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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Participants’ Understanding of Informed Consent for Biobanking: A Systematic Review (Papers: Elizabeth R. Eisenhauer, et al | 2017)0

Posted by Admin in on August 7, 2019
 

Abstract
Nurses are increasingly asked to obtain consent from participants for biobanking studies. Biobanking has added unique complexities to informed consent. The purpose of this systematic review was to evaluate participants’ level of understanding of the information presented during the informed consent process unique to the donation of biological specimens for research. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were utilized to conduct the review. PubMed, EMBASE, CINAHL, PsycINFO, Scopus, Web of Science, and ProQuest bibliographic databases were searched. Results indicated that elements of informed consent unique to biobanking were poorly understood. Most studies had authors or funding associated with a biobank. Only one study disclosed and assessed participants’ understanding of moral risks. Increased disclosures, values-clarification, and presenting information via multiple modalities may facilitate understanding. There is a need to improve the quality of informed consent for biobanking studies by utilizing standardized instruments, definitions, and encouraging research about informed choice outside the biobanking industry.

Keywords
biological specimen banks, biobanking, informed consent, moral risks, understanding

Eisenhauer, E. R., Tait, A. R., Rieh, S., Y. & Arslanian-Engoren, C., M. (2017) Participants’ understanding of informed consent for biobanking: a systematic review. Clinical Nursing Research. 28(1) pp30-51
Publisher: https://journals.sagepub.com/doi/10.1177/1054773817722690

Incorporating Exclusion Clauses into Informed Consent for Biobanking (Papers: Zubin Master and David B. Resnik)0

Posted by Admin in on August 7, 2019
 

Determining how best to obtain valid consent for the use of human biological samples collected for research is a challenging issue for investigators, sponsors, and institutional review boards (IRBs) because the goals of maximizing participants’ autonomous decisionmaking and advancing scientific research may conflict. Some participants want control over their samples to avoid research projects that they find morally objectionable. In this article, we argue that the use of exclusion clauses in informed consent can minimize risks to participants and social groups and promote accountability and trust without significantly deterring research.

Exclusion clauses are written statements used during informed consent to (1) exclude the use of biological samples and personal health information for certain types of research and (2) limit sharing of biological samples and personal health information with specific researchers, biobanks, or organizations—for example, investigators working on certain types of research projects, insurance companies, government or law enforcement agencies, advocacy organizations, and private companies, that is, employers. Exclusion clauses are meant to capture contentious research that could risk discrimination or stigmatization of individuals or groups and sharing with organizations the public perceives as less trustworthy. Exclusion clauses are statements included in consent forms by the researchers on areas of contentious research in which they will not take part in the future and organizations they are unlikely to share with. Although exclusion clauses may limit unrestricted use and global sharing, they can be useful for smaller biobanks with specific purposes.

Biobanking and Informed Consent
Biobanking involves the collection of human biological materials and health information that are used for a current study and stored for future research. Samples can be tested to detect the presence of cell types, proteins, metabolites, antibodies, DNA sequences, and other biomarkers in a given population.1 With the accompanying health information of participants, investigators can analyze data derived from biological samples (such as genomic information), as well as other types of data (such as demographic and health information), to discover statistical relationships between various factors and diseases and patterns of heritability within families and populations. Sharing of biological samples is important for promoting scientific progress, because investigators can take advantage of one another’s labor and resources and can access diverse populations and include more samples in their studies. Sometimes, samples come from populations where individuals are thought to have unique genetic predispositions or environmental exposures.

MASTER, Z., & RESNIK, D. (2013). Incorporating Exclusion Clauses into Informed Consent for Biobanking. Cambridge Quarterly of Healthcare Ethics, 22(2), 203-212. doi:10.1017/S0963180112000576
Publisher: https://www.cambridge.org/core/journals/cambridge-quarterly-of-healthcare-ethics/article/incorporating-exclusion-clauses-into-informed-consent-for-biobanking/B73A45B1050893729219B0076EFF4D67

(Australia) Medicare data used to recruit people with bipolar for research – Sydney Morning Herald (Kate Aubusson | July 2019)0

Posted by Admin in on July 29, 2019
 

A letter sent to almost 50,000 patients prescribed lithium inviting them to take part in a bipolar study has raised questions about how Medicare stores and uses private healthcare information.

Shocking cases like this highlight the need for caution when recruiting using data held by a third party.  Even if a strategy is legal, did the potential participants understand their information was being held in an identified form and consent to being contacted about participating in future research projects (even if, as in this case their information won’t be shared)?

UNSW psychiatrist Professor Gordon Parker first became aware of a study investigating the genetics of bipolar when a former patient sent him an angry email accusing him of breaching her privacy.
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“She was furious with me, believing that she was contacted by Medicare because I had blown her confidentiality,” he said.
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But the letter had been sent by the Department of Health Services (DHS) on behalf of a research team at QIMR Berghofer Medical Research Institute inviting recipients to participate in a study exploring potential biomarkers for bipolar disorder.
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Journal Publishes Concern About Study Using Forced Organ Donation – Medscape (Diana Swift | June 2019)0

Posted by Admin in on July 21, 2019
 

The Clinical Journal of the American Society of Nephrology (CJASN) recently issued an “Expression of Concern” regarding a 2008 article on renal allograft recipients written by Chinese researchers.

The Expression of Concern stems from an Australian report published online in February in BMJ Open, which urged the repudiation by English-language journals of more than 445 studies involving 85,477 organ transplants done in China. The reason? Many of the organs used were likely forcibly harvested from Chinese prisoners of conscience, such as practitioners of Falun Gong, Uyghurs, Tibetans, and underground Christians.

“We reached out for clarification of the organ source to the senior authors, but one was deceased and the other had left the institution where the research was done,” said CJASN Editor-in-Chief Rajnish Mehrotra, MD, MBBS, a professor of medicine at the David Geffen School of Medicine at University of California Los Angeles.

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