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

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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Video: Life Sciences Quarterly: The Use of Social Media and Mobile Applications in Clinical Trials & Recent Developments in Research Fraud0

Posted by Admin in on February 4, 2018
 

“What are the legal implications of using social media and mobile applications in clinical trials and the recent developments impacting research fraud investigations?

While this 50 minute talk is very US based, its underlying ideas remain relevant well beyond. AHRECS has delivered REC professional development presentations (pre-recorded audio and video connection) lasting 30 minutes that can be incorporated into a Committee’s agenda.

In this recap of our fourth quarter presentation, which includes video and an accompanying transcript, panelists – health care partner Mark Barnes and associate David Peloquin – address such topics as:
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  • Use of social media for research subject recruitment
  • Privacy considerations related to the use of social media and mobile applications
  • Institutional review board and research ethics committee views of social media
  • Obligations of research sponsors to monitor adverse events posted on social media
  • International considerations in use of social media and mobile applications
  • Strategies for conducting research fraud investigations in industry

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This presentation is part of Life Sciences Quarterly, a quarterly seminar series that delivers insights from Ropes & Gray attorneys, speakers from government and industry and other professionals as they examine key developments, issues and trends affecting the life sciences sector.”
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Watch the Life Science Quarterly video

Rethinking Informed Consent in Biobanking and Biomedical Research: a Taiwanese Aboriginal Perspective and the Implementation of Group Consultation (Papers: Chih-hsing Ho | 2017)0

Posted by Admin in on February 1, 2018
 

Abstract
The current informed consent mechanism is based mainly on the rationale of individualism, particularly for its emphasis on autonomy and self-determination. However, in biobanking and genetic research, research findings may pose a risk of harm to the collective, quite aside from a particular individual. Under this circumstance, individual consent needs to be supplemented by other mechanisms, such as group consent obtained from the relevant group or community. In Taiwan, the inclusion of Taiwanese aborigines in biobanking and genetic research challenges the conventional wisdom of individual consent-taking, which overlooks the significance of collective involvement in decision-making. This paper discusses the rationale of the group consent requirement in Taiwan, which seeks to include Taiwanese aborigines’ perspectives, and the related measures that have been pronounced to implement group consultation. It is further argued that consent procedures should not be transactional in being primarily focused on types of information that is to be communicated. Rather, it should be a process that ensures comprehension, empowerment and trust.

Keywords
Informed consent, Biobanking, Biomedical research. Group consultation, Taiwanese aborigines, Human Subjects Research Act

Ho, C.-h. (2017). “Rethinking Informed Consent in Biobanking and Biomedical Research: a Taiwanese Aboriginal Perspective and the Implementation of Group Consultation.” Asian Bioethics Review 9(4): 353-365.
Publisher (Open Access):  https://link.springer.com/article/10.1007/s41649-017-0037-5

Friday afternoon’s funny – How many people does it take?0

Posted by Admin in on January 19, 2018
 

Cartoon by Don Mayne www.researchcartoons.com

Some research projects can require the involvement of 20 or more people, and that’s without the research team, actual participants, the regulators or those involved with the research outputs. And then there are the friendly consultants (like AHRECS!) on hand to advise and assist to make the process as collegiate, effective and efficient as possible. 🙂

Ethical issues concerning the recruitment of university students as research subjects (Papers: Albert F.G. Leentjens & James L. Levenson | 2013)0

Posted by Admin in on January 9, 2018
 

Abstract
OBJECTIVE:
To discuss the ethical issues in the recruitment of university students as research subjects.

METHODS:
Narrative review and discussion.

RESULTS:
The recruitment and inclusion of students in university research projects raise ethical issues specific to this population. Students may be required or coerced to participate, receive course credits for their participation, and their privacy may be violated. Some ethically questionable procedures are standard practice at some universities, and endorsed by their institutional review boards and faculties. Some changes will not be easy to achieve because this implies a change of organization of research and will affect funding and output.

CONCLUSION:
The authors call for international standards to be set for research with students, that are in line with applicable standards in research with other subjects, such as medically ill patients, on which researchers, members of institutional review boards and editors can base their policies, opinions and decisions.

KEYWORDS:
Ethics; Recruitment; University students

Leentjens, A. F., & Levenson, J. L. (2013). Ethical issues concerning the recruitment of university students as research subjects. Journal of psychosomatic research, 75(4), 394‐398.
Publisher (Open Access): http://www.jpsychores.com/article/S0022-3999(13)00078-0/fulltext

Also see:
The SoTL research ethics resource booklets produced by AHRECs

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