The Saint James's Hospital Biobank was established in 2008, to develop a high-quality breast tissue BioResource, as a part of the breast cancer clinical care pathway. The aims of this work were: (1) to ascertain the quality of RNA, DNA, and protein in biobanked carcinomas and normal breast tissues, (2) to assess the efficacy of AllPrep(®) (Qiagen) in isolating RNA, DNA, and protein simultaneously, (3) to compare AllPrep with RNEasy(®) and QIAamp(®) (both Qiagen), and (4) to examine the effectiveness of Allprotect(®) (Qiagen), a new tissue stabilization medium in preserving DNA, RNA, and proteins. One hundred eleven frozen samples of carcinoma and normal breast tissue were analyzed. Tumor and normal tissue morphology were confirmed by frozen sections. Tissue type, tissue treatment (Allprotect vs. no Allprotect), extraction kit, and nucleic acid quantification were analyzed by utilizing a 4 factorial design (SPSS PASW 18 Statistics Software(®)). QIAamp (DNA isolation), AllPrep (DNA, RNA, and Protein isolation), and RNeasy (RNA isolation) kits were assessed and compared. Mean DNA yield and A(260/280) values using QIAamp were 33.2 ng/μL and 1.86, respectively, and using AllPrep were 23.2 ng/μL and 1.94. Mean RNA yield and RNA Integrity Number (RIN) values with RNeasy were 73.4 ng/μL and 8.16, respectively, and with AllPrep were 74.8 ng/μL and 7.92. Allprotect-treated tissues produced higher RIN values of borderline significance (P=0.055). No discernible loss of RNA stability was detected after 6 h incubation of stabilized or nonstabilized tissues at room temperature or 4°C or in 9 freeze-thaw cycles. Allprotect requires further detailed evaluation, but we consider AllPrep to be an excellent option for the simultaneous extraction of RNA, DNA, and protein from tumor and normal breast tissues. The essential presampling procedures that maintain the diagnostic integrity of pathology specimens do not appear to compromise the quality of molecular isolates.

No abstract

Background Irish Health Research Regulations (HRRs) were introduced following the commencement of the General Data Protection Regulation (GDPR) in 2018. The HRRs set out supplementary regulatory requirements for research. A legal analysis presented under the auspices of the Irish Academy of Medical Sciences (IAMS) on April 8 and November 25, 2019 at the Royal College of Surgeons in Ireland welcomed the introduction of GDPR and the HRRs. The analysis found the GDPR "explicit consent" introduced by the HRRs is problematic. A call was made to regulate informed consent in line with the common law as an achievable alternative safeguard, bringing Ireland in line with other EU Member States. Aims This article aims to review academic papers, legal opinion, EU opinion and advice and data protection law in relation to research and explicit consent, in order to examine the legal burden of GDPR and the HRRs on health research in Ireland and to determine whether the analysis presented at the IAMS meetings is reflected more widely in legal text. Methods Legal literature review of academic papers, legal opinion, EU opinion and advice and data protection legislation. Results The legal literature review overwhelmingly supports the concerns raised. Conclusions Our results confirm the GDPR explicit consent requirement of the HRRs is having had a significantly negative and far-reaching impact on the conduct of health research in Ireland. Urgent review of the HRRs and meaningful engagement between the health research community and legislators in healthcare is required.

Abstract:In response to the increasing global demand for high quality biospecimens and data for biomedical research, biobanking is rapidly gaining popularity as an efficient and user-friendly platform for translational research. The advent of increasingly sophisticated technologies for specimen and data analysis, in the face of growing economic pressures, are converging to encourage consolidation, centralization, and harmonization of biobanks into networks. Several types of biobank networks exist worldwide. Individuals involved in network establishment and day-to-day function hail from varying disciplines, including health care, academia, information technology, and the pharmaceutical industry. However, they may work together within and between networks to enhance the rapid progression of patient/donor-centered research through standardization of procedures and robust quality management systems. Regularly updated standards, policies, and guidelines are published by large biobanking organizations and made available to biobankers and those interested in biospecimen science. A biobank network's ability to reliably disseminate specimens and data depends on a variety of factors, including a well stocked inventory, a robust information technology platform, and adequate support, including the goodwill of collectors who supply specimens, and of end-users who return experimental data to the network. High quality experimental data may be recycled, thus accelerating biomarker discovery. Access to large amounts of personal data, however, carries risk, and ethical issues surrounding data protection are of paramount importance. All biobank networks require data security measures in keeping with local ethical and legal requirements. Return of results to individual donors is another emerging ethical and administrative challenge for biobank networks as technology steadily increases the overlap between research and patient care. Finally, as the bioresource impact factor concept is further developed, and as more scientific journals require biospecimen and source details in submitted manuscripts, biobank networks will be securely established as an essential platform for biomedical research.

Background Irish Health Research Regulations (HRRs) were introduced following the European Union (EU) General Data Protection Regulation (GDPR) in 2018. The HRRs described specific supplementary regulatory requirements for research regarding governance, processes and procedure that impact on several facets of research. The numerous problems that the HRRs and particularly "explicit consent" inadvertently created were presented under the auspices of the Irish Academy of Medical Sciences (IAMS) on November 25, 2019, at the Royal College of Surgeons in Ireland. Aims The objective of this review was to obtain feedback and to examine the impact of GDPR and the HRRs on health research in Ireland in order to determine whether the preliminary feedback, presented at the IAMS meetings, was reflected at a national level. Methods Individuals from the research community were invited to provide feedback on the impact, if any, of the HRRs on health research. Retrospective patient recruitment and consent outside a hospital setting for a multi-institutional Breast Predict study (funded by the Irish Cancer Society) were also analysed. Results Feedback replicated the issues presented at the IAMS with additional concerns identified. Only 20% of the original target population (n = 1987) could be included in the Breast Predict study. Conclusions Our results confirm that the HRRs have had a significantly negative impact on health research in Ireland. Urgent meaningful engagement between patient advocate groups, the research community and legislators would help ameliorate these impacts.