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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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

Conducting Accessible Research: Including People With Disabilities in Public Health, Epidemiological, and Outcomes Studies (Papers: Dianne Rios, et al | November 2016)0

Posted by Admin in on July 25, 2019
 

Abstract

People with disabilities are largely absent from mainstream health research. Exclusion of people with disabilities may be explicit, attributable to poorly justified exclusion criteria, or implicit, attributable to inaccessible study documents, interventions, or research measures. Meanwhile, people with disabilities experience poorer health, greater incidence of chronic conditions, and higher health care expenditure than people without disabilities. We outline our approach to “accessible research design”—research accessible to and inclusive of people with disabilities. We describe a model that includes 3 tiers: universal design, accommodations, and modifications. Through our work on several large-scale research studies, we provide pragmatic examples of accessible research design. Making efforts to include people with disabilities in public health, epidemiological, and outcomes studies will enhance the interpretability of findings for a significant patient population.

Rios, D., Magasi, S., Novak, C. & Harniss, M. Conducting Accessible Research: Including People With Disabilities in Public Health, Epidemiological, and Outcomes Studies, American Journal of Public Health 106, no. 12 (December 1, 2016): pp. 2137-2144.
https://doi.org/10.2105/AJPH.2016.303448
Publisher: https://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2016.303448

A Russian Biologist Wants To Create More Gene-Edited Babies – NPR (Rob Stein | June 2019)0

Posted by Admin in on July 20, 2019
 

A Russian scientist says he wants to create more genetically modified babies, flouting international objections that such a step would be premature, unethical and irresponsible.

Denis Rebrikov, a molecular biologist who heads a gene-editing lab at the Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology in Moscow, claims he has developed a safe — and therefore acceptable — way to create gene-edited babies.

“How it can be unethical if we will make [a] healthy baby instead of diseased?” Rebrikov told NPR during his first broadcast interview. “Why? Why [is it] unethical?”

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Alarmed by new ‘CRISPR babies’ plan, top science figures say they’re powerless to stop it – STAT (Rick Berke | June 2019)0

Posted by Admin in on July 19, 2019
 

ASPEN, Colo. — Two influential leaders in science for the first time publicly condemned a Russian biologist who said he plans to produce gene-edited babies but conceded that it was beyond their organizations’ authority to halt him from doing so.

In separate interviews with STAT over the weekend, Margaret Hamburg, co-chair of an international advisory committee on human genome-editing, and Victor Dzau, president of the U.S. National Academy of Medicine, said they were deeply concerned by the plans outlined by Russian scientist Denis Rebrikov.

Still, said Hamburg, “I don’t know where we get the teeth to do some of what may ultimately need to be done’’ to respond in such situations.

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