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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Scientists’ perspectives on consent in the context of biobanking research (Zubin Master, et al 2015)0

Posted by Admin in on May 12, 2016
 

Abstract: Most bioethics studies have focused on capturing the views of patients and the general public on research ethics issues related to informed consent for biobanking and only a handful of studies have examined the perceptions of scientists. Capturing the opinions of scientists is important because they are intimately involved with biobanks as collectors and users of samples and health information. In this study, we performed interviews with scientists followed by qualitative analysis to capture the diversity of perspectives on informed consent. We found that the majority of scientists in our study reported their preference for a general consent approach although they do not believe there to be a consensus on consent type. Despite their overall desire for a general consent model, many reported several concerns including donors needing some form of assurance that nothing unethical will be done with their samples and information. Finally, scientists reported mixed opinions about incorporating exclusion clauses in informed consent as a means of limiting some types of contentious research as a mechanism to assure donors that their samples and information are being handled appropriately. This study is one of the first to capture the views of scientists on informed consent in biobanking. Future studies should attempt to generalize findings on the perspectives of different scientists on informed consent for biobanking.

Master Z, Campo-Engelstein L, Caulfield T (2015) Scientists’ perspectives on consent in the context of biobanking research. European Journal of Human Genetics. 23(5): 569-574. doi: 10.1038/ejhg.2014.143
NCBI (Free access): http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4402622/
Publisher (Free access): http://www.nature.com/ejhg/journal/v23/n5/full/ejhg2014143a.html

Clarifying ethical responsibilities in paediatric biobanking (Papers Merle Spriggs & Craig L. Fry)0

Posted by Admin in on May 11, 2016
 

ABSTRACT

Background: The creation of biobanks for storage of human specimens and use in health and medical research is expanding globally. Biobanks hold significant potential to facilitate such research. However, important ethical questions arise, particularly in the pediatric setting, in relation to consent, future use, and the balance of benefits against potential harms. To date, these ethical issues have been undertheorized and under-researched in the biobanks domain. The aim of this study was to examine stakeholder attitudes regarding the ethical responsibilities of researchers, biobank custodians, Human Research Ethics Committees (HRECs), research institutions, and parents.

Methods: A qualitative study using semistructured interviews with a purposive sample of key informants (n = 14) with relevant expertise was conducted. Participants were interviewed about their pediatric biobank experiences, the main ethical issues observed as an HREC member, researcher, or custodian, and future needs.

Results: Participants expressed concerns about consent processes in the biobanking context, including issues regarding the provision of information, level of understanding, voluntariness, and the point at which children have a role or can consent for themselves. Other major issues raised were biobank quality management, the return of results, and the idea of human tissue as a scarce precious resource. Key informants also highlighted uncertainties about the custodianship of biobank samples and reasonable limits on the custodian’s role.

Conclusions: Pediatric biobanks are a valuable resource, presenting unique opportunities to advance children’s health and well-being. Properly run pediatric biobanks entail responsibilities for institutes, custodians, researchers, and research ethics committees. We discuss ethical implications for pediatric biobank policy and practices, as well as future information needs in light of the study findings.

Spriggs, M. & Fry, C. (2015). Clarifying ethical responsibilities in paediatric biobanking. AJOB Empirical Bioethics DOI:10.1080/23294515.2015.1049718
http://www.tandfonline.com/eprint/QDVEzAwZsTqT9QkwvBjB/full xxxx

Ethics in Health Research: Principles, Processes and Structures (2nd ed.) – South Africa0

Posted by Admin in on April 9, 2016
 

Chapter 1 Ethics in research
1.1 Introduction
1.2 The research context
1.3 Regulatory authority
1.4 Research with humans
1.5 Research using animals
1.6 Ethical research review
1.7 Glossary and resources
1.8 Purpose and status of these Guidelines
1.9 Structure of these Guidelines

Chapter 2 Guiding principles for ethical research
2.1 Ethical principles
2.2 Role of ethical principles
2.3 Key norms & standards

Chapter 3 Substantive norms and operational processes
3.1 Ethical basis for decision-making in the review process
3.2 Vulnerability and incapacity
3.3 Data and biological materials for research purposes
3.4 Considerations specific to research methods or contexts
3.5 Special topics

Chapter 4 Research Ethics Committees
4.1 Introduction
4.2 Legislative framework
4.3 Role of Research Ethics Committees
4.4 Membership
4.5 Standard operating procedures
4.6 Compliance reporting to NHREC

Chapter 5 Health research ethics infrastructure
5.1 Introduction
5.2 National Health Research Ethics Council
5.3 Research Ethics committees

Department of Health (2015) Ethics in Health Research: Principles, Processes and Structures (2nd ed.). Pretoria: Department of Health.
http://www0.sun.ac.za/research/assets/files/Integrity_and_Ethics/DoH%202015%20Ethics%20in%20Health%20Research%20-%20Principles,%20Processes%20and%20Structures%202nd%20Ed.pdf

Attitudes of the general public towards the disclosure of individual research results and incidental findings from biobank genomic research in Australia (Papers: Jenn Fleming, et al 2015)0

Posted by Admin in on January 14, 2016
 

Abstract:

BACKGROUND:
Over the past decade, managing the disclosure of findings of genomic research has been the subject of extensive scientific, ethical and legal commentary and is a major challenge for biobanks.

AIMS:
To examine views of the general Australian public about the disclosure of individual research results (IRR) and incidental findings (IF) from biobank genomic research.

METHODS:
A national computer assisted telephone interview was conducted amongst a representative sample of (n = 800) adult residents across each Australian State and Territory.

RESULTS:
The majority of the Australian general public would be interested in receiving IRR and IF if they allowed their blood/tissue to be used in research; 94.4% (n = 800) reported that they would like to receive ‘specific information obtained from your sample that may be important to your health or treatment’, and 83.4% their ‘potential genetic risk of an inherited disease’. Although fewer desired to receive ‘any IF that were not directly related to your (potential) diagnosed condition’ (70.0%), most would still like to receive IF. A latent class analysis on the desire to receive (or not) all types of results revealed differences in preferences in the information they wished to receive.

CONCLUSION:
The majority of Australians desire to receive most information arising from research involving their tissue, including IRR and IF. Differences in the extent and type of information they desire to receive are noted. Biobanks must establish strategies to identify information needs of donors, assess research data and communicate with donors and donor families. Processes need to take account of differences in donor preferences and in the clinical or research context(s).

Fleming, J., Critchley, C., Otlowski, M., Stewart, C., Kerridge, I. (2015). Attitudes of the general public towards the disclosure of individual research results and incidental findings from biobank genomic research in Australia. Internal Medicine Journal, 45(12), 1274-1279

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