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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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.

Read the rest of this news story

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


Listening to the Voices of the People: The Psychosocial Influences and Consequences of Research in Ethnocultural Communities (Books: Joseph Trimble, et al | 2017)0

Posted by Admin in on February 14, 2017

In the past three decades, there has been a dramatic increase in mental health research conducted among ethnic and nationalistic groups. As the interest has increased so have the concerns of many ethnocultural communities about research in general and the presence of researchers in their communities. The rising community concerns accompanied with the emergence of community-based research review committees presents extraordinary challenges for researchers – challenges that are only beginning to be fully and seriously acknowledged at methodological, procedural, and conceptual levels. The most important challenge though is the actual responsible conduct of researchers while they are in the field and the relationship they establish with their respondents. The chapter discusses the history of how research has been conducted in ethnocultural communities with the use of culturally inappropriate designs, methodology, and interpretation. Consequently, communities are now taking steps to protect themselves against the harm, which has come from the past abuses of research practices and the insensitivities of the researchers. Moreover, it is essential to educate ethnocultural communities about healing from the effects of past research and subsequently teach communities how to empower themselves in future research endeavors. Research can be beneficial to ethnocultural communities if appropriate measures are taken to ensure cultural responsiveness and solid grounding in the culturally unique lifeways and thoughtways of the communities.

Keywords: ethics; community empowerment; participatory action research; culturally sensitive research.

Trimble, J. E., Casillas, D. M., Boyd, B., & King, J. (2017). Listening to the Voices of the People: The Psychosocial Influences and Consequences of Research in Ethnocultural Communities. In Social Issues in Living Color: Challenges and Solutions from the Perspective of Ethnic Minority Psychology [3 volumes], 305. Praeger Books
Research Gate:…

The Role of Intuition in Risk/Benefit Decision-Making in Human Subjects Research (Papers: David B. Resnik | June 2016)0

Posted by Admin in on February 2, 2017

One of the key principles of ethical research involving human subjects is that the risks of research to should be acceptable in relation to expected benefits. Institutional review board (IRB) members often rely on intuition to make risk/benefit decisions concerning proposed human studies. Some have objected to using intuition to make these decisions because intuition is unreliable and biased and lacks transparency. In this article, I examine the role of intuition in IRB risk/benefit decision-making and argue that there are practical and philosophical limits to our ability to reduce our reliance on intuition in this process. The fact that IRB risk/benefit decision-making involves intuition need not imply that it is hopelessly subjective or biased, however, since there are strategies that IRBs can employ to improve their decisions, such as using empirical data to estimate the probability of potential harms and benefits, developing classification systems to guide the evaluation of harms and benefits, and engaging in moral reasoning concerning the acceptability of risks.

Benefits, human subjects research, institutional review boards, intuition, reasoning, risks

Resnik DB (2016) The Role of Intuition in Risk/Benefit Decision-Making in Human Subjects Research. Accountability in Research
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