ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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Research Ethics MonthlyISSN 2206-2483

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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

A Common Standard for Conflict of Interest Disclosure (Guidance: Center for Science in the Public Interest | 2008)0

Posted by Admin in on February 18, 2018

Merrill Goozner, Arthur Caplan, Jonathan Moreno, Barnett S. Kramer, Thomas F. Babor, Wendy Cowles Husser

The reporting of conflicts of interest in science and medicine in the scientific literature1 has come under increasing scrutiny in recent years. Failures to disclose conflicts of interest have become front page news, and a major embarrassment to publishers, editors, and professional societies.2

These failures to disclose relevant relationships have stemmed in part from a lack of uniform definitions for conflicts of interest and confusion about what needs to be reported. Academic investigators operate under varying institutional rules, and many are unable to accurately describe their institutions’ policies.3 Science and biomedical journals have a range of disclosure policies with differences in definitions of conflicts of interest, reporting requirements, and promises to publish.4

In the face of heightened scrutiny, several publishers have moved in the past several years to implement stricter conflict-of-interest disclosure and publication rules. 5 6 7 Organizations are paying greater attention to conflict-of-interest disclosure in the context of redefining the rules of engagement between academic investigators and private industry.8 The need for common standards in defining conflicts of interest has never been greater.

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Identifying and Mitigating Risk of Violence in the Scientific Workplace (Papers: Renée Binder, et al | 2017)0

Posted by Admin in on February 13, 2018

 Forensic psychiatrists can have an important role in helping to improve safety in the scientific workplace by evaluating the potential for violence and develop- ing strategies to mitigate the risk. Forensic psychiatrists engage in violence risk assessment in both criminal and civil settings.1 In fact, core competencies of forensic psychiatry fellowships include being able to opine about risks of reoffending and making decisions about hospitalization and release. In addition, forensic psychiatrists develop skills in protecting their personal safety as they work with potentially dangerous evaluees and work in correctional settings.

Valuable, but scary, discussion. A salient reminder that being a psychologist doesn't necessarily mean a person will spot the warning signs of impending violence.

In contrast to psychiatrists’ experience and expertise, of psychiatrists within the academic setting, scientists rarely, if ever, have the proper skills to identify or mitigate risk in the workplace. There may be a lack of awareness that warning signs occur and often precede violent acts.2 Similarly, non–mental health clinicians are typically not trained in assessing and mitigating risk of violence.
The authors of this article work as Deans and Director of Academic Affairs at a large research university. They are often consulted by leaders, faculty, staff, and trainees about problematic behaviors exhibited in the clinical and scientific workplace. One of the authors (R.B.) is also a forensic psychiatrist and has been able to develop training and consultation for the dean’s office about recognizing and mitigating risk. As violence in the scientific workplace receives more attention, forensic psychiatrists should expect to be called on for their expertise on this matter…

 Binder, R., Garcia, P., Johnson, B. and Fuentes-Afflick, E. (2017). “Identifying and Mitigating Risk of Violence in the Scientific Workplace.” Journal of the American Academy of Psychiatry and the Law Online 45(4): 400-403.
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Social and Communicative Functions of Informed Consent Forms in East Asia and Beyond (Papers: Go Yoshizawa, et al | 2017)0

Posted by Admin in on February 11, 2018

The recent research and technology development in medical genomics has raised new issues that are profoundly different from those encountered in traditional clinical research for which informed consent was developed. Global initiatives for international collaboration and public participation in genomics research now face an increasing demand for new forms of informed consent which reflect local contexts. This article analyzes informed consent forms (ICFs) for genomic research formulated by four selected research programs and institutes in East Asia – the Medical Genome Science Program in Japan, Universiti Sains Malaysia Human Research Ethics Committee in Malaysia, and the Taiwan Biobank and the Taipei Medical University- Joint Institutional Review Board in Taiwan. The comparative text analysis highlights East Asian contexts as distinct from other regions by identifying communicative and social functions of consent forms. The communicative functions include re-contact options and offering interactive support for research participants, and setting opportunities for family or community engagement in the consent process. This implies that informed consent cannot be validated solely with the completion of a consent form at the initial stage of the research, and informed consent templates can facilitate interactions between researchers and participants through (even before and after) the research process. The social functions consist of informing participants of possible social risks that include genetic discrimination, sample and data sharing, and highlighting the role of ethics committees. Although international ethics harmonization and the subsequent coordination of consent forms may be necessary to maintain the quality and consistency of consent process for data-intensive international research, it is also worth paying more attention to the local values and different settings that exist where research participants are situated for research in medical genomics. More than simply tools to gain consent from research participants, ICFs function rather as a device of social communication between research communities and civic communities in liaison with intermediary agents like ethics committees, genetic counselors, and public biobanks and databases.

Keywords: medical genomics, consent documents, group consent, family consent, community engagement

Yoshizawa G, Sasongko TH, Ho C-H and Kato K (2017) Social and Communicative Functions of Informed Consent Forms in East Asia and Beyond. Frontiers in Genetics. 8:99. doi: 10.3389/fgene.2017.00099
Publisher (Open Access):….

(University of the South Pacific) HUMAN RESEARCH ETHICS: A Handbook for USP Researchers (Guidance | Updated 2013)0

Posted by Admin in on February 6, 2018

“This Handbook explains the values and principles that guide processes and practices of research involving human participants at the University of the South Pacific.

We believe this handbook provides some useful guidance about responsibility to the region

The ethical values and principles described here apply to all University activities, to all its staff and student researchers including those visiting for short periods, and to any research agreements or partnerships that the University establishes.
The University’s human ethics will be compliant with the laws of individual University member states, particularly in relation to privacy, confidentiality, ownership, intellectual property requirements, research permit requirements and human rights.”

  1. Introduction
  2. Ethical principles
  3. The University Research Ethics Committee (UREC)
  4. Ethical responsibilities of researchers at the University
  5. Procedures for applying for ethical approval of proposed research

Appendix 1. Screening Questionnaire for Human Ethics (sample)

Appendix 2. Application for Human Ethics Approval (sample)

Appendix 3. Information Sheet (model)

Appendix 4. Participant Consent Form (model)

Appendix 5.Confidentiality Agreement (model)

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