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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Long-Sought Research Deregulation Is Upon Us. Don’t Squander the Moment – The Chronicle of Higher Education (Richard A. Shweder and Richard E. Nisbett | March 2017)0

Posted by Admin in on March 19, 2017

We can’t help but feel that the revision of the US Common Rule was a missed opportunity to reflect on how institutions should replace IRB control through review with an approach that aims at building reflective ethical practice. Given past patterns of exporting US regulatory approaches to other parts of the world, many more jurisdictions may come to regret this.

It has been a 40-year labor: Regulatory systems are not easy to undo. Nevertheless, in January the federal government opened the door for universities to deregulate vast portions of research in the social sciences, law, and the humanities. This long-sought and welcome reform of the regulations requiring administrative oversight of federally funded human-subject research on college campuses limits the scope of institutional review board, or IRB, management by exempting low-risk research with human subjects from the board’s review.
The new regulations state: “We acknowledge that guidance may be useful for interpreting some of the terms in this exemption, and that some cases will be debatable. However, we also believe that a substantial number of research activities will plainly fit this exemption, and should be allowed to proceed without IRB review.”
The exempted research activities include surveys, interviews, and other forms of free communication between researchers and human adults, aptitude testing, the observation and recording of verbal and nonverbal behavior in schools and public places (for example, courtrooms), benign behavioral interventions (including ordinary psychology experiments), secondary-data analysis, and other low-risk projects and research procedures.

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Friday afternoon’s funny – Over using abbreviations and acronyms0

Posted by Admin in on March 3, 2017

Game show participants fail to guess what GCP means

Cartoon by Don Mayne – Using abbreviations and acronyms is confusing

Cartoon by Don Mayne

Friday afternoon funny – Urgent or just last minute review applications0

Posted by Admin in on February 17, 2017

Health workers and patient in an operating room wait anxiously for ethical clearance

Cartoon by Don Mayne – Why you should not leave research ethics review until the last moment

Cartoon by Don Mayne

Terminology and timing matter. For researchers: An application/variation isn’t urgent if you did not plan for the usual review turnaround. For reviewers and institutions: Do you have agile mechanisms for situations that are genuinely urgent?

Update: U.S. abandons controversial consent proposal on using human research samples – Science (Jocelyn Kaiser | January 2017)0

Posted by Admin in on February 16, 2017

Federal officials have dropped a controversial plan to impose new rules that researchers say would have made it much harder to use patient blood and tissue samples in research. The final Common Rule released this morning omits these provisions, but leaves some other changes intact.

Biomedical and university research groups that lobbied against the biospecimens provisions are relieved. “We are very pleased at the amount of time, attention, and effort that went into reviewing the comments. The process worked,” says Lizbet Boroughs, who follows biomedical research policy for the Association of American Universities in Washington, D.C.

The 26-year-old Common Rule protects people who volunteer for federally funded research studies. The Department of Health and Human Services (HHS) and other agencies began an overhaul in 2011 to incorporate changes in how medical research is done, such as a growing number of clinical trials, the use of electronic medical health records, and privacy concerns raised by advances in genomics.

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Other news about the update to the US ‘Common rule’