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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Common Rule Revision – The Ethics Police Fight Back – Social Science Space (Robert Dingwall 2015)0

Posted by Admin in on December 20, 2015

“As might have been expected, the proposed revisions to the Common Rule regulating research ethics in federally funded research in the U.S. have not gone unchallenged.

The proposals are contained in a long and complex document. Even those of us who take a close interest in these things have struggled to assimilate 500 pages of dense prose. It is not, then, unreasonable that the consultation period has been extended by another 30 days. However, it is important that scholars who basically support the proposals take advantage of this to express positive views – because it is clear that there is a determined push back.

As I outlined in a previous blog, these revisions would mean that most social science research would be excluded from IRB review.

Any research involving standardized testing, surveys, interviews, or observations, including audio and video recording, of public behavior, including behavior online, will be able to proceed without further review. Certain types of experimental work will also be excluded, where participants experience ‘benign interventions [which are] brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact…[or to be] offensive or embarrassing.’ These studies may include an element of deception provided the participant agrees to this in advance. Oral history, journalism, biography and historical scholarship about named individuals can proceed solely with reference to the disciplines’ own codes of ethics. The secondary analysis of administrative data, including many health and criminal justice records, even in identifiable form, will be excluded from review provided it complies with data protection legislation. Some research with children would still require review: standardized tests and non-participant observation would be excluded but not surveys, interviews and participant observation.”

Read the full item here.
Also see the earlier item about the change to the Common Rule

Launch of the TRUST project call for competition – Enhancing better ethical practices in research0

Posted by Admin in on December 18, 2015

“INSERM is launching an international call for competition under the European project TRUST. This call aims at promoting better ethical pratices in research in low and middle income countries. We are seeking for 5 situations of ethics dumping in all the fields of research, open to all continents. An international judging committee will select 5 winners, each will receive €2,000.

•Launch date: Decembre the 14th, 2015
•Phase 1 deadline: March the 2nd, 2016
•Return date of letters of intent: March the 31st, 2016
•Phase 2 deadline: May the 2nd, 2016
•Date of announcement of results: June the 3rd, 2016

No personal data must be revealed in the case of study.

The application form is available at the following link, available both in English and in French:

It would be great if you could participate and/or disseminate this information to possible interested parties.

I hope my explainations are clear. Please, do not hesitate to come back
to us – – if you have questions.

With best regards,

Solveig FENET
Deputy-manager for the Horizon 2020-TRUST partner Inserm”

Research Ethics in Ethnography/Anthropology (Dr Ron Iphofen AcSS)0

Posted by Admin in on December 16, 2015

“This Report was prepared for the Ethics Unit B6, DG Research and Innovation of the European Commission (EC). The primary audience for this Report are ethics review committees or panels who might not be so directly familiar with the methods regularly adopted by ethnographers and anthropologists. There is nothing new here for practitioners of those disciplines, but it is hoped anyone with an interest in ethics review in ethnography/anthropology may also find the information contained here useful. Although there are some fundamental core ethical principles that can be applied to all human subjects research, the operationalisation of those principles varies according to the methodology adopted. A wide variety of research methods can be found within the social sciences and humanities (SSH) – for this reason the contribution that can be made to advancing human knowledge and scientific understanding from the SSH disciplines may be obstructed or undermined if inappropriate review criteria are applied to research proposals. Ethical review should be informed by the underlying theoretical and methodological assumptions of the discipline which frames the research proposal. This requires the provision of a full justification of the research approach from the research proposer, together with a properly
constituted and competent review panel and a robust, fair and transparent review process.

“Section 1 in this paper deals with basic theoretical assumptions and methodology. Sections 2 and 3 establish the ethical principles by which all scientific research should be assessed. In section 4 those general ethical principles are applied to the ‘special consideration’ that needs to be given to given to ethnographic and anthropological research, given the nature of its theoretical assumptions and primary research methods. This paper draws on previously published material – Iphofen (2011), Iphofen, Krayer and Robinson (2009). I am grateful for the comments made by a range of experts to improve upon the first draft of this Report and particularly wish to acknowledge the constructive contributions to this final version made by Prof. Robert Dingwall

PDF copy of the report

Reform of Clinical Research Regulations, Finally (PAPERS: E. J. Emanuel, M.D. 2015)0

Posted by Admin in on November 18, 2015

“In 1972, Jean Heller of the Associated Press reported on a 40-year-old research study that had followed black Alabama sharecroppers, some of whom had syphilis. The revelation of deception, withholding of appropriate treatment, and other unethical practices exploded into the Tuskegee scandal. Tuskegee led to the National Research Act of 1974, which authorized the Department of Health, Education, and Welfare (now the Department of Health and Human Services [HHS]) to augment government policies for protecting human research subjects.1 The protections, ultimately codified as 45 Code of Federal Regulations 46 (45 CFR 46), specify requirements for valid institutional review board (IRB) assessment of most human-subjects research and informed consent by research participants.2

In the decade after 1974, specific safeguards were added for pregnant women, fetuses, neonates, children, and prisoners. For instance, research involving prisoners, such as commonly conducted early-phase drug studies, was severely restricted; only research on “possible causes, effects, and processes of incarceration, and of criminal behavior, prisoners as incarcerated persons, [and] . . . conditions particularly affecting prisoners as a class” was permitted. In 1991, many other (though not all) federal departments and agencies adopted the main part of 45 CFR 46 for their human-subjects research, which became known as the Common Rule.”

Emanuel, E. J. (2015). Reform of Clinical Research Regulations, Finally. New England Journal of Medicine.
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