proxy consent.

Read More: http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2011.300389

Saved once (save to my bookmarks)
Bookmarked by Dina Bogecho on 13 Feb 2012
0 points

WHO Standards for Ethics Committees now published

“Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants” a compilation of 10 standards that are applicable to the ethics review of health related research with human participants. It can be found at http://www.who.int/ethics/publications/en/

Saved once (save to my bookmarks)
Bookmarked by Dina Bogecho on 9 Feb 2012
0 points

Ethical questions around genetic testing

Written by John Donnelly on February 2, 2012

Just 10 years ago, a complete personalized genome test cost $3 billion. Some groups say that this cost could drop to as low as $1000 this year.

With the tests becoming more affordable, and more and more people getting whole genome sequencing tests, a host of related ethical issues are getting more attention, experts told the Presidential Commission for the Study of Bioethical Issues today in San Francisco.

Among them: Who will interpret this genetic data? Is it ethical to allow health care providers to interpret the data without a health systems infrastructure to help them interpret it? What will be the privacy protections to people who have the testing? Are privacy issues around genetic testing any different from other personal health information?

The Commission heard differing views on the thicket of ethical issues surrounding the emerging field.

Click on the link above for the rest of this blog post.

Saved once (save to my bookmarks)
Bookmarked by Dina Bogecho on 9 Feb 2012
0 points

Experts give top concerns on genetic tests

Written by John Donnelly on February 2, 2012

In the final session today before the Presidential Commission for the Study of Bioethical Issues, Chair Dr. Amy Gutmann asked all the experts who presented information to talk about their greatest concern with genetic tests.

Gutmann, the President of the University of Pennsylvania, told them: “The Commission is very likely to focus its report on issues of privacy broadly construed. Anything that is relevant to privacy would be of great interest to the Commission.”

Among the responses:

Jane Kaye, Director of the Centre for Law, Health and Emerging Technologies at Oxford University: “I would say I see the whole genome sequencing is another twist on things happening already on science. … What we need to do is make (privacy concerns) more nuanced and allow individuals to say how whole genomes are used.”

See link for the rest of this blogpost

Saved once (save to my bookmarks)
Bookmarked by Dina Bogecho on 9 Feb 2012
0 points

Nuffield Council Symposium Report: ‘Global health: responsibility, ethics and policy’

A report of the Nuffield Council on Bioethics’ 20th anniversary symposium ‘Global health: responsibility, ethics and policy’ has been published.
At the symposium, which took place on 22 June 2011, speakers from around the globe discussed topics such as ethics and responsibility in global health, non-communicable diseases, the role of emerging biotechnologies in global health, and social determinants of health.
Over 150 people attended the meeting, including clinicians, government officials, and representatives of research funding bodies, charities and pharmaceutical companies, both from the UK and abroad.
Albert Weale, Chair of the Council, summed up the day by highlighting some major themes that had emerged, including medical training and migration, interdependence, responsibility, and ‘health for all’ policies. The symposium will inform the Council as it considers its future work in the field of global health.

Download the report, a video showing highlights of the symposium, the programme, and speaker slides at: www.nuffieldbioethics.org/international/international-global-health-symposium

Saved once (save to my bookmarks)
Bookmarked by Dina Bogecho on 9 Feb 2012
0 points