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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Holiday funny – Consent for future research use0

Posted by Admin in on October 31, 2017

Cartoon by Don Mayne

There are very sound reasons why it is prudent to seek consent for future use of blood (or other human biospecimens) and such consent must be sought for any commercial use, but it is important to recognise some potential participants might then refuse to participate because of that future use. One option is to provide a tick box so individuals can consent to the procedure but elect not to consent to the future use.

ScottisH Informatics Programme – SHIP0

Posted by Admin in on June 8, 2017

SHIP is a Scotland-wide research platform for collating, managing, disseminating and analysing Electronic Patient Records (EPRs). Cute but wonderfully clear animation about role of data custodians, indexers, safe havens in managing data ethically. Almost a case study on how to explain complex research well. And, it’s narrated by Brian Cox.

SHIP is an ambitious, Scotland-wide research platform for the collation, management, dissemination and analysis of Electronic Patient Records (EPRs). The programme brings together the Universities of Dundee, Edinburgh, Glasgow and St Andrews with the Information Services Division (ISD) of NHS Scotland.
SHIP is funded by the Wellcome Trust, the Medical Research Council and the Economic and Social Research Council and aims to:

  • Provide access to an exciting new national research facility, firmly embedded within and supported by NHS Scotland, providing the basis for numerous future studies using EPRs.

Read more about SHIP

Traditional and Electronic Informed Consent for Biobanking: A Survey of U.S. Biobanks (Papers: Simon Christian, et al 2014)0

Posted by Admin in on March 5, 2017

Biobanks face unique challenges obtaining consent from biospecimen contributors. Electronic consent (e-consent) presents one option for streamlining the biobank consent process, and improving contributor understanding of consent information. An e-mail survey was conducted to establish the extent of current biobank e-consent and interest in future use of e-consent. A total of 235 biobanks were surveyed and 65 (28%) responded with a fully completed survey. Few of these 65 biobanks (8%) reported using e-consent; however, the majority (75%) were interested in e-consent. Many (48%) biobanks were in discussions with institutional stakeholders about using e-consent in the future. Anticipated benefits of e-consent included improved efficiency and increased enrollment. Perceived barriers to e-consent adoption included lack of funding, issues with human subjects approval, and factors affecting user uptake (e.g., computer literacy). Biobanks using e-consent reported cost, technology issues, and difficulty training staff as barriers to e-consent adoption. Traditional consenting methods (e.g., face-to-face, phone, and mail) continued to be used at biobanks reporting use of e-consent. The survey results suggest strong interest in e-consent among U.S. biobanks, and a need to consider a range of implementation issues, including user preferences and receptivity; institutional and technical support; integration with clinical data networks; electronic signature capture; and what type of e-consent to implement. Biobanks will need evidence-based guidance for purposes of addressing these issues, so that e-consent processes enhance efficiency, as well as contributor receptivity, understanding, and trust.

Simon Christian M, Klein David W, and Schartz Helen A (2014) Biopreservation and Biobanking. December 2014, 12(6): 423-429. doi:10.1089/bio.2014.0045

Update: U.S. abandons controversial consent proposal on using human research samples – Science (Jocelyn Kaiser | January 2017)0

Posted by Admin in on February 16, 2017

Federal officials have dropped a controversial plan to impose new rules that researchers say would have made it much harder to use patient blood and tissue samples in research. The final Common Rule released this morning omits these provisions, but leaves some other changes intact.

Biomedical and university research groups that lobbied against the biospecimens provisions are relieved. “We are very pleased at the amount of time, attention, and effort that went into reviewing the comments. The process worked,” says Lizbet Boroughs, who follows biomedical research policy for the Association of American Universities in Washington, D.C.

The 26-year-old Common Rule protects people who volunteer for federally funded research studies. The Department of Health and Human Services (HHS) and other agencies began an overhaul in 2011 to incorporate changes in how medical research is done, such as a growing number of clinical trials, the use of electronic medical health records, and privacy concerns raised by advances in genomics.

Read the rest of this news story

Other news about the update to the US ‘Common rule’